• Most study participants understand research goals (Reuters)

    Fri, 04 Jul 2008 07:29:02 PDT
    Reuters - People who take part in clinical trials often do so out of a desire to advance scientific knowledge and to help others, a new international study demonstrates.

  • Tongue-Driven Device Aids Handicapped (HealthDay)

    Thu, 03 Jul 2008 20:47:58 PDT
    HealthDay - THURSDAY, July 3 (HealthDay News) -- A tongue drive system that enables severely disabled people to operate powered wheelchairs and to perform other tasks has been developed by engineers at the Georgia Institute of Technology.

  • Freeze-Dried Formula May Block HIV Virus in Breast Milk (HealthDay)

    Thu, 03 Jul 2008 20:47:52 PDT
    HealthDay - THURSDAY, July 2 (HealthDay News) -- In developing countries where breast-feeding is a necessity, and HIV is rampant, the risk of disease transmission through breast milk might be reduced if infants were first fed a freeze-dried formula full of good bacteria that could capture and potentially destroy the deadly virus.

  • S.African addicts turn to AIDS medication to get high (AFP)

    Wed, 02 Jul 2008 10:07:25 PDT
    AFP - South African AIDS patients in Durban are under siege from drug addicts who rob them of their antiretroviral treatment to get high, the provincial health department said Wednesday.

  • Bush urges Congress to pass AIDS funds (Reuters)

    Wed, 02 Jul 2008 09:29:12 PDT
    Reuters - President George W. Bush urged Congress on Wednesday to approve funds to fight AIDS in Africa and other countries, and said the issue was high on his agenda for a Group of Eight summit in Japan next week.

  • Death Rates for HIV Patients Decrease Dramatically (HealthDay)

    Tue, 01 Jul 2008 20:46:56 PDT
    HealthDay - TUESDAY, July 1 (HealthDay News) -- Death rates for HIV-infected people lucky enough to get their hands on antiretroviral medications have decreased dramatically since the introduction of these drugs in 1996, new British research shows.

  • Anti-retroviral drug cocktails slash AIDS deaths: study (AFP)

    Tue, 01 Jul 2008 15:39:54 PDT
    AFP - Anti-retroviral drug therapy has slashed AIDS death rates in the first five years after infection to equal the normal death rates in developed countries, scientists said Tuesday.

  • People with HIV living longer, study shows (Reuters)

    Tue, 01 Jul 2008 13:25:44 PDT
    Reuters - People with HIV in the developed world are no more likely to die in the first five years following infection than men and women in the general population, British researchers said on Tuesday.

  • Political will helping India's AIDS battle: U.N. (Reuters)

    Mon, 30 Jun 2008 08:13:31 PDT
    Reuters - A strong political will was stimulating India's fight against AIDS, raising hopes of controlling its spread in the country with the world's third-largest caseload, the U.N.'s AIDS agency said on Monday.

  • NYC urges docs to do routine HIV testing on adults (AP)

    Thu, 26 Jun 2008 23:19:44 PDT
    AP - Health officials are trying to persuade doctors to offer HIV tests to nearly every patient in a New York City community hit harder than most by AIDS.

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.
July 2006
GS-21-937-001
EMTRIVA, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc.
SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. REYATAZ and VIDEX are trademarks of Bristol-Myers Squibb Company. PRAVACHOL® is a registered trademark of ER Squibb & Sons, LLC. Other brands listed are the
trademarks of their respective owners and are not trademarks of Gilead Sciences, Inc, Bristol-Myers Squibb Company, or Bristol-Myers Squibb & Gilead Sciences, LLC.
© 2006 Bristol-Myers Squibb & Gilead Sciences, LLC
© 2006 Bristol-Myers Squibb Company
© 2006 Gilead Sciences, Inc.