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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 High Barrier to Resistance Through 96 Weeks –
“This study demonstrated the high efficacy, high barrier to resistance
and long-term tolerability profile of Biktarvy through 96 weeks,
reaffirming its role as a first-line treatment option for appropriate
adult HIV patients who are starting therapy,” said Hans-Jürgen
Stellbrink, MD, PhD, Professor of Internal Medicine, Infectious
Diseases, at the
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. 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 1490, treatment-naïve adults (n=645) were randomized 1:1 in a blinded fashion to receive Biktarvy or DTG+FTC/TAF. At Week 96, non-inferiority was maintained from the primary endpoint measurement at Week 48, with 84.1 percent (n=269/320) of patients taking Biktarvy and 86.5 percent (n=281/325) of patients taking DTG+FTC/TAF achieving HIV-1 RNA levels less than 50 copies/mL (difference: -2.3 percent, 95 percent CI: -7.9 percent to 3.2 percent, p=0.41). In the resistance analysis population, none of the study participants randomized to Biktarvy developed treatment-emergent resistance.
Biktarvy was well-tolerated with low discontinuations due to adverse events in both treatment arms (2 percent (n=6) for Biktarvy vs. 2 percent (n=5) for DTG+FTC/TAF [1 Biktarvy and 4 DTG+FTC/TAF after Week 48]). The most commonly reported adverse events (all grades) were diarrhea (18 percent for Biktarvy vs. 16 percent for DTG+FTC/TAF) and headache (16 percent vs. 15 percent). There were fewer treatment-related adverse events (all grades) in the Biktarvy arm compared to DTG+FTC/TAF (20 percent for Biktarvy vs. 28 percent for DTG+FTC/TAF). Lipid changes were not significantly different between the two arms, and there were no renal discontinuations or cases of proximal renal tubulopathy.
“These data presented at HIV Glasgow further demonstrate the efficacy
and tolerability profile of Biktarvy, supporting the use of this
once-daily single tablet regimen in a broad range of adults living with
HIV who are new to HIV therapy,” said
Additional clinical trials of Biktarvy are ongoing, including dedicated studies in older adult women, African-American people living with HIV, adolescents and children living with HIV, as well as an additional study in treatment-naïve HIV-1 infected adults (Study 1489). Data from an analysis of pooled treatment-naïve adults in Studies 1489 and 1490 with high viral loads (HIV-1 RNA > 100,000 c/mL) or low CD4 counts (CD4 < 200 cells/µL) are also being presented in a poster session at HIV Glasgow. Biktarvy is only approved for use in adults.
Study 1490 is ongoing and will remain randomized and blinded through 144 weeks.
Biktarvy is approved in
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
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Gilead Sciences, Inc.
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