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Oct-Dec2002-10(4)
DISCUSSION
Programme to prevent mother to
child transmission of HIV: some concerns
TK
Rajalakshmi
The National AIDS Control Organisation (NACO) has
embarked on an ambitious programme aimed at controlling paediatric AIDS in the
country. NACO has reason to believe that HIV prevalence among ante-natal women
is more than one per cent in the high-prevalence states of Maharashtra, Tamil
Nadu, Karnataka, Andhra Pradesh, Manipur and Nagaland. The Prevention of Mother
to Child Transmission or PMTCT programme is directed at preventing transmission
of the virus from pregnant woman to foetus or breast-feeding infant. Feasibility
studies involving the use of anti-retroviral (ARV) prophylaxis and therapy are
underway with the longer objective of making it a nation-wide programme. NACO
estimates that there are 3.86 million HIV-infected persons in the country and
20,304 AIDS cases as of March 2001.
In January 2000, NACO embarked on a pilot study in
the Obstetrics and Gynaecology departments of 11 institutions in
Maharashtra, Tamil Nadu, Manipur, Karnataka and Andhra Pradesh. The objective,
according to a NACO report titled 'Combating HIV/AIDS in India, 2000-2001', was
to assess the feasibility of administering AZT or Zidovudine to prevent mother
to child transmission of HIV-1 infection in pregnant mothers.
All pregnant women attending the antenatal clinics
in these instititutions were offered a group education-cum-counselling session
on HIV, supported by a video film session. Written informed consent was obtained
from the women and blood samples for the HIV test taken from them. Post-test
counselling was also provided. After 36 weeks of gestation, women who tested
positive for HIV were given AZT 300 mg orally twice a day. During labour, the
same dose was given every three hours. (This is a shorter and cheaper version of
the AZT regimen followed as standard practice in the US.) Following delivery a
Polymerase Chain Reaction test was done at 48 hours and at two months to
determine the HIV status of the infant. The mother was given the option of
breast feeding after being counselled on the risks and benefits of the various
infant feeding practices. It is significant that only 658 of the 751 women who
accepted AZT in the study were followed - the rest did not return and the
institutes did not monitor them further.
The study completed one year in March last year. It
established that PMTCT was a cost-effective strategy for prevention and control
of the epidemic, and recommended that NACO expand the strategy to the level of a
national programme. It noted that this would require a massive training exercise
to cover 600 districts in the country in a phased manner. The 11 centres where
the study was conducted would be nodal training centres and their technical
expertise used for "scaling up PMTCT activities". The study further
recommended undertaking operational research, especially of a single-dose
regimen of Nevirapine which, it was felt, could be a more feasible option than
AZT. The first phase of a feasibility study involving a single-dose application
of Nevirapine was concluded recently and the second phase has been launched. The
PMTCT strategy, using either AZT or Niverapine, is now expected to be expanded
to a national programme.
Questions about the
drugs
However, this programme does not taken into account
the serious side effects of these drugs, and the possible development of
resistant strains. Organisations like the Joint Action Council, Kannur, argue
that the government is disregarding the findings of several studies bearing
testimony to the ill-effects of Niverapine and AZT. Not only do they have
established side-effects, they are also very expensive. Further, mothers and
children taking the drugs need to be monitored. However, the system for
monitoring in the Indian situation has not been thought out. It is feared that
PMTCT will be another top-down programme dissociated from public health
realities and people's needs.
In response to such criticism, J V Prasada Rao,
then director of NACO, said the interventions should not be looked at only as a
HIV prevention programme. Since the programme would be implemented through
voluntary counselling and testing (VCT) centres, many pregnant women would
counselled about reproductive health issues. Further, Rao said, it was only in a
prolonged regime that drug resistance developed and side-effects could emerge.
The single dose of Nevirapine was not likely to develop resistance among the
recipients, he said. He said that the feasibility studies of Nevirapine
conducted between October and December of 2001 had shown no adverse reactions.
