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AIDSTAR-One | CASE STUDY SERIES                                                                                                                                April 2011

HIV Treatment Guidelines
in Guyana
The Fast Track to Diagnosis and Treatment



                                                                      I
                                                                        n 2002, the World Health Organization (WHO) first published
                                                                        guidelines for a public health approach to scaling up
                                                                        antiretroviral therapy (ART) in resource-limited settings. These
                                                                      guidelines were simplified in 2003 and revised in 2006. In October
                                        Photo courtesy of JSI staff




                                                                      2009, WHO led a multidisciplinary committee of HIV treatment
                                                                      experts to further revise the guidelines. Their recommendations
                                                                      were packaged as Rapid Advice: Antiretroviral Therapy for HIV
                                                                      Infection in Adults and Adolescents and were disseminated in late
                                                                      November 2009 (WHO 2009).
National AIDS Programme
Secretariat, Georgetown, Guyana,
April 2010.                                                           The key messages that emerged from these recommendations are
                                                                      earlier initiation of ART, the use of less toxic treatment regimens,
                                                                      and an expanded role for laboratory monitoring, including both CD4
                                                                      testing and viral load (VL) monitoring (WHO 2010). Table 1 lists eight
                                                                      key Rapid Advice recommendations. The full revised guidelines,
                                                                      Antiretroviral Therapy for HIV Infection in Adults and Adolescents:
                                                                      Recommendations for a Public Health Approach, were released in July
                                                                      2010 (WHO 2010).

                                                                      The WHO committee of experts that developed the recommendations
                                                                      agreed on a set of guiding principles for countries developing
                                                                      or revising their national HIV treatment guidelines. Principal
                                                                      consideration was given to the need for public health interventions
                                                                      that “secure the greatest likelihood of survival and quality of life for
By Victoria Rossi and                                                 the greatest numbers of people living with HIV” (WHO 2009, 4). The
Bisola Ojikutu                                                        guidelines also specify that “the individual rights of people living


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TABLE 1. WHO RAPID ADVICE KEY RECOMMENDATIONS (WHO 2009)
1.    Start ART in all patients with HIV who have a CD4 count of less than 350 cells/mm3, irrespective of clinical symptoms.
2.    •	 Start one of the following regimens in ART-naïve individuals eligible for treatment.
      •	 Zidovudine (AZT) + lamivudine (3TC) + efavirenz (EFV)
      •	 AZT + 3TC + nevirapine (NVP)
      •	 Tenofovir (TDF) + 3TC or emtricitabine (FTC) + EFV
      •	 TDF + 3TC or FTC + NVP
3.    Start ART in all individuals living with HIV with active tuberculosis, irrespective of CD4 cell count.
4.    Start ART in all individuals living with both HIV and hepatitis B virus (HBV) who require treatment for their HBV infection,
      irrespective of CD4 cell count or WHO clinical stage.
5.    Start ART in all pregnant women with HIV and a CD4 count of less than 350 cells/mm3, irrespective of clinical symptoms.
6.    Where available, use VL to confirm treatment failure.
      •	 Where routinely available, use VL every six months to detect viral replication.
      •	 A persistent VL above 5,000 copies/mL confirms treatment failure.
      •	 When VL is not available, use immunological criteria to confirm clinical failure.
7.    A boosted protease inhibitor (PI/r) plus two nucleoside analogues are recommended for second-line ART.
      •	 For second-line ART, atazanavir/ritonavir (ATV/r) and lopinavir/ritonavir (LPV/r) are preferred.
8.    National programs should develop policies for third-line therapy that consider funding, sustainability, and equitable access to
      ART.




with HIV should not be forfeited in the course of                          providing continued, life-long access to ART for
a public health approach” (WHO 2009, 4). The                               those in need.
four guiding principles for countries revising their
treatment guidelines are as follows:                                    Many countries plan to revise their national
                                                                        guidelines to reflect the recent WHO
•	 Do no harm: When introducing changes,                                recommendations. Côte d’Ivoire, Malawi, Nigeria,
   preserve access for the sickest and most in need.                    Tanzania, and Zambia have undertaken feasibility
•	 Ensure access and equity: All clinically eligible                    studies, including cost analyses, to assess
   people should be able to enter treatment services                    the impact of adopting such recommendations
   (including ART) with fair and equitable distribution                 (PlusNews 2010). These studies have
   of treatment services.                                               demonstrated that many countries face significant
                                                                        challenges as they move to incorporate the
•	 Promote quality and efficiency: Ensure delivery
                                                                        recommendations into their national treatment
   of the highest standards of care within a public
                                                                        protocols, including ensuring the availability of
   health approach so as to achieve the greatest
                                                                        resources to support increased patient loads,
   health impact with the optimal use of available
                                                                        improving supply chain management capacity,
   human and financial resources.
                                                                        ensuring sufficient human resources, and building
•	 Ensure sustainability: Understand the long-                          in-country consensus around protocol changes.
   term consequences of change with the vision of




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Since 2006, the National AIDS Programme in                 HIV and AIDS, Government of Guyana 2009). By
Guyana has been implementing WHO’s 2010                    mid-2001, despite a flourishing epidemic, there was
recommendations of a CD4 threshold of 350                  still no public access to ART in Guyana because of
cells/mm3 for initiation of ART and a TDF-based            the prohibitive cost of antiretrovirals (ARVs) in the
first-line treatment regimen. Strong political             global market.
will and leadership from the government,
collaborative partnerships between local and               In 2001, Cipla Ltd., the generic pharmaceutical
international agencies, low patient loads,                 manufacturer, began marketing a generic fixed-
effective supply chain management, and resource            dose combination (FDC) of stavudine (d4T)/3TC/
availability are key factors contributing to               NVP to Guyana. After negotiating with Cipla in
Guyana’s successful implementation of WHO’s                2001, the MOH was able to secure significant price
new recommendations.                                       reductions in the cost of first-line ART to U.S.$250
                                                           per patient per year. Additionally, both Cipla and
                                                           Ranbaxy, another leading generic pharmaceutical
The Response to HIV                                        company, offered technical assistance to build
                                                           the capacity of a local pharmaceutical company,
in Guyana                                                  Georgetown Pharmaceutical Corporation (GPC),
                                                           to manufacture ARVs in-country. Through these
Guyana is a small, English-speaking Caribbean              capacity-building efforts, by the end of 2001,
country located on the northeast coast of South            GPC was able to produce first-line FDCs at a
America, with a population of 748,486 (Central             price of U.S.$140 per patient per year, allowing
Intelligence Agency 2009). According to 2008               the government to announce its support of HIV
national HIV estimates, HIV prevalence in Guyana           treatment through the public health care system. In
is 1.9 percent and the country’s estimated                 December 2001, the distribution of first-line therapy
population of adults living with HIV (over 15 years        began free of charge at the national sexually
of age) is 16,900, disaggregated into 8,900 males          transmitted infection referral center, then called
and 8,000 females (Presidential Commission on              the Genitourinary Medicine Clinic, in Georgetown,
HIV and AIDS, Government of Guyana 2009). The              Guyana’s capital.
first case of AIDS in Guyana arose in 1987 within
the men who have sex with men community. Since             With additional support from the U.S. President’s
then, the number of reported cases has increased           Emergency Fund for AIDS Relief (PEPFAR) and
steadily, and the epidemic is considered to be             the Global Fund for AIDS, Tuberculosis and Malaria
generalized (Presidential Commission on HIV and            (GFATM), treatment services expanded to 16 sites
AIDS, Government of Guyana 2009).                          by 2008. Second-line treatment was made available
                                                           free of charge through the public system in 2006.
In response to the burgeoning HIV epidemic, the            Local capacity for CD4 testing was established
Government of Guyana established the National              in 2003 and VL capacity in 2010 (Presidential
AIDS Programme (NAP) under the Ministry of                 Commission on HIV and AIDS, Government
Health (MOH) in 1989. In 1992, the National AIDS           of Guyana 2009). Currently, ART services are
Programme Secretariat (NAPS) was formed and                available in all regions, and all medical care offered
charged with coordination of the national response         by the public system, including HIV care and
to the HIV epidemic (Presidential Commission on            treatment, is free of charge.



