The Malawian context of the new WHO recommendations for HIV treatment

The WHO on the eve of World Aids Day (30^th November) issued new recommendations for treatment, prevention and infant feeding in the context of HIV,  based on the latest scientific evidence.  Highlights of the new recommendations include starting antiretroviral therapy (ART) earlier in adults and adolescents, delivery and use of better-tolerated and more conveniently administered antiretroviral drugs (ARVs), and longer use of ARVs to lower the risk for mother-to-child HIV transmission.

In the last five years close to 50 scientific articles have published research on Malawi, recommending similar actions. The Ministry of Health in Malawi has been slow to act, ignoring these findings and awaiting guidance from the WHO. This is ironic because some of the WHO advisers are the very same said local researchers but government  prefers WHO to rubberstamp new guidelines.  I am certain that our local research has influenced the revised WHO policy, however  I am not sure to what extent, but none the less I would like to highlight some papers that were published and discuss the implications of these recommendations in reference to Malawi.

Earlier start to ARVs and clinical laboratory tests

The WHO advocates starting ART when CD4 cells, which are defense cells of the immune system, fall below 350 cells per millilitre. The previous recommendation was 200 cells per millilitre but research has shown that an early start can reduce death rates.  A paper published last year  found that death rates were high in those who started ART at CD4 counts of less than 200. However,  in some cases  in the absence of diagnostic equipment, WHO clinical staging has been used. This system uses patient’s clinical symptoms to guide decision making but often fails to diagnose those eligible to start ART.

In accordance with the change in the CD4 level threshold, WHO is also encouraging increased access to laboratory tests that can not only determine CD4 levels but also viral load, the amount of HIV in the blood.

Breast feeding and mother to child transmission

WHO is recommending, for the first time I must add,  that HIV-positive mothers take ARVs during the entire course of breastfeeding to prevent disease transmission.  Several seminal papers have been published by researchers at Johns Hopkins in Blantyre on mother to child transmission, which have called for extended prophylaxis for infants.  The argument in the past has been  – to reduce mother to child transmission,  mothers should not breastfeed, but  in resource poor settings, mothers  often cannot afford to give their baby formula, plus there is  the added problem of providing formula with safe drinking water.  The new recommendations also call for HIV pregnant mothers to start ARVs at 14 weeks instead of the previous 28 weeks.

ARV drugs

The WHO is also urging for the replacement of stavudine, or d4T — a first-line antiretroviral with tenofovir or zidovudine. Stavudine is readily available and cheap in developing countries but has been known to produce irreversible side effects.

The new recommendations will lead to more people needing treatment, said the WHO, but they say: “The associated costs of earlier treatment may be offset by decreased hospital costs, increased productivity due to fewer sick days, fewer children orphaned by AIDS and a drop in HIV infections.” But I ask what could this mean for Malawi?

Some reports estimate that the new recommendations would mean 2.5 to 3 times as many people will be eligible for treatment. In 2005, only 14,300 people were on treatment, in 2009 250,00, this is a commendable achievement by Malawi’s National AIDS Council (NAC) although this still falls short of the number in need of treatment which was estimated as 340,000 by UNAIDS in 2007. Therefore NAC has to double their efforts in order to provide universal access to the “newly” eligible .

Access to laboratory testing facilities must be improved so that people in remote areas should be able to conveniently and regularly have CD4 count and viral load tests  and even in the absence of these tests should not be denied treatment.  This will require machines and trained staff in places as far as Nsanje and Chitipa.  A paper by van Oosterhout has discussed how viral loads can also determine patients whose treatment is not working.

The current recommended first-line treatment for ARVs in Malawi is a combination of three drugs that include stavudine, with the average cost of this combination therapy pegged at  US$ 15 per person per year (2005) . Replacing this drug will be expensive but if the President follows through with his commitment,  we could be manufacturing our own ARVs which would drastically reduce the cost.  The drugs recommended to replace stavudine , tenofovir or zidovudine, although more expensive will offset the cost of reduced toxicity management in hospital.

All the recommendations urgently require money, but with so much criticism of late in funding AIDS programs, where will the money come from?