Gilead Sciences : to Present Latest Antiviral Research Data Addressing Urgent Global Needs in Infectious Disease at IDWeek 2021
GILD
– Data Provide New Clinical Insights on Use of Veklury for Treatment of COVID-19 –
– Research Examines Strategies to Enhance the Participation of Communities Underrepresented in HIV Clinical Trials –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new data from the company’s virology research and development programs at the virtual IDWeek 2021 conference, taking place September 29 – October 3. The findings in COVID-19 research, HIV treatment research and HIV prevention research are the latest example of Gilead’s ongoing commitment to help address the evolving COVID-19 pandemic and the needs of people affected by HIV.
“In partnership with the infectious disease community, we continue to monitor and respond to the devastating global viral pandemic, while simultaneously working to maintain the tremendous progress that has been made toward ending the HIV epidemic,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “Our antiviral research program is not only expanding the scientific understanding of our current HIV and COVID-19 medicines, it also urgently pursues innovation to address the dynamic nature of these pandemics and evolving needs of the communities most impacted.”
COVID-19 Research
At IDWeek 2021, Gilead will present real-world analyses of Veklury, the antiviral standard of care for the treatment of hospitalized patients with COVID-19, to help inform real-time decision-making of clinicians and frontline healthcare workers. These data include a comparative retrospective analysis evaluating the impact of Veklury on mortality rates across the spectrum of baseline oxygen requirements. A second analysis, drawing on data from a large cohort study of U.S. hospitals, looks at the association of patients treated with Veklury and 30-day readmission rates. Further late-breaking data on Veklury in COVID-19 will also be presented at IDWeek.
HIV Research
HIV treatment research data at IDWeek include long-term results from the BRAAVE 2020 study evaluating the safety and efficacy of switching to the once-daily, single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virally suppressed Black or African American adults with pre-existing resistance, viral blips and suboptimal adherence. Data from the ongoing BRAAVE 2020 study could help inform the design of future research programs in Black adults, who continue to be underrepresented in HIV clinical research despite being disproportionately affected by the epidemic.
As part of the company’s HIV prevention research program, Gilead will present long-term outcomes from an open-label extension phase of the DISCOVER trial, which is an ongoing, randomized, double-blind, multicenter, active-controlled, phase 3, non-inferiority clinical trial evaluating the efficacy and safety of Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) for PrEP (pre-exposure prophylaxis). Additional HIV prevention research includes insights into improving the recruitment of historically underrepresented individuals for the PURPOSE 2 trial of the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir for PrEP – specifically, optimizing enrolment of Black and Hispanic or Latinx gay and other men who have sex with men, transgender women, transgender men and gender nonbinary individuals.
Additionally, to further inform HIV treatment strategies across a broad range of people and communities affected by HIV, Gilead will present results from an in vitro study evaluating the concept of regimen forgiveness with integrase strand transfer inhibitor (INSTI)-based regimens at drug concentrations simulating variable adherence. Gilead will also present a clinical study evaluating methods for measuring adherence in people taking antiretroviral therapy.
Gilead’s accepted abstracts are as follows:
COVID-19 Research (excluding late-breaking data)
Oral presentation 38
Remdesivir treatment in patients hospitalized with COVID-19: A comparative analysis of in-hospital all-cause mortality
Poster 459
COVID-19 hospitalizations and 30-day readmission: A cohort study of U.S. hospitals
HIV Treatment Research
Oral presentation 69
Incidence of metabolic complications among treatment-naïve adults living with HIV-1 randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF after 144 weeks
Poster 629
High efficacy of B/F/TAF in African American adults with HIV including those with pre-existing resistance, viral blips, and suboptimal adherence
Poster 902
Unreturned pill bottles in the 1489 and 1490 clinical trials: An important measure of poor adherence that is often ignored in pill count calculations
Poster 888
In vitro forgiveness of INSTI-containing regimens at drug concentrations simulating variable adherence
Investigational Long-Acting HIV Treatment Research (Lenacapavir)
Oral presentation