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PUBLIC
-

PRIVATE INTERACTIONS AIMED AT
INCREASING ACCESS TO AIDS MEDICINES





Phase 1
-

Country Situation Analysis
-

VIETNAM

(Report prepared for Health Action International)







By: Nguyen Tran Lam, ASSR

and

Tran Quoc Tuan,
Dong Da Hospital, Hanoi






















Amsterdam, October 2004







2


Abbreviations and Acronyms




ARV


AUSAID

CBO

CDC

CSW

DFID

DOTS

ESTHER

FHI

GFATM

GIPA

HCM

HHTD

HITD

IDU

LIFE
-
GAP

MCNV

MOH

NORAD

Ois

PHA

TD

UNAIDS

UNODC

VCHAP

WB

WHO



Anti
-
retrovial

Australia Agency for Inte
rnational Development

Community
-
Based Organisations

Center for Disease Control, US

Commercial Sex Worker

Department for International Development, UK

Directly Observed Treatment Strategy

Ensemble Solidarite Therapeutique Hospitaliere en Reseau

Family Healt
h International

Global Fund for AIDS, Tuberculosis and Malaria

Greater Invovement of People Living with HIV/AIDS

Ho Chi Minh City

Ho Chi Minh City Hospital for Tropical Diseases

Ha Noi Institute for Tropical Diseases

Injecting Drug User

A CDC Sponsored pro
ject

Medical Committee Netherland Vietnam

Ministry of Health

Norwegian ODA

Opportunistic Infections

People Living with HIV/AIDS

Treatment Doctor

United Nations for AIDS

United Nations for Drug Control

Vietnam
-
Harvard Medical School Project

World Bank

World

Health Organisation



















3


Table of Contents


1. Overview

2. The Health System and ART Program: Critical Aspects

2.1 Institutional change

2.2
-

Treatment network capacity

2.3
-
Wage policy and corruptions

2.4
-
National guidelines on diagnosis and

treatment

2.5
-
Training and research

2.6
-
The integration of treatment and care

2.7
-
Infrastructure

2.8
-

Private models

2.9
-
Access and equity

2.10
-
Treatment progression 1990
-

2004

2.11
-
Problems with the drug use:

2.12
-
Treatment adherence

2.13
-
Stigma and dis
crimination

2.14
-
Ethical issues

2.15
-
Interactions between HIV/AIDS care and other programs


























3. Community involvement

3.1
-
ART related ongoing programs

3.2
-
Local NGO
-

CBO

3.3
-
The involvement of PHA, IDUs, CSWs


4
-

ARV Situation

4.1. Overview

4.2
-

Kinds of ARVs, manufacturers an
d prices

4.3
-

Drug policy and patent issues


5
-

Challenges

5.1 Health systems

5.2. Adherence

5.3. Equity and accessibility

5.4. Ethical issues

5.5. Community involvement

5.6. Drug policy and patent issues


6
-

Emerging Issues


Reference

List of Annexes

Ann
ex 1
-

ARV Related pending projects

Annex 2
-

ESTHER Project

Annex 3
-

Global Fund project

Annex 4
-

Patent status of 22 ARVs

Annex 5
-

List of stakeholders




4

1. Overview


Currently, Vietnam is in the concentrated epidemic stage. HIV prevalence had increased
si
gnificantly in all surveillance populations in the 1990s. The current prevalence among
IDUs
and CSWs is 26.8% and 4.2% respectively. The prevalence

among adult population is 0.4%
(2003); pregnant women 0.34% (2002)
-

but in some areas
1%;

and among military

0.7%
(2002).
The national HIV prevalence increased from 0% in 1994 to 0.7% in 2002 among TB
patients.
Estimated, 200,000 people (2/1000 total population) are living with HIV/AIDS. The
majority (65%) of reported HIV cases are among IDUs. As estimated, with

30,000 people are
now in need of ARVs,
Vietnam needs $150 mil to cover treatment cost for 2004 alone.

Although the epidemic is becoming worse and there is a high demand for ARVs to be
made widely available, Vietnam is not well prepared for a large scale
ART program. The
national health system is currently under
-
equipped to deliver or monitor treatment services.
Public
-
private interactions on ARVs are operational mainly at national level and almost
non
-
existent at provincial and district level. Treatment g
uidelines on ARVs and Ois are being
revised. The involvement of civil society is very limited. The participation of PHA in the
AIDS program is merely a token effort. Drug policy is being amended. Negotiations between
the government and WB, UNAIDS, and othe
r pharmaceutical companies are in progress.
Recently the MOH has submitted to the Government a proposal titled “Access to AIDS
Medicines Initiative”, which covers three directions: a) negotiating with international
pharmaceutical companies for reduced ARV
price; b) domestic manufacturing; c) developing
traditional regimens. However, the fact that Vietnam is going to become a member of WTO
(possibly 2007) may affect this process because once recruited, Vietnam should be obedient
to WTO/TRIPS patent regulatio
ns.

There is also a good sign that the Government budget for AIDS treatment has increased
over the last three years ($191,000 in 2003; $ 637,000 in 2004; and is expected to $ 955,000
in 2005). Measures to speed up national efforts on HIV/AIDS were discusse
d during the
December 2003 Consultative Group (CG) Meeting. The
Ministry of Planning and Investment
made a commitment to work with other Ministries to develop streamlined approval
procedures for HIV/AIDS projects
.

On 17 March 2004, the new National Strat
egy on HIV/AIDS Prevention and Control for
2004
-
2010 and 2020 vision was approved. This is the backbone legislation for the national
AIDS program, including ART program. Some fresh components of the strategy include: a)
Approving harm reduction as policy f
or HIV prevention; b) calling for greater involvement of
PHA; c) establishing self
-
help groups; and d) emphasising the rights and responsibilities of
PHA. According to this strategy, until 2010, 70% of PHA will be treated with ARVs; 100%
pregnant women and

children with HIV/AIDS will be provided with appropriate treatment,
care and counselling (NCADP, 2004, p143). This is actually a good goal; however, the
translation of this strategy into practice is supposed to be difficult in terms of insufficient
instit
utional capacity (the role of each level agency is unclear, both horizontally (across
ministries; between government and civil society) and vertically (central government vs. local
authorities)

Since 2003, the UN, bilateral agencies, INGOs have substantia
lly increased financial
support for Vietnam (now about $15 mil per year). Major funding sources come from Global
fund, USA, UK, Norway, Germany, Australia, Canada, France, ADB and WB In June 2004,
Vietnam was named by President Bush as 15
th

country eligibl
e for US $15 bil. Global AIDS
Plan ($10 mil will be released this year; $8 mil was already received earlier). PEPFAR hopes
to prevent 660,000 new infections; care for 65,000 people infected and affected; and provide
treatment for 13,000 PHA. Clinton Founda
tion’s Executive Director, Edward Wood, came to
Vietnam in 12 July 2004, with a promise to further assistance to Vietnam’s HIV prevention
research and activities. CDC Vietnam (via CDC
-
LIFE GAP Project) also runs a project ($10
mil for 5 years), which focus
es on setting up outpatient clinics and treating OIs.
The most
important source to purchase ARVs is the Global Fund
project “Strengthening care,
counselling and support for PLWAs and related community based activies to prevent

5

HIV/AIDS in Vietnam”. The tot
al budget approved is $12 mil and the project will be
implemented through 2004
-
2007, covering 20 provinces and 3 regional hospitals. However,
the actual budget for ARV purchase has not been determined (see annex 1). So far, only the 3
year ESTHER project s
upported by France provides money to buy ARVs to treat 100 patients
a year (annex 2).


