WHO Releases New Guidelines on Second-Line Antiretrovirals

The World Health Organization recently released new guidelines on second-line antiretroviral drugs in an attempt to assist developing countries in formulating treatment policies, PlusNews reports. The guidelines aim to speed approval for second-line antiretrovirals and reduce costs. The guidelines also will reduce the number of second-line drugs with WHO approval, PlusNews reports.

According to PlusNews, many second-line antiretrovirals are prohibitively expensive or unavailable in developing countries, and physicians often lack knowledge about or experience with what combination to prescribe HIV-positive people. The guidelines -- created from meetings held in May 2007 -- in part were released in response to requests from governments for more direction on which second-line antiretrovirals to include in their countries' treatment programs, PlusNews reports. The guidelines also address other barriers to drug access, including the lack of capacity in many developing countries to administer tests that diagnose resistance to first-line drugs. The guidelines read, "In order to maximize the efficacy and durability of first- and second-line antiretroviral regimens, WHO continues to support the universal availability and use of appropriate and affordable [CD4+ T cell] and HIV viral load testing."

According to WHO estimates, of the two million HIV-positive people in low- and middle-income countries with treatment access as of December 2006, 2% were on second-line drugs. That number will increase because about 3% of people receiving first-line drugs switch to second-line drugs annually. WHO said that without price reductions, the cost of second-line drugs -- which can cost two to nine times more than first-line drugs -- could account for as much as 90% of funding used for antiretroviral treatment by 2012. According to the Clinton Foundation HIV/AIDS Initiative, the prices of various generic second-line drugs currently in the pipeline or awaiting regulatory approval will depend on limiting the number of different drugs used for second-line treatment.

Tido von Schoen-Anderer, head of Medecins Sans Frontieres' Campaign for Access to Essential Medicines, said, "These new guidelines are good news." He added, "Before there were so many different drug options and now there is much clearer guidance, and that has major advantages at the program level, and also the choice of drugs means it's going to be cheaper." Andy Gray, a consultant pharmacist for the Centre for the AIDS Programme of Research in South Africa, said he welcomes the guidelines but worries that the choices might be too restrictive. "Limiting the number of second-line options may look attractive to a country program, but in a middle-income country such as South Africa, there's going to be a lot of pressure from clinicians that they need more options," Gray said. Von Schoen-Anderer added that "in terms of making second-line treatment more available, the only way forward was to make it simpler and easier to implement" (PlusNews, 2/7).

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