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Tuesday, March 17th
2009
"HIV Research
and Public Health in Thailand:
Prevention and Care"
A talk by Marc
Lallemant - Director of Programs
for HIV Prevention and Treatment (PHPT) and his colleague Dr. Gonzague Jourdain
Present: Linda Rochester,
Christa Sollner, Mark Tuckson,
Rebecca Weldon, Sithiwong, Mark and Dianne Barber-Riley, Nance
Cunningham, Oliver Hargreave, Louis Gabaude, Klaus and Heidi Berkmuller, Kongkaew
Inthanon. An audience of 12 plus a few more.
This summary is
adapted from a paper published in "AIDS in ASIA"
(Max Essex: Editor), Kluwer Boston; 1st ed. (Jul. 14, 2004) with
information available on www.phpt.org
Of all Asian countries, Thailand was one of the
first and hardest hit by the first Human Immunodeficiency Virus (HIV-1)
pandemic. A national surveillance system was implemented in 1989 to
monitor the spread of the epidemic to the general population: in 1994,
the prevalence of HIV infection in pregnant women presenting at the
antenatal clinics exceeded 10% in highly impacted regions such as
Phayao, which is located in the Northern part of the country. With the
nationwide prevention campaigns, the prevalence rates in pregnant women
dropped significantly. In June 2006, the prevalence rate of HIV-1 among
pregnant women was less than 1% nationwide, with the highest rates
found in the Central and Eastern provinces of the country. Despite this
outstanding progress, many infants in Thailand are still born to
an HIV infected mother and are at risk of acquiring the Human
Immunodeficiency Virus (HIV) causing the Acquired Immune Deficiency
Syndrome (AIDS). Thailand
currently has an estimated 570,000 people living with HIV.
Thai response to the
epidemic The Royal Thai Government responded quickly to the HIV/AIDS
epidemic and implemented a multi-sector AIDS program. At its onset,
this program involved all government ministries, non-governmental
organizations, multilateral donors and private businesses. Cooperation
at the national level among ministries was carried out through the
National AIDS Prevention and Control Committee chaired by the Prime
Minister.
THE NATIONAL AIDS
PROGRAM PARTICULARLY FOCUSED ON:
1. Public
information, education and prevention
As early as 1989,
bi-annual sentinel surveillance surveys were conducted in each province
among drug users, direct and indirect commercial sex workers, military
recruits, blood donors, and antenatal care women. The data collected
highlighted the most affected provinces and documented the dynamic of
the epidemic spreading from one group of high- risk behaviors such as
sex workers to other sectors of the general population such as the
military recruits. The publication of these prevalence results in the
national newspapers, illustrating the visible progression of the
epidemic, was instrumental in raising public/government awareness
towards the spread of the HIV/AIDS.
The government
responded with several national campaigns, bombarding the public with
information on HIV/AIDS using all forms of mass media as well as
innovative and powerful methods of communication. For example, a
nationwide network of volunteers was mobilized to distribute cards,
audio-cassettes and videos containing information about AIDS. Condom
use was heavily promoted through the 100% condom use campaign in which
the active involvement of the charismatic public figure, Mechai
Viravaidya was critical for its success. Finally, HIV testing was
rapidly made available in all government hospitals and in many private
facilities. The comprehensive monitoring and surveillance system in
place since 1989 enabled the documentation of the success of these
prevention programs in curtailing the spread of the epidemic. Indeed,
the impact of these preventive measures was particularly visible in the
North. For example, the prevalence rates in pregnant women dropped from
more than 10% to less than 5% between 1994 and 1997 in the Phayao
province, to around 2% today. The surveillance system also allowed
observers to follow the epidemic, demonstrating the overall HIV
prevalence decline in commercial sex workers and in the general
population, while pointing out the relative failure of the campaign
among intravenous drug users
2. Human rights and
social support
A national counseling
plan was launched in 1990 including training of counselors, and
promotion of voluntary anonymous HIV counseling and testing at the
national level. This plan was expanded in 1993 to provide training for
nurses in the antenatal care setting. In addition, the government took
a clear stand against the discrimination of HIV-infected individuals
and the protection of their rights. For example, calls for mandatory
blood testing and result disclosure were strongly opposed to.