2. The Health System and ART Program: Critical Aspects


At the Donor meeting on Health Sector on 8
-
9 April 2004, the Minister of Health stated that
until 2005, 70% (abo
ut 15,000 persons) of PLWA could buy cheap ARV. This is really an
ambitious goal, given the fact that the national health system is currently under
-
equipped to
deliver or monitor treatment and care services. In order to increase access to ART program,
Viet
nam should deal with a wide range of problems.


2.1 Institutional change


Since 1987, the executive organisation to deal with AIDS has undergone many changes in
terms of structure, as shown below:




1987: Sub
-
Committee of AIDS established within MOH, Chaire
d by the Director of
National Institute of Hygiene and Epidemiology (NIHE)



1990: National AIDS Committee (NAC) set up, chaired by Minister of Health



1994: NAC upgraded to Government Office, chaired by Deputy Prime Minister, with 16
members from ministries
and mass organisations



2000:National Committee for Prevention and Control of AIDS, Drug Use and
Prostitution, chaired by Deputy PM



2003: National AIDS Bureau was dissolved; Department for Preventive Medicine and
HIV/AIDS was set up.


Because of these chang
es, many officials have moved to new positions, and many others had
to abandon their full time position, looking for another job. This personnel chaos affects the
quality of AIDS work within this government body. The Department for Preventive Medicine
and
HIV/AIDS, with a limited number of both old and new staff, seem unable to manage
different big programs at the same time.


2.2
-

Treatment network capacity


-

Since 1995, Hanoi Institute for Tropical Diseases (HITD), Hue Central Hospital, and Ho
Chi Minh Hosp
ital for Tropical Diseases (HHTD) have been assigned as three regional
centers responsible for developing guidelines and treatment program in the Northern,
Central and Southern parts respectively. HITD takes the overall guidance for AIDS
treatment work nat
ionwide.

-

Often, AIDS patients are referred to Infectious Disease Departments located within a
hospital. If these patients have TB or STDs, they are referred to TB Institute or
Dermatology Institute. The problem is that in these ID departments, PHA and non
-
PHA
are mixed up. Number of beds is very limited to meet the increasing number of AIDS
patients. For example, there are only 10 beds at HITD; 20 beds at Dong Da Hospital; and
10 beds at HHTD. Meanwhile, number of HIV/AIDS inpatients has increased rapidly
(for
example, from 152 (2001) to 298 (2003) in Dong Da Hospital; from 658 (2001) to 1457
(2003) in HHTD). As a result, these departments are overloaded with AIDS patients.
Normally, 2 or even 3 patients have to share one bed. Most of PHA ( above 95%) in
Vi
etnam are outpatients.

-

To deal with this problem, some models were initiated. On 01 December 2003, the first
HIV/AIDS outpatient clinic in Vietnam was opened in the Clinical Institute for Tropical

6

Diseases, Bach Mai Hospital in Hanoi. The clinic provides H
IV test monitor, medicine
(limited) to PHA and some counselling. It is estimated that the clinic can conduct tests
and provide counselling services for about 100 persons and this model will be applied in
at least 40 cities and provinces in the time to come
. In Ho Chi Minh City, the biggest
Community Support and Counselling Center for people living with HIV/AIDS in
Vietnam was also opened on 29 November 2003.

-

Due to stigma and discrimination, new information about AIDS medicine, and mistrust in
local doctor
capacity, more AIDS patients from different provinces (
benh nhan vuot
tuyen)

are rushing to urban hospitals for their treatment. Most of PHA coming here when
their illness has become serious, and thus they are unable to pay for medicines. Usually,
PHA are
released from the hospital after the treatment of opportunistic infections. As
most of them are poor and homeless, many decide to stay in the hospital. This is really a
burden to the hospital and hospital staffs.

-

Similarly, most of obstetric and gynecology

hospitals would feel relieved if they could
transfer children born to infected mothers to the children hospital as soon as they have an
excuse. The fact is, with the exception of Tu Du Hospital (in HCM City), most of the
other obstetric and gynecology hos
pitals don’t have the necessary facilities and are not
ready to care for those children.


2.3
-
Wage policy and corruptions


This is one of the hottest topics, which were frequently mentioned by health personnel, who
often complain about inappropriate wage

policy of the government. The average salary of a
medical doctor is about $50/month, which, as they say, is “not enough for daily breakfast”.
This is one of the reasons that make some health personnel to sell medicines to the black
market. To earn a livin
g and to maximise the profit, there is also a sophisticated network
between marketing people (from pharmaceutical companies or private companies), health
personnel, and pharmacists: doctors often prescribe the medicines, which are available at the
hospital

pharmacy. The doctor then advises the patient to go and buy at that “convenient
pharmacy”, where the price is often higher than outside market. The hospital pharmacist then
has to pay some commission to the doctor for his prescription and patient referral
. In this way,
the doctor is compensated both by the marketing staff and the pharmacist. Some treatment
doctors also have private consulting room, where drugs are illegally distributed and sold back
to patients, who come there after the doctor’s advice.



























2.4
-
National guidelines on diagnosis and treatment


The first HIV case was reported in 1990. Since 1993 the epidemic has developed rapidly.
Ho
wever, only until 2000 that the National Guideline on
diagnosis and treatment was issued,
yet merely focusing on OIs treatment. During 1993
-
2000, it was unclear about the treatment
regimen applied by both Northern and Southern doctors. Currently, the new G
uideline (both
on ARV and OIs) is still being drafted
. A group of experts has been set up for the revision,
which is based on guidelines of WHO and other models (ESTHER, VCHAP, Thai Land) and
hopefully available by the end of this year. Thus, for years, tr
eatment doctors did not know
about the appropriate diagnosis and treatment. The prescription of ARVs, as some said, was
based on the doctor’s “feeling”, drug availability at moment of prescription and, in many
cases, the doctor’s money motivation.


2.5
-
Tr
aining and research


-

There is a great demand for various training types in Vietnam, as a doctor said:


It is very difficult for the increasing access to ARV program in Vietnam…there
should be training coursers…for different people at different levels. I m
ean the
decentralisation of management…it is vital for the treatment program…


7

(A TD, Hanoi)


-

CDC Vietnam has supported Harvard University in providing training courses on HIV
management and treatment (including management of ARV) for health professionals a
t
different levels. MOH/LIFE
-
GAP staffs were trained to develop “standard operating
procedures” for the outpatient clinics and data monitoring and evaluation systems. CDC
is also supporting MOH/LIFE
-
GAP project and the National TB Program in promoting
earl
y identification, referral and treatment of HIV
-
TB co
-
infected patients using a variety
of programs.

-

A greatest obstacle for ART program in Vietnam is the neglect of social sciences, such as
anthropology, psychology and sociology. During the last ten years
, research programs
have focused only on medical aspects of the epidemic, forgetting the social paradigm.
Given the fact that the number of social scientists working on AIDS is very short, it is
important for Vietnam to provide training courses on social a
spects of the epidemic for
health care providers, especially those are engaging in the ART program.

-

Foreign language training is an important topic raised by many health workers, especially
treatment doctors. Due to foreign language capacity, health worker
s cannot access update
information outside Vietnam. Meanwhile, the domestic materials or guidelines are often
out of date. Some “International best practices” are translated into Vietnamese
inaccurately. This language limitation also creates some problems
(for example, research
output dissemination, communicating with international experts, etc). CDC
-
LIFE GAP
project is a pioneer to fill in this gap, by proving funding for several staff to attend
English short courses in the US.


2.6
-
The integration of trea
tment and care


-

There are no documented examples of programs that integrate ART into the continuum of
HIV/AIDS prevention and care.

-

Up to now there are few projects (CDC, ESTHER) adapting this model

-

In fact, treatment programs and care programs are separa
tely conducted by different
institutions (Government agencies deal with treatment; NGO deal with care). There is a
lack of coordination and collaboration between these agencies, leading to the overlapping
of activities.


