-- New Findings on Biktarvy® to Include Long-term Switch Studies as well as Real-World Data and Patient Reported Outcomes from the BICSTaR Study --
-- Data Evaluating Drug Resistance in People Receiving Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor, as Part of a Long-acting HIV Treatment Regimen to be Presented --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming contributions to the HIV Glasgow 2020 conference, taking place virtually from October 5-8. Gilead will present 13 studies from the company’s HIV research and development programs in addition to supporting several other independent studies at the conference, which, along with its community-focused programs, reflect Gilead’s ongoing focus and commitment to advancing scientific discovery and supporting the development and delivery of practical solutions that can help improve care for all people affected by HIV.
"As the needs of the HIV community evolve, we must also evolve our efforts to end the HIV epidemic through our scientific innovation and community support," said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. "We constantly seek to understand the evolving unmet needs among persons living with HIV, and we are pleased to present new switch data for Biktarvy, as well as real-world findings and patient-reported outcomes from a treatment perspective, and new data on our first-in-class investigational long-acting injectable lenacapavir, which may represent a novel approach to HIV treatment."
Key Gilead data to be presented:
Gilead will present new studies evaluating the safety, efficacy and resistance profile of the once-daily single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in people living with HIV, including older adults and those with a history of resistance, who have switched from other regimens. Twelve-month data and a preliminary, descriptive analysis of patient-reported outcomes will also be presented from the global BICSTaR study, a real-world, observational study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people living with HIV.
The results of this large-scale study are expected to underline the importance of real-world evidence and patient-reported outcomes in understanding the impact on mental health component scores, health-related quality of life (HRQoL) and treatment satisfaction of people living with HIV, which could inform treatment strategies for these groups.
Additional treatment research presented at the meeting includes findings from a Phase 1b proof-of-concept study evaluating Gilead’s investigational, novel inhibitor of HIV-1 capsid function, lenacapavir, which is being developed as a component of a long-acting regimen in combination with other antiretroviral agents. Data on the impact of the COVID-19 pandemic on HIV clinics and services in Greece will also be presented.
Key Gilead activities during the conference:
Beyond presenting scientific data from the company’s HIV research and development program, Gilead will address the impact of COVID-19 on the HIV community in a satellite symposium that will explore the shifting management strategies and treatment approaches to deliver patient-centered care during and after the COVID-19 pandemic.
In an effort to better understand the barriers that can influence engagement in HIV care at individual, systemic and community levels, Gilead will also convene discussions with the HIV community. These Gilead-supported sessions are part of the company’s ongoing efforts to help change the future of the epidemic through partnerships that help to support community goals of getting to zero new infections and AIDS-related deaths.
Select Gilead HIV clinical development program data to be presented at Glasgow 2020:
HIV treatment research
- Poster 036: Long-term follow-up after a switch to bictegravir/emtricitabine/tenofovir alafenamide, from a boosted protease inhibitor-based regimen
- Poster 123: Sustained viral suppression after switch to bictegravir/emtricitabine/tenofovir alafenamide among clinical trial participants with pre-existing M184V/I
- Poster 038: Switching to bictegravir/emtricitabine/tenofovir alafenamide in adults aged >65 or older: week 72 results from an international, Phase 3b, open-label trial
- Poster 046: Starting or switching to bictegravir/emtricitabine/tenofovir alafenamide in clinical practice: pooled 12-month results from the global BICSTaR study
- Poster 053: Patient-reported outcomes after one year of routine clinical practice with bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV: the BICSTaR cohort
- Poster 124: Bictegravir/emtricitabine/tenofovir alafenamide shows high efficacy in clinical study participants infected with HIV-1 subtype F
- Poster 029: Impact of adherence on viral suppression with bictegravir and dolutegravir containing triple therapy in clinical practice
- Poster 100: The clinical relevance of potential drug-drug interactions with bictegravir/emtricitabine/tenofovir alafenamide – real-world data from the German IQVIA prescription database
- Poster 032: Persistence of guideline-recommended antiretroviral therapy regimens among veterans with HIV newly initiating treatment in the U.S.
Investigational long-acting HIV therapy
- Oral 324: Lenacapavir resistance analysis in a Phase 1b clinical proof-of-concept study
For more information, including a complete list of abstract titles at the meeting, please visit: http://www.hivglasgow.org/wp-content/uploads/2020/09/Poster-Listing_16-September.pdf
Please see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. In the U.S., the use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.
Lenacapavir is an investigational compound and is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority and its safety and efficacy are not yet known. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir (GS-6207) for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance.
There is no cure for HIV or AIDS.
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.
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.
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 lenacapavir, and the possibility that we are unable to complete one or more of such trials in the currently anticipated timelines or at all. In addition, it is possible that Gilead may make a strategic decision to discontinue development of lenacapavir and as a result, lenacapavir may never be successfully commercialized. 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. full 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.
Douglas Maffei, PhD, Investors
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Brian Plummer, Media
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Rhiannon Bid, Media (Europe)
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