The Body Covers: The 38th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy
I-84: Adefovir Dipivoxil Therapy Significantly Decreases HIV RNA in Patients With High Level AZT-3TC Resistant HIV
September 25, 1998
GS-96-408 was a Gilead-funded study of what happened when adefovir (120 mg/day) was added to prior antiretroviral therapy in patients who still had detectable plasma HIV RNA. In this virologic substudy, plasma HIV RNA specimens from 142 patients were fully evaluated for viral load and genotypic mutations at baseline and 24 weeks. The participants in this study were heavily nucleoside experienced, most had previously taken at least 3 nucleosides (more than 50% AZT, more than 40% D4T), with at least 3 years' experience of AZT. Initially, they all had CD4 counts over 200 cells/mm3 and plasma viral loads over 2,500 copies/ml at baseline. 53% had viruses that had at least 3 AZT mutations consistent with high level resistance, and 76% had the 3TC mutation, M184V. Overall, participants that received adefovir had a plasma viral load decrease of .53 logs at 24 weeks. However, when the researchers looked at those participants who had baseline M184V mutations, the drop was .94 logs. This supports the in vitro finding that the 184 mutation increases susceptibility to adefovir. When participants had only pre-existing high level AZT resistance mutations, they did not have a meaningful drop in plasma HIV RNA, but when they had both AZT and 3TC resistance mutations at baseline, the addition of adefovir resulted in a .51 log drop. This data suggest that adefovir may be a very useful part of a new regimen in patients who have a rebound in plasma HIV RNA after having received regimens that contain 3TC in addition to AZT and other NRTIs; in NRTI-experienced patients who have not received prior 3TC, however, the addition of adefovir may not be useful.
Authored by: Cherrington et al
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