2.7
-
Infrastructure


There is a grea
t shortage of laboratory services. Clinical monitoring is especially difficult for
many regions. Nationwide, only 8 centers are equipped with CD4 counting machines.


CD counters in the North:



HITD: 01 FAS Calibur
-

Becton
-

Dickison (USA); price (1998): $

65
-

70,000



The Central Institute for Blood Transfusion: 01 FAS Count
-

BD (USA); price (1995) $
45


50,000



Army Hospital 108: 01 FAS Count
-

BD (USA); price (1999): $ 50,000.



Dong Da Hospital: 01 CyFlow Counter


CyTecs (Germany); belongs to
ESTHER
proj
ect

; price $ 22,000



2.8
-

Private models




There are only few private treatment doctors nationwide, concentrated mainly in
Hanoi and HCM city. Often
treatment doctors have their own consulting rooms, which
also attract some well off PHA who come for treat
ment and ARV purchase. However,
one can not be sure about the quality of treatment and care in these services


8



In terms of treatment alone, there is a lack of (even no) collaboration between public and
private sector.



Some well
-
off PHA also seek care from t
raditional healers after being treated by public
doctors. These patients do so partly because their confidentiality is not secured when they
go the public sector for treatment.


2.9
-
Access and equity


Although the number of PHA who need ARVs is substantial
ly increasing, only a few people
can have access to treatment program. Within the Government budget ($200,000

per year)
,
priority is given to government officials
who are infected through occupational risks (i.e.,
health workers, policemen, etc) and positi
ve pregnant women and children. Because of the
high cost of ARVs and the lack of appropriate services, only a few well off PHA living in big
cities (Hanoi, Khanh Hoa, Ho Chi Minh) can have access to ART program.


In Vietnam, Esther project is so far the f
irst program aimed to
improve both treatment and
care for PHA. Inclusion criteria are WHO
-
based ones, but strictly applied to those who are
Hanoi residents, not currently injecting drugs, and do not have active TB. Given the fact that
nearly seventy percen
t of PHA in Vietnam are IDUs (many among them are women), it is
necessary to develop more equal approaches so that IDUs can be benefited from the ART
program.



2.10
-
Treatment progression 1990
-

2004




1990
-
1995: AIDS programs focus merely on IEC work



1995
-
2000: providing some OI treatment and care; ARV monotherapy (Zidovudine)



2000: MOH issued guidelines on HIV/AIDS diagnostics, treatment, OIs, and ARV
regimens



2000
-
2003: see Table 1


Table1
-

Treatment regimens 2000
-
2003



1 Drug

2 Drug Therapy


3 Drug Th
erapy

For adults

CD4
200
-

499
cells/ mm
3
, RNA
5,000
-

10,000
copies/ mm
3


Alternatively:

Zidovudine+Lamivudine

;

Didanosine + Stavudine

;

Zidovudine + Didanosine



Clinical symptoms
at category C
(CDC standard) or
CD4<200;or RNA
>10,000cop/m
m
3



Combivir

(ZDV + 3TC) + Indinavir

Zidovudine +Didanosine + Indinavir

Zidovudine+ Zalcitabine + Indinavir

Stavudine + Lamivudine + Indinavir

Stavudine + Didanosine + Indinavir

For ppregnan women
,

From 36 week of
pregnancy:

AZT 600mg




During delivery:

AZT 300mg

or
Nevirapine
200mg



For children




0


6 years

Zidovudine
2mg/kg/6hrs
starting 8
-
10
hrsafter born




9

Below 13 yrs


Combined regimen

Zidovudine: 5mg/kg

Didanosine: %mg/kg

Zalcitabine: 0,01 mg/kg

Lamivudine: 4mg/kg





From June 2004: new treatment gui
deline is revised and hopefully ready by Dec 2004



It is noted that the treatment regimens are differently practiced by Northern and Southern
treatment doctors (TD), subject to the availability of ARV at the moment of treatment and
the doctor capacity:


…no
t many [TD] know that [regimen]…many people [TDs] prescribe any medicine
[ARV] available, without caring about the effect of drugs…they use ddI, d4t and
crixivan [indinavir], because first they don’t understand about the standardised
treatment regimenl, se
condly due to a sharp shortage of commodity [ARV], so they
have no choice, and let it be…meanwhile patients want to be treated…but at that
moment there were only such drugs, so [the doctor] had to prescribe like that ,
accepting the wrong regimen..and this

creates drug resistance

(a TD, Hanoi)

2.11
-
Problems with the drug use:


-

Commonly, Vietnamese people use drugs very freely following self
-
diagnosis, obtaining
their medication from pharmacists: their justification for using certain medicines is not
always
guided by a scientific rationale

-

All kinds of drugs, including ARVs, are sold without prescription.

-

PHA families often spend a great deal of money on herbal medicines, which have their
own benefits.

-

Prescription itself is also problematic: the drug prescr
ibed is subject to the marketing
drugs available. In addition, physicians themselves lack of knowledge and info about
ARVs

-

A drive for profit making leads to corruption, violating medical ethics

-

A lack of control in drug management


2.12
-
Treatment adherenc
e


-

Most of treatment doctors I met said that non
-
adherence is very serious. Although
compliance is one of the inclusion criteria and patients should sign in a compliance form,
but this signature is only superficial in nature. Written consent is affected by

low level of
education of patient, and the “pressure” of the doctor. Many patients fail to return to pick
up the treatment drug. This is also because most of doctors do not provide any
information or counselling to their patients.

-

For IDUs, adherence is
more problematic. Because of craving or heroin motivation IDUs
may give a written consent by signing the form to take the drug. But then they sell the
medicine for addictive drugs. Our observations show that IDUs need heroin more than
ARV. This difficulty
is reinforced by the fact that follow up activities are nearly non
-
existent. It is suggested that IDUs should take drug with the witness of health workers.

-

Often those who are accidentally infected from their spouses; or those infected from
positive sex wo
rkers express great desire to live. These people regret for what they did in
the past and are more obedient to doctor advice, and thus more compliant to ART
program.

-

Because of high rate of non
-
adherence, side effects and drug resistance are very common.
A
lso, due to adverse effects of ARVs, some people throw the drugs away.

-

Confidentiality is also an important factor that impedes adherence. Some regulations of
the health system structure make PHA confidentiality insecure. For example, if someone
is tested
positive at 05
-
06 centers (rehabilitation camps), his or her positive test result is

10

notified to the residential authority. This process leads to the disclosure, which, again
leads to distrust in the authority, culminating in non
-
adherence.

-

Often when the
symptoms of AIDS develop, doctors advise the family to feed the patient
the best food possible (sugar, milk, meat, fruit). Such advice, however signifies the
seriousness of the patient’s situation, and thus frighten the family, leading to non
-
adherence.


2
.13
-
Stigma and discrimination


-

Stigma and discrimination are strongly associated with the behaviour that leads to being
infected, especially for sex work and drug injection.
IDUs and CSWs are presented as
“vectors” or “bridging populations”. As risk is def
ined on the basis of occupational
description, being an IDU or CSW is synonymous with “high risk groups” or “social
evils”. The stigma is so strong that even female IDUs hide their occupation as a SW to
their male injecting partners

-

Vietnam has no AIDS an
ti
-
discrimination law in the workplace and PHA are often
deinied the basic right to support themselves and their families. While
PHA rank job
opportunities for themselves and their family members as the most important intervention
to improve their living c
ondition, they fear discrimination especially when seeking and
maintaining employment opportunities.

