Gilead Receives Approval in Canada for BIKTARVY™ (bictegravir, emtricitabine, tenofovir alafenamide) for the Treatment of HIV-1 Infection
Published: Jul 12, 2018
- In clinical trials, BIKTARVY demonstrated high efficacy, and a high barrier to resistance
- BIKTARVY offers a demonstrated tolerability profile, and few drug-drug interactions
- BIKTARVY is the smallest INSTI-based triple-therapy single tablet regimen available
MISSISSAUGA, Ontario--(BUSINESS WIRE)-- Gilead Sciences Canada, Inc.(Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for Biktarvy™ (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. BIKTARVY combines the potency of a novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available. BIKTARVY is Gilead’s third DESCOVY-based STR approved in Canada in the past three years.
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GILEAD RECEIVES APPROVAL IN CANADA FOR BIKTARVY™ FOR THE TREATMENT OF HIV-1 INFECTION (Photo: Business Wire)
BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adults with no known substitution associated with resistance to the individual components of BIKTARVY. No dosage adjustment is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
“To help support the long-term health of people living with HIV, it is ideal that treatment regimens deliver both durable viral suppression and a demonstrated tolerability profile,” said Dr. Jason Brunetta, Operations and Finance Director at Maple Leaf Research, a treating physician at Maple Leaf Medical Clinic, and a Principal Investigator on BIKTARVY clinical trials. “In clinical trials through 48 weeks, BIKTARVY has shown high efficacy and zero resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, BIKTARVY will simplify treatment initiation, and follow-up, over time.”
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. These trials are comprised of a diverse population of 2,414 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 (600/50/300mg) (ABC/DTG/3TC) once daily. At Week 48, 92 per cent (n=290/314) of patients taking BIKTARVY and 93 per cent (n=293/315) of patients taking ABC/DTG/3TC achieved the primary endpoint of HIV-1 RNA <50 c/mL. In Study 1490, a total of 645 treatment-naïve adults with HIV were randomized 1:1 to receive BIKTARVY or DTG+FTC/TAF. At Week 48, 89 per cent (n=286/320) of patients taking BIKTARVY and 92 per cent (n=302/325) of patients taking DTG+FTC/TAF achieved the primary endpoint of HIV-1 RNA <50 c/mL.
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 (ABC/3TC or FTC/tenofovir disoproxil fumarate) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated BIKTARVY once daily. At the primary endpoint of Week 48, switching to BIKTARVY was non-inferior to continuing on a bPI regimen with 2 per cent of patients in each group having HIV-1 RNA ≥50 c/mL; the proportion of patients with HIV-1 RNA <50 c/mL was 92 per cent in the BIKTARVY arm and 89 per cent in the bPI arm, according to FDA snapshot algorithm.
In Study 1844, a total of 563 virologically suppressed adults with HIV taking a regimen containing abacavir, dolutegravir and lamivudine (600/50/300mg) (ABC/DTG/3TC) were randomized 1:1 in a blinded fashion to continue a once-daily fixed-dose combination of ABC/DTG/3TC or to switch to BIKTARVY, to evaluate the efficacy and safety of switching from a regimen to BIKTARVY. Through Week 48, BIKTARVY was found to be statistically non-inferior to ABC/DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance.
“Gilead Canada is committed to improving care and simplifying therapy for people living with HIV. We continue to invest in research in next-generation treatments, including the ultimate goal of therapies that could potentially cure HIV infection in patients,” said Kennet Brysting, General Manager, Gilead Canada. “We are pleased to offer BIKTARVY, our latest triple-therapy treatment, which brings together the potency of an integrase inhibitor with guideline-recommended dual-NRTI backbone of DESCOVY in a once-daily single tablet regimen.”
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.
BIKTARVY does not cure HIV infection or AIDS.
Important Safety Information
BIKTARVY has serious warnings and precautions in its product label including the risk of post-treatment acute exacerbation of hepatitis B in patients who are co-infected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Prior to, or when initiating BIKTARVY, healthcare professionals should test for hepatitis B virus infection, and closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV-1 and HBV and discontinue BIKTARVY. Patients with chronic hepatitis B or C and treated with antiretroviral therapy are at increased risk for severe hepatic adverse events.
BIKTARVY should not be co-administered with any other antiretroviral products including those containing bictegravir, emtricitabine and tenofovir alafenamide, or those containing lamivudine or tenofovir disproxil fumarate. BIKTARVY should not be administered with adefovir dipivoxil.
For all important safety information, including contraindications, additional warnings and precautions, adverse reactions and drug interactions, please see the Canadian Product Monograph at www.gilead.ca.
About Gilead Sciences
Gilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc., and was established in Mississauga, Ontario, in 2006.
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 10-Q for the quarter ended March 31, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Canadian Product Monograph for BIKTARVY™, including Boxed Warning, is available at www.gilead.ca.
BIKTARVY, DESCOVY, Gilead, and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
FOR MORE INFORMATION IN CANADA:
Gilead Sciences Canada, Inc.
Karen M. Chow, 905-363-8083
National Stakeholder Relations and Communications
Source: Gilead Sciences Canada, Inc.