In April the World Health Organization (WHO) announced that, for the first time, it was adding 12 antiretrovirals to its Essential Medicines List. What took so long? There were no official guidelines for prescribing HIV meds in poor nations -- until WHO unveiled them along with the revised list. The UN agency's endorsement of HAART was timed to coincide with the first round of grants to poor countries by its Global Fund.
While the stated goal of WHO's move is to up access to HAART from the current 300,000 to 3 million by 2005, it is also expected to heighten competition for further price reductions in poor nations by "pre-qualifying" -- and even recommending -- generic manufacturers that produce the drugs. (Ten of the formulations are products of Cipla, the first company to break Western patent monopolies by offering HAART for $350 a year.) Big Pharma was notably silent on the list revision.
Three combos are identified as the simplest to start with -- a foundation of Combivir (AZT/3TC) plus either the nuke abacavir or non-nukes efavirenz or nevirapine. Protease inhibitors are recommended only after first-line failure. In a bow to reality, the new guidelines call for low-tech lab monitoring, basic blood cell counts and liver tests, allowing for treatment decisions based entirely on a person's clinical condition sans CD4-cell counts and viral load tests.
A watershed for HIV treatment worldwide, the move is also a political response to critics who argue either that the drugs don't work (think South African Prez Thabo Mbeki) or that poor people can't take them properly (think former USAID head Andrew Natsios, who wrote in a New York Times op-ed piece that Africans could never adhere to HAART because they "don't know what Western time is").
Jonathan Quick, head of WHO's essential-drugs program, said the addition "should dispel any questions about the safety, effectiveness and public-health relevance of these drugs." Yet even at $350 a year -- or $2 billion a year for all 6 million HIVers who currently need it -- HAART remains out of reach of the health budgets of most governments.