-

In a 200 workers survey, 88% respondents linked HIV/AIDS with “social evils”; 70%
said PLWAs should not be allowed to work; 63% said they should work in a
separate
area; one third said they should be fired. For years, the stigma was fuelled by the
government policy of stereotypically linking it to the so
-
called “social evils”. Many
people say PLWAs deserve their fate and should be excluded from the society

-

Health workers hold similar attitude towards their AIDS patients. In a Quang Ninh study,
93% felt that health care professionals should be allowed to test patients for HIV without
consent; 35% of the physicians agreed that health workers should have the ri
ght to refuse
working with AIDS patients. Almost all of them want to have separate hospitals for
PLWAs. Such attitudes enforce stigma.

-

PHA suffer from a lack of human rights protection and discrimination and marginalised
by their legal status.

-

PHA familie
s also experience stigma

-

Greater level of stigma is experienced among women than men; women are deprived of
parenting rights


2.14
-
Ethical issues


-

Due to the shortage of staff, a treatment doctor often takes responsibility in different
tasks, including som
e positions in different projects and programs. This reduces the
required time a doctor should be devoted to his patients.

-

Some doctors have private consulting rooms and thus trying to attract patients to go there.
By this way, the doctors can gain money f
rom selling medicines to patients. This affects
their treatment quality at the hospital.

-

There is an emergence of corruption of many kinds thanks to the influx of funding
sources for AIDS programs and ARVs in particular.

-

For many years before the Renovatio
n under the subsidy system health workers had been
accustomed to ‘loosely
-

working style’ and bureaucratic manners. Many say they can not
follow the strict regulations required by some AIDS programs and projects. As a result,
with the slogan “low salary, l
ow quality”, some treatment doctors still maintain the old
working style, neglecting the quality of their work, and thus affecting the quality of care
for the patients.

-

Although there are some inclusion criteria for ART program, concern is raised in terms

of
competition between PHAs themselves. Consequently, those who have more access to

11

information will be more easily to be recruited. PHAs who live in rural areas (and even
doctors working in these areas) are marginalised off the ART programs.

-

PHA utilisat
ion of health services is haunted by the fear toward aggressive services


2.15
-
Interactions between HIV/AIDS care and other programs


-

PMTCT, VCT, TB, and harm reduction programs run separately. However, in Hanoi, Hai
Phong, Khanh Hoa, Ho Chi Minh City ther
e are some good “pilot models”, which link
these programs together

-

There is a lack of coordination between TB and AIDS program although t
he impact of the
HIV epidemic on TB is substantial. The number of patients who died because of
TB/AIDS co
-
infection in
HCM city was over 50% of all patients who died of TB.
TB
doctors have little knowledge about ARVs and pharmacological interactions between TB
drugs and ARVs.

-

ART program in Vietnam tends to adapt DOT model. However, duration of TB
-
DOT is
limited whereas AR
T is life long. Given that the number of people in need of ARV is
increasing and the involvement of community is weak, how can health workers observe
treatment

taking behaviour?

-

Esther project is a good model which networks with local and international as
sociations
related to HIV/AIDS activities involved in Dong Da hospital (and Saint Paul hospital).
Patients referred by outpatient clinics and Communication Service are considered to be
enrolled in ESTHER project.

-

There are some initial collaborations betwe
en Australian Red Cross (IEC), ESTHER
(psychological and nutritional assessment), CDC
-
Life Gap (prevention, care and OI
treatment) and MCVN (support for positive women and children).


3. Community involvement


Vietnam is currently receiving assistance from

multilateral and bilateral agencies,
International NGOs and the Global Fund for a range of activities supporting prevention, care
and treatment.

The many donors and NGOs on the ground offers real advantages that can be
blended and built upon to maximize
effectiveness of resources (see annexes 3,4,5)
.
Below are
major donors in Vietnam and their contribution:

-

ESTHER, CDC/VCHAP: clinical training

-

Policy Project, FHI: community based care and support

-

DFID/NORAD, CDC, AuSAID: harm reduction

-

Global Fund: ARV, c
are and support

-

UNAIDS, UNODC: multidisciplinary collaboration


3.1
-
ART related ongoing programs


a. Global fund initiative (see annex 3)

b. Esther project (see annex 2)

c. UNAIDS pilot program


-

This was the first initiative on ART in Vietnam (2000) suppor
ted by UNAIDS, which
provided ARVs for four countries (Vietnam, Uganda, Cote d’Ivoire and Chile). However,
only small amount of ARVs was purchased from Boehringer to support mother
-
to child
transmission program. Some respondents say this program runs slowl
y and ineffectively.


d. CDC
-

Life Gap project


CDC provides technical assistance and financial support for prevention and care programs in
40 provinces, focusing on the following areas:


12


-

Anonymous voluntary counseling, testing, and referral services (VC
T) for highly
vulnerable populations (now running in 18 provinces);

-

Community outreach programs using peer educators to provide information, support, and
referral services to IDUs and CSWs (now running in 18 provinces);

-

A model prevention of maternal
-
to
-
ch
ild transmission program

that promotes early HIV
testing,

provides early

ARV therapy (AZT/3TC) to

HIV
-
infected women;

encourages safe
delivery with

trained obstetricians at district or provincial facilities; provides

formula
substitution for willing women
who have access to safe water; and uses a community
-
based health worker for

support pre and post delivery (running in 3 provinces);

-

Support for early diagnosis and referral of TB
-
HIV co
-
infections through a variety of
community programs, and with collabora
tion from the National TB Program (running in
4 provinces);

-

Support for HIV outpatient services at provincial and district hospitals, with collaboration
from the National Institute of Clinical Research on Tropical Medicine and regional
hospitals (running i
n 18 provinces including the program at Dong Da Hospital in Hanoi);

-

Specifically the support for HIV outpatient services entails provision of basic clinical and
laboratory services for HIV infected patients, promotion of "healthy living" practices in
PHA,
and provision of counseling to reduce HIV infections to partners. Program
components include preventing, screening, and treatment of opportunistic infections;
counseling on preventing transmission, partner notification, healthy living and nutritional
pract
ices; referral to social support and other services in the community


e. Medical Committee Netherlands


Vietnam (MCNV)


MCNV is supporting a pilot project focusing on positive women and children. A support
group for positive mothers and children was set u
p in April 2004. Currently the group has 10
members and is operating in cooperation with Dong Da Distirct Red Cross. This group
provides access to: nutrition; vaccinations; medical examinations; referral; income generation;
conflict resolution; community r
ecruitment and information.


f. Australian Red Cross


ARC supports Hanoi Red Cross, Dong Da Red Cross, and Dong Da hospital to establish a
“Communication Room” located in the HIV/AIDS ward, Dong Da hospital. The intention of
the room is to provide IEC rela
ting to HIV/AIDS. The room was officially opened on 11 June
2004. It is open on Tuesday afternoons, at the same time that the ESTHER program
participants come to the hospital to collect their ARV drugs. On Friday afternoons, inpatients
and out patients mee
t and talk in this club. The room is managed by peer educators.


3.2
-
Local NGO
-

CBO


The involvement of local NGO
-
CBO is one of the weakest components in the ART program.
Up to now there are few community and home based care models in Vietnam. Although in
1998 the MOH launched the QCT model (management
-
care
-
counseling), it is only superficial
and non
-
operational.


3.3
-
The involvement of PHA, IDUs, CSWs


-

The involvement of PHA, IDUs, and CSWs is merely a token effort. Up to now, there is
no systematic analys
is exploring the needs, coping strategies and linkages of and between
PHA. Groups of PHA exist but are not coordinated through network and thus non
-
sustainable.