                                             HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment   3
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By the end of 2009, a total of 2,832 persons were                                  protocols. In 2003, WHO guidelines recommended
actively receiving ART through the NAP. Of those                                   a minimum CD4 cell count initiation threshold of
persons receiving treatment in 2009, 178 were                                      200 cells/mm3, irrespective of clinical disease stage,
children. Females made up 55.6 percent of all                                      while guidelines in the United States and Europe
persons on treatment in 2009. In 2008, patients on                                 were changing to reflect earlier ART initiation, up
second-line treatment accounted for 6.8 percent                                    to CD4 cell counts of 350 cells/mm3. The Minister
of all persons on treatment. At 12 months, average                                 of Health, the Honorable Dr. Leslie Ramsammy,
survival on treatment was 72 percent (Presidential                                 aware of the treatment protocols being followed
Commission on HIV and AIDS, Government of                                          in the United States and Europe, has strongly
Guyana 2009).                                                                      advocated for guidelines aligned with the treatment
                                                                                   protocols in resource-rich settings because he does
                                                                                   not believe in setting a different standard for the
2004 and 2006 Guideline                                                            developing world.

Revision Processes                                                                      I believe that the restrictive protocol of
                                                                                        using CD4 cut-offs for eligibility for ARV
Developing initial HIV treatment                                                        treatment is a backward protocol and an
guidelines: Following the Government of                                                 immoral one and we should pursue earlier
Guyana’s announcement at the end of 2001 that                                           treatment with ARVs. It is still my wish
there would be universal access to HIV treatment,                                       to place persons who are HIV-positive
practitioners received a two-page brief that offered                                    on ARV treatment as early as possible…
very limited guidance on prescribing. By 2003,                                          Treating people even though we don’t
Guyana had developed the capacity to conduct                                            know their CD4 is better than them dying.
in-country CD4 testing, which prompted robust                                              –The Honorable Dr. Leslie Ramsammy,
discussion among stakeholders about clinical                                                          Minister of Health, Guyana

                                                                                   The Minister argues that, as with other diseases,
                                                                                   clinicians should be given the discretion to manage
                                                                                   their patients based on their best clinical judgment.
                                                                                   He believes “HIV diagnosis [is] good enough” to
                                                                                   start treatment and “they [health care providers]
                                                                                   should not wait for somebody to get sick” before
                                                                                   providing treatment. He wants patients to get
                                                                                   early treatment to maintain their health, but also
                                                                                   because he views widespread early treatment
                                                     Photo courtesy of JSI staff




                                                                                   as an important component of an effective HIV
                                                                                   prevention strategy.

                                                                                   After negotiations within the Government of Guyana
                                                                                   and with other international organizations, the
National Care and Treatment Centre, Georgetown,                                    MOH launched the treatment access program
Guyana, April 2010.                                                                with an initiation threshold of 200 cells/mm3, but



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emphasized that the national program would be              United States through in-person meetings,
working toward a threshold of 350 cells/mm3.               conference calls, and emails. When the draft
Formal guidelines recommending a CD4 initiation            guidelines were complete, WHO and the Joint
threshold of 200 cells/mm3 and a first-line regimen        U.N. Programme on HIV/AIDS also reviewed the
of d4T/3TC/NVP were finalized and disseminated             document and provided comments. FXB-USA and
in 2004. As the NAP expanded, the Minister                 IHV, both implementing partners under PEPFAR,
mandated and approved membership of a Technical            conducted a full external review of the guidelines
Working Group (TWG) for HIV Care and Treatment             prior to their finalization.
to be chaired by NAPS with participation from key
technical partners. The TWG was to serve as an             Both global scientific research and local
advisory board to NAPS and meet on a quarterly             anecdotal evidence were considered by the
basis to discuss emerging issues facing the NAP,           guideline revision committee during their
with the goal of strengthening Guyana’s national           discussions, a process detailed later in this case
HIV response.                                              study (see “Evidence Considered”). Following
                                                           technical approval of the 2006 revised guidelines,
Developing the 2006 HIV treatment                          some time passed before they were officially
guidelines revision: Supported by local                    endorsed as policy and disseminated by the
clinicians and key international partners, when            government. Meanwhile, to foster adoption of
the WHO released its revised 2006 guidelines               the revised guidelines as quickly as possible,
advocating more strongly for a CD4 initiation              NAPS “piggybacked” on already planned national
threshold of 350 cells/mm3, the Minister of Health         and regional training efforts, such as those
mandated a revision of Guyana’s national HIV               on prevention of mother-to-child transmission,
treatment guidelines. The TWG identified additional        by adding brief, informal training on the new
technical experts to join the group and invited            treatment guidelines to the agenda.
them to become members of the guideline revision
committee. The committee was composed of: staff            Implementation and roll-out: Once the
from various departments of the MOH, including             revised guidelines were formally endorsed and
NAPS, disease control, maternal and child health,          disseminated, NAPS conducted official training
and tuberculosis; local public and private sector          led by MOH staff and partners, which was rolled
clinicians; and partners including the François-           out nationally to all 360 health facilities. They
Xavier Bagnoud Center (FXB)-USA and FXB-                   employed a combination of training approaches
Guyana (University of Medicine and Dentistry of
New Jersey), the Canadian Society for International
Health, the Centers for Disease Control and                      To foster adoption of the
Prevention (CDC), the AIDS Relief Consortium
                                                                 revised guidelines as
(Institute for Human Virology [IHV], University
of Maryland), Dartmouth Medical School, and                      quickly as possible, NAPS
the Guyana HIV/AIDS Reduction and Prevention                     “piggybacked” on already
Program (MOH 2006).                                              planned national and regional
Technical consultations funded by international                  training efforts.
partners were conducted with experts in the



                                             HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment   5
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depending on the circumstances, so that some              Initiation thresholds for antiretroviral
training sessions for health workers from different       therapy: Clinicians from the National Care
regions took place in Georgetown, while others            and Treatment Centre (NCTC), the center of
were conducted in the regions with support from           excellence for management of HIV and sexually
the regional health offices. Implementers and             transmitted infections in Guyana, were members
health workers from the field were invited to the         of the guideline revision committee. They, along
quarterly TWG meetings on an ongoing basis                with other private and public sector clinicians,
and were asked to give feedback on the progress           were concerned about how sick and weak
and challenges facing implementation of the new           their patients were by the time their CD4 count
guidelines. The MOH maintained and cultivated             reached 200 cells/mm3. They completed informal
the TWG as a forum for troubleshooting.                   assessments via patient chart reviews in which
                                                          patient CD4 levels were plotted against their
The newly revised 2006 guidelines were                    health outcomes, beginning at ART initiation
disseminated to all ART sites in different formats.       and continuing over time, to show the change
NAPS made packages for distribution at the TWG            in CD4 levels and how those changes affected
meetings, sent packages to regional health offices        overall health. From these informal assessments
with instructions to distribute the guideline materials   and their clinical observations, they reported
throughout the region, and distributed packages at        increased morbidity, opportunistic infections, and
quarterly immunization meetings. NAPS followed            longer recuperation periods in those patients who
up with each of the ART sites through the regional        started treatment when their CD4 count was at or
health offices to ensure they had received and were       below 200 cells/mm3.
implementing the new guidelines.
                                                          Citing the findings of their informal assessments
Additionally, the new guidelines were announced           and clinical observation, these local clinicians
at the Minister’s News Conference, a regularly            began advocating strongly for earlier initiation of
scheduled meeting between the media and the               ART. There were varying views within the revision
Minister of Health, which was covered by both print       committee about the sustainability of increasing
and television news outlets. The total timeframe          the initiation threshold to 350 cells/mm3, with some
for the 2006 revision process was approximately           members advocating for maintaining 200 cells/
one year, beginning with the Minister’s mandate           mm3 and others supporting a more tempered
to update the guidelines to the government’s              increase to 300 cells/mm3. PEPFAR-supported
endorsement of the final revised guidelines.              local treatment partners FXB and IHV were
However, it took an additional year before all            especially supportive of revising the guidelines
of the health workers were trained and actively           to initiate patients at less than 350 cells/mm3,
implementing the guidelines.                              based on cohort data in the United States and
                                                          Europe showing improved clinical outcomes with
                                                          earlier ART initiation. Both organizations provided
Evidence Considered                                       remote technical assistance from the United States
                                                          through a combination of in-person meetings,
The guideline revision committee considered both          conference calls, and emails.
global scientific research and local anecdotal
evidence as they deliberated on the updates to            Tenofovir-based first-line regimen: The
make. The evidence they considered regarding              local clinicians on the TWG also provided anecdotal
each of the key 2006 revisions is summarized next.        evidence of d4T-related neuropathy and lipodystrophy