The government also
supported many Non Governmental Organizations (NGOs) involved in
various aspects of HIV/AIDS prevention and care including home care,
building AIDS patients network, income generating activities, family
support groups, etc. For example, the Thai Business Initiative in Rural
Development, a project aimed at diverting young rural women from
prostitution by providing them with training and employment.
3. Promotion of
research
Important
epidemiological, clinical, virological and socio-behavioral research
programs conducted in Thailand were encouraged
and supported by the Ministry of Public Health. The research allowed a
better understanding of the dynamic of the epidemic and documented
uniquely in the world the success of the prevention campaigns (Nelson
et al, 1996). These research programs also helped instigate pilot
projects, which were launched at the regional level, and proved to be
crucial in guiding interventions and policies at the national level.
The close collaboration between researchers and policy makers at the
Ministry of Public Health was particularly effective in the field of
mother-to-child prevention. Finally, Thailand was and continues
to be actively involved at the forefront of the global research effort
towards an HIV/AIDS vaccine, coordinated by a National HIV vaccine
committee of knowledgeable experts.
4. Medical treatment
and care
The use of zidovudine
(AZT), the first antiretroviral with proven clinical efficacy, was
approved in 1987, and until the mid nineties it was provided by the
Ministry of Public Health to HIV-infected patients. The Thai Food and
Drug Administration (FDA) then rapidly allowed the importation of many
other antiretrovirals. Later, an agreement between the Thai government
and the manufacturer of AZT allowed the Government Pharmaceutical
Organization (GPO) to purchase the drug in bulk at a competitive price.
In 2002, the GPO started producing several generic antiretroviral fixed
dose combinations (ARV) including GPOvirSฎ and GPOvirZฎ pills to be taken
twice a day opening access to triple therapy at affordable price (1,200
Baht per month in 2004). With the expansion of access to treatments
through the national program, in 2009 over 197,000 persons receive
antiretroviral treatments under the universal coverage system.
Approximately 50,000 receive treatment from other programs.
A success story :
Prevention of mother-to-child transmission program Within the national
HIV/AIDS prevention program, Thailand specifically
targeted mother-to-child transmission of HIV.
From as early as
1990, even before any measures to reduce mother-to-child transmission
of HIV were discovered, some hospitals were conducting HIV testing for
pregnant women. At that time, this practice reflected general fears
among health care workers who felt the need to know the HIV status of
their patients in order to protect themselves. However, when discovered
to be HIV-positive, most women were informed of their HIV status.
Theoretically, the
women could then make a decision with regard to the continuation of
their pregnancy; decide about infant feeding mode, post-partum
contraception and prevention of sexual transmission to their partners.
At this time, most women confirmed as HIV positive had their pregnancy
terminated, while many of those who continued with their pregnancy were
sterilized thereafter. This trend reflected the fact that most health
care workers felt they had nothing to offer these women who were often
perceived as unable to manage a pregnancy and raise a child. This
attitude amongst the health care workers changed significantly, from
1993, when the intense training on HIV counseling provided by the
Ministry of Public Health was extended to nurses within the antenatal
care settings.
In the same year, in
response to the clear evidence that HIV could be transmitted through
breastfeeding, the Ministry of Public Health recommended formula
feeding to HIV-infected women only, while continuing to support the
UNICEF Baby-Friendly Initiative and promoting breastfeeding in the
general population. In the public hospitals, formula milk was provided
for free to the poorest of HIV-infected women until the child reached
18 months of age. The Ministry of Public Health ensured that this
recommendation was only targeted towards HIV-infected women who could
then decide on the safest mode of feeding for their infants.
As soon as the
results of a clinical trial in the United States and France were
released in 1994, demonstrating the remarkable efficacy of zidovudine
(AZT) in reducing perinatal transmission of HIV, the Ministry of Public
Health reevaluated its HIV treatment program and concluded that, given
Thailand's budget for antiretrovirals and the quality of its health
care infrastructure, AZT prophylaxis for HIV-infected pregnant women
and their newborns was feasible, affordable and by far the most
cost-effective way to use the budget for antiretrovirals compared to
the use of AZT mono-therapy for patients. At about this time, the Thai
Food and Drug Administration approved the use of AZT for the prevention
of perinatal HIV.
