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ATRIPLA combines SUSTIVA(R) (efavirenz), manufactured by Bristol-MyersSquibb Company, and Truvada(R) (emtricitabine/tenofovir disoproxil fumarate),manufactured by Gilead Sciences. Truvada itself is a fixed-dose product thatcontains two of Gilead's anti-HIV medications, Viread(R) (tenofovir disoproxilfumarate) and Emtriva(R) (emtricitabine), in a single once-daily tablet foruse as part of combination therapy. All three medicines work by blockingreverse transcriptase, an enzyme necessary for HIV replication.
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"ATRIPLA represents a milestone in treatment for this disease," said MarkWainberg, MD, director of the McGill AIDS Centre and professor of medicine andmicrobiology at McGill University. "I commend the companies involved forjoining forces to make ATRIPLA, the first complete three-drug regimen in asingle once-daily pill."
ATRIPLA was developed through a joint venture partnership betweenBristol-Myers Squibb Company and Gilead Sciences. The product was approved bythe U.S. Food and Drug Administration in July 2006 and has since become themost-prescribed treatment regimen for patients starting HIV therapy in theUnited States. In Canada, approximately 60,000 people are living with HIV, andaround 2,500 new HIV diagnoses are reported each year.
Clinical data support the use of the three-drug regimen contained inATRIPLA in HIV treatment-naive patients. A randomized, open label,active-controlled, multicenter, non-inferiority study, Study 934, compared aonce-daily regimen of Viread, Emtriva and SUSTIVA, the components of ATRIPLA,with twice-daily Combivir(R) (lamivudine/zidovudine) and once-daily SUSTIVA intreatment-naive patients with HIV. Through 48 weeks, 84 percent of patients inthe Viread/Emtriva/SUSTIVA group (n=244) compared to 73 percent of patients inthe Combivir/SUSTIVA group (n=243) achieved and maintained a viral load ofless than 400 copies/mL. This difference largely results from the highernumber of discontinuations in the Combivir/SUSTIVA group due to adverse events(9 percent vs. 4 percent in the Viread/Emtriva/SUSTIVA group) and otherreasons including loss to follow-up, patient withdrawal, non-compliance andprotocol violation (14 percent vs. 10 percent in the Viread/Emtriva/SUSTIVAgroup).
In addition, 80 percent and 70 percent of patients in theViread/Emtriva/SUSTIVA group and the Combivir/SUSTIVA group, respectively,achieved and maintained a viral load less than 50 copies/mL through 48 weeks.Selected treatment-emergent adverse events (Grades 2-4) reported in greaterthan or equal to 5 percent of patients in the Viread/Emtriva/SUSTIVA groupthrough 48 weeks included dizziness, nausea, diarrhea, fatigue, headache andrash.
Important Product Safety Information About ATRIPLA (efavirenz 600mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), Emtriva(emtricitabine), Viread (tenofovir disoproxil fumarate [DF]) and Truvada(emtricitabine/tenofovir DF)
Lactic acidosis and severe hepatomegaly with steatosis, including fatalcases, have been reported with the use of nucleoside analogues alone or incombination with other antiretrovirals.
Emtriva, Viread, Truvada and ATRIPLA are not approved for the treatment ofchronic hepatitis B virus (HBV) infection and their safety and efficacy havenot been established in patients co-infected with HBV and HIV. Severe acuteexacerbations of hepatitis B have been reported