-

GIPA (Greater Involvement of People with HIV/AIDS) is the first project dealing with
the needs
and coping strategies of PHA in Vietnam


13

-

Some pilot models: Vietnam's first needle exchange project conducted at C
afe Hy Vong
;
There are some Condom Cafes in Hanoi and HCM city

-

The only End
-
of
-
life care center in Vietnam, Mai Hoa Hospice, established in 200
1 by a
religious association (Tu hoi Nu tu Bac Ai Vinh Son), with 20 beds. The objective of this
hospice is to provide charitable care and treatment for infected adults and children.
However, difficulties are numerous regarding a small and unstable fund an
d limited
capacity of physicians who can provide appropriate care and treatment

-

IDUs, who take up 70% of PHA, are currently excluded from ARV program.


4
-

ARV Situation


4.1 Overview


-

In 1998, within the UNAIDS Initiative, the Governmenr p
rovided a mechani
sm for the
importation of medical products at subsidised prices, which does not require the
establishment of a non
-
profit company. Imports of HIV/STD drugs were made through
one of four national import companies.

-

In 2002 The National AIDS Control Programm
e imported 20 different AIDS medications
from abroad.

-

Currently, nine different ARVs are registered in Vietnam
(see Table 2)
. Most of them are
branded products, and are imported. However they are not always available and their high
prices are unaffordable
for most PHA. In addition, four manufacturers have a license
from the Ministry of Health (MOH) for the local production of ARVs. However, only one
company (STADA Vietnam JV Ltd) is actually producing. Currently STADA has two
ARV products on the market (lam
ivudine and a combination tablet of
lamivudine+zidovudine). STADA buys raw materials from a company in India and
supplies the product in Vietnam. It also exports lamivudine to some countries in Africa.

-

Local manufacturers in Vietnam have not been prequalif
ied by WHO.

-

The market and manufacture of ARVs in Vietnam is very restricted. All 22 ARV drugs
are under patent
(see Annex 4)

-

No appropriate first line triple regimen (as recommended by WHO) is available from
local producers. It is recommended that the su
pply of first line ARVs has to be expanded
to include efavirenz, nevirapine and stavudine.

-

Prices of the two ARV drugs currently produced in Vietnam are generally much higher
than the current international best prices, as shown in

Table 3
.


Table 2. Antir
etrovirals Registered in Vietnam (July 2003)


First line ARVs

Registered

Second line
ARVs

Registered


Originator
brand

Generic


Originato
r brand

Generic

Zidovudine



Abacavir



Lamivudine

yes

yes*

Tenofovir



Stavudine

yes


Didanosine

yes


Nevir
apine



Lopinavir/Ritonav
ir

yes


Efavirenz



Ritonavir

yes


Stavudine+Lamivudine



Saquinavir

yes


Zidovudine+Lamivudine

yes

yes*




Zidovudine+Lamivudine+N
evirapine



Other ARVs:



Indinavir

yes


Stavudine+Lamivudine+Ne
virapine



Nelfin
avir





* Locally produced ARVs


14


Table 3
-

Cost per Patient per Year (US$)



Lamivudine 150mg

Lamivudine+zidovudine
150/300mg

Current price imported ARVs
(originator company)

$ 1860
-
2240

$ 2336

Best offer originator company
(Vietnam not eligible)

$ 69*

$ 237*

Locally produced

$ 487

$ 949

International best price
i

(WHO prequalified)

$ 65*

(Hetero, India)

$ 197*

Cipla (India)

Manufacturers’ sales price. Note that the actual price of these products in Vietnam would be about 30%
higher (due to the cost o
f transport, insurance and taxes).



4.2
-

Kinds of ARVs, manufacturers and prices


In general, AIDS medicines appeared in the south (mainly HCM city) earlier than those did in
the north (mainly Hanoi). Also, there are more kinds of ARVs in HCM market (se
e Table 4
and Table 5)


Table 4
-

ARVs in Ha Noi


Product


Manufacturer

Cost/ month

VND

Cost/unit (USD)

National program
-

bidding winners


AZT 100mg, 300mg+3TC 150mg
(Combivir)

GSK


0.89

Zidovudine (AZT)

GSK


-

Epivir (3TC)

GSK


0.34

DDI (Videx) 25
-
100 mg

BMS


-

D4T (Zerit) 30 mg

BMS


0.75

Indinavir (Crixivan) 400mg

MSD


-

AZT+3TC (Lamzidivir)

STADA


0.82

Nevirapine (Viramune) 200mg?

Boehringer


0.71

Saquinavir 200mg?

Roche


-

Market (visa registered)

DDI (Videx) 25mg, 100mg

BMS

1.200.000


D4T (Zerit) 30mg

BMS

1.820.000

0.75

Indinavir (Crixivan)

-
> DDI+D4T +Indinavir
-
> 4.6mil/month

MSD

1.600.000



Zidovudine + Lamivudine (
Lamzidivir)


STADA

720.000


Lamivudine 150mg

STADA

540.000


Stavudine 30mg

STADA

300.000


Stavudine 40mg

STADA

330.
000


Nevirapine

STADA

540.000


Black market (hang xach tay)

Zidovudine + Lamivudine (
Combivir)

GSK

2.700.000

0.89

Abacavir +lamivudine+zidovudine (Trizivir)

GSK

5.900.000

-

Zidovudine 100
-
300
-
600mg

GSK


-

Indinavir (Crixivan) 200mg

MSD


-








15

Tabl
e 5
-

ARV in HCM City


1. Zidovudine (AZT), 1987

Retrovir 100, 300 mg

TTM: 10mg/ml

Syrup: 10mg/ml

Zidovex 300mg (India)

AZT 100mg? (VN, Korea)

2. Dinanosin (DDI), 1991

Videx 200, 150, 100, 50, 25 mg

3. Zalcitabin (DDC), 1992

Hivid 0,375; 0,75 mg

4. Stavudi
n (D4T), 1994

Zerit 15, 20, 30, 40 mg; syrup 1mg/ml

5. Lamivudin (3TC), 1995

Epivir 150mg; syrup 10mg/ml

Lamivox,Virolam,Lamiret, Lamidac,…(India)

Hivir (Korea)

Lamivudin (MST, VN)

6. Abacavir (ABC), 1999

Ziagen comp 300mg; syrup 20mg/ml

7a. Two drug combi
nation: AZT/3TC, 1997

Combivir

Virocomb

Lamzidivir (MST, VN)

7b.Three drug combination: AZT/3TC/ABC,
2001
-

Trizivir

8. Nevirapin (NVP), 1996

Viramune comp 200mg; syrup 50mg/ml
(Boehringer)

9. Delavirdin (DLV), 1997

Rescriptor comp 100mg, 200mg

10. Efaviren
z (EFV), 1998

Sustiva, Stocrin 50, 100, 200mg

11. Indinavir (IDV), 1996

Crixivan 200, 333, 400 mg

12. Ritonavir (RTV), 1996

Norvir 100mg; syrup 600mg/7,5ml

13. Nelfinavir (NFV), 1997

Viracept 250mg

14. Saquinavir (SQV), 1995

Invirase, Fortovase 200mg

15. A
mprenavir (APV), 1999

Agenerase 50, 150mg

* Lopinavir/Ritonavir (LPV/RTV), 2000


4.3
-

Drug policy and patent issues


-

22 ARV drugs are under patent protection or subject to patent applications. Patents have
also been granted to protect new uses and new com
positions of the known ARV drugs.
Yet, for some ARVs, these patents do not cover some useful Fixed Dose Combinations
(FDCs), or certain single component products. As a result, some useful FDCs, and the
generic versions of several single ingredient products

can be marketed and used without
violating patents.

-

Vietnamese law requires pharmaceuticals to be registered with the competent authority
before they are sold domestically. Only a limited number of ARV drugs are currently
registered in Vietnam. Therefore
‘missing’ ARV drugs, especially those needed for the
WHO
-
recommended first line regimen, should be registered as soon as possible.