By 1996-1997, after
completing preliminary research studies, the Thai Red Cross began
providing AZT to HIV-infected pregnant women in its affiliated
hospitals throughout the country using funds raised with the help of
members of the royal family. Knowing that most mother-to-child
transmission occurs close to delivery, the Ministry of Public Health
quickly initiated in northern Thailand a pilot perinatal
HIV prevention program using a short course AZT treatment. This program
was established in collaboration with a large clinical trial, the
Perinatal HIV Prevention Trial (PHPT-1, see www.phpt.org) conducted by
Harvard University and the French Institut de Recherche pour le D้veloppement (IRD).
The main objective of this trial was to compare the efficacy of
abbreviated AZT treatments in mothers and/or children with the regimen
tested in the US
and France.
PHPT-1 demonstrated that a short course of AZT prophylaxis (delayed
until 35 weeks gestation, and for 3 days in the newborn) was less
effective than a long one (from 28 weeks gestation and 6 weeks in the
newborn) with transmission rates of 10.5% versus 4.1%, respectively.
Both programs, the Ministry of Public Health program in the North and
the PHPT-1 research study complemented each other greatly and both
benefited from the other's program in terms of training, coverage, and
capacity building.
In December 1999, the
Ministry of Public Health convened a meeting to issue national
guidelines on perinatal HIV transmission prevention, based on evidence
from clinical trials, along with the pilot programs and the Ministry of
Public Health decided to launch its first nationwide perinatal
transmission prevention program.
These great
achievements were made possible due to a variety of factors: the
pragmatic approach of the Ministry of Public Health using the latest
scientific knowledge from clinical research, testing them through pilot
projects before scaling up to the national level; emphasizing on
training particularly on HIV counseling, the high quality of HIV
testing and health care system delivery.
The most striking
results of the Prevention of Mother to Child Transmission of HIV
(PMTCT) program is uniquely illustrated by the dramatic drop in number
of pediatric AIDS cases reported to the Ministry of Public Health,
although this also reflects the impact of the public campaigns on the
prevention of sexual transmission.
Following the results
of another trial in Uganda demonstrating the efficacy of one dose of
nevirapine (NVP) at onset of labor and 2 days after birth in the
newborns, the Perinatal HIV Prevention Trial 2 (PHPT-2; see
www.phpt.org) tested the addition of one single oral 200 mg dose of
nevirapine at onset of labor and one 6 mg dose for the newborn 48 to 72
hours after birth to the standard AZT regimen. The transmission rate in
women who received zidovudine (AZT) plus nevirapine (NVP) was 2.0%,
significantly lower than the 6.3% transmission rate experienced by
women who received AZT alone. This simple regimen of AZT during the
last trimester of pregnancy combined with a single dose of NVP at onset
of labor is able to achieve transmission rate as low as those obtained
using a triple combination regimen, or Highly Active Antiretroviral
Therapy (HAART) during pregnancy. Following the remarkable results of
this trial, the Ministry of Public Health has again responded in a
pragmatic manner, convening a meeting of experts and reviewing its
national guidelines for the prevention of mother-to-child transmission
of HIV in order to advance the initiation of AZT from 28 weeks
gestation and incorporate nevirapine (NVP) in the prevention package.
Also, the World Health Organization (WHO) decided to recommend this
treatment for pregnant women who do not need immediate combination
therapy for their own health.
Moving towards Access
to Highly Active Antiretroviral Therapy (HAART) The extension of the
Prevention of Mother to Child Transmission of HIV (PMTCT) program to
include long term provision of Highly Active Antiretroviral Therapy
(HAART) to immuno-compromised mothers and to the few infected children
is referred to as "PMTCT Plus". For example, immuno-compromised
HIV-infected mothers and infected children who had participated in the
Perinatal HIV Prevention trials have received antiretroviral fixed dose
combinations (ARV) drugs since 1999 and continue to be closely
monitored. The follow-up of these cohorts has demonstrated that "PMTCT
Plus" was feasible, well accepted and highly beneficial to the patients
involved. "PMTCT Plus" was also identified as a unique opportunity to
reach out and treat HIV-infected fathers/partners so that both parents
can care for their children.
