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|Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine|
-Through 48 Weeks, Biktarvy Found to Be Non-Inferior to Abacavir-Containing Regimen in Virologically Suppressed Adults Living With HIV-
– No Patients in Biktarvy Treatment Arm Demonstrated Treatment-Emergent Resistance Through 48 Weeks –
“In this study, Biktarvy maintained high rates of virologic suppression
and demonstrated a high barrier to resistance through 48 weeks of
treatment, findings that have been consistently observed across all
Phase 3 studies of the regimen,” said
Biktarvy is indicated 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 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 patients with estimated creatinine clearance greater than or equal to 30 mL per minute. Biktarvy has a Boxed Warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B. See below for Important Safety Information.
In Study 1844, a total of 563 virologically suppressed adults with HIV
taking a regimen of
Patients in the Biktarvy arm had a lower incidence of study drug-related
adverse events than those in the
Through Week 48, no patients in either treatment arm developed
treatment-emergent resistance. In addition, there were no renal adverse
events leading to discontinuations and no cases of proximal renal
tubulopathy in either treatment group. At Week 48, lipid profiles were
unchanged after switching to Biktarvy from
“The data presented at CROI this week, in addition to previously
reported studies in both treatment-naïve and virologically suppressed
adult patients, further demonstrate that Biktarvy may be appropriate for
a wide range of people living with HIV who are either new to treatment
or who choose to switch regimens,” said
Biktarvy was approved by the
Additional clinical trials of Biktarvy are ongoing, including a dedicated study in women, as well as a study in adolescents and children living with HIV. Data from the women’s study (Study 1961) and a cohort of adolescent subjects enrolled in the pediatric study (Study 1474) are being presented in poster sessions (Posters 2539 and 2271) at CROI.
Biktarvy does not cure HIV infection or AIDS.
Important U.S. Safety Information for Biktarvy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Dosage and administration
Pregnancy and lactation
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
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. In addition, the
Biktarvy is a trademark of Gilead Sciences, Inc., or its related companies.
For more information on
Gilead Sciences, Inc.
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