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and advocated for a more patient-friendly first-line            enabled the implementation of the 2006 revised
regimen. There was extensive debate about which                 guidelines.
nucleoside reverse transcriptase inhibitors (NRTIs)
to use. Data supporting the superiority of TDF-FTC              Supply chain management: With the advent
NRTI backbones in virologic suppression and CD4                 of the SCMS Project in Guyana in 2006, the supply
response were released in 2006 (Gallant et al. 2006).           chain in Guyana was significantly strengthened,
In addition, fewer side effects, such as nausea and             enabling it to effectively support the national HIV
anemia, were noted with TDF than with regimens                  program. A satellite MOH Materials Management
including AZT. In the face of mounting concerns about           Unit Farm Annex Warehouse was established
including d4T in the first-line regimen, the revision           to provide suitable storage conditions for ARVs
committee agreed to alter the first-line regimen.               procured by major HIV donors, including PEPFAR
                                                                and GFATM. A fleet of two trucks delivered ARVs
To help determine which drugs should be included                directly to 13 of the 15 fixed ART sites, with the two
in the first line, NAPS asked the PEPFAR-supported              main private sector sites managing their own pick-up
Supply Chain Management System (SCMS) Project                   (SCMS Project-Guyana 2008).
in Guyana to complete a cost analysis comparing
the old d4T-based first-line regimen to regimens                SCMS-Guyana supported NAPS to complete a
containing TDF. SCMS-Guyana studied actual                      forecasting and quantification of ARV requirements
invoices, made assumptions about annual ART                     according to the new treatment guidelines using
patient targets, and used the new treatment initiation          the software package Quantimed, which was the
threshold of 350 cells/mm3 to determine the cost                standard quantification tool for the country. Using
of first-line therapy, including branded TDF/FTC.               Quantimed, CDC-Guyana and NAPS worked with
Although the TDF/FTC-based regimen proved                       SCMS-Guyana to forecast and quantify CD4 testing
more costly, the MOH believed that this regimen                 supplies to support earlier initiation of ART through
was superior to the other options considered. After             routine CD4 testing. Finally, NAPS used the ARV
exhaustive discussion, the revision committee came              and laboratory forecasts in the software package
to a consensus that a TDF-based first-line regimen              PipeLine to develop a procurement and supply plan
was the best option for patients and would be                   to help manage the supply chain of ARVs according
cost-effective in the long-term. While cost was an              to the new treatment guidelines.
important factor in all of the discussions, the efficacy
                                                                Registration and importation of the new ARVs
and quality of the treatment regimen were the
                                                                were significantly expedited by the fact that
priorities. All new patients initiating ART began TDF/
                                                                in 2001 the government established a policy
FTC in combination with a non-NRTI, specifically
                                                                allowing the Food and Drug Department (FDD)
NVP or EFV. Guidance for the management
                                                                to issue registration waivers for new ARVs upon
of existing patients on d4T-based therapy
                                                                request from the MOH’s Chief Medical Officer. A
recommended an immediate switch to a TDF-based
                                                                registration waiver was requested by the Chief
regimen in the absence of contraindications.
                                                                Medical Officer for the new ARVs and promptly
                                                                issued by FDD, allowing for importation of ARVs
Factors Supporting                                              recommended by the new guidelines.

Successful Implementation                                       Resources available: In 2006, Guyana’s
                                                                NAP was in the enviable and relatively unique
Important supply chain management factors in                    position of having multiple donors supporting the
Guyana along with financial resource availability               MOH in covering the costs of all its public sector

                                                  HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment   7
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HIV services. Guyana was receiving substantially          sick because they sought services sooner and
greater money per patient than any other PEPFAR-          treatment was initiated earlier. Decentralization of
supported country at that time. GFATM was                 services to primary health centers further fostered
providing funds for procurement of ARVs to cover all      access to treatment, with the potential to lessen the
first-line adult patients, post-exposure prophylaxis,     stigma around HIV infection.
and prevention of mother-to-child HIV transmission.
PEPFAR procured ARVs for all adult second-line and        The Minister of Health believes that the sense of
pediatric patients through the end of 2006, at which      hopelessness in Guyana prior to universal treatment
point the Clinton Health Access Initiative (CHAI) took    access lifted as patients initiated ART earlier and
over coverage for all pediatric patients. Since 2007,     were able to live healthier, longer lives. He feels this,
GFATM has provided all first-line ARVs. Currently,        in turn, gave confidence to health workers because
PEPFAR covers second-line ARVs and CHAI                   they were better able to serve their patients, and thus
provides pediatric treatment. However, CHAI funding       improved overall morale at the health centers.
will be entirely phased out by 2011. Fortunately,
Guyana has recently secured a Rolling Continuation        No formal study of the clinical outcomes of the
Channel under GFATM Round 9, which secures                2006 guideline revision or Guyana’s national HIV
funding for all first-line and pediatric treatment from   program in general has been completed to date.
2010 through 2015. Given this funding landscape,          However, NAPS has plans to conduct an outcomes
the availability of resources to support more patient-    study in collaboration with CDC-Guyana in the
friendly regimens and earlier initiation of ART was       near future and is currently developing a database
not a major concern of the 2006 revision committee.       to analyze cohort data to determine clinical
                                                          outcomes. An HIV drug resistance study is also
                                                          planned to begin in early 2011.
Results
Following implementation of the 2006 revised              What Worked Well
guidelines, all patients had access to ART once
they entered the national program and were                The key factors that contributed to the successful
deemed eligible for treatment. With strong donor          revision of Guyana’s treatment guidelines
and ministry support, funding for HIV treatment was       included strong political will and leadership
able to match scale-up plans, so an ART waiting           from the government, collaborative partnerships
list never developed. Anecdotal reports from local        between local and international agencies, and low
clinicians showed that patients were generally less       patient loads.

                                                          The importance of political will: Dating
                                                          back to the early days of the emergence of
     Anecdotal reports from local
                                                          HIV in Guyana, there was very strong political
     clinicians showed that patients                      commitment from the government to the fight
     were generally less sick                             against the epidemic. Ministry officials, including
     because they sought services                         the Minister of Health, remained aware of the
                                                          latest global research around HIV treatment, care,
     sooner and treatment was                             and support, and the public health community
     initiated earlier.                                   in Guyana remained receptive to changes and
                                                          advances in the field.

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Strong global partnerships: Guyana’s HIV                       Patient concerns about switching
program has also benefited enormously from a                   regimens: Initial reports from implementers
strong, collaborative partnership between local                and health workers revealed that patients were
and international agencies. The Pan American                   concerned about moving from the simple dosing of
Health Organization, WHO, the U.N. Children’s                  one pill with the d4T-based FDCs in the old regimen
Fund, and U.S. Government partners have been                   to the more complicated dosing of two different
important allies that worked closely with the MOH              pills in the new TDF-based regimens. The TWG
to understand and support its goals. Although there            discussed the issue with the implementers and, while
were varying opinions on technical issues at certain           a multidisciplinary approach to treatment counseling
points throughout the revision process, the revision           is the norm, everyone agreed to focus on the role of
committee generally agreed that long-term cost                 the social workers at the health centers to assuage
effectiveness and a higher quality of patient care             patient fears. Social workers were mentored by
were the proper direction for the NAP.                         MOH staff and encouraged to work very closely
                                                               with ART patients to increase their understanding of
Consistent leadership from the MOH:                            the benefits of the new regimen and the reasoning
Different international partners bring different               behind the switch. Patients were told that the new
perspectives to the development of guidelines;                 drugs reduced their risk of treatment failure and
therefore, molding the guidelines into a uniquely              adverse side effects and therefore increased the
Guyanese approach required strong national                     quality of care they received.
leadership. The Minister of Health provided that
leadership at all stages of the development of the             Fostering patient adherence to new
national guidelines, resulting in a strategy that              guidelines: Patient adherence to treatment was
provides highly effective treatment for all eligible           an ongoing challenge faced by the NAP that was
patients living with HIV.                                      exacerbated by the new treatment guidelines.
                                                               The NCTC, located in Georgetown, developed
The availability of funding to cover                           a Group Discussion Program to address this
national treatment needs: Low patient load                     challenge. Before a patient was initiated on
and funding availability in Guyana undoubtedly                 treatment at the NCTC, he or she was required
facilitated consensus around the 2006 guideline                to attend three compulsory treatment-related
revisions. Although concerns about longer term                 counseling sessions. The patient was asked to
funding were discussed by the revision committee,              select and bring a “support buddy” to at least
the extent of these concerns was less than it would            one of the three counseling sessions. Once a
have been in the African treatment context of limited          patient successfully attended the three counseling
funding for hundreds of thousands of patients.                 sessions and selected a support buddy, he or she
                                                               began ART and was asked to attend the focus
                                                               group discussions, which were held biweekly at
Challenges                                                     the NCTC. The focus groups consisted of five
                                                               members of the NCTC staff, including a doctor,
The key challenges that Guyana faced during                    pharmacist, nurse, social worker, and home-based
the 2006 guideline revision process were patient               care person, and all of the ART patients with their
understanding, adherence, human resource                       support buddies. The objective of the focus group
shortages, and supply chain management                         discussions was for adherent HIV patients to
constraints related to the timing for dissemination of         talk about their successes and for non-adherent
the new guidelines.                                            patients to share their struggles. The NCTC has

