Latest HIV Clinical Research and Development Data Drive the Next Wave of Innovation in Treatment, Prevention and Reaches Towards a Cure –
– Key Initiatives Highlight Role of Catalytic Collaboration to Help End the Epidemic for Everyone, Everywhere –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming contributions to the 24th International AIDS Conference (AIDS 2022). AIDS 2022 will be a hybrid conference, taking place in person in Montreal, Canada, as well as virtually, from July 29-August 2, 2022. As the leader in HIV innovation, the company will provide an update on its signature initiatives, key collaborations and share new scientific data from its HIV research and development programs as part of its ongoing commitment to help end the HIV epidemic for everyone, everywhere.
"Continued scientific innovation and inclusive approaches are essential in the discovery and development of person-centered options that address the evolving needs of a broad range of individuals and communities affected by HIV," said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "Our scientific advancements are grounded in collaboration with community and research partners around the world. AIDS 2022 will highlight how our expertise and dedication are helping us drive the next generation of innovation in HIV treatment and prevention and reach towards cure."
"At Gilead we recognize that scientific innovation alone will not end the epidemic, so we are committed to advancing equity, and optimizing health outcomes in partnership with the global HIV community," said Alex Kalomparis, Senior Vice President, Public Affairs, Gilead Sciences. "The convergence of the COVID-19 pandemic and HIV epidemic has further highlighted how inequities result in adverse health outcomes. Through innovative programs like the COMPASS Initiative ® , RADIAN ® , and Zeroing In ™ , Gilead seeks to address the evolving needs of the communities most impacted by HIV. As part of our enduring commitment to helping end the HIV epidemic, we look forward to sharing the latest from these and other key programs at AIDS 2022."
Advancing Efforts to Address Barriers to HIV Care
At AIDS 2022, Gilead will convene a diverse, global panel – "Working Together to End the Epidemic: Guided by the Voices on the Ground" – to discuss community perspectives and Gilead's ongoing efforts to change the future of the HIV epidemic through catalytic collaboration. The panel will discuss different challenges in delivering HIV care around the world, and programs that support practical solutions with sustainable impact toward better care for people with HIV or people who could benefit from PrEP medicines. The panel will convene on Aug. 1 at 8:00-9:00 a.m. ET.
Driving Transformational Innovation in HIV Research
Gilead is driving scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead's long-standing research leadership and community engagement, built over decades of collaborative research and development, enable the company to help advance preclinical and clinical programs with the goal of achieving a functional cure for HIV. During AIDS 2022, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company's continued pursuit of an HIV cure. Updates will be shared on efforts to ensure HIV clinical trials are inclusive, representative and meaningful through expanding the participation of communities most affected. Presentations from Gilead's HIV research and development programs will include:
- Five-year cumulative outcomes from two Phase 3 trials (Study 1489 and Study 1490), evaluating Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve people living with HIV, reinforcing Biktarvy's high barrier to resistance, durability, efficacy, and safety in people with HIV who initiated treatment with the single-tablet regimen.
- First data from the ALLIANCE trial, a first-of-its-kind study evaluating the efficacy of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) versus dolutegravir (50 mg, DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV-1/HBV co-infection who are initiating treatment.
- Multiple studies evaluating the antiviral activity of investigational lenacapavir, Gilead's potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Specifically, the studies evaluate resistance data from the CAPELLA trial in heavily treatment-experienced people with HIV, and the CALIBRATE trial in people with HIV initiating treatment for the first time, as well as the pharmacokinetics and potential dosing schedules of lenacapavir.
- Results evaluating innovative testing methods and real-world utilization of PrEP medicines, emphasizing the company's progress in research that can help shape the future of HIV prevention options.
- Early data identifying potential biomarkers associated with time-to-HIV-rebound (TTHR) post-antiretroviral therapy (ART) interruption following treatment with Gilead's investigational TLR-7 agonist, vesatolimod. In a pre-clinical study, researchers tested a novel vaccine combination that showed promise in eliciting a strong anti-HIV immune response, specifically in the cell types seen in HIV-infected elite controllers. This early data suggests that this treatment regimen may have the potential to become part of a combination therapeutic approach for an HIV cure.
Summary of Presentations
Accepted abstracts at the 24 th International AIDS Conference include:
HIV Treatment Research
Long-term integrated analysis of B/F/TAF in treatment-naïve adults living with HIV through five years of follow-up
Real-world HIV renal outcomes with TDF to TAF conversions
Longitudinal analysis of weight change in HIV-1 treatment-naïve and -experienced people living with HIV (PLWH) initiating/switching to an NNRTI- or INSTI-based antiretroviral therapy in four large cohort studies
Week 48 results of a phase 3 randomized controlled trial of bictegravir/emitricitabine/tenofovir alafenamide (B/F/TAF) vs dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF) in ART-naïve, HIV/HBV-coinfected adults (ALLIANCE)
Investigational Long-Acting HIV Treatment Research (Lenacapavir)
Resistance analysis of long-acting lenacapavir in highly treatment-experienced people with HIV after 52 weeks of treatment
Injection site reaction experience in clinical studies of people using lenacapavir for HIV treatment
Impact of intrinsic and extrinsic factors on the pharmacokinetics of long-acting lenacapavir for treatment of HIV
Simulations for once weekly dosing of oral lenacapavir
Pharmacokinetics of a simplified subcutaneous lenacapavir regimen versus Phase 2/3 regimen
Resistance analysis of long-acting lenacapavir in treatment-naïve people with HIV at 54 weeks
HIV Prevention Research
Lipid parameters and lipid modifying agent use in participants initiating F/TAF or F/TDF for PrEP in the DISCOVER trial
Concordance between laboratory serologic testing and HIV-1 RNA testing among participants who acquired HIV in the DISCOVER trial
Real-world utilization of HIV pre-exposure prophylaxis (PrEP) by cisgender and transgender individuals in the United States
HIV Cure Research
Metabolomic and lipidomic correlates of Time-to-HIV-Rebound in viremic controllers treated with vesatolimod
FLT3 agonist enhances immunogenicity of arenavirus-vector based vaccines in macaques
For more information about Gilead at AIDS 2022, including a complete list of abstracts, please visit: https://aids2022.org . To learn more about Gilead's unique collaborations around the world and the work to help end the epidemic for everyone, everywhere, visit: https://www.gileadhivtogether.com .
Please see below for U.S. Indications and Important Safety Information, including Boxed Warnings, for Biktarvy ® .
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 and vesatolimod are investigational compounds and are not approved anywhere globally. Their safety and efficacy have not been established.
There is currently no cure for HIV or AIDS.
U.S. Indication for Biktarvy
Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components 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: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) 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: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to
- Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to
- 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 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 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 11 HIV medications , including the first single-tablet regimen to treat HIV and the first antiretroviral 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 was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.
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, and the possibility of unfavorable results from such ongoing and additional clinical trials, including those involving Biktarvy, Descovy for PrEP, lenacapavir and vesatolimod; 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, 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, 2022, 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 involve risks and uncertainties, 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.
U.S. full Prescribing Information for Biktarvy, including its BOXED WARNING, is available at www.gilead.com .
Biktarvy, COMPASS Initiative, RADIAN, Zeroing In, Gilead and the Gilead logo are registered 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.
Jacquie Ross, Investors
Brian Plummer, Media