On February 12, just in time for Valentine’s Day, the U.S. Department of Health and Human Services (DHHS) antiretroviral treatment (ART) guidelines panel issued updates to their recommendations for when people living with HIV should start ART and which drugs are best to use, among other important treatment considerations.
Though there were a number of changes, three key areas are worth mentioning. First, though the guidelines panel still recommends that ART be offered to all people with HIV regardless of the status of their immune health, measured by CD4 cell counts, and though the strength and weight of that recommendation did not change, the data cited by the panel to back up their decisions was supplemented with additional studies.
This is notable, because the Institutes of Medicine recommends that guidelines panels base their decisions on high quality data. There is exceptionally strong data that starting ART when CD4 cells drop below 350 is protective not only against major illness, but also death. Data is moderately strong for starting when CD4s drop to 500. The data on treating at higher CD4 counts has been a bit mixed, however, and experts don’t expect to have a more definitive answer until a randomized control study currently underway concludes in 2015 or 2016.
In the meantime, the DHHS panel has issued an “expert opinion” recommending treatment at higher CD4 counts. This is based on more limited data showing an increase in some health problems even in people with high CD4s. The new data added to this recommendation found that people who took ART for only a six month period soon after becoming infected with HIV were less likely to later see their CD4 counts fall to more dangerous levels.
Another new study also highlighted the fact that after San Francisco instituted a policy of recommending ART to all people with HIV, the number of people with higher CD4s who had undetectable HIV levels rose from as low as 9% to over 50%. Since low HIV levels result in less chance of passing on HIV, this implies that offering treatment to all could have a positive impact on the epidemic.
The second change to the guidelines was about what drugs to use rather than when to use them. A new recommendation on the drug rilpivirine (Edurant) was that it should only be used in people who before starting treatment have a viral load under 100,000. Another new drug recommendation was that an alternate regimen could include the new four-drugs-in-one combination pill called Stribild. This pill includes an integrase inhibitor with a blood-level boosting agent and a nucleoside backbone of two drugs.
Lastly, the guidelines panel issued a new recommendation about the drug efavirenz (Sustiva or Atripla) during pregnancy. Efavirenz is categorized as potentially dangerous to the developing fetus, particularly during the first trimester of pregnancy. Previously, the guidelines recommended against any use of the drug, if possible, during the first trimester of pregnancy. The new guidelines highlight the fact that more recent data on efavirenz during pregnancy is more promising. Given that most women don’t find out they are pregnant until five or six weeks after conception, and given that changing ART regimens when one is working well can lead to loss of control of the virus, the new guidelines say that women who become pregnant while taking efavirenz may continue to take it provided that their virus is at undetectable levels. Women who are not yet pregnant, but trying to get pregnant or who aren’t using contraceptives should consider other drugs if possible, however.