Response by Baseline Viral Load

Robust virologic response regardless of baseline viral loads1-3

In Study 103 and Study 102, subjects were stratified by baseline HIV-1 RNA (≤100,000 copies per mL or >100,000 copies per mL). STRIBILD was noninferior to ATV + RTV + FTC/TDF and EFV/FTC/TDF at week 144 in subjects regardless of baseline viral load.4

Noninferior efficacy in subjects with a baseline viral load ≤100,000 copies or >100,000 copies/mL at week 1441,3


Viral suppression rates stratified by baseline viral load at week 96

See how viral load affected STRIBILD efficacy


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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.

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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 single-tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive.

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.
  • Data on File. Gilead Science, Inc.
  • Wohl DA, Cohen C, Gallant JE, et al; for the GS-US-236-0102 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF versus single-tablet regimenefavirenz/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.
  • STRIBILD [package insert]: Foster City, CA: Gilead Sciences, Inc, 2014.

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

Important Safety Information

Adverse reactions

  • Common adverse drug reactions in clinical studies (incidence ≥5%; all grades) were nausea (16%), diarrhea (12%), abnormal dreams (9%), and headache (7%).

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