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|Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy|
– Biktarvy Showed High Efficacy and a Demonstrated Tolerability Profile Through 96 Weeks –
“Healthcare providers who care for people living with HIV are always
seeking treatment options that offer high efficacy, a high barrier to
treatment-emergent resistance and a long-term tolerability profile,”
Biktarvy is indicated in the U.S. as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. No dosage adjustment of Biktarvy is required in adult patients with estimated creatinine clearance greater than or equal to 30 mL per minute. Biktarvy carries a Boxed Warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for Important Safety Information.
In Study 1489, treatment-naïve adults (n=629) were randomized 1:1 in a
blinded fashion to receive Biktarvy (BIC/FTC/TAF) or
There were no renal discontinuations and no cases of proximal renal
tubulopathy or Fanconi syndrome in the Biktarvy treatment group. The
median change in estimated glomerular filtration rate (eGFR) from
baseline to Week 96 was significantly less with Biktarvy compared with
Biktarvy was well tolerated through Week 96. Discontinuations due to
adverse events were low in both groups (0.0 percent (n=0) for Biktarvy
vs. 2 percent (n=5) for
“Gilead is committed to developing innovative treatments like Biktarvy
that help address the unmet needs of people living with HIV,” said
Study 1489 is ongoing and will remain randomized and blinded through 144 weeks.
Biktarvy does not cure HIV infection or AIDS.
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR BIKTARVY
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Pregnancy and lactation
Dosage and administration
Biktarvy 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 those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen for ≥3 months with no history of treatment failure and no known resistance to any component of Biktarvy.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that physicians may not see the benefits of prescribing Biktarvy for the
treatment of HIV-1 infection and the possibility of unfavorable results
from additional clinical trials involving Biktarvy. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended
Biktarvy, Gilead and the Gilead logo are trademarks of
For more information on
Gilead Sciences, Inc.
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