VZCZCXRO8416
RR RUEHHM RUEHLN RUEHMA RUEHPB
DE RUEHHI #1450/01 1651014
ZNR UUUUU ZZH
R 141014Z JUN 06
FM AMEMBASSY HANOI
TO RUEHC/SECSTATE WASHDC 2360
INFO RUEHHM/AMCONSUL HO CHI MINH CITY 1352
RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE
RUEHPH/CDC ATLANTA GA
RUEAUSA/DEPT OF HHS WASHDC
RUEKJCS/SECDEF WASHDC

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 
 
 
HANOI 00001450  001.2 OF 005 
 
 
¶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. 
 
--------------------------------------------- - 
The President's Emergency Plan for AIDS Relief 
--------------------------------------------- - 
 
¶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. 
 
-------------------------------- 
The HIV/AIDS Epidemic in Vietnam 
-------------------------------- 
 
¶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. 
 
--------------------------------------------- ---------- 
Antiretroviral Therapies: Opening the Door to Treatment 
--------------------------------------------- ---------- 
 
¶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 
 
HANOI 00001450  002.2 OF 005 
 
 
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. 
 
HANOI 00001450  003.2 OF 005 
 
 
 
------------------------------------------- 
PEPFAR's Strategy for Achieving ART Targets 
------------------------------------------- 
 
¶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. 
 
--------------------------------------------- ----- 
An Action Plan for FY06:  Scaling Up ARV Treatment 
--------------------------------------------- ----- 
 
¶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 
 
HANOI 00001450  004.2 OF 005 
 
 
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. 
 
--------------------------------------------- -------- 
Critical Challenges and Paths to Expand ARV Treatment 
--------------------------------------------- -------- 
 
¶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 
 
HANOI 00001450  005 OF 005 
 
 
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. 
 
--------------- 
The Cost of ART 
--------------- 
 
¶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. 
 
------- 
Summary 
------- 
 
¶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