FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GLD) today announced long-term study results, which showed that people living with HIV who switched to the once-daily, single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) from a boosted protease inhibitor-based regimen consisting of atazanavir (ATV) or darunavir (DRV) plus either emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) or abacavir (ABC)/lamivudine (3TC) maintained virologic suppression (defined as HIV-1 RNA <50 copies/mL) with no emergent resistance, through a maximum of 156 weeks. In the study (study 1878), Biktarvy was generally well-tolerated with minimal changes to estimated glomerular filtration rate (eGFR), lipids and weight through 96 weeks. The most common drug-related adverse event was headache (two percent). The primary endpoint was at week 48; results of the open-label extension period through week 156 were presented at HIV Glasgow 2020.
Additional switch data presented included a pooled analysis of six studies evaluating the efficacy of switching to Biktarvy among virologically-suppressed people living with HIV who have the most common treatment-emergent resistance mutations (M184V/I). In the analysis, of the 2,034 people living with HIV who switched to Biktarvy retrospective proviral DNA genotyping was performed on baseline samples from 90 percent (1824/2034) of study participants and preexisting M184V/I was detected in 10 percent (182/1824). In those with preexisting resistance, 98 percent (n=179/182) of participants with M184V/I maintained virologic suppression with Biktarvy at the point of last study visit (24-156 weeks), with no treatment resistance emerging. The results support the continued evaluation of Biktarvy as an effective and durable option for virologically-suppressed people living with HIV with known resistance. The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational.
Gilead also presented new findings from a Phase 3b open-label trial showing people aged 65 years and older who switched to Biktarvy (n=86) from Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) or a TDF-based complete treatment regimen maintained high rates of virologic suppression, with no virologic failures or emergent resistance through 72 weeks. The results reinforce Biktarvy as an effective and generally well-tolerated treatment option with a high barrier to resistance in the growing population of older people living with HIV. Throughout the course of the study, there were two (two percent) Grade 3-4 study-drug related adverse events reported; no serious adverse events considered to be study-drug related were reported.
“People living with HIV have diverse and evolving needs as they age, requiring antiretroviral therapies that address these needs. The data presented at HIV Glasgow confirm that Biktarvy is an effective long-term treatment choice that can help achieve this,” said Hal Martin, Executive Director, Clinical Research, Virology at Gilead Sciences. “It’s a proud moment for Gilead to see that modern triple therapy with the F/TAF backbone continues to demonstrate durable efficacy with an established safety profile in a broad range of people living with HIV.”
Gilead also presented data from an observational, real-world, global BICSTaR study, which aims to evaluate the effectiveness, safety and patient-reported outcomes of treatment with Biktarvy in 1,400 people living with HIV in Germany, Canada, France and the Netherlands. Of the 513 participants enrolled who completed 12 months of treatment, results from the real-world clinical cohort showed effectiveness (based on virological suppression defined as HIV-1 RNA <50 copies/mL) in 100 percent (n=74) of treatment-naïve and 96 percent (n=357) of treatment-experienced participants with available follow up at 12 months in routine clinical practice. Notably, over a third of participants had more than three comorbidities at baseline. During the study, Biktarvy was generally well-tolerated and no primary resistance mutations to the components of Biktarvy emerged. The most common drug-related adverse events were gastrointestinal (two percent) and neuropsychiatric (four percent).
A preliminary, descriptive analysis of patient-reported outcomes after 12 months of treatment with Biktarvy from the BICSTaR study was also presented at the meeting, with the results underlining the importance of collecting patient-reported outcomes in order to understand the impact on mental health status, health-related quality of life and treatment satisfaction of people living with HIV, which could inform treatment strategies for these groups.
“Regardless of whether people living with HIV are new to treatment or have switched their regimen, it is encouraging to see the results of this analysis on the impact of treatment with Biktarvy in the real-world settings,” said Fernando Bognar, Vice President, Medical Affairs, HIV at Gilead Sciences. “Patient-reported outcomes observed in the BICSTaR study are particularly important as they provide a more holistic understanding of the impact on quality of life that people living with HIV experience.”
Biktarvy is indicated in the United States as a complete regimen for the treatment of HIV-1 infection in patients who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known mutations 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.
There is no cure for HIV or AIDS.
U.S. Important Safety Information for Biktarvy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
- Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected 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. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.
- Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
Warnings and precautions
- Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
- Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
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, assess serum phosphorus.
- Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
- Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
- Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
- Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
- Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
- Renal impairment: Not recommended in patients with CrCl <30 mL/min.
- Hepatic impairment: Not recommended in patients with severe hepatic impairment.
- Prior to or when initiating: Test patients for HBV infection.
- Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
- Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
U.S. Indication for Biktarvy
Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg 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 with no history of treatment failure and no known resistance to any component of Biktarvy.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For more than 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 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19.
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 possibility of unfavorable results from ongoing and additional clinical trials involving Biktarvy, and the possibility that we are unable to complete one or more of such trials in the currently anticipated timelines or at all. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. 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 June 30, 2020, 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.
U.S. Prescribing Information for Biktarvy including BOXED WARNING, is available at www.gilead.com.
Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.