ATRIPLA SUMMARY
ATRIPLA™
(efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets
ATRIPLA™ is a fixed dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate (tenofovir DF). SUSTIVA® is the brand name for efavirenz, a non-nucleoside reverse transcriptase inhibitor. EMTRIVA is the brand name for emtricitabine, a synthetic nucleoside analog of cytidine. VIREAD is the brand name for tenofovir DF, which is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. VIREAD and EMTRIVA are the components of TRUVADA®. ATRIPLA Tablets are for oral administration. Each tablet contains 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir DF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients.
ATRIPLA is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
Description of Clinical Studies
Clinical Study 934 supports the use of ATRIPLA Tablets in antiretroviral treatment naïve HIV-1 infected patients. Additional data in support of the use of ATRIPLA in treatment naïve patients can be found in the prescribing information for VIREAD.
In antiretroviral treatment-experienced patients, the use of ATRIPLA Tablets may be considered for patients with HIV strains that are expected to be susceptible to the components of ATRIPLA as assessed by treatment history or by genotypic or phenotypic testing (see MICROBIOLOGY, Drug Resistance and Cross Resistance).
Study 934: Emtricitabine + Tenofovir Disoproxil Fumarate + Efavirenz Compared with Zidovudine/Lamivudine + Efavirenz
Data through 48 weeks are reported for Study 934, a randomized, open-label, active-controlled multicenter study comparing emtricitabine + tenofovir DF administered in combination with efavirenz versus zidovudine/lamivudine fixed-dose combination administered in combination with efavirenz in 511 antiretroviral-naïve patients. Patients had a mean age of 38 years (range 18–80), 86% were male, 59% were Caucasian and 23% were Black. The mean baseline CD4 cell count was 245 cells/mm3 (range 2–1191) and median baseline plasma HIV-1 RNA was 5.01 log10 copies/mL (range 3.56–6.54). Patients were stratified by baseline CD4 count (< or ≥ 200 cells/mm3) and 41% had CD4 cell counts <200 cells/mm3. Fifty-one percent (51%) of patients had baseline viral loads >100,000 copies/mL. Treatment outcomes through 48 weeks for those patients who did not have efavirenz resistance at baseline (n=487) are presented in Table 6.
Table 6 Outcomes of Randomized Treatment at Week 48 (Study 934) | Outcome at Week 48 | FTC + TDF + EFV
(N=244) | AZT/3TC+ EFV
(N=243) |
|---|
| % | % |
|---|
| ResponderPatients achieved and maintained confirmed HIV-1 RNA <400 copies/mL through Week 48. | 84% | 73% |
| Virologic failureIncludes confirmed viral rebound and failure to achieve confirmed <400 copies/mL through Week 48. | 2% | 4% |
| Rebound | 1% | 3% |
| Never suppressed through week 48 | 0% | 0% |
| Change in antiretroviral regimen | 1% | 1% |
| Death | <1% | 1% |
| Discontinued due to adverse event | 4% | 9% |
| Discontinued for other reasonsIncludes lost to follow-up, patient withdrawal, noncompliance, protocol violation and other reasons. | 10% | 14% |
The difference in the proportion of patients who achieved and maintained HIV-1 RNA <400 copies/mL through 48 weeks largely results from the higher number of discontinuations due to adverse events and other reasons in the zidovudine/lamivudine group in this open-label study. In addition, 80% and 70% of patients in the emtricitabine + tenofovir DF and the zidovudine/lamivudine group, respectively, achieved and maintained HIV-1 RNA <50 copies/mL. The mean increase from baseline in CD4 cell count was 190 cells/mm3 in the emtricitabine + tenofovir DF group, and 158 cells/mm3 for the zidovudine/lamivudine group.
Through 48 weeks, 7 patients in the emtricitabine + tenofovir DF group and 5 patients in the zidovudine/lamivudine group experienced a new CDC Class C event.
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