                                                 HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment   9
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continued implementing this program and has             Georgetown with the support of the Ministries of
made a formal recommendation to NAPS that               Health and of Amerindian Affairs.
the program be rolled out to ART sites nationally.
Many clinics have begun implementing similar            Anticipating supply chain difficulties:
support activities but with variations based on         When the 2006 revised guidelines were formally
clinic size and staffing levels.                        endorsed and disseminated to health facilities,
                                                        the MOH had a national overstock of ARVs for the
Dealing with personnel shortages: An                    old, d4T-based first-line therapy. They were not
additional challenge for the NAP was a shortage of      comfortable allowing all the old ARVs to expire, so
human resources to manage the increased patient         they were forced to delay distribution of the ARVs
load. Early in the epidemic’s history, Guyana worked    for the new TDF/FTC-based first-line therapy until
to prevent the establishment of a parallel HIV          more of the old ARVs had been consumed. This
service delivery system and leverage existing human     resulted in some confusion among health workers
resources by integrating HIV services into the public   who had been trained to use the new guidelines
health infrastructure. Task-shifting ART away from      because the corresponding ARVs were not
the physicians to lower cadres of health care workers   available to them at the health facilities. To address
was also considered as a potential solution to the      this challenge, ongoing updates were provided to
human resource challenge, especially in the remote      the clinicians at the treatment sites regarding stock-
hinterland areas. The NAPS decided to recruit 11        on-hand of the old ARVs and ordering new ARVS.
doctors from the U.N. Volunteer Program to provide
additional support to the ART sites. While keeping
ART initiation under the purview of physicians,         Recommendations
NAPS did undertake some measures to better
distribute the workload of clinicians and nurses who    National health leaders must build
were managing the country’s HIV patients. NAPS          consensus: The success of Guyana’s 2006
introduced a new position, the lay counselor, to        guideline revision was due in large part to strong
provide HIV counseling in the larger clinics and thus   leadership from the MOH and collaborative
alleviate the bottleneck presented by long lines of     partnership with both local and international
patients waiting for counseling sessions with nurses.   agencies. A country’s MOH must work to build
                                                        consensus among the various players while at the
Reaching remote communities: While HIV                  same time clearly articulating its vision and guiding
prevalence in remote areas of Guyana is relatively      the revision committee to develop guidelines that will
low, there was some concern that mining and logging     most effectively achieve their vision.
activities, coupled with limited access to treatment
facilities, could worsen the epidemic among those       Keep the committee small and flexible:
communities. As a result, NAPS has begun to             Countries should closely review the latest
provide HIV services through mobile ART clinics         HIV research with a small group of technically
visiting remote areas quarterly. Mobile clinicians      competent stakeholders who are open to new ideas
initiate patients on ART according to the new           and approaches. A smaller revision committee
initiation criteria, and local medics monitor them on   will keep the process focused and efficient. Once
an ongoing basis. The mobile clinicians remain on       consensus has been reached within the revision
call by radio and telephone communication to advise     committee and the updated guidelines have been
the local medics as needed. If an emergency arises,     drafted, the guidelines can then be circulated for
arrangements are made for the patient to travel to      comments to a larger group of stakeholders. To

10	AIDSTAR-One | April 2011
AIDSTAR-One | CASE STUDY SERIES



  LESSONS LEARNED FROM GUIDELINE REVISION PROCESS IN GUYANA

  •	 Ensure top MOH policymakers remain abreast of HIV global research, WHO recommendations, and emerging
     local evidence so that ongoing revisions are made to the national HIV treatment guidelines as appropriate.
  •	 Issue a mandate from the MOH to revise national HIV treatment guidelines when deemed necessary.
  •	 Establish a small, technically competent guideline revision committee, led by the MOH, which has clear terms of
     reference through which consensus can be achieved.
  •	 Garner financial and technical support from strong local and international partners and arrange for an external third
     party review of the draft revised guidelines.
  •	 Assess supply chain management implications of guideline revisions including drug forecasting and quantification,
     procurement, storage and distribution, importation requirements, etc.
  •	 Assess resource availability to support guideline revisions including robust cost analyses.
  •	 Consider the impact of guideline revisions on patient loads and implement locally appropriate human resource
     interventions including rollout of lay counselors, phlebotomists, and/or task-shifting.
  •	 Review ARV supply and procurement plans before rolling out revised guidelines so that drugs from a previous
     protocol are consumed before the guidelines are fully rolled out.
  •	 Officially endorse the revised guidelines as policy by having MOH leadership hold a public press conference
     announcing them.
  •	 Collaborate with the local health offices to train health care workers nationally and distribute hard copies of the
     revised guidelines.
  •	 Establish a feedback mechanism, such as quarterly implementer meetings, for local health officers and health
     care workers to relay any challenges with implementation of the revised guidelines back to the central level so that
     appropriate interventions can be developed.


successfully adapt WHO recommendations to the
local context of a specific country so that quality
                                                                  Future Plans
and sustainability of HIV treatment are effectively               Recently, Guyana has gone through another process
balanced, members of the revision committee will                  of revising its national HIV treatment guidelines.
need to be open, flexible, and free-thinking.                     In 2009, the Minister of Health convened a similar
                                                                  revision committee to plan for the addition of VL
Plan around current ARV supply: It is                             monitoring, potential initiation of ART for all patients
recommended that countries look carefully at their                diagnosed with HIV irrespective of CD4 level,
ARV supply and procurement plans before rolling                   revision of the pediatric ART regimens to include
out new guidelines. Ongoing updates should be                     abacavir (ABC) in first-line therapy, and further
provided to the clinicians at the treatment sites                 guidance on ART initiation in tuberculosis/HIV co-
regarding stock-on-hand of old ARVs and ordering                  infection. Currently, the 2009 guidelines remain in
new ARVS. Timing of the roll-out should be                        draft form and are being reviewed by various local
managed so that drugs from a previous protocol are                and international partners. In addition, an in-depth
consumed before the revised guidelines are fully                  costing of the new guidelines is underway to explore
rolled out. Proper timing will foster rapid uptake of             the resource implications for different guideline
the new guidelines by ensuring that health workers                scenarios. Following incorporation of the comments
and patients receive clear messages and immediate                 resulting from these reviews, the MOH plans to
distribution of the new ARVs is possible.                         officially endorse and disseminate the revised

                                                   HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment   11
AIDSTAR-One | CASE STUDY SERIES


guidelines through a process similar to the one used         WHO. 2010. Antiretroviral Therapy for HIV Infection in
for rollout of the 2006 guidelines. n                        Adults and Adolescents. Recommendations for a Public
                                                             Health Approach (2010 Version). Available at www.who.int/
                                                             hiv/pub/arv/adult2010/en/index.html (accessed July 2010)
REFERENCES
Central Intelligence Agency. 2009. The World Factbook        ACKNOWLEDGMENTS
2009. Washington, D.C.: Central Intelligence Agency.

Gallant, J. E., E. DeJesus, J. R. Arribas, et al. 2006.      AIDSTAR-One would like to thank the following partners
Tenofovir DF, Emtricitabine, and Efavirenz vs. Zidovudine,   for providing input and guidance in the development
Lamivudine, and Efavirenz for HIV. New England Journal       of this case study: the Ministry of Health, Guyana and
of Medicine 354(3):251–260.                                  several of its programs and departments, including the
                                                             National AIDS Programme Secretariat, the National
Ministry of Health (MOH), Guyana. 2006. National             Care and Treatment Centre, the National Tuberculosis
Guidelines for Management of HIV-Infected and HIV-           Programme, and the Maternal and Child Health
Exposed Adults and Children. August 2006 revision.           Department; the Food and Drug Department, Guyana;
Georgetown, Guyana: Ministry of Health.                      U.S. Agency for International Development (USAID)/
                                                             Washington and USAID/Guyana; the Supply Chain
PlusNews, “Malawi: Malawi Moves to Adopt WHO                 Management Systems Project and Management Sciences
Guidelines,” Integrated Regional Information Networks        for Health; Centers for Disease Control and Prevention-
(IRIN), May 27, 2010. Available at www.irinnews.org/         Guyana, Global AIDS Program; and François-Xavier
report.aspx?Reportid=89266 (accessed June 2010)              Bagnoud Center (FXB)-Guyana and FXB-USA, University
                                                             of Medicine and Dentistry of New Jersey. We would also
Presidential Commission on HIV and AIDS, Government of       like to thank the following members of the AIDSTAR-
Guyana. 2009. UNGASS Country Progress Report: Republic       One Treatment Technical Working Group: Robert Ferris
of Guyana. Reporting Period: January 2008 - December         (USAID) and Tom Minior (USAID).
2009. Georgetown, Guyana: Government of Guyana.