-

Vietnam protects intellectual property (IP) rights under the Civil Code of 1996, which
stipulates three conditions that a pat
entable invention must satisfy: (i) novelty; (ii)
inventive step; and (iii) industrial applicability. The most important regulation for the
protection of patents is the Decree 63/CP, 24 October 1996, for the Implementation of the
Provisions of the Civil Co
de on Industrial Property, which is amended and supplemented
by Decree 06/2001, 01 February 2001.

-

Vietnam is seeking entry to WTO. Although Vietnam is not tied by TRIPS, the USA
-
Vietnam Bilateral Trade Agreement (BTA) contains several provisions similar to

those
under TRIPS.

-

Compulsory licensing

provisions under Vietnamese patent law are more restricted than
necessary. Notably, the conditions are more stringent than required by TRIPS and the
BTA.

-

The law limits the amount of a drug a person can import to

Vietnam for personal use.
This prevents the entry of generic drugs into the market and constrains

-

Foreign investment is encouraged in the production of medicines from natural material
available in Vietnam as well as the transfer of technology to domestic
enterprises


16

-

Most specialized drugs must be imported, and 90 per cent of the ingredients used in
domestic drugs are imported, leading to high prices,

-

Domestic industry has focused too much on producing commonly used drugs, causing a
shortage of medicine for

more serious diseases.

-

MOH has also pledged to protect domestic drug manufacturers by using trade barriers
that do not violate international rules.


5
-

Challenges


5.1 Health systems


-

Identify different needs, views, and links of different institutions an
d groups

-

Training for public and private physicians about social and medical aspects of ART
program (in particular:
ethical principles of informed consent, confidentiality, ethical
disclosure and partner counselling
, adherence, stigma, side effects, drug r
esistance;
storage and quality management of test kits; the use of test kits; record
-
keeping; foreign
language for treatment doctors)

-

Unavailability of National guidelines on safe storage as well as the regulation for
accountability of clinicians

-

Quality o
f care: infrastructure, laboratory, staff, community involvement, mechanism to
deliver ARVs: centralised vs de
-
centralised.

-

Decisions should be made about which type of health care worker should provide ART
and at what level of the health care systems this

treatment should be provided.

-

There is a great need to evaluate on
-
going initiatives (e.g. Management
-
Care
-
Counselling
-
QCT; pilot models on OIs and ARVs) and draw lessons for action.

-

There is a shortage of social scientists on AIDS


5.2. Adherence


-

Counse
lling, social support, psychology, nutrition

-

Treatment monitoring

-

Hospital administrative obstacles

-

Stigma

-

Side effects

-

Drug resistance

-

Confidentiality

-

The range of costs for test, ARVs, transport, boarding, bribery


5.3. Equity and accessibility


-

Access t
o health care, ARVs and drugs for many PLWAs, including IDUs and CSWs

-

Exclusion of drug injectors in ART projects

-

Improve access to good quality and friendly voluntary counselling and testing services

-

Rural and mountainous areas: Unequal distribution of t
reatment services


5.4. Ethical issues


-

Quality of work and quality of care

-

Work overload; low salary; no incentives

-

Habitual loosely working style

-

Doctors and patients sell drugs


5.5. Community involvement



17

-

Strengthen the active involvement of PHA in car
e and treatment

-

Strengthen the active involvement of policy advisers, private sector, academic institutes
and religious groups in AIDS care programs

-

Should pilot models for care and support be developed massively while neglecting a
comprehensive package fo
r care and treament?

-

It is good that the health system is well established at all levels. The problem now is how
to match them into one systematic system so that ART can be integrated in the direction
to strengthen ( rather than conflicting with ) other e
xisting programs (OI, TB, etc).

-

How to coordinate and link ART program with other programs (harm reduction, VCT,
STD) in a timely manner


5.6. Drug policy and patent issues


-

Negotiations with the patent holders

-

Patent applications process for HIV/AIDS dr
ugs

-

Compulsory lisencing

-

Import of generic drugs

-

Registration of relevant ARV drugs in the first line and second line regimens

-

Review and amend existing patent law and existing drug registration regulations that
impact on the provision of affordable and
accessible ARV drugs and inhibit the entry of
generic ARV drugs into Vietnam.


6
-

Emerging Issues


-

More high ranking leaders pay attention to AIDS

-

Changes in policy on drugs and patents

-

AIDS stakeholders are more interactive

-

Competition between different
stakeholders with the influx of money for ARV

-

Staffs move from government organisations to work for international NGOs.

-

Corruption at all levels (black market/ marketing/ prescription)

-

Critical voices of local NGOs and PHAs

-

New religious groups are establi
shed

-

Migration of PHAs (Many PHA migrate to big cities for ARV treatment, resulting in the
overload to treatment hospitals)

-

The political economy of AIDS treatment programs


References


1.

‘3 by 5’ Initiative in Vietnam’, Report of the Joint MOH
-
WHO
-
UNAIDS E
mergency
Country Mission, 8
-
17 March 2004.

2.

‘Rapid assessment of access to HIV/AIDS medicines in Viet Nam’, July 2003 (draft),
WHO Vietnam.

3.

‘Untangling the web of price reductions: a pricing guide for the purchase of ARVs for
developing countries’, December

2003, MSF available at

4.

Birungi,.H et al. 2001.
The policy on public
-
private mix in the Ugandan health sector:
catching up with reality. Health Policy and Planning 16(suppl 2), 80
-
87.

5.

Blower, S and P. Farmer. 2003. Predicting the public health impact of a
ntiretrovirals:
preventing HIV in developing countries. AIDScience 3(11)

6.

Brugha, R. 2003. Antiretroviral treatment in developing countries: the peril of neglecting
private providers. The British Medical Journal 326, 1382
-
1384.

7.

Chesney, MA, M. Morin, and L.

Sherr. 2000. Adherence to HIV combination therapy.
Social Science and Medicine 50, 1599
-
1605.


18

8.

Decree 54/2000/ND
-
CP, 3 October 2000, for the Protection of Industrial Property Rights
upon Business Secrets, Geographical Indications, Trade Names, and Protect
ion of Rights
against Unfair Competition Relating to Industrial Property.

9.

Decree 63/CP, 24 October 1996, for the Implementation of the Provisions of the Civil
Code on Industrial Property which is amended and supplemented by Decree 06/2001, 01
February 2001
; and

10.

Farmer P, F.Leandre and JS Mukherjee et al. 2001. Community based approached to HIV
treatment in resource
-
poor settings.
Lancet 358, 404
-
409.

11.

Hardon, A. & Hodgkin. Increasing Access to HIV
-

related Medicines in Resource
-
poor
Settings: Confronting the

Challenge. Royal Tropical Institute.

12.

http://w3.whosea.org/hivaids/pdf/138/New%20Folder/Vietnam.pdf

13.

http://www.accessmedmsf.org/prod/morepublications.asp?catid=1&subcatid=173&status
=172

and

14.

http://www.popcouncil.org/pdfs/horizons/accesstotreatment.pd
f

15.

http://www.smartwork.org/programs/pdf/project
-
plan_vn.pdf

16.

http://www.un.org.vn/undocs/hivemp/hivemple.pdf

17.

http://www.unesco.org.vn/documents/Report_HMC_and_QNP_2003.pdf

18.

Kasper, T, D. Coetzee, F. Louis, A. Boulle, K
-

Hilderbrand.
2003 Demystifying
antiretroviral therapy in resource
-
poor se
ttings. Essential Drug Monitor 32, 20
-
21.

19.

Lam, NT. Injecting Drug Users in Vietnam: the Dynamics of AIDS Risks and Sexual
Relationships. Medical Publishing House, Ha Noi, 2004.

