BACKGROUND: A one-tablet, once-daily abacavir/lamivudine fixed-dose combination (FDC) has been recently approved to treat HIV-1 infection. METHODS: A randomized, open-label, parallel-group, multicenter study to compare the efficacy and safety of the FDC group to the separate entities (SE) group, in combination with tenofovir and a new protease inhibitor or nonnucleoside reverse transcription inhibitor in antiretroviral-experienced adults experiencing virologic failure (VF). Eligible subjects had viral loads >1000 copies/mL with < or =3 nucleoside reverse transcription inhibitor-associated mutations. The primary efficacy end point was time-average changed from baseline (average area under the curve minus baseline) in plasma HIV-1 RNA over 48 weeks. RESULTS:A total of 186 subjects were enrolled. The average area under the curve minus baseline was -1.65 and -1.83 log10 copies/mL in the FDC and SE groups, respectively (intention to treat; 95% confidence interval: -0.13, 0.38). Patients in the FDC (50%) and SE groups (47%) achieved viral loads <50 copies/mL based on the time to loss of virologic response algorithm. VF was low and similar in both groups (FDC, 16%; SE, 18%). Tolerability was similar between the 2 groups. CONCLUSIONS: The FDC group had noninferior efficacy over 48 weeks to the SE group in treatment-experienced subjects with VF.
RCT Entities:
BACKGROUND: A one-tablet, once-daily abacavir/lamivudine fixed-dose combination (FDC) has been recently approved to treat HIV-1 infection. METHODS: A randomized, open-label, parallel-group, multicenter study to compare the efficacy and safety of the FDC group to the separate entities (SE) group, in combination with tenofovir and a new protease inhibitor or nonnucleoside reverse transcription inhibitor in antiretroviral-experienced adults experiencing virologic failure (VF). Eligible subjects had viral loads >1000 copies/mL with < or =3 nucleoside reverse transcription inhibitor-associated mutations. The primary efficacy end point was time-average changed from baseline (average area under the curve minus baseline) in plasma HIV-1 RNA over 48 weeks. RESULTS: A total of 186 subjects were enrolled. The average area under the curve minus baseline was -1.65 and -1.83 log10 copies/mL in the FDC and SE groups, respectively (intention to treat; 95% confidence interval: -0.13, 0.38). Patients in the FDC (50%) and SE groups (47%) achieved viral loads <50 copies/mL based on the time to loss of virologic response algorithm. VF was low and similar in both groups (FDC, 16%; SE, 18%). Tolerability was similar between the 2 groups. CONCLUSIONS: The FDC group had noninferior efficacy over 48 weeks to the SE group in treatment-experienced subjects with VF.
Authors: Yeon Joo Lee; Jiaqi Fang; Phaedon D Zavras; Susan E Prockop; Farid Boulad; Roni Tamari; Miguel Angel Perales; Esperanza B Papadopoulos; Ann A Jakubowski; Sergio A Giralt; Genovefa A Papanicolaou Journal: J Infect Dis Date: 2020-09-01 Impact factor: 5.226
Authors: Jean B Nachega; Jean-Jacques Parienti; Olalekan A Uthman; Robert Gross; David W Dowdy; Paul E Sax; Joel E Gallant; Michael J Mugavero; Edward J Mills; Thomas P Giordano Journal: Clin Infect Dis Date: 2014-01-22 Impact factor: 9.079
Authors: Victor Musiime; Philip Kasirye; Bethany Naidoo-James; Patricia Nahirya-Ntege; Tawanda Mhute; Adrian Cook; Lincoln Mugarura; Marshall Munjoma; Navdeep K Thoofer; Emmanuel Ndashimye; Immaculate Nankya; Moira J Spyer; Margaret J Thomason; Wendy Snowden; Diana M Gibb; Ann Sarah Walker Journal: AIDS Date: 2016-07-17 Impact factor: 4.177