Supply Chain Management Systems (SCMS) Project-
Guyana. 2008. Supply Chain Management Systems                RECOMMENDED CITATION
Guyana – Its Evolution & Current. Georgetown, Guyana:
SCMS Project.                                                Rossi, Victoria, and Bisola Ojikutu. 2011. HIV Treatment
                                                             Guidelines in Guyana: The Fast Track to Diagnosis and
WHO. 2009. Rapid Advice: Antiretroviral Therapy for HIV      Treatment. Case Study Series. Arlington, VA: USAID’s
Infection in Adolescents and Adults. Available at www.who.   AIDS Support and Technical Assistance Resources,
int/hiv/pub/arv/advice/en/index.html (accessed March 2010)   AIDSTAR-One, Task Order 1.




  AIDSTAR-One’s Case Studies provide insight into innovative HIV programs and approaches
  around the world. These engaging case studies are designed for HIV program planners and
  implementers, documenting the steps from idea to intervention and from research to practice.

  Please sign up at www.AIDSTAR-One.com to receive notification of HIV-related resources,
  including additional case studies focused on emerging issues in HIV prevention, treatment,
  testing and counseling, care and support, gender integration and more.

12	AIDSTAR-One | April 2011

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AIDSTAR-One HIV Treatment Guidelines in Guyana - The Fast Track to Diagnosis and Treatment