20.

Ministry of Health, ‘HIV/AIDS: The Challenge in Social
-
Economic Development’,
R
eport of the Ministry of Health at the Consultative Group Meeting 2003, Hanoi,
December 2003.

21.

Radyowijati A. and H. Haak. 2003. Improving antibiotic use in low
-
income countries: an
overview of evidence on determinant. Social Science and Medicine, 57, 733
-
7
44.

22.

Spire B, S Duran, M Souville et al. 2002. Adherence to highly active antiretroviral
therapies (HAART) in HIV
-
infected patients: from a predictive to a dynamic approach.

Social Science and Medicine 54, 1481
-
1496.

23.

Thu, P.D. Towards Rational Use of Antibi
otics in Vietnam: Present Status of Infectious
Diseases in Vietnam. Autralian Prescriber Vol.20 Suppl 1, 1997.

24.

Weide PJ, S. Malamba, R. Mwebaze, et. al. 2002.
Assessment of a pilot antiretroviral
drug therapy programme in Uganda: patients’ response, surviv
al and drug resistance.
Lancet 360, 34
-
40.
















19





Annex 1
-

ARV
-

RELATED PENDING PROJECTS IN VIETNAM


1.

PEPFAR:

US Global AIDS Plan (selected in June 2004). $10 mil will be released this year. $8
mil was already received earlier. Target: prevent 66
0,000 new infections, care for 65,000 people
infected and affected; provide treatment for 13,000 PLWHA. Possible fund for care and
treatment: 55%

(The budget for the Abstinence and Faithfulness IEC components (both A & B) of PEPFAR funds
for Vietnam is a
bout 7% of the total budget).

Condition: ARVs should be approved by FDA.


2. Clinton Foundation


Executive Director, Edward Wood, came to Vietnam in 12 July 2004, met Deputy PM, with a promise
to further assistance to Vietnam’s HIV prevention research and

activities


3. CDC Life Gap


-

$10 mil project

-

Period 2001
-
2006

-

Support in building an integrated HIV program, focusing on prevention, care and support, and
capacity building in 40 out of 64 provinces nationwide

-

Up to now, it has provided care and treatment

for PHA outpatients in 28 provinces

-

Condition: health technology should be obedient to CDC guideline; exchange experts and fellows


4. DFID


-

2004
-
2009

-

25 $ mil

-

Focus on prevention and intervention in more than 20 provinces/cities


5a. WHO project “Prevent
ing HIV in Vietnam”


-

2004
-
2008

-

25 mil $

-

21 provinces/cities

-

Airm: contain the prevalence rate among adults at below 1% in 2006

-

Small budget for ARV?


5b WHO 3X 5


-

Target: provide treatment for 2000 PHA in 2004; 14,775 PHA in 2005

-

Treatment cost estimate:
$ 300 /patient/year

-

ARV for 2004: $600,000

-

ARV for 2005: $ 4,432,.500


6.World Bank HIV/AIDS Prevention Project


-

Within framework of
Country Assistance Strategy (CAS)

-

Possible start 2005

-

Budget: 3.5 mil USD

-

Aim: provide support and guidance on the fram
ework within which to operationalize the
Government’s strategy.

-

Help to design effective prevention strategy; support different interventions (harm reduction,
stigma reduction, VCT, strengthen health system, support NGOs, PLWAs)



20




Annex 2
-

ESTHER PROJE
CT


Name of ARV access effort,
and period of
implementation

Objective: improving care and access to ARV treatment for
PLWHA
-

2003
-
2006


Donors involved, specify
contribution to the program
in resources

Ha Noi Department of Health

GIP
-

Esther

Lomoges Hosp
ital

Versailles Hospital

Target: 100 patients each year=> 300 patients for 3 years

To provide free ARV treatment and medical follow up
(biological tests, OI treatments)

To develop adherence to ARV treatment

To develop counselling to PLWHA

To train health
workers on medical and psychosocial aspects
on HIV/AIDS

To develop IEC materials specific to ARV treatment

To network with local and international associations related to
HIV/AIDS activities involved in Dong Da hospital (and Saint
Paul hospital)

Temporary
activities:

To assess nutrition needs of HIV+ in/outpatients

To assess psychosocial needs in/outpatients (ISDS)

Conditions set by donors, if
any

Maximum 110$ per month/per treatment


Inclusion criteria: WHO
-
based criteria , in addition:

Hanoi residents (
registered)

Adherence commitment (signed)

CD4<200; if CD4>200=> treat Ois

Non
-

IDUs

Have normal liver function tests

Don’t have TB

National level stakeholders
involved in formulation of
the program

French Ministry of Health and Vietnam MOH signed a
proto
col


Geographical and health
care sites involved

Dong Da, Sain Paul. Plan to expand to Hai Phong (General
Hospital) and HCM (Tropical Hospital,) in 2005


Who is provided access to
ARVs, list kinds of users
(pregnant women, TB
patients, others groups)

So
far 42 PHA are under treatment




Constellation of care,
specify

Specify if integrated in
PMTCT, or TB programs

level of care offered

kind of health facilities
involved, private, faith
-
based, public, etc

Collaborate with Dong Da PHA Club, ARC, Vietnam R
C,
CDC, MCVN

monitoring and evaluating

referral services (CDC Outpatient Clinics; ARC counseling
services); limited couselling and care



Types of ARV provided

Manufacturer

Costs per unit

Funded/subsidized

21

by?

Nevirapine

Boehringer

$495/person/year

Esthe
r project

AZT+3TC (Combivir)

GSK

$0.86/unit



ESTHER Plan for ARVs




Total number of patients: 120 (100 people for First
-
line, 20 patients for Second
-
line).



09 month/ patient.



A/ AZT + 3TC + NVP (50 patients)



d4T + 3TC + NVP (50 patients)



20 % patients
are estimated to be failed in treatment due to

-

side effects (toxicity) of drugs

-

clinical failure

-

immunology failure

-

virutology failure


ESTHER laboratory facilities:

1/ Cyfow
-

Partec (Germany)

2/ Hotte
-

Sanyo (Japan)

3/ Tu am sau (
-
70 do C)
-

Sanyo (J
apan)

4/ ELISA
-

Birad (France)

5/ Autoclave
-

Sanyo (Japan)


Regiment:
AZT + 3TC + NVP


Regiment:

D4T + 3TC + NVP


AZT + 3TC

40 P x 60 tab x 09 month = 21.600 tab

10 P x 60 tab x 06 month = 3.600 tab


D4T (ZERIT
-

BMS)

40 P x 60 tab x 09 month
= 21.600 tab

10 P x 60 tab x 06 month = 3.600 tab


3TC ( EPIVIR
-

GSK)

10 P x 60 tab x 09 month = 21.600 tab

10 P x 60 tab x 06 month = 3.600 tab

NVP (VIRAMUNE)

40 P x 60 tab x 09 month = 21.600 tab

10 P x 60 tab x 06month = 3.600 tab

NVP (VIRAMUNE)

40 P x 60 tab x 09 month = 21.600 tab

10 P x 60 tab x 06month = 3.600 tab

Budget for 1 patient/month


AZT + 3TC: (LAMZIDIVIR
-

MST):

60 tab x 0.82 $ = 49.2 $

(COMBIVIR
-

GSK): 60 tab x 0.8925 $ = 53.55 $

NVP (VIRAMUNE
-

Boehringer):

60 tab x 0.7175 $

= 43.05 $

=> LAMZIDIVIR + VIRAMUNE
: 92.2 $

=> COMBIVIR + VIRAMUNE
: 96.6 $

Budget for 1 patient/month


D4T (ZERIT
-

BMS):60 tab x 0.75 $ = 45 $

3TC ( EPIVIR
-

GSK):