The PMTCT programme is to be expanded in
three stages. All medical colleges in the high prevalence states of Tamil Nadu,
Andhra Pradesh, Karnataka, Maharashtra, Manipur and Nagaland would have to set
up VCT centres, and laboratory technicians would be trained to deal with the
demands of the programme. In the second stage, all district hospitals would be
covered, and in the third, medical colleges in the rest of the country
would come under the programme. "If need be, district level hospitals in the low
prevalence states will also be covered but that would come later," said Prasada
Rao. An estimated six to seven million mothers could be covered in a year. Of an
estimated 25 million annual pregnancies, some six to seven million women
deliver in government hospitals and institutions. The majority of them are poor
and vulnerable and more prone to HIV, said Rao.
Unrealistic programme
The fact is that the target group for this
programme consists of millions of poor, illiterate or semi-literate women for
whom no choice of any kind exists. Breast feeding and non-Caesarean deliveries
are known to be conduits for virus transmission. But the HIV positive pregnant
and working class woman cannot avoid breast-feeding. Nor can she afford a
Caesarean. Anju Singh and Puroshottaman Mulloli of the Joint Action Council are
highly critical of NACO's proposal. Singh argues that given the stigma attached
to HIV/AIDS, a woman not breast-feeding her infant would be singled out. Second,
the infant would be deprived of the immunity provided by breast milk. NACO is
also unrealistic to 'leave the option' to the woman after counselling her on the
various infant feed choices. One such option the NACO director suggested was
encouraging the consumption of 'diluted cow milk' for the infant. It is not
clear who would pay for the diluted cow milk.
Drug toxicity
On February 5, 2001, US federal health authorities
responded to emerging evidence of drug toxicity with new guidelines for ARV
therapy. JACK points out that US guidelines now recommend that treatment for HIV
be delayed as long as possible for asymptomatic people. The new guidelines
have made treatment regimens very complex. The administration of these drugs
demands a number of conditions including patient involvement and close medical
supervision to constantly monitor the effects. US scientists emphasise that not
enough is known about HIV/AIDS for them to set hard and fast rules. They advise
that each individual requires specific responses under the supervision of
experts on the use of ARV drugs. According to a press statement issued by John G
Bartlett, chief of infectious diseases at Johns Hopkins and co-chair of the
panel that produced the new guidelines, "The updated guidelines recognise that
we need to make definitive recommendations about the optimal time to start
treatment. We highlight the uncertainty, allow for flexibility, encourage an
individualised approach to treatment, and, at the same time, try to provide
guidance."
Singh and Mulloli state that at the very least, the
use of ARV drugs calls for very sophisticated medical supervision that the US
has - and it should be more than obvious that this is not possible in developing
countries. Countries like ours, with scarce medical facilities, surely call for
a different approach to HIV/AIDS care altogether.
Singh and Mulloli note that South Africa stopped
Nevirapine drug trials when five patients died. A report in the April 15, 2000,
issue of the BMJ (Pat Sidley. South Africa to tighten control on drug
trials after five deaths.BMJ 2000;320:1028) states that about 11 per cent of
patients in the trial showed signs of severe liver toxicity. It was alleged that
women involved in one site of the trial had not given fully informed consent.
In January last year, US federal health officials
warned that health-care workers who take Nevirapine after possible
occupational exposure to the AIDS virus risk potentially life-threatening side
effects. The Centers for Disease Control and Prevention (CDC) reported 22 cases
of serious side effects among people who took the drug fearing exposure to HIV.
The side effects included liver toxicity and severe skin reactions. In one case,
a 43-year-old health care worker needed a liver transplant after suffering liver
failure.
The CDC stated: "In this (health care) setting, the
risk of HIV transmission is very low and, in most cases, the risk of taking
Nevirapine would outweigh the risk of using it for possible prevention of HIV."
It also said the adverse reactions reported among health care workers "do
not, in any way, apply to the use of Nevirapine in other settings."
Need for transparency
What is required is complete transparency on the
part of NACO and the union health ministry regarding the trial methodology, and
detailed results of the feasibility studies. The section on the feasibility
study of AZT in the NACO report does not mention the words 'side effects'.
Neither are the details of the Nevirapine trials made available for scrutiny
even by the public health community. It should be remembered that the
constituency that NACO will be dealing with is not an informed, highly literate
and empowered one. Accountability to this section should not be a casualty in
the zeal to push anti-retrovirals as life-saving drugs.
Adapted fromRajalakshmi TK.Health: Programmes and pitfalls. Frontline 2002; 19 (6).http://www.flonnet.com/fl1906/19060880.htm. Printed here with the permission of the writer and the editor.