Efficacy
and Safety of Atripla (Fixed-dose Tenofovir, Emtricitabine and Efavirenz) Compared
to Combivir (Fixed-dose Zidovudine/Lamivudine) and EFV: 96-week Results This
is the first large phase III trial comparing once daily Atripla [tenofovir (TDF),
emtricitabine (FTC) and efavirenz (EFV)] to twice daily Combivir (CBV) and once
daily EFV. At week 48, the proportion of patients reaching primary endpoint of
HIV RNA<400 c/mL using the FDA TLOVR algorithm was significantly higher in
the TDF+FTC arm. This
is an ongoing phase III, multicenter, open-label, randomized trial in treatment-naïve
patients with HIV RNA>10,000 c/mL and any CD4 cell count. Whole body DEXA scans
were collected on available patients at week 96. Results
- Baseline characteristics
(ITT, n=509) were similar between arms (median age 37, 14% female, 59% white,
median HIV RNA 5.0 log10 c/mL, median CD4 237 cells/mm3).
- Excluding
patients(n=22) with baseline NNRTI mutations, 76% in TDF+FTC arm (n=244) vs 64%
in CBV arm (n=243) achieved and maintained HIV RNA<400 c/mL through Week 96;
- 69% in TDF+FTC
arm vs. 63% in CBV arm achieved and maintained HIV RNA<50 c/mL.
- The
mean increase in CD4 cell count from baseline was significantly greater in TDF+FTC
arm (270 vs 237, p=0.036).
- No
patient developed the K65R mutation.
- Significantly
more patients on CBV developed M184V/I (9 vs 2, p=0.037).
- Adverse
events leading to study regimen discontinuation (most common: anemia, nausea,
fatigue, vomiting, rash) were fewer for TDF+FTC arm (5%) vs CBV arm (11%), p<0.001.
- The renal
safety profile was similar in both arms. Median limb fat at week 96 was greater
in TDF+FTC arm (7.7 kg, n=144) compared to CBV arm (5.5 kg, n=136), p<0.001.
The
authors conclude, “Through Week 96, significantly more patients on TDF+FTC+EFV
[Atripla] achieved HIV RNA<400 c/mL and had higher CD4 cell increase from baseline.” “More
patients in CBV arm discontinued study regimen due to adverse events. Limb fat
was significantly higher in TDF+FTC arm.” Johns
Hopkins Univ School of Medicine, Baltimore, MD, USA; Chelsea & Westminster
Hosp, London, UK; Orlando Immunology Center, Orlando, FL, USA; Univ Hosp La Paz,
Madrid, Spain; Univ Miami, Miami, FL, USA; 6Gilead Sciences, Inc., Foster City,
CA, USA. Reference
J
Gallant, A Pozniak, E J DeJesus, and others (for the Study 934 Team). Efficacy
and Safety of Tenofovir DF (TDF), Emtricitabine (FTC) and Efavireenz (EFV) Compared
to Fixed Dose Zidovudine/Lamivudine (CBV) and EFV through 96 Weeks in ANtiretorviral
Treatment-naïve Patients. 16th International AIDS Conference. August 13-18,
2006. Toronto, Canada. Abstract TUPE0064
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