  • 1. AIDSTAR-One | CASE STUDY SERIES April 2011 HIV Treatment Guidelines in Guyana The Fast Track to Diagnosis and Treatment I n 2002, the World Health Organization (WHO) first published guidelines for a public health approach to scaling up antiretroviral therapy (ART) in resource-limited settings. These guidelines were simplified in 2003 and revised in 2006. In October Photo courtesy of JSI staff 2009, WHO led a multidisciplinary committee of HIV treatment experts to further revise the guidelines. Their recommendations were packaged as Rapid Advice: Antiretroviral Therapy for HIV Infection in Adults and Adolescents and were disseminated in late November 2009 (WHO 2009). National AIDS Programme Secretariat, Georgetown, Guyana, April 2010. The key messages that emerged from these recommendations are earlier initiation of ART, the use of less toxic treatment regimens, and an expanded role for laboratory monitoring, including both CD4 testing and viral load (VL) monitoring (WHO 2010). Table 1 lists eight key Rapid Advice recommendations. The full revised guidelines, Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach, were released in July 2010 (WHO 2010). The WHO committee of experts that developed the recommendations agreed on a set of guiding principles for countries developing or revising their national HIV treatment guidelines. Principal consideration was given to the need for public health interventions that “secure the greatest likelihood of survival and quality of life for By Victoria Rossi and the greatest numbers of people living with HIV” (WHO 2009, 4). The Bisola Ojikutu guidelines also specify that “the individual rights of people living AIDSTAR-One John Snow, Inc. 1616 North Ft. Myer Drive, 11th Floor This publication was produced by the AIDS Support and Technical Assistance Resources Arlington, VA 22209 USA (AIDSTAR-One) Project, Sector 1, Task Order 1. Tel.: +1 703-528-7474 USAID Contract # GHH-I-00-07-00059-00, funded January 31, 2008. Fax: +1 703-528-7480 Disclaimer: The author’s views expressed in this publication do not necessarily reflect the views of the United States www.aidstar-one.com Agency for International Development or the United States Government.
  • 2. AIDSTAR-One | CASE STUDY SERIES TABLE 1. WHO RAPID ADVICE KEY RECOMMENDATIONS (WHO 2009) 1. Start ART in all patients with HIV who have a CD4 count of less than 350 cells/mm3, irrespective of clinical symptoms. 2. • Start one of the following regimens in ART-naïve individuals eligible for treatment. • Zidovudine (AZT) + lamivudine (3TC) + efavirenz (EFV) • AZT + 3TC + nevirapine (NVP) • Tenofovir (TDF) + 3TC or emtricitabine (FTC) + EFV • TDF + 3TC or FTC + NVP 3. Start ART in all individuals living with HIV with active tuberculosis, irrespective of CD4 cell count. 4. Start ART in all individuals living with both HIV and hepatitis B virus (HBV) who require treatment for their HBV infection, irrespective of CD4 cell count or WHO clinical stage. 5. Start ART in all pregnant women with HIV and a CD4 count of less than 350 cells/mm3, irrespective of clinical symptoms. 6. Where available, use VL to confirm treatment failure. • Where routinely available, use VL every six months to detect viral replication. • A persistent VL above 5,000 copies/mL confirms treatment failure. • When VL is not available, use immunological criteria to confirm clinical failure. 7. A boosted protease inhibitor (PI/r) plus two nucleoside analogues are recommended for second-line ART. • For second-line ART, atazanavir/ritonavir (ATV/r) and lopinavir/ritonavir (LPV/r) are preferred. 8. National programs should develop policies for third-line therapy that consider funding, sustainability, and equitable access to ART. with HIV should not be forfeited in the course of providing continued, life-long access to ART for a public health approach” (WHO 2009, 4). The those in need. four guiding principles for countries revising their treatment guidelines are as follows: Many countries plan to revise their national guidelines to reflect the recent WHO • Do no harm: When introducing changes, recommendations. Côte d’Ivoire, Malawi, Nigeria, preserve access for the sickest and most in need. Tanzania, and Zambia have undertaken feasibility • Ensure access and equity: All clinically eligible studies, including cost analyses, to assess people should be able to enter treatment services the impact of adopting such recommendations (including ART) with fair and equitable distribution (PlusNews 2010). These studies have of treatment services. demonstrated that many countries face significant challenges as they move to incorporate the • Promote quality and efficiency: Ensure delivery recommendations into their national treatment of the highest standards of care within a public protocols, including ensuring the availability of health approach so as to achieve the greatest resources to support increased patient loads, health impact with the optimal use of available improving supply chain management capacity, human and financial resources. ensuring sufficient human resources, and building • Ensure sustainability: Understand the long- in-country consensus around protocol changes. term consequences of change with the vision of 2 AIDSTAR-One | April 2011
  • 3. AIDSTAR-One | CASE STUDY SERIES Since 2006, the National AIDS Programme in HIV and AIDS, Government of Guyana 2009). By Guyana has been implementing WHO’s 2010 mid-2001, despite a flourishing epidemic, there was recommendations of a CD4 threshold of 350 still no public access to ART in Guyana because of cells/mm3 for initiation of ART and a TDF-based the prohibitive cost of antiretrovirals (ARVs) in the first-line treatment regimen. Strong political global market. will and leadership from the government, collaborative partnerships between local and In 2001, Cipla Ltd., the generic pharmaceutical international agencies, low patient loads, manufacturer, began marketing a generic fixed- effective supply chain management, and resource dose combination (FDC) of stavudine (d4T)/3TC/ availability are key factors contributing to NVP to Guyana. After negotiating with Cipla in Guyana’s successful implementation of WHO’s 2001, the MOH was able to secure significant price new recommendations. reductions in the cost of first-line ART to U.S.$250 per patient per year. Additionally, both Cipla and Ranbaxy, another leading generic pharmaceutical The Response to HIV company, offered technical assistance to build the capacity of a local pharmaceutical company, in Guyana Georgetown Pharmaceutical Corporation (GPC), to manufacture ARVs in-country. Through these Guyana is a small, English-speaking Caribbean capacity-building efforts, by the end of 2001, country located on the northeast coast of South GPC was able to produce first-line FDCs at a America, with a population of 748,486 (Central price of U.S.$140 per patient per year, allowing Intelligence Agency 2009). According to 2008 the government to announce its support of HIV national HIV estimates, HIV prevalence in Guyana treatment through the public health care system. In is 1.9 percent and the country’s estimated December 2001, the distribution of first-line therapy population of adults living with HIV (over 15 years began free of charge at the national sexually of age) is 16,900, disaggregated into 8,900 males transmitted infection referral center, then called and 8,000 females (Presidential Commission on the Genitourinary Medicine Clinic, in Georgetown, HIV and AIDS, Government of Guyana 2009). The Guyana’s capital. first case of AIDS in Guyana arose in 1987 within the men who have sex with men community. Since With additional support from the U.S. President’s then, the number of reported cases has increased Emergency Fund for AIDS Relief (PEPFAR) and steadily, and the epidemic is considered to be the Global Fund for AIDS, Tuberculosis and Malaria generalized (Presidential Commission on HIV and (GFATM), treatment services expanded to 16 sites AIDS, Government of Guyana 2009). by 2008. Second-line treatment was made available free of charge through the public system in 2006. In response to the burgeoning HIV epidemic, the Local capacity for CD4 testing was established Government of Guyana established the National in 2003 and VL capacity in 2010 (Presidential AIDS Programme (NAP) under the Ministry of Commission on HIV and AIDS, Government Health (MOH) in 1989. In 1992, the National AIDS of Guyana 2009). Currently, ART services are Programme Secretariat (NAPS) was formed and available in all regions, and all medical care offered charged with coordination of the national response by the public system, including HIV care and to the HIV epidemic (Presidential Commission on treatment, is free of charge. HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 3
  • 4. AIDSTAR-One | CASE STUDY SERIES By the end of 2009, a total of 2,832 persons were protocols. In 2003, WHO guidelines recommended actively receiving ART through the NAP. Of those a minimum CD4 cell count initiation threshold of persons receiving treatment in 2009, 178 were 200 cells/mm3, irrespective of clinical disease stage, children. Females made up 55.6 percent of all while guidelines in the United States and Europe persons on treatment in 2009. In 2008, patients on were changing to reflect earlier ART initiation, up second-line treatment accounted for 6.8 percent to CD4 cell counts of 350 cells/mm3. The Minister of all persons on treatment. At 12 months, average of Health, the Honorable Dr. Leslie Ramsammy, survival on treatment was 72 percent (Presidential aware of the treatment protocols being followed Commission on HIV and AIDS, Government of in the United States and Europe, has strongly Guyana 2009). advocated for guidelines aligned with the treatment protocols in resource-rich settings because he does not believe in setting a different standard for the 2004 and 2006 Guideline developing world. Revision Processes I believe that the restrictive protocol of using CD4 cut-offs for eligibility for ARV Developing initial HIV treatment treatment is a backward protocol and an guidelines: Following the Government of immoral one and we should pursue earlier Guyana’s announcement at the end of 2001 that treatment with ARVs. It is still my wish there would be universal access to HIV treatment, to place persons who are HIV-positive practitioners received a two-page brief that offered on ARV treatment as early as possible… very limited guidance on prescribing. By 2003, Treating people even though we don’t Guyana had developed the capacity to conduct know their CD4 is better than them dying. in-country CD4 testing, which prompted robust –The Honorable Dr. Leslie Ramsammy, discussion among stakeholders about clinical Minister of Health, Guyana The Minister argues that, as with other diseases, clinicians should be given the discretion to manage their patients based on their best clinical judgment. He believes “HIV diagnosis [is] good enough” to start treatment and “they [health care providers] should not wait for somebody to get sick” before providing treatment. He wants patients to get early treatment to maintain their health, but also because he views widespread early treatment Photo courtesy of JSI staff as an important component of an effective HIV prevention strategy. After negotiations within the Government of Guyana and with other international organizations, the National Care and Treatment Centre, Georgetown, MOH launched the treatment access program Guyana, April 2010. with an initiation threshold of 200 cells/mm3, but 4 AIDSTAR-One | April 2011
  • 5. AIDSTAR-One | CASE STUDY SERIES emphasized that the national program would be United States through in-person meetings, working toward a threshold of 350 cells/mm3. conference calls, and emails. When the draft Formal guidelines recommending a CD4 initiation guidelines were complete, WHO and the Joint threshold of 200 cells/mm3 and a first-line regimen U.N. Programme on HIV/AIDS also reviewed the of d4T/3TC/NVP were finalized and disseminated document and provided comments. FXB-USA and in 2004. As the NAP expanded, the Minister IHV, both implementing partners under PEPFAR, mandated and approved membership of a Technical conducted a full external review of the guidelines Working Group (TWG) for HIV Care and Treatment prior to their finalization. to be chaired by NAPS with participation from key technical partners. The TWG was to serve as an Both global scientific research and local advisory board to NAPS and meet on a quarterly anecdotal evidence were considered by the basis to discuss emerging issues facing the NAP, guideline revision committee during their with the goal of strengthening Guyana’s national discussions, a process detailed later in this case HIV response. study (see “Evidence Considered”). Following technical approval of the 2006 revised guidelines, Developing the 2006 HIV treatment some time passed before they were officially guidelines revision: Supported by local endorsed as policy and disseminated by the clinicians and key international partners, when government. Meanwhile, to foster adoption of the WHO released its revised 2006 guidelines the revised guidelines as quickly as possible, advocating more strongly for a CD4 initiation NAPS “piggybacked” on already planned national threshold of 350 cells/mm3, the Minister of Health and regional training efforts, such as those mandated a revision of Guyana’s national HIV on prevention of mother-to-child transmission, treatment guidelines. The TWG identified additional by adding brief, informal training on the new technical experts to join the group and invited treatment guidelines to the agenda. them to become members of the guideline revision committee. The committee was composed of: staff Implementation and roll-out: Once the from various departments of the MOH, including revised guidelines were formally endorsed and NAPS, disease control, maternal and child health, disseminated, NAPS conducted official training and tuberculosis; local public and private sector led by MOH staff and partners, which was rolled clinicians; and partners including the François- out nationally to all 360 health facilities. They Xavier Bagnoud Center (FXB)-USA and FXB- employed a combination of training approaches Guyana (University of Medicine and Dentistry of New Jersey), the Canadian Society for International Health, the Centers for Disease Control and To foster adoption of the Prevention (CDC), the AIDS Relief Consortium revised guidelines as (Institute for Human Virology [IHV], University of Maryland), Dartmouth Medical School, and quickly as possible, NAPS the Guyana HIV/AIDS Reduction and Prevention “piggybacked” on already Program (MOH 2006). planned national and regional Technical consultations funded by international training efforts. partners were conducted with experts in the HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 5
