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5-year safety and efficacy of the once-daily antiretroviral regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)
Journal of the International AIDS Society volume 13, Article number: P6 (2010)
The goal of highly active antiretroviral therapy (HAART) is to suppress HIV RNA to undetectable levels over many years and is primarily dependent on adherence, which is aided by using a once daily regimen with good tolerability and low pill burden. In Study 934 the time to discontinuation for the twice daily regimen of EFV qd + zidovudine/lamivudine bid was significantly shorter than for the once daily regimen (EFV+FTC+TDF) (p=0.003). Herein are the 5 year safety and efficacy data for this once daily regimen.
160 subjects (89% male, 64% white, mean age 41 yrs) in Study 934 originally randomized to the once daily regimen of EFV+FTC+TDF who completed 144 weeks agreed to switch to the single tablet formulation (EFV/FTC/TDF) and remain on study for an additional 96 weeks for a total of 240 weeks.
At baseline (BL), mean HIV RNA= 5.03 log10 c/mL, mean CD4 count= 243 cells/mm3, and 88% had symptomatic HIV or AIDS. After 240 weeks of follow-up:
87% had HIV RNA <400 c/mL and 84% <50 c/mL (M=F); mean CD4 cell increase from BL= 346 cells/mm3. The mean (range) adherence rate was 97% (83-100%). Seventeen subjects discontinued EFV/FTC/TDF: withdrew consent (6); lost to follow-up (5); adverse events (2: osteoporosis (1) and anal cancer (1)); incarceration (2); non-adherence (1); and relocated (1). No patient discontinued due to renal adverse events. Mean change from BL in estimated glomerular filtration rate (e-GFR) by Cockcroft-Gault was -7 mL/min (Mean BL e-GFR, 129 mL/min).
Through 240 weeks, the once daily HAART regimen of EFV+FTC+TDF (dosed as single tablet regimen, EFV/FTC/TDF, from Week 144-240) demonstrated durable antiretroviral efficacy and immunologic recovery in antiretroviral-naïve patients. The decline in e-GFR was mild and not clinically significant.
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Lazzarin, A., Johnson, M., Ribera, E. et al. 5-year safety and efficacy of the once-daily antiretroviral regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF). JIAS 13, P6 (2010). https://doi.org/10.1186/1758-2652-13-S4-P6
- Tenofovir Disoproxil Fumarate
- Daily Regimen
- Pill Burden