THE ROLE OF ANTIRETROVIRAL THERAPY IN VIETNAM'S

UNCLAS SECTION 01 OF 05 HANOI 001450

SIPDIS

STATE FOR O/GAC, EAP/MLS, EAP/EP, INR, OES/STC, AND OES/IHA
STATE PASS TO USAID FOR ANE AND GH (DCARROLL, SCLEMENTS AND
PCHAPLIN)
STATE PASS TO HHS/OGHA (WSTIEGER, EELVANDER AND ABHAT)
BANGKOK FOR USAID (TBEANS, LBRADSHAW AND BSLATER)

SIPDIS

E.O. 12958: N/A
TAGS: TBIO KHIV EAID SOCI TBIO VM
SUBJECT: THE ROLE OF ANTIRETROVIRAL THERAPY IN VIETNAM'S
FIGHT AGAINST HIV/AIDS


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1. (U) Summary. Although the estimated prevalence of
HIV/AIDS in Vietnam is relatively low compared to most
Southeast Asian countries, it has continued to rise in each
of the past five years, increasing by 25 percent from 2004
to 2005. The estimated national HIV prevalence rate is 0.44
percent, or approximately 215,000 HIV-infected persons. It
appears that the epidemic is spreading outside the most-at-
risk populations to infect clients of sex workers, spouses
of clients and intravenous drug users, and to their
children. A key element of any comprehensive treatment of
HIV-infected individuals is appropriate antiretroviral
therapy (ART). The availability of quality ART in Vietnam
is limited and the estimated number of people receiving ART
is low due to lack of capacity. Since August 2005, the
President's Emergency Plan for AIDS Relief (PEPFAR) Vietnam
program has provided the majority of high-quality ART in
Vietnam in the form of imported brand-name ARVs with FDA
tentative approval. In January 2006, the MOH agreed to
allow PEPFAR to procure and import FDA tentatively approved
generic ARVs. Consequently, the PEPFAR Vietnam program is
procuring increasing numbers of imported generic ARV
medications. Sustainability of ARV treatment programs is of
critical concern. Unless Vietnam obtains Round 6 Global
Fund funding, or the Government of Vietnam (GVN) or other
donor is able to procure additional ARVs, PEPFAR will
continue to be the main supplier of ARVs for the next
several years. End Summary.

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The President's Emergency Plan for AIDS Relief
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2. (U) President Bush's Emergency Plan for AIDS Relief
(PEPFAR) is a five-year USD 15 billion plan to provide
prevention, care and treatment programs for People Living
with HIV/AIDS (PLWH) and to prevent new cases. In 2004,
Vietnam became the 15th focus country to join the Emergency
Plan and the only focus country in Asia. In FY2006, the
United States will provide approximately USD 34 million to
support Vietnam's fight against HIV/AIDS.

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The HIV/AIDS Epidemic in Vietnam
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3. (U) Of Vietnam's 83 million inhabitants, approximately
57 percent are less than 30 years old. The majority of HIV
positives in Vietnam occur among young males ages 20-29
(greater than 1 percent prevalence). Based on GVN data, the
national HIV prevalence rate is 0.44 percent, or
approximately 215,000 HIV-infected persons. Although the
estimated prevalence of HIV/AIDS in Vietnam is relatively
low compared to most Southeast Asian countries, it has
continued to rise in each of the past five years, increasing
by 25 percent from 2004 to 2005. The HIV epidemic in
Vietnam has been primarily driven by intravenous drug users
(IDUs) and commercial sex workers (CSW) and concentrated in
population segments traditionally thought to be at high
risk.


4. (U) According to UNAIDS Country Coordinator Nancy Fee,
there is great concern that the epidemic appears to be
spreading outside the most-at-risk populations to infect
clients of sex workers, and spouses of clients and IDUs, and
to their children. In addition, given the prevalence is
rising in women not normally associated with the most-at-
risk groups, UNAIDS and the Ministry of Health (MOH)
attribute an increasing proportion of HIV transmission to
sexual transmission. Although HIV/AIDS has been detected in
each of Vietnam's 64 provinces, the highest rates of
prevalence have been recorded in Haiphong, Vung Tau, Ho Chi
Minh City (HCMC),and Quang Ninh Province.

