Gilead to Present New Data at IAS 2021 Demonstrating the Company's Commitment to Advancing Innovation in HIV Research
MISSISSAUGA, ON, July 19, 2021 /CNW/ - Gilead Sciences, Inc. yesterday announced the company's upcoming contributions to the 11th International AIDS Society (IAS) Conference on HIV Science, taking place virtually from July 18-21. Thirty-one abstracts reflect Gilead's ongoing commitment to scientific innovation, a key pillar to addressing unmet needs in HIV treatment and prevention. Beyond presenting new scientific data from the company's HIV research and development programs, Gilead will convene a symposium featuring a diverse, global panel of leading HIV researchers and people living with HIV, to discuss potential clinical pathways to achieve a functional cure and community perspectives on the process.
"Continued scientific innovation is essential to helping end the global HIV epidemic and we are committed to advancing the next generation of therapies to improve the care of people and communities impacted by this disease," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Our data at this year's meeting demonstrate the important scientific advancements we are making to help address critical unmet needs for people with HIV and those who could benefit from PrEP medicines."
Presentations from Gilead's HIV research program will include:
- A pooled analysis of 192-week data from open-label extension periods of two Phase 3 trials evaluating the once-daily, single tablet regimen, BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve adults living with HIV
- 72-week data from the BRAAVE trial evaluating the safety and efficacy of switching to BIKTARVY in Black or African American adults who are virologically supressed
- Data from the Phase 2/3 CAPELLA trial evaluating the company's investigational, long-acting subcutaneously administered HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people living with multidrug resistant HIV
- Interim Phase 2 data from the open-label CALIBRATE trial evaluating the safety and efficacy of lenacapavir as an investigational, long-acting HIV capsid inhibitor in combination with other antiretroviral agents in treatment-naïve people living with HIV
- Data from a Phase 1b trial examining the impact from the investigational TLR7 agonist, vesatolimod, between certain immune responses in people living with HIV on antiretroviral therapy
- Prevention research, including data exploring adherence to PrEP medicines among new PrEP users initiating DESCOVY (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP™, real-world utilization of PrEP medicines during the COVID-19 pandemic and the safety and efficacy profile of DESCOVY for PrEP, as well as the use of novel study designs for HIV prevention trials
Select accepted abstracts are as follows:
HIV Treatment Research
Week 72 Outcomes and COVID-19 Impact From the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African American Adults Living With HIV
Long-Term Efficacy Among Participants Switched to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) With Pre-Existing Resistance and Viral Blips
Long-Term Analysis of B/F/TAF in Treatment-Naïve Adults Living with HIV Through Four Years of Follow-Up
Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naïve Clinical Trials
Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged 65 Years or Older: Week 96 Results From an International, Phase 3b, Open-Label Trial
Investigational Long-Acting HIV Treatment Research (Lenacapavir)
Long-Acting Subcutaneous Lenacapavir Dosed Every 6 Months as Part of a Combination Regimen in Treatment-Naïve People With HIV: Interim 16-Week Results of a Randomized, Open-Label, Phase 2 Induction-Maintenance Study (CALIBRATE)
Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People With HIV: Week 26 Results (CAPELLA)
HIV Cure Research
Proteomic Evidence of Vesatolimod-Induced Enhancement of "Cross-talk" Between Innate and Adaptive Immune Cells in HIV Controllers on ART
HIV Prevention Research
Outcomes of Participants Switching from F/TDF to F/TAF for PrEP: Week 48 Results From the DISCOVER Open Label Phase
Comparing Adherence to HIV Pre-Exposure Prophylaxis (PrEP) Among New, Male PrEP Users Initiating F/TAF vs. F/TDF
Real-World Utilization of F/TDF and F/TAF for HIV Pre-Exposure Prophylaxis During the COVID-19 Pandemic in the U.S., December 2019 – June 2020
HIV Recent Infection Test-Based Incidence as a Counter-Factual for New PrEP Trials
For more information, including a complete list of abstracts, please visit: www.ias2021.org/the-programme.
Please see below for Canada Indications and Important Safety Information, including Serious Warnings and Precautions, for BIKTARVY® and DESCOVY for PrEP™.
Lenacapavir and vesatolimod are investigational compounds and are not approved by the U.S. Food & Drug Administration, Health Canada or any regulatory authority for any use. Their safety and efficacy have not been established. In May 2019, FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance.
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.
There is currently no cure for HIV or AIDS.
Canada Indication for BIKTARVY
BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients weighing ? 25 kg with no known substitution associated with resistance to the individual components of BIKTARVY.
BIKTARVY Important Safety Information
BIKTARVY has serious warnings and precautions box in its product label including the risk of post-treatment acute exacerbation of hepatitis B (HBV) 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. If appropriate, anti-hepatitis B therapy may be warranted.
BIKTARVY is contraindicated with the following drug products: dofetilide, rifampin. BIKTARVY is also contraindicated with the herbal product, St. John's wort.
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 disoproxil 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.
Canada Indication for DESCOVY®
Treatment of HIV-1 Infection
DESCOVY is indicated in combination with other antiretrovirals (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing ? 25 kg.
HIV-1 Pre-Exposure Prophylaxis (PrEP)
DESCOVY is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing ? 35 kg, excluding individuals at risk from receptive vaginal sex.
Important Safety Information for DESCOVY for HIV Treatment and PrEP1
DESCOVY does not prevent other sexually transmitted infections or cure HIV infection or AIDS.
The DESCOVY Product Monograph includes a Serious Warnings and Precautions Box:
Post-treatment Exacerbation of Hepatitis B Virus: DESCOVY is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of DESCOVY have not been established in individuals infected with HBV. Discontinuation of DESCOVY therapy in individuals infected with HBV may be associated with severe acute exacerbations of hepatitis due to the emtricitabine (FTC) or tenofovir alafenamide (TAF) components of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals infected with HBV who discontinue DESCOVY. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Risk of Drug Resistance with Use of DESCOVY for HIV-1 PrEP in Undiagnosed Early HIV-1 Infection: DESCOVY used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate DESCOVY for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.
DESCOVY for PrEP is contraindicated in individuals with unknown or positive HIV-1 status.
The safety and efficacy of DESCOVY for HIV-1 PrEP in individuals at risk from receptive vaginal sex have not been studied.
The safety and efficacy of DESCOVY has not been established in HIV-1 patients with virologic failure.
DESCOVY should not be coadministered with products containing any of the same components, or with products containing lamivudine or tenofovir disoproxil fumarate. In addition, DESCOVY should not be administered with adefovir dipivoxil.
For all important safety information for DESCOVY, 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. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed eleven HIV medications, including the first single tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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 Gilead's ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, including those involving BIKTARVY, DESCOVY for PrEP, lenacapavir and vesatolimod; the possibility of unfavorable results from such ongoing and additional clinical trials; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and vesatolimod and as a result, these compounds may never be successfully commercialized; Gilead's ability to receive regulatory approvals in a timely manner or at all, including marketing approvals of lenacapavir and vesatolimod, and the risk that any such approvals, if granted, may have significant limitations on its use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
The Canadian Product Monographs for BIKTARVY and DESCOVY are available at www.gilead.ca.
BIKTARVY, DESCOVY for PrEP, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
SOURCE Gilead Sciences Canada, Inc.
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