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GILEAD SCIENCES PRESENTS DATA FROM HIV RESEARCH AND DEVELOPMENT PROGRAMS AT HIV GLASGOW 2020
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For Immediate Release
-- 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 --
Foster City, Calif. - September 30, 2020 - 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.
Contraindications
• 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
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