Response by Baseline Viral Load

Robust virologic response regardless of baseline viral loads

Noninferior efficacy at week 144 in adults who had no ARV treatment history1,2


Viral suppression rates stratified by baseline viral load at week 96

Click here to view the virologic outcomes at week 48 (primary endpoint) and weeks 96 and 144 (secondary endpoints) using FDA snapshot analysis.

Click here to review the study designs.

Download a summary of two long-term, 144-week studies for STRIBILD

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STRIBILD Patient Brochure

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Important Safety Information

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH
STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (tenofovir DF), a component of STRIBILD, in combination with other antiretrovirals.
  • STRIBILD is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of STRIBILD have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF, components of STRIBILD. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Indication

STRIBILD is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen for ≥6 months with no history of treatment failure and no known resistance to any component of STRIBILD.

References:

  • Clumeck N, Molina JM, Henry K, et al; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014;65(3):e121-e124.
  • Wohl DA, Cohen C, Gallant JE, et al; GS-US-236-0102 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF versus single-tablet regimen efavirenz/emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014;65(3):e118-e120.

Please click here to view full Prescribing Information for STRIBILD, including BOXED WARNING

Important Safety Information

Adverse reactions

  • In adults with no ARV treatment history: Common adverse reactions in clinical studies (incidence ≥5%; all grades) were nausea (16%), diarrhea (12%), abnormal dreams (9%), and headache (7%).
  • In virologically suppressed adults: Common adverse reactions in clinical studies (incidence ≥2%; all grades) were nausea (4%), headache (2%), and flatulence (2%); the frequency of adverse reactions (all grades) was 24% in subjects switching to STRIBILD compared to 6% of subjects who stayed on their baseline ARV regimen.

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