The Changing Standards for Anti-Retroviral Treatment of HIV/AIDS in Developing Countries
July 22, 2010
Senior Associate, Global Health Policy Center, CSIS
Infection with human immunodeficiency virus (HIV) causes severe illness and death through a slow but steady destruction of the immune system that progressively increases the risk of serious infection with other bacteria or viruses. The function of the immune system of people living with HIV/AIDS (PLWHA) is most easily measured by a blood test that counts the numbers of CD4 cells, the cells responsible for stimulating a normal immune response. The lower the CD4 count, the greater the chance of developing one of the “opportunistic” infections (e.g., tuberculosis) that defines the onset of AIDS in someone infected with HIV.
Treatment of PLWHA with life-extending anti-retroviral drugs (ARVs) can slow or even reverse the decline of CD4 cells and, for the last several years, the recommendation for beginning anti-retroviral drugs (ARVs) has been to begin when the CD4 count fell below 200/ml of blood.
The most recent guidance from various advisory groups, however, has relaxed that CD4 threshold, now recommending that ARVs be started whenever the CD4 count falls below 350.
Although these expanded CD4 guidelines were intended to provide a bit of extra protection to the immune system of HIV-infected people with CD4 counts between 200 and 350, certainly a useful idea for any individual PLWHA with ready access to ARVs, the new guidelines are likely to have a less helpful impact on many other PLWHA in developing countries. For example, even with the older threshold of 200 CD4 cell, only about a third of the 15 million PLWHA needing ARVs are being treated now. The resources for reaching the other 10 million are currently lacking.
Those least likely to have been reached so far under the older 250 CD4 threshold probably include those poorer and more marginalized people who cannot afford the travel or laboratory tests needed to qualify for ARVs. Others who have not been reached yet probably include those PLWHA who yet don’t realize that they are infected, i.e., those without adequate access to HIV testing and counseling because, e.g., they are unaware of the value of testing and counseling, or cannot afford it, or do not live close to a testing and counseling center.
Relaxing the ARV treatment standards from the prior 250 threshold to the new 350 threshold thus means that the previous 10 million HIV-infected but unreached people will now also be competing for scarce ARVs with additional millions of PLWHA whose CD4 counts are above 200 but below 350.
Although the new treatment guidance includes a principle of preserving treatment access for the sickest and most in need, PEPFAR and other organizations who have been working hard to reach those PLWHA with CD4 counts under 200 will be put in a difficult position. In general, decisions about changes to national treatment guidelines within any particular developing country should usually be left to that country’s government. However, to maintain the ethical principle of justice, some clear agreements will be needed between donors and recipient countries about the methods to be used to insure that the sickest PLWHA, usually those with the lowest CD4 counts, receive ARVs and other care before those who are not yet as ill – or not yet ill at all.
In summary, the recent CD4 treatment threshold changes, while well-intentioned, are likely to make an already complex global ARV situation even more complex.