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Gail Skowron, Daniel R. Kuritzkes, Melanie A. Thompson, Kathleen E. Squires, S. Diane Goodwin, Betsy A. Dusak, Jerry M. Tolson, Michael Stevens, Geoffrey J. Yuen, Intercompany Collaboration for AIDS Drug Development Protocol 604 Team, Once-Daily Quadruple-Drug Therapy with Adefovir Dipivoxil, Lamivudine, Didanosine, and Efavirenz in Treatment-Naive Human Immunodeficiency Virus Type 1–Infected Patients, The Journal of Infectious Diseases, Volume 186, Issue 7, 1 October 2002, Pages 1028–1033, https://doi.org/10.1086/343740
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Abstract
A 48-week open-label study of 11 antiretroviral-naive, human immunodeficiency virus type 1 (HIV-1)–infected adults evaluated once-daily treatment with adefovir dipivoxil, lamivudine, didanosine, and efavirenz. At baseline, the median plasma HIV-1 RNA level was 4.99 log10 copies/mL, and the median CD4 cell count was 471 cells/mm3. At 24 and 48 weeks after initiation of treatment, median HIV-1 RNA levels decreased from baseline by 4.77 and 4.99 log10 copies/mL, respectively, and median CD4 cell counts increased by 135 and 177 cells/mm3, respectively. The regimen was generally well tolerated. No patients withdrew from the study because of adverse events. However, 7 patients developed adefovir-related nephrotoxicity after ⩾20 weeks of treatment; this resolved without sequelae after adefovir was discontinued. Overall adherence was 85%. Once-daily quadruple-drug therapy with adefovir, lamivudine, didanosine, and efavirenz provides pronounced and durable suppression of HIV-1 RNA and elevation of CD4 cell counts over the course of 48 weeks, with generally good tolerability and adherence