Day 40: New DHHS guidelines

The new Department of Health and Human Services adult HIV treatment guidelines were updated earlier this month. There were a number of changes, none of which were particularly shocking. Of note, though, the entire section on when to start therapy has been re-written. This section seems to change every so often; this time it has shifted back towards starting therapy at higher CD4 counts. It is by no means the “hit hard, hit early” scenario when HAART was first introduced, but it is the most significant shift in a while. The DHHS recommends that patients initiate therapy at CD4 levels <350. The evidence has been building up to this in the past few years, so this probably reflects what is already happening in the clinics.

The DHHS also recommends initiating therapy for pregnant women regardless of CD4, for patients with HIV-associated nephropathy, and for those starting anti-hepatitis B virus therapy. Out of the three, the HBV recommendation is the most controversial, as patients may start HBV therapy with high CD4 counts. The DHHS panel makes the recommendation based on the anti-HIV activity of entecavir, noting that use of the agent without combination anti-HIV therapy may result in the emergence of M184V reverse transcriptase mutations.

A few lab tests were also recommended. The DHHS panel recommends HLA-typing for patients who may receive abacavir. It is fairly clear that patients who carry the HLA-B*5701 allele are at risk for ABC-associated hypersensitivity reactions, while those who do not carry the allele are not. The guidelines also recommend the tropism assay for those patients starting maraviroc—which you would expect for a CCR5 inhibitor. There’s no point in taking a drug if it is not going to have activity against the predominant tropism. As an aside, I still think maraviroc should be reformulated as a microbicide. Finally, the DHHS recommends that all patients entering care receive viral genotyping, as it may be easier to detect resistance during initial infection, prior to the outgrowth of wild-type virus.

Other than that, the guidelines take on the two new medications (maraviroc and raltegravir). The guidelines are always worth a read, but I think we have all seen these changes coming down the line.

M. Linde