Viral decay dynamics in HIV-infected patients receiving ritonavir-boosted saquinavir and efavirenz with or without enfuvirtide: A randomized, controlled trial (HIV-NAT 012)

The availability of enfulvirtide enables assessment of whether human immunodeficiency virus (HIV) decay can be enhanced by targeting reverse transcriptase, protease, and fusion. We performed a 12-week study of 22 patients randomized to receive ritonavir-boosted saquinavir and efavirenz with (the 3-target arm) or without (the 2-target arm) enfuvirtide. We observed no difference in the mean +/- SD elimination-rate constant for overall decay (0.142 +/- 0.040 per day and 0.128 +/- 0.033 per day in the 2- and 3-target arms, respectively; P >.1) or for modeled first-phase decay rate (-0.62 +/- 0.34 per day and -0.51 +/- 0.16 per day, P > .1). Antiretroviral therapy that inhibits HIV reverse transcriptase and protease exerts potent antiviral effects that might not be augmented by the addition of an HIV fusion inhibitor.