60 tab x 0.34125 $ =20.475$

NVP (VIRAMUNE
-

Boehringer)

60 tab x 0.7175 $ = 43.05 $




=>D4T+3TC+NVP:
108.5 $

Total budget

AZT + 3TC (LAMZIDIVIR
-

MST):


25.200 tab x 0.82 $ = 20.664 $

(COMBIVIR
-

GSK):

25.200 tab x 0.8925 $ = 22.491 $

NVP (VIRAMUNE
-

Boehringer):

25.200
tab x 0.7175 $ = 18.081 $


=>LAMZIDIVIR + VIRAMUNE:
38,745 $

=>COMBIVIR + VIRAMUNE:
40,572 $

Total budget

D4T (ZERIT
-

BMS):25.200 tab x 0.75 $= 18.900
$

3TC (EPIVIR
-

GSK): 25.200 tab x 0.34125 $ =
8.5995$

NVP (VIRAMUNE
-

Boehringer):

25.200 tab x 0.717
5 $ = 18.081 $





=> D4T+3TC+NVP:

45,580 $






22




Annex 3
-

GFATM Project


Name of ARV access effort,
and period of implementation

Global Fund
project “Strengthening care, co
unselling and
support for PLWAs and related
community based activies to
prevent HIV/AIDS in Vietnam

12 mil $; 2004
-
2007; 20 provinces and regional hospitals


The Project components:


a)

strengthening capacity and implementing at all levels
of 20 provinces on
care and support;

b)

implementing a comprehensive program on care,
counselling and support to PLWHAs;

c)

integrating prevention and care through a
programme on VCT and PMTCT


Donors involved, specify
contribution to the program in
resources

Start May 2004, un
clear how much for ARV purchase (estimated $1
mil)

UNDP, WHO, UNAIDS, JICA


Conditions set by donors, if
any

Divided into 2 phases: First phase $7.5 mil
(
for 2004 and 2005)
.
Fund for second phase $4.5 mil is released if first phase is effective.



Natio
nal level stakeholders
involved in formulation of the
program

Ministry of Health, National Institute for Clinical Research and
Tropical Diseases (NICRTD); National Insitute for Pediatric (NIP);
National Institute for Protection of Mother and Newborns (NIPM
N) ;
National Institute for TB (NIB); National Institute for Dermatology
(NID); Hanoi Medical University; Women Union; Ministry of
Finance; Vietnam Chamber of Commerce and Industry


National level stakeholders
involved in implementation of
the program

Dep
artment for Preventive Medicine and HIV/AIDS; NICRTD, NIP,
NIPMN, NIB, NID, Women Union, Vietnam Red Cross, Youth
Union

Geographical and health care
sites involved

Quang Ninh, Hai Phong, Ho Chi Minh City, Hanoi, An Giang, Lang
Son, Nghe An, Khanh Hoa, Cao

Bang, Hai Duong, Thai Nguyen,
Tay Ninh, Can Tho, Kien Giang, Soc Trang, Thanh Hoa, Phu Tho,
Ca Mau

Health institutions: NICRTD; Tropical Disease Center HCM; Hue
Hospital

Who is provided access to
ARVs, list kinds of users
(pregnant women, TB patients,
o
thers population groups)

PHA but not yet determined

Constellation of care, specify

-

Specify if integrated in
PMTCT, or TB programs

-

level of care offered

-

kind of health facilities
involved, private, faith
-
based, public, etc


Types of ARV provided

Manufac
turer

Costs per unit

Funded/subsidized
by?

Not yet determined



GFTAM



23




Annex 4
-

Patent Status of 22 Antiretrovirals


Antiretroviral drug ( X )

Patented/pending patent applications



Pharmaceutical
composition having
only X as active
ingredient

Pharm
aceutical
composition
having X and
another compound

First line ARVs:



Zidovudine

yes

yes

Lamivudine

yes

yes

Nevirapine

yes

yes

Efavirenz

yes

yes

Stavudine

no

yes

First line FDCs:



Stavudine+Lamivudine

no

yes

Zidovudine+Lamivudine

yes

yes

Zidovudine+Lamivudine+Nevirapine

no

yes

Stavudine+Lamivudine+Nevirapine

no

yes

Zidovudine + Lamivudine + Efavirenz

yes

yes

Stavudine + Lamivudine + Efavirenz

yes

yes

Second line ARVs:



Tenofovir

no

yes

Didanosine

no

yes

Abacavir

no

yes

Ritona
vir


no

yes

Lopinavir

no

yes

Saquinavir

no

yes

Lopinavir + Ritonavir

no

yes

Other ARVs:



Nelfinavir

yes

yes

Amprenavir

no

yes

Indinavir

no

yes

zidovudine + lamivudine + abacavir

no

yes

















24


Annex 5
-

STAKEHOLDERS FOR ART VIETNAM

(ongo
ing updates)


Organisation/Project


Individuals involved

International



UNADIS

Nancy Fee

WHO

Dominique Ricard

Australian Red Cross

Ms Clare Murphy; Ms. Huong; Mr. Robert Baldwin
(Regional Program Advisor ARC, Bangkok); Ms.Hai

USAID Vietnam

Daniel Le
vitt

Clinton Foundation

Ed Wood

Esther Project

Myriam de Loenzien (IRD)

Xuan Phan

ANRS
-

Agence Nationale de Researcher sur
le Sida

Fransoise Barre
-

Sinoussi

Maryvonne Maynard medical practitioner
-

permanent
in Saigon
-

coordinator

Xuan
-

phychologist and
MD
-
Binh Trieu

CDC Vietnam

Trinh T Thuy (CDC), Lisa Cosimi (CDC), Mary
Kamb (CDC), Marie Nguyen; Van Anh

CDC
-

Life Gap Project

Luu Minh Chau; Do Thi Nhan (LIFE
-
GAP

Harvard University

Eric Krakauer; Lisa Cosimi

Fhi

Dr Phinh

Medical Committee Netherland
s


Vietnam

Pamela Wright; Pauline Oosterhoff

STADA

Ong Van Dung, General Manager

Bright Futures Group

Ong Van Tung

Governmental



Department of Therapy, MOH


NV Kinh, Luong Ngoc Khue

Bureau for Preventative Medicine and
HIV/AIDS Control, MOH

Nguyen
Thanh Long, Nguyen Van Kinh, Nguyen
Duy Tung, Le Ngoc Yen

Natinal TB Institute

Dinh Ngoc Sy, Director

School of Public Health

Thu Huong (Drug Policy), DV Trung

Hospital for Tropical Diseases HCM

Nguyen Huu Chi

Pham Ngoc Thach TB and Lung Diseases
Cent
er

Hoang Thi Quy, Director

National Institute of Clinical Research on
Tropical Medicine

Nguyen Duc Hien (Direcotr), Nguyen Tien Lam, Le
Dang Ha

Dong Da Hospital

Dr Tuan, Dr Hien; Dr Nguyet

Saint paul

Nguyen Yen Binh (St Paul
-
ESTHER

Hue Hospital


Trop
ical Hospital HCM


Hanoi RC

Nguyen Mai Phuong

Pauteur Institute

Lien

Dong Da RC

Nguyen Thi Dao; Ms. Quy

Le and Le Law Firm

Le Hoai Duong

National Office of Intellectual Property
(NOIP)
-

Ministry of Science and Technology

Pham Dinh Chuong, Director

D
rug Administration
,

Ministry of Health,


National Patent Office


National Committee for International
Economic Cooperation

Mr. Nguyen Son, Deputy Director General,

Department of International Organizations
Ministry of Foreign Affairs.

Mr. Le Hoai Trung
, Deputy Director

Vietnam NGO


Policy Project

Ngoc, Trang


25