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|U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection|
– In Clinical Trials, Biktarvy Demonstrated High Efficacy, Few Interactions With Other Drugs and a High Barrier to Resistance Through 48 Weeks –
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 does not require testing for HLA-B*5701, has no food intake requirements, and has no baseline viral load or CD4 count restrictions. According to Biktarvy’s Prescribing Information, prior to or when initiating treatment with Biktarvy, healthcare providers should test for hepatitis B virus (HBV) infection and renal function, and monitor renal function as clinically appropriate during therapy.
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.
Photos and a multimedia gallery are available at www.GileadHIVMedia.com.
“In clinical trials through 48 weeks, no patients taking the regimen of
bictegravir plus FTC/TAF developed treatment-emergent resistance,
results that were observed both in people new to therapy and those who
were virologically suppressed and chose to switch regimens,” said
The approval of Biktarvy is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a diverse population of 2,415 participants, including a wide range of adult age groups and races/ethnicities. Biktarvy met its primary objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies failed Biktarvy with treatment-emergent virologic resistance, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking Biktarvy were diarrhea, nausea and headache.
In Study 1489, a total of 629 treatment-naïve adults with HIV were
randomized 1:1 to receive Biktarvy or abacavir/dolutegravir/lamivudine
In Study 1878, a total of 577 virologically suppressed (HIV-1 RNA <50
c/mL) adults with HIV taking regimens of a boosted protease inhibitor
(bPI; atazanavir or darunavir) plus a dual-NRTI backbone (
“Gilead is committed to improving care and simplifying therapy for
people living with HIV. We continue to invest in research in
next-generation treatments, including therapies that could potentially
cure HIV patients,” said
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. Gilead plans to present data from these studies at scientific conferences in 2018.
Biktarvy does not cure HIV infection or AIDS.
Patient Assistance Programs
Gilead’s U.S. Advancing Access® program provides assistance to appropriate patients in the United States who are uninsured, underinsured or who need financial assistance to pay for their medications, including Biktarvy.
The program offers information and assistance for patients, including:
Additionally, Gilead is working closely with the ADAP Crisis Task Force, as the company has done for each of its other HIV medications, to provide discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure access to Biktarvy for patients who receive medications through these programs.
Information about how to apply for any of these forms of assistance can
be found at www.GileadAdvancingAccess.com
or by calling 1-800-226-2056 Monday through Friday between
Important U.S. Safety Information for Biktarvy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Renal monitoring: Prior to or when initiating Biktarvy and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus.
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 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 10Q for the quarter ended
Biktarvy, Descovy, Advancing Access, Truvada, Truvada for PrEP, Gilead
and the Gilead logo are trademarks of
For more information on
Gilead Sciences, Inc.
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