Initial viral decay to assess the relative antiretroviral potency of protease inhibitor-sparing, nonnucleoside reverse transcriptase inhibitor-sparing, and nucleoside reverse transcriptase inhibitor-sparing regimens for first-line therapy of HIV infection
Year: 2011
Type: article
Abstract: OBJECTIVES: To evaluate the effects of sex and initial antiretroviral regimen on decay of HIV-RNA and virologic outcome. METHODS: We conducted a viral dynamics substudy of A5142, a trial comparing lopinavir (LPV)/ritonavir with efavirenz (LPV/EFV) versus LPV and two nucleoside reverse transcriptase inhibitor (NRTI) (LPV) versus EFV and two NRTI (EFV) in antiretroviral (ARV)-naive individuals. HIV-RNA was measured at days 2, 10, and 14 in the substudy and at weeks 1, 4, and 8 in A5142 participants. Two-phase viral decay was estimated in the substudy with biexponential mixed-effects modeling and compared using Wilcoxon tests. Week 1 HIV-RNA change was assessed as a predictor of virologic failure (HIV-RNA above 50 or 200 copies/ml) at weeks 24-96 using logistic regression. RESULTS: Sixty-eight individuals were enrolled in the substudy (median HIV-RNA 4.9 log(10) copies/ml). Median rates of phase 1 viral decay by treatment were 0.61(EFV/LPV), 0.53(LPV), and 0.63(EFV) per day. Phase 1 decay was significantly faster for EFV than LPV (P = 0.023); other comparisons were not significant (P > 0.11). Viral decay did not differ by sex (P = 0.10). Week 1 HIV-RNA change, calculated in 571 participants of A5142, was greater for the EFV (median -1.47 log(10) copies/ml) than either the LPV/EFV or LPV groups (-1.21 and -1.16 log(10 ) copies/ml, respectively; P < 0.001). Week 1 HIV-RNA change was associated with virologic failure above 50 copies/ ml at weeks 24 and 48 (P < 0.018), but not above 200 copies/ml at these time points or for any value at week 96. CONCLUSION: Phase 1 decay was faster for EFV than LPV or LPV/EFV. Week 1 HIV-RNA change predicted virologic outcome up to week 48, but not at week 96.
Source: AIDS
Institutions: University of California San Diego, University of Pittsburgh, Harvard University, State University of New York, University at Albany, State University of New York, National Institute of Allergy and Infectious Diseases, Abbott (United States), Bristol-Myers Squibb (United States), Gilead Sciences (United States), University of California, San Francisco
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G101757908, G1033683653, G1065691059, G1068660208, G1143685601, The Ohio State University AIDS Clinical Trials Unit, G123932167, G1276011396, University of Cincinnati AIDS Clinical Trials Unit- UC ACTU, WASHINGTON UNIVERSITY AIDS CLINICAL TRIALS UNIT, The Ohio State University AIDS Clinical Trials Unit, New York University HIV/AIDS Clinical Trial Unit, G1346130624, Atlanta Clinical and Translational Science Institute (UL1), G1479152345, Stanford AIDS Clinical Trials Unit, G1534260048, G154087045, G1586133245, G161582775, UW Clinical HIV Integrated Research Program, Emory HIV/AIDS Clinical Trials Unit, WASHINGTON UNIVERSITY AIDS CLINICAL TRIALS UNIT, G1681955143, Chinese Clinical Trials Unit for HIV Research (CCTU), G174905615, U.T. SOUTHWESTERN ADULT AIDS CLINICAL TRIALS UNIT, G1805005405, G1819583291, G1840998190, G185513119, Vanderbilt HIV Clinical Trials Unit, G1939027404, G1939689254, G1944963898, G2069435444, G2135258891, G2199452652, G2220623200, G229144670, G2368841045, G2381598486, G2398866917, Miami HIV/AIDS Clinical Therapeutic and Vaccine Trial Unit, G2507544392, G251702431, G2682253789, G2709153970, University of North Carolina AIDS Clinical Trials Unit (UNC ACTU), ADULT AIDS CLINICAL TRIALS UNIT, G299859194, G3116536149, Cornell Clinical Trials Unit, MODEL DEVELOPMENT FOR MATERNAL/FETAL TRANSMISSION OF HIV, G3206835426, G3277483280, Johns Hopkins AIDS Clinical Trials Unit, General Clinical Research Center, ADULT AIDS CLINICAL TRIALS UNIT (ACTU), G3525517067, Miami Treatment and Prevention Clinical Trials Unit (CTU), AIDS Clinical Trials Group Network, G367367271, G373348672, UCLA AIDS Prevention and Treatment Clinical Trials Unit, G3788978964, UW Clinical HIV Integrated Research Program, G3873853564, General Clinical Research Center, ADULT AIDS CLINICAL TRIALS UNIT, G4122054131, GENERAL CLINICAL RESEARCH CENTER, General Clinical Research Center, G4166928756, General Clinical Research Center, General Clinical Research Center, G4316068824, G4317913406, Northwestern University Clinical Trial Unit, Colorado AIDS Clinical Trials Unit, Institute of Human Virology Clinical Trials Unit, G473273920, Case Clinical Trials Unit, Stanford AIDS Clinical Trials Unit, General Clinical Research Center, University of Pittsburgh Clinical Trials Unit, G517861501, ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM IN AIDS, UCSF HIV Clinical Trials Unit, New York University HIV/AIDS Clinical Trial Unit, ADULT ACTG CENTRAL GROUP, Improving Antiretroviral Management for HIV, Statistical and Data Management Center for the AIDS Clinical Trials Group, UCSD Department of Medicine HIV/AIDS Clinical Trials Unit, HIV/AIDS Clinical Trial Unit in NCAIDS, China CDC, General Clinical Research Center, G5937357401, Atlanta Clinical and Translational Science Institute (ACTSI) Renewal, G602580346, Case AIDS Clinical Trials Unit, GENERAL CLINICAL RESEARCH CENTER, ADULT AIDS CLINICAL TRIAL UNIT, G6103943158, Partners Healthcare Systems/Harvard Medical School/Boston Medical Center AIDS CTU, G6547381117, Therapeutic Strategies for HIV Disease, University of Cincinnati AIDS Clinical Trials Unit- UC ACTU, Colorado AIDS Clinical Trials Unit, UCSF HIV Clinical Trials Unit, AIDS CLINICAL TRIALS UNIT, Partners Healthcare Systems/Harvard Medical School/Boston Medical Center AIDS CTU, Columbia Collaborative HIV/AIDS Clinical Trials Unit, G7348756, HAWAII ACTU - ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM, G749807406, HIV/AIDS Clinical Trials Unit, HIV/AIDS Clinical Trials Unit, AIDS RESEARCH, Institute of Human Virology Clinical Trials Unit, ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM FOR HIV/AIDS, UCSD Collaborative Clinical Trials Unit, Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials Unit, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Emory-CDC CTU, Chicago Clinical Trials Unit, San Diego Center for AIDS Research (SD CFAR), Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), Penn Center for AIDS Research, Johns Hopkins University Baltimore India Clinical Trail Unit (JHUBI CTU), The University of North Carolina Center for AIDS Research, Pitt-Ohio State Clinical Trials Unit, Columbia Collaborative HIV/AIDS Clinical Trials Unit, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit, San Francisco Bay Clinical Trials Unit (CTU), UCSF-Bay Area Center for AIDS Research, Harvard University Center for AIDS Research, UCLA AIDS Prevention and Treatment Clinical Trials Unit, Vanderbilt HIV Clinical Trials Unit (CTU), G939730012, G964886957
OpenAlex ID: W1965602853