  • 6. AIDSTAR-One | CASE STUDY SERIES depending on the circumstances, so that some Initiation thresholds for antiretroviral training sessions for health workers from different therapy: Clinicians from the National Care regions took place in Georgetown, while others and Treatment Centre (NCTC), the center of were conducted in the regions with support from excellence for management of HIV and sexually the regional health offices. Implementers and transmitted infections in Guyana, were members health workers from the field were invited to the of the guideline revision committee. They, along quarterly TWG meetings on an ongoing basis with other private and public sector clinicians, and were asked to give feedback on the progress were concerned about how sick and weak and challenges facing implementation of the new their patients were by the time their CD4 count guidelines. The MOH maintained and cultivated reached 200 cells/mm3. They completed informal the TWG as a forum for troubleshooting. assessments via patient chart reviews in which patient CD4 levels were plotted against their The newly revised 2006 guidelines were health outcomes, beginning at ART initiation disseminated to all ART sites in different formats. and continuing over time, to show the change NAPS made packages for distribution at the TWG in CD4 levels and how those changes affected meetings, sent packages to regional health offices overall health. From these informal assessments with instructions to distribute the guideline materials and their clinical observations, they reported throughout the region, and distributed packages at increased morbidity, opportunistic infections, and quarterly immunization meetings. NAPS followed longer recuperation periods in those patients who up with each of the ART sites through the regional started treatment when their CD4 count was at or health offices to ensure they had received and were below 200 cells/mm3. implementing the new guidelines. Citing the findings of their informal assessments Additionally, the new guidelines were announced and clinical observation, these local clinicians at the Minister’s News Conference, a regularly began advocating strongly for earlier initiation of scheduled meeting between the media and the ART. There were varying views within the revision Minister of Health, which was covered by both print committee about the sustainability of increasing and television news outlets. The total timeframe the initiation threshold to 350 cells/mm3, with some for the 2006 revision process was approximately members advocating for maintaining 200 cells/ one year, beginning with the Minister’s mandate mm3 and others supporting a more tempered to update the guidelines to the government’s increase to 300 cells/mm3. PEPFAR-supported endorsement of the final revised guidelines. local treatment partners FXB and IHV were However, it took an additional year before all especially supportive of revising the guidelines of the health workers were trained and actively to initiate patients at less than 350 cells/mm3, implementing the guidelines. based on cohort data in the United States and Europe showing improved clinical outcomes with earlier ART initiation. Both organizations provided Evidence Considered remote technical assistance from the United States through a combination of in-person meetings, The guideline revision committee considered both conference calls, and emails. global scientific research and local anecdotal evidence as they deliberated on the updates to Tenofovir-based first-line regimen: The make. The evidence they considered regarding local clinicians on the TWG also provided anecdotal each of the key 2006 revisions is summarized next. evidence of d4T-related neuropathy and lipodystrophy 6 AIDSTAR-One | April 2011
  • 7. AIDSTAR-One | CASE STUDY SERIES and advocated for a more patient-friendly first-line enabled the implementation of the 2006 revised regimen. There was extensive debate about which guidelines. nucleoside reverse transcriptase inhibitors (NRTIs) to use. Data supporting the superiority of TDF-FTC Supply chain management: With the advent NRTI backbones in virologic suppression and CD4 of the SCMS Project in Guyana in 2006, the supply response were released in 2006 (Gallant et al. 2006). chain in Guyana was significantly strengthened, In addition, fewer side effects, such as nausea and enabling it to effectively support the national HIV anemia, were noted with TDF than with regimens program. A satellite MOH Materials Management including AZT. In the face of mounting concerns about Unit Farm Annex Warehouse was established including d4T in the first-line regimen, the revision to provide suitable storage conditions for ARVs committee agreed to alter the first-line regimen. procured by major HIV donors, including PEPFAR and GFATM. A fleet of two trucks delivered ARVs To help determine which drugs should be included directly to 13 of the 15 fixed ART sites, with the two in the first line, NAPS asked the PEPFAR-supported main private sector sites managing their own pick-up Supply Chain Management System (SCMS) Project (SCMS Project-Guyana 2008). in Guyana to complete a cost analysis comparing the old d4T-based first-line regimen to regimens SCMS-Guyana supported NAPS to complete a containing TDF. SCMS-Guyana studied actual forecasting and quantification of ARV requirements invoices, made assumptions about annual ART according to the new treatment guidelines using patient targets, and used the new treatment initiation the software package Quantimed, which was the threshold of 350 cells/mm3 to determine the cost standard quantification tool for the country. Using of first-line therapy, including branded TDF/FTC. Quantimed, CDC-Guyana and NAPS worked with Although the TDF/FTC-based regimen proved SCMS-Guyana to forecast and quantify CD4 testing more costly, the MOH believed that this regimen supplies to support earlier initiation of ART through was superior to the other options considered. After routine CD4 testing. Finally, NAPS used the ARV exhaustive discussion, the revision committee came and laboratory forecasts in the software package to a consensus that a TDF-based first-line regimen PipeLine to develop a procurement and supply plan was the best option for patients and would be to help manage the supply chain of ARVs according cost-effective in the long-term. While cost was an to the new treatment guidelines. important factor in all of the discussions, the efficacy Registration and importation of the new ARVs and quality of the treatment regimen were the were significantly expedited by the fact that priorities. All new patients initiating ART began TDF/ in 2001 the government established a policy FTC in combination with a non-NRTI, specifically allowing the Food and Drug Department (FDD) NVP or EFV. Guidance for the management to issue registration waivers for new ARVs upon of existing patients on d4T-based therapy request from the MOH’s Chief Medical Officer. A recommended an immediate switch to a TDF-based registration waiver was requested by the Chief regimen in the absence of contraindications. Medical Officer for the new ARVs and promptly issued by FDD, allowing for importation of ARVs Factors Supporting recommended by the new guidelines. Successful Implementation Resources available: In 2006, Guyana’s NAP was in the enviable and relatively unique Important supply chain management factors in position of having multiple donors supporting the Guyana along with financial resource availability MOH in covering the costs of all its public sector HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 7
  • 8. AIDSTAR-One | CASE STUDY SERIES HIV services. Guyana was receiving substantially sick because they sought services sooner and greater money per patient than any other PEPFAR- treatment was initiated earlier. Decentralization of supported country at that time. GFATM was services to primary health centers further fostered providing funds for procurement of ARVs to cover all access to treatment, with the potential to lessen the first-line adult patients, post-exposure prophylaxis, stigma around HIV infection. and prevention of mother-to-child HIV transmission. PEPFAR procured ARVs for all adult second-line and The Minister of Health believes that the sense of pediatric patients through the end of 2006, at which hopelessness in Guyana prior to universal treatment point the Clinton Health Access Initiative (CHAI) took access lifted as patients initiated ART earlier and over coverage for all pediatric patients. Since 2007, were able to live healthier, longer lives. He feels this, GFATM has provided all first-line ARVs. Currently, in turn, gave confidence to health workers because PEPFAR covers second-line ARVs and CHAI they were better able to serve their patients, and thus provides pediatric treatment. However, CHAI funding improved overall morale at the health centers. will be entirely phased out by 2011. Fortunately, Guyana has recently secured a Rolling Continuation No formal study of the clinical outcomes of the Channel under GFATM Round 9, which secures 2006 guideline revision or Guyana’s national HIV funding for all first-line and pediatric treatment from program in general has been completed to date. 2010 through 2015. Given this funding landscape, However, NAPS has plans to conduct an outcomes the availability of resources to support more patient- study in collaboration with CDC-Guyana in the friendly regimens and earlier initiation of ART was near future and is currently developing a database not a major concern of the 2006 revision committee. to analyze cohort data to determine clinical outcomes. An HIV drug resistance study is also planned to begin in early 2011. Results Following implementation of the 2006 revised What Worked Well guidelines, all patients had access to ART once they entered the national program and were The key factors that contributed to the successful deemed eligible for treatment. With strong donor revision of Guyana’s treatment guidelines and ministry support, funding for HIV treatment was included strong political will and leadership able to match scale-up plans, so an ART waiting from the government, collaborative partnerships list never developed. Anecdotal reports from local between local and international agencies, and low clinicians showed that patients were generally less patient loads. The importance of political will: Dating back to the early days of the emergence of Anecdotal reports from local HIV in Guyana, there was very strong political clinicians showed that patients commitment from the government to the fight were generally less sick against the epidemic. Ministry officials, including because they sought services the Minister of Health, remained aware of the latest global research around HIV treatment, care, sooner and treatment was and support, and the public health community initiated earlier. in Guyana remained receptive to changes and advances in the field. 8 AIDSTAR-One | April 2011
  • 9. AIDSTAR-One | CASE STUDY SERIES Strong global partnerships: Guyana’s HIV Patient concerns about switching program has also benefited enormously from a regimens: Initial reports from implementers strong, collaborative partnership between local and health workers revealed that patients were and international agencies. The Pan American concerned about moving from the simple dosing of Health Organization, WHO, the U.N. Children’s one pill with the d4T-based FDCs in the old regimen Fund, and U.S. Government partners have been to the more complicated dosing of two different important allies that worked closely with the MOH pills in the new TDF-based regimens. The TWG to understand and support its goals. Although there discussed the issue with the implementers and, while were varying opinions on technical issues at certain a multidisciplinary approach to treatment counseling points throughout the revision process, the revision is the norm, everyone agreed to focus on the role of committee generally agreed that long-term cost the social workers at the health centers to assuage effectiveness and a higher quality of patient care patient fears. Social workers were mentored by were the proper direction for the NAP. MOH staff and encouraged to work very closely with ART patients to increase their understanding of Consistent leadership from the MOH: the benefits of the new regimen and the reasoning Different international partners bring different behind the switch. Patients were told that the new perspectives to the development of guidelines; drugs reduced their risk of treatment failure and therefore, molding the guidelines into a uniquely adverse side effects and therefore increased the Guyanese approach required strong national quality of care they received. leadership. The Minister of Health provided that leadership at all stages of the development of the Fostering patient adherence to new national guidelines, resulting in a strategy that guidelines: Patient adherence to treatment was provides highly effective treatment for all eligible an ongoing challenge faced by the NAP that was patients living with HIV. exacerbated by the new treatment guidelines. The NCTC, located in Georgetown, developed The availability of funding to cover a Group Discussion Program to address this national treatment needs: Low patient load challenge. Before a patient was initiated on and funding availability in Guyana undoubtedly treatment at the NCTC, he or she was required facilitated consensus around the 2006 guideline to attend three compulsory treatment-related revisions. Although concerns about longer term counseling sessions. The patient was asked to funding were discussed by the revision committee, select and bring a “support buddy” to at least the extent of these concerns was less than it would one of the three counseling sessions. Once a have been in the African treatment context of limited patient successfully attended the three counseling funding for hundreds of thousands of patients. sessions and selected a support buddy, he or she began ART and was asked to attend the focus group discussions, which were held biweekly at Challenges the NCTC. The focus groups consisted of five members of the NCTC staff, including a doctor, The key challenges that Guyana faced during pharmacist, nurse, social worker, and home-based the 2006 guideline revision process were patient care person, and all of the ART patients with their understanding, adherence, human resource support buddies. The objective of the focus group shortages, and supply chain management discussions was for adherent HIV patients to constraints related to the timing for dissemination of talk about their successes and for non-adherent the new guidelines. patients to share their struggles. The NCTC has HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 9
  • 10. AIDSTAR-One | CASE STUDY SERIES continued implementing this program and has Georgetown with the support of the Ministries of made a formal recommendation to NAPS that Health and of Amerindian Affairs. the program be rolled out to ART sites nationally. Many clinics have begun implementing similar Anticipating supply chain difficulties: support activities but with variations based on When the 2006 revised guidelines were formally clinic size and staffing levels. endorsed and disseminated to health facilities, the MOH had a national overstock of ARVs for the Dealing with personnel shortages: An old, d4T-based first-line therapy. They were not additional challenge for the NAP was a shortage of comfortable allowing all the old ARVs to expire, so human resources to manage the increased patient they were forced to delay distribution of the ARVs load. Early in the epidemic’s history, Guyana worked for the new TDF/FTC-based first-line therapy until to prevent the establishment of a parallel HIV more of the old ARVs had been consumed. This service delivery system and leverage existing human resulted in some confusion among health workers resources by integrating HIV services into the public who had been trained to use the new guidelines health infrastructure. Task-shifting ART away from because the corresponding ARVs were not the physicians to lower cadres of health care workers available to them at the health facilities. To address was also considered as a potential solution to the this challenge, ongoing updates were provided to human resource challenge, especially in the remote the clinicians at the treatment sites regarding stock- hinterland areas. The NAPS decided to recruit 11 on-hand of the old ARVs and ordering new ARVS. doctors from the U.N. Volunteer Program to provide additional support to the ART sites. While keeping ART initiation under the purview of physicians, Recommendations NAPS did undertake some measures to better distribute the workload of clinicians and nurses who National health leaders must build were managing the country’s HIV patients. NAPS consensus: The success of Guyana’s 2006 introduced a new position, the lay counselor, to guideline revision was due in large part to strong provide HIV counseling in the larger clinics and thus leadership from the MOH and collaborative alleviate the bottleneck presented by long lines of partnership with both local and international patients waiting for counseling sessions with nurses. agencies. A country’s MOH must work to build consensus among the various players while at the Reaching remote communities: While HIV same time clearly articulating its vision and guiding prevalence in remote areas of Guyana is relatively the revision committee to develop guidelines that will low, there was some concern that mining and logging most effectively achieve their vision. activities, coupled with limited access to treatment facilities, could worsen the epidemic among those Keep the committee small and flexible: communities. As a result, NAPS has begun to Countries should closely review the latest provide HIV services through mobile ART clinics HIV research with a small group of technically visiting remote areas quarterly. Mobile clinicians competent stakeholders who are open to new ideas initiate patients on ART according to the new and approaches. A smaller revision committee initiation criteria, and local medics monitor them on will keep the process focused and efficient. Once an ongoing basis. The mobile clinicians remain on consensus has been reached within the revision call by radio and telephone communication to advise committee and the updated guidelines have been the local medics as needed. If an emergency arises, drafted, the guidelines can then be circulated for arrangements are made for the patient to travel to comments to a larger group of stakeholders. To 10 AIDSTAR-One | April 2011
  • 11. AIDSTAR-One | CASE STUDY SERIES LESSONS LEARNED FROM GUIDELINE REVISION PROCESS IN GUYANA • Ensure top MOH policymakers remain abreast of HIV global research, WHO recommendations, and emerging local evidence so that ongoing revisions are made to the national HIV treatment guidelines as appropriate. • Issue a mandate from the MOH to revise national HIV treatment guidelines when deemed necessary. • Establish a small, technically competent guideline revision committee, led by the MOH, which has clear terms of reference through which consensus can be achieved. • Garner financial and technical support from strong local and international partners and arrange for an external third party review of the draft revised guidelines. • Assess supply chain management implications of guideline revisions including drug forecasting and quantification, procurement, storage and distribution, importation requirements, etc. • Assess resource availability to support guideline revisions including robust cost analyses. • Consider the impact of guideline revisions on patient loads and implement locally appropriate human resource interventions including rollout of lay counselors, phlebotomists, and/or task-shifting. • Review ARV supply and procurement plans before rolling out revised guidelines so that drugs from a previous protocol are consumed before the guidelines are fully rolled out. • Officially endorse the revised guidelines as policy by having MOH leadership hold a public press conference announcing them. • Collaborate with the local health offices to train health care workers nationally and distribute hard copies of the revised guidelines. • Establish a feedback mechanism, such as quarterly implementer meetings, for local health officers and health care workers to relay any challenges with implementation of the revised guidelines back to the central level so that appropriate interventions can be developed. successfully adapt WHO recommendations to the local context of a specific country so that quality Future Plans and sustainability of HIV treatment are effectively Recently, Guyana has gone through another process balanced, members of the revision committee will of revising its national HIV treatment guidelines. need to be open, flexible, and free-thinking. In 2009, the Minister of Health convened a similar revision committee to plan for the addition of VL Plan around current ARV supply: It is monitoring, potential initiation of ART for all patients recommended that countries look carefully at their diagnosed with HIV irrespective of CD4 level, ARV supply and procurement plans before rolling revision of the pediatric ART regimens to include out new guidelines. Ongoing updates should be abacavir (ABC) in first-line therapy, and further provided to the clinicians at the treatment sites guidance on ART initiation in tuberculosis/HIV co- regarding stock-on-hand of old ARVs and ordering infection. Currently, the 2009 guidelines remain in new ARVS. Timing of the roll-out should be draft form and are being reviewed by various local managed so that drugs from a previous protocol are and international partners. In addition, an in-depth consumed before the revised guidelines are fully costing of the new guidelines is underway to explore rolled out. Proper timing will foster rapid uptake of the resource implications for different guideline the new guidelines by ensuring that health workers scenarios. Following incorporation of the comments and patients receive clear messages and immediate resulting from these reviews, the MOH plans to distribution of the new ARVs is possible. officially endorse and disseminate the revised HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 11
  • 12. AIDSTAR-One | CASE STUDY SERIES guidelines through a process similar to the one used WHO. 2010. Antiretroviral Therapy for HIV Infection in for rollout of the 2006 guidelines. n Adults and Adolescents. Recommendations for a Public Health Approach (2010 Version). Available at www.who.int/ hiv/pub/arv/adult2010/en/index.html (accessed July 2010) REFERENCES Central Intelligence Agency. 2009. The World Factbook ACKNOWLEDGMENTS 2009. Washington, D.C.: Central Intelligence Agency. Gallant, J. E., E. DeJesus, J. R. Arribas, et al. 2006. AIDSTAR-One would like to thank the following partners Tenofovir DF, Emtricitabine, and Efavirenz vs. Zidovudine, for providing input and guidance in the development Lamivudine, and Efavirenz for HIV. New England Journal of this case study: the Ministry of Health, Guyana and of Medicine 354(3):251–260. several of its programs and departments, including the National AIDS Programme Secretariat, the National Ministry of Health (MOH), Guyana. 2006. National Care and Treatment Centre, the National Tuberculosis Guidelines for Management of HIV-Infected and HIV- Programme, and the Maternal and Child Health Exposed Adults and Children. August 2006 revision. Department; the Food and Drug Department, Guyana; Georgetown, Guyana: Ministry of Health. U.S. Agency for International Development (USAID)/ Washington and USAID/Guyana; the Supply Chain PlusNews, “Malawi: Malawi Moves to Adopt WHO Management Systems Project and Management Sciences Guidelines,” Integrated Regional Information Networks for Health; Centers for Disease Control and Prevention- (IRIN), May 27, 2010. Available at www.irinnews.org/ Guyana, Global AIDS Program; and François-Xavier report.aspx?Reportid=89266 (accessed June 2010) Bagnoud Center (FXB)-Guyana and FXB-USA, University of Medicine and Dentistry of New Jersey. We would also Presidential Commission on HIV and AIDS, Government of like to thank the following members of the AIDSTAR- Guyana. 2009. UNGASS Country Progress Report: Republic One Treatment Technical Working Group: Robert Ferris of Guyana. Reporting Period: January 2008 - December (USAID) and Tom Minior (USAID). 2009. Georgetown, Guyana: Government of Guyana. Supply Chain Management Systems (SCMS) Project- Guyana. 2008. Supply Chain Management Systems RECOMMENDED CITATION Guyana – Its Evolution & Current. Georgetown, Guyana: SCMS Project. Rossi, Victoria, and Bisola Ojikutu. 2011. HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and WHO. 2009. Rapid Advice: Antiretroviral Therapy for HIV Treatment. Case Study Series. Arlington, VA: USAID’s Infection in Adolescents and Adults. Available at www.who. AIDS Support and Technical Assistance Resources, int/hiv/pub/arv/advice/en/index.html (accessed March 2010) AIDSTAR-One, Task Order 1. AIDSTAR-One’s Case Studies provide insight into innovative HIV programs and approaches around the world. These engaging case studies are designed for HIV program planners and implementers, documenting the steps from idea to intervention and from research to practice. Please sign up at www.AIDSTAR-One.com to receive notification of HIV-related resources, including additional case studies focused on emerging issues in HIV prevention, treatment, testing and counseling, care and support, gender integration and more. 12 AIDSTAR-One | April 2011