In May 2001, during
the Third International Symposium on Pediatric AIDS in Thailand,
in a public Declaration, the clinicians, researchers and public health
officers requested from the Ministry of Health the provision of Highly
Active Antiretroviral Therapy (HAART) to infected mothers, children and
families within the Thai national Prevention of Mother to Child
Transmission of HIV (PMTCT) program.
With the increasing
production of generic drugs worldwide, the price of antiretroviral
fixed dose combinations (ARV) drugs has dropped dramatically, and the
possibility of providing long term ARV treatment to HIV-infected
patients has become more realistic. In Thailand, the Government
Pharmaceutical Organization (GPO) started producing GPOvir, a
combination of d4T, 3TC and nevirapine in a single pill to be
administered twice a day, which costs approximately US$30 a month.
Using the same
strategy of building upon the success of small pilot programs before
scaling up nationally and using the results of the clinical trials
performed in Thailand, the Ministry of Public Health organized in 2003
the revision of the national guidelines for the use of antiretroviral
fixed dose combinations (ARV) and launched, in collaboration with the
Global Fund, a national program to provide access to Highly Active
Antiretroviral Therapy (HAART) to 70,000 patients over the next five
years.
In clinical trials,
antiretroviral therapy has been shown to have a dramatic impact on
reducing the risk of progression to AIDS and death in HIV-infected
adults and children. Large observational cohorts in Europe and the US
demonstrated the impact of antiretroviral therapy on mortality in
HIV-infected patients in routine care settings, with up to 70%
reductions in risk of death.
With support from the
Thai Ministry of Public Health, Oxfam GB and the Global Fund, PHPT/IRD
program has been working within 50 public hospitals throughout Thailand
to provide treatment for the participants of the research studies and
other people living with HIV/AIDS. All patients in this treatment
cohort are monitored to ensure their safety and to examine the efficacy
and impact of the treatment provided.
In 2002, Perinatal
HIV Prevention Trial (PHPT) submitted a joint proposal to the Global
Fund to fight AIDS, TB and Malaria (GFATM) to demonstrate the
feasibility of the provision of high quality HIV care including
antiretroviral treatment. The PHPT-GFATM program will have provided
antiretroviral fixed dose combinations (ARV) treatment and monitoring
to more than 2,000 patients, one third of whom are children.
To ensure optimal use
of antiretrovirals and the durability of drug regimens, the program
highlights the critical importance of active involvement of People
Living with HIV/AIDS, the need for hands-on training of medical
professionals and the benefits of establishing independent networks of
HIV care specialists. The development of clear procedures for patient
screening, clinical and biological evaluations and systematic data
collection enabled the program to document the high rate of virological
and immunological success and low rate of mortality achieved.
This cohort is
closely monitored with regular clinical and demographic data
collection. To inform future policies and programs in order to optimize
benefits of antiretroviral therapy, data are analysed to address the
following key research areas:
… Long term
efficacy of antiretroviral therapy: long term survival, factors
associated with survival, immunological and virologic response
… Antiretroviral safety: incidence and risk factors to
toxicities,
incidence of hospitalisation/serious adverse events (HIV related, ARV
related, others)
… Drug resistance: durability of first line regimen and patterns
of resistance, resistance mutations at baseline.
… Co-infections: HIV and Hepatitis B, Hepatitis C and
tuberculosis
… Adherence to therapy
… Cost effectiveness of antiretroviral treatment: diagnosis
strategies for infants born to HIV infected mothers, treatment
regimens, monitoring strategies.
Through ongoing
training and the development of specific clinical procedures, the
program will continue to strengthen HIV care teams and their
collaboration with people living with HIV/AIDS.
For more information,
please visit the www.phpt.org website.
The presentation
concluded with a question and answer in which members of the audience
asked the speakers for more information on many of the topics outlined
in their talk.
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