Indications and usage

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-na?ve HIV-1 infected patients. Additional demo in version of the use of ATRIPLA in treatment na?ve 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 CrossResistance).
Study 934: Emtricitabine + Tenofovir Disoproxil Fumarate + Efavirenz Comparedwith 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-na?ve patients. Patients had a mean age of 38 years (range 18­80), 86% were male, 59% were Caucasian and 23% were Black. The mean baseline CD4 cell count was 245 cells/mm3 (range 2­1191) and median baseline plasma HIV-1 RNA was 5.01 log10 copies/mL (range 3.56­6.54). 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

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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July 2006
GS-21-937-001
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