Malawi’s
Ministry of Health is planning to provide triple-drug antiretroviral therapy
(ART) to all pregnant women with HIV as the most practical way for the country’s
impoverished health system to quickly reduce transmission of HIV from mother to
child
– and protect mother’s lives at the same time
– the
Eighteenth International AIDS Conference heard yesterday.
New
guidance from the World Health Organization (WHO) recommends that women diagnosed with HIV during pregnancy
and with CD4
counts below 350 cells/mm3 should start lifelong antiretroviral therapy immediately.
For women
with CD4 counts above 350, WHO recommends two options:
- Option A: AZT prophylaxis for
the mother during pregnancy; single-dose nevirapine for mother and infant
around delivery; AZT/3TC for the mother during delivery and for seven days
afterwards; daily nevirapine for the infant until one week after
breastfeeding ceases.
- Option B: Three-drug antiretroviral therapy
from week 14 of pregnancy until the end of the breastfeeding period.
At a
satellite meeting organised by the Elizabeth Glaser Pediatric AIDS Foundation,
representatives of country programmes talked about the dilemmas they have faced
in deciding how to adapt the guidelines to their national contexts.
In Zimbabwe, for
example, the national AIDS programme has decided to provide nevirapine-based ART
regimens to mothers with CD4 counts below 350, and has chosen option A as the
more affordable route to reducing mother-to-child HIV transmission.
But the
AIDS programme recognises that a lot of work will be needed to get everyone up
to speed on the new guidance, and has been conducting extensive stakeholder
consultations to make sure that everyone is happy with the new direction.
At the
moment, almost 85% of sites providing PMTCT services in Zimbabwe are
still employing single-dose nevirapine, and there is very limited capacity for
ART initiation because antiretroviral therapy must be prescribed by doctors. The
country also has only limited laboratory capacity to carry out CD4 cell monitoring, with
few machines, unreliable supplies and a failure to communicate results.
But as well
as HIV-specific problems, the AIDS programme also has to contend with some more
fundamental weaknesses of the health system. There is high turnover of health
care staff, which means a constant need for retraining to ensure that all
staff understand the correct procedures for offering HIV tests, counselling and
recording information, and administering drugs. Record-keeping remains a
weakness, and there are problems in referral and follow-up of mothers with HIV
and their infants.
Last, but
not least, the recent introduction of user fees for the use of health
facilities is likely to deter women from attending antenatal clinics.
In Kenya, the
government is also planning to introduce Option A for mothers in less immediate
need of ART for their own health, but similarly faces limited healthcare worker capacity and a shortage of CD4 counting machines.
In Malawi, said Dr
Erik Schouten of the country's Ministry of Health, stakeholders had looked at the WHO
guidance and tried to assess which option would be most realistic for the
country’s health system to implement.
“The
success of antiretroviral therapy in Malawi was based on a public health
approach that acknowledges the realities of the health system’s capacity,” said
Dr Schouten. That means limited use of CD4 counts, task-shifting to allow
nurses to initiate and monitor ART, and devolution of care down to the local
health centre.
Whilst
incorporating treatment for all pregnant women below 350 presents no problem
apart from cost, option A for
women with CD4 counts above 350 would prove challenging, he noted. It’s too
complicated for health care workers to administer, requiring four separate
stages of treatment for the mother, plus infant prophylaxis throughout
breastfeeding. On average women in Malawi breastfeed for 23 months,
according to Dr Schouten.
The CD4
count requirement is also a major challenge for the country where only 20% of
people living with HIV presently have access to immunological monitoring. The
country has about 50 CD4 counting machines, but their maintenance has proven so
difficult that many of the machines haven’t produced results in months. Dr
Schouten said that this is even the case in some of the larger cities in the
country. Providing access to CD4 cell monitoring at antenatal clinics in the
periphery would be even more challenging. Even if blood specimens were drawn,
packaged and transported to a working laboratory, pregnant women would have to come
back within a week or two for the results. There is a chance that a significant
proportion would not, and would fall through the cracks.
Dr Schouten
said that these clinics generally only have one clinical officer and two nurses
managing about 150 to 200 patients a day. Even if point-of-care CD4 cell tests
were to become available, they would still take time to administer and read,
straining clinics already operating past capacity. But the technology is not
available to fill this gap at the moment, said Dr Schouten, and it’s unlikely
to be developed for several years.
So Malawi has
decided to start all pregnant women with HIV on ART and to keep them on treatment
for life. They call this 'Option B-Plus', and says Dr Schouten, it could offer
several advantages:
- It protects the mother from the
beginning of her next pregnancy as well.
- It could reduce maternal
postpartum mortality and AIDS mortality (a retrospective review of the
DREAM cohort
– which included women with CD4 cells above 350
–
presented at IAS last year
found significantly lower maternal mortality among women more extensively
treated with ART.
- It will reduce the risk of TB.
- It prevents maternal exposure
to single-dose nevirapine, thus preventing resistance and preserving the
mother’s treatment options.
As
Professor Anthony Harries pointed out, Option B-Plus will depend on getting money
from the Global Fund, but, said Dr Schouten, it’s the only realistic option for
Malawi.
It’s clear
that, as countries gear up to submit proposals for expansion of PMTCT programmes
to the Global Found round 10 in late August, slightly different decisions are
being reached in each country about how far to go in implementing WHO
recommendations.
However, Malawi is the
only country that appears to be pushing the envelope, and Professor Harries
says that the Malawian approach will offer a major opportunity to assess the
feasibility and acceptability of a staged introduction of 'universal test and
treat', with pregnant
women as the first group.