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Antiretroviral Therapies: Opening the Door to Treatment
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5. (U) A key element of the PEPFAR program in Vietnam is
the comprehensive treatment of HIV-infected individuals
using appropriate ART. (NOTE: Antiretroviral therapy (ART)
is the program delivering antiretroviral drugs (ARV).
ENDNOTE) The PEPFAR country operational plan for Vietnam

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establishes a target of treat 22,000 ART-eligible
individuals by 2008. In Vietnam, an estimated 35,000 HIV-
infected individuals are eligible for ART.


6. (U) The Vietnam PEPFAR program is initially focusing
comprehensive ART activities in six high-prevalence PEPFAR
"focus" provinces and cities: Haiphong, Hanoi and Quang Ninh
in the north and Ho Chi Minh City, Can Tho and An Giang in
the south. In these provinces, approximately 14,500 persons
are eligible for treatment with ARVs. Eligibility for ARV
treatment is based on established clinical criteria from WHO
recommendations and agreed upon by members of the PEPFAR
Vietnam and MOH team.


7. (U) The availability of quality ART in Vietnam is
limited, as is competent supervision of care. Although MOH
guidelines for ART exist, domestically produced and
imported, generic ARV medications are freely prescribed by
untrained physicians and are readily available directly to
customers by local pharmacies with few controls. As a
result, some PLWAs are exposed to inadequate treatments,
including mono- and dual-therapy (one or two-drug regimens),
instead of the standard three-drug regimen, thereby reducing
quality of care and increasing the risk of developing drug-
resistant HIV strains.


8. (U) Since August 2005, the PEPFAR Vietnam program has
provided the majority of high-quality ART in Vietnam, in the
form of imported branded and FDA tentatively approved ARVs.
Over 1,500 adults and children have initiated ARV therapy at
21 PEPFAR-supported outpatient clinics. Eleven sites in
four focus provinces are providing services for Prevention
of Mother to Child Transmission (PMTCT) and ARVs to prevent
transmission has been provided to over 400 HIV-positive
mothers and infants.


9. (U) In January 2006, the MOH agreed to allow PEPFAR to
procure and import FDA tentatively approved generic ARVs.
(NOTE: Vietnam is only the fourth of 15 focus countries to
approve this. ENDNOTE) Consequently, the PEPFAR Vietnam
program is now procuring increasing numbers of imported
generic ARV medications with FDA tentative approval. To
date, no ARVs produced in Vietnam have received FDA
tentative approval or WHO pre-qualification, although the
MOH Drug Administration has indicated that they are applying
for the latter.


10. (U) Other, non-PEPFAR programs also provide ART in
Vietnam. These include the MOH, the Global Fund for
HIV/AIDS, Tuberculosis and Malaria (GFATM),and ESTHER,
which is a project sponsored by the Government of France.
These programs procure ARVs for distribution, but management
of drug distribution and oversight over care and treatment
programs is variable. ESTHER provides ART to approximately
400 patients. However, they plan to phase-out purchase and
provision of ARVs as additional sources of reliable ARVs
become more readily available.


11. (U) The MOH distributed to treatment facilities in 64
provinces ARVs for 3,000 persons. However, the capacity of
provincial facilities to delivery ART is fairly limited.
The MOH reports that ARVs have not yet been distributed to
patients due to lack of adequate clinical training and
oversight. As the MOH is the principal recipient for the
GFATM, capacity to adequately supervise GFATM-supported ART
also suffers from the same limitations in care and
treatment. During 2006, GFATM-Vietnam will procure ARV to
treat approximately 2000 persons, yet as of the end of April
2006, only 300 patients receive ARV through GFATM
procurement.


12. (U) Since the end of 2005, PEPFAR Vietnam program has
been working closely with GFATM and MOH representatives to
coordinate ARV distribution and management and to provide
PEPFAR assistance to GFATM ART in the form of
clinical/laboratory support and clinical technical
assistance. In addition to closer donor coordination, which
ensures that the ARVs are getting to the right people, the
PEPFAR Vietnam program actively pressed the GVN to allow the
importation of generic ARV medications with FDA tentative
approval, which allows limited resources to support more
people.

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PEPFAR's Strategy for Achieving ART Targets
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13. (U) To achieve the target of treating 22,000 ART-
eligible individuals by 2008, the PEPFAR Vietnam strategy
applies a four-tiered program of activities. First, PEPFAR-
procured ARVs will be provided to eligible individuals at 36
sites in the six focus provinces. The services to be
offered include initiation and scale up of adult, pediatric
and PMTCT ART with comprehensive services including ARV,
laboratory services, training, adherence and patient
readiness training, and linkages to comprehensive prevention
and care services.


14. (U) Second, PEPFAR Vietnam will strengthen coordination
with MOH and GFATM to support ART provided from these
sources in existing USG-supported outpatient clinics through
training, technical assistance and patient laboratory
monitoring. Third, PEPFAR Vietnam supports the improvement
of national reference laboratories including external
quality assurance, and provincial laboratory capacity.


15. (U) Finally, PEPFAR Vietnam will provide leadership to
strengthen national capacity-building initiatives including
support of national training strategies, national ARV
implementation guidelines, quality assurance programs,
monitoring and evaluation, and development of an MOH Drug
Management Information System Task Force to coordinate drug
procurement and supply mechanisms throughout Vietnam. In
the near future, PEPFAR Vietnam will begin using the PEPFAR-
developed Supply Chain Management System (SCMS) to procure
ARVs.


16. (U) In FY05, PEPFAR Vietnam supported the MOH to
develop a national ARV protocol and training strategy and to
establish an ARV site readiness assessment protocol for
GFATM sites. This protocol is designed to help the MOH
determine if clinics are capable to receive and manage ARVs,
to prescribe the appropriate ARVs, to monitor ARV
effectiveness and manage follow-up care. PEPFAR Vietnam
collaborated with other agencies including WHO to develop
and distribute national guidelines for treatment of
opportunistic infections with ARV and supported training for
over 150 physicians, nurses, counselors and pharmacists to
begin ARV for adults and children.

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An Action Plan for FY06: Scaling Up ARV Treatment
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17. (U) With USG-funded ARVs, PEPFAR Vietnam will continue
to put more patients on ARVs in the 26 existing clinics and
five new clinics that will start prescribing ARVs by the end
of 2006. The PEPFAR Vietnam team expects to meet and
perhaps even exceed the FY06 target of 1,900 patients by
September, 2006.


18. (U) Scale-up will be achieved according to the strategy
outlined above. As previously noted, the GFATM and the MOH
procure ARVs through other funding mechanisms. In a
continued partnership and under the leadership of the MOH,
PEPFAR Vietnam supported the development of a National ARV
treatment implementation and readiness protocol and the
National Care and Treatment Plan of Action. The National
ARV treatment protocol is based on protocols developed for
PEPFAR Vietnam-supported ARV clinics. The MOH requested
assistance from PEPFAR Vietnam to support training and
technical assistance in the provinces where the MOH will be
supporting ARV treatment through drugs procured by GFATM and
MOH. PEPFAR Vietnam is currently working with the MOH to
develop a national training curriculum and plans for follow
up training and technical assistance to sites outside of the
six focus provinces/cities. ARV lab monitoring services in
some sites where GFATM and MOH provide treatment services is
also underway.


19. (U) Additionally, PEPFAR Vietnam is developing an
innovative pilot program in HCMC to support transition
residents moving from drug rehabilitation centers ("06
Centers") to community-based clinics that will support them

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with counseling, relapse prevention, care and treatment
services. If successful, the pilot will serve as a model
for expanding treatment services in this large population of
marginalized patients. PEPFAR Vietnam will also expand
capacity of USG partners in Vietnam by providing technical
assistance for all PEPFAR Vietnam sites as requested;
providing technical assistance to sites jointly supported by
USG and GFATM; strengthening Vietnamese clinical training
teams; and, developing an on-call system to provide HIV
expertise by phone and email back up to clinics in more
remote areas.

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Critical Challenges and Paths to Expand ARV Treatment
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20. (U) The PEPFAR Vietnam program faces a number of
challenges as it supports the GVN and its partners to
provide quality ARV treatment and care. Among these
challenges is the lack of transparency by the MOH, which
limits the extent to which resources can be collaboratively
used. To address this challenge, the PEPFAR Vietnam program
will assist the MOH to maximize resources and provide
treatment that meets international standards of care across
MOH clinics. PEPFAR Vietnam, in collaboration with other
donors and international organizations, will also encourage
MOH to coordinate ARV procurement, distribution and care.
In addition, PEPFAR Vietnam will continue to meet regularly
with representatives of MOH and GFATM to encourage greater
collaboration in programming.


21. (U) Care and treatment services must be accessible,
despite the increasing number of patients served and the
increasing number of clinics providing ARVs. Accessibility
is particularly challenging for marginalized populations
such as IDUs and CSWs. With an estimated 160,000 registered
IDUs, of whom approximately 30-50 percent are HIV-positive
and approximately 40,000 reside in rehabilitation centers,
the establishment of comprehensive treatment programs
requires a systematic, coordinated program that ensures
continuity of care as many of the center residents are
released into the community. To address this challenge,
PEPFAR Vietnam will explore ways to support effective
programs that reach the most patients in need of treatment
including more marginalized populations and hidden groups
that may not be accessing via current care services. PEPFAR
Vietnam will assist programs funded by the World Bank and
GFATM that provide ARVs to patients living in the
rehabilitation centers.


22. (U) In settings where ongoing intravenous drug use may
complicate ARV treatment and methadone will not be
immediately available, a continued focus needs to be placed
on quality, adherence support, and good treatment readiness
preparation for patients. Using evidence-based results,
PEPFAR Vietnam will assess adherence to ARV regimens and
program loss to follow-up and explore ways to improve these
indicators based on data. PEPFAR Vietnam, in collaboration
with other donors and international agencies, will continue
to encourage the MOH to allow implementation and rapid scale-
up of medication-assisted therapy (i.e., methadone and other
medications) as an important adjunct to successful ARV
programming.


23. (U) Another challenge is the lack of an established
national-level drug management and patient monitoring
system. Through the World Health Organization (WHO),PEPFAR
Vietnam supports the formation of a centralized procurement
and distribution system for all Vietnam programs and is
developing an in-house drug management system based on
established principles tailored to Vietnam's needs.


24. (U) Sustainability of ARV treatment programs is of
critical concern. Unless Vietnam obtains Round 6 GFATM
funding, or the GVN or another donor is able to procure
additional ARVs, PEPFAR Vietnam may continue to be the main
supplier of ARVs and drugs for opportunistic infections for
the next several years. The GVN has requested PEPFAR
Vietnam to assist with their Round 6 application to the
GFATM. PEPFAR Vietnam will assist MOH in this effort where
appropriate. The MOH decision on January 2006 to allow the
procurement and importation of FDA tentatively approved

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generic ARVs will ensure that limited resources reach a
greater number of patients. PEPFAR Vietnam has also offered
assistance to MOH's Drug Administration to provide support
for domestically produced ARVs to receive tentative approval
from FDA. However, the MOH has decided to delay their
application to FDA and apply for WHO prequalification,
citing stringent requirements by FDA.

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The Cost of ART
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25. (U) Currently, the cost of the first-line regimen is
approximately USD 350 per year and is estimated to fall to
as low as USD 320. This is comparable to regimens procured
through other donors such as the GFATM and the Clinton
Foundation. This has been achieved through the importation
of some FDA tentatively improved drugs, which have both
lowered the overall costs and improved the rapidity of drug
delivery. Vietnam has experience delays in delivery of up
to nine months for some branded ARVs. Currently, PEPFAR is
the only donor procuring second-line ARVs, which is
estimated to account for seven percent of the purchased
drugs in 2006. The Clinton Foundation will be procuring
some second line drugs for children for 2007. The current
cost of the standard second line adult regimen is just over
USD 3,000 per patient per year.

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Summary
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26. (U) The lack of sufficient quality and quantity of ARV
to treat Vietnam's HIV/AIDS patients continues to be
troubling. Although Vietnam is receiving considerable
financial and technical assistance from the international
donor community, the introduction of ARV treatment programs
requires infrastructure development, including physical
plants and personnel, at the many levels of Vietnam's vast
health care system administered by the MOH. Domestic
production of low-cost ARVs meeting international standards
of quality does not appear to be coming soon, although the
GVN decided to allow the importation of ARVs with tentative
FDA approval or WHO prequalification. Sustainability of
funding for sufficient quantities of ARV may be in jeopardy
if Vietnam does not contend well in Round 6 of the GFTAM.
Developing a sustainable funding stream for ART and
prevention programs is critical to the ability of the GVN to
control a growing public health problem, and to ensure the
long-term success of PEPFAR Vietnam's initial achievements
in expanding ARV treatment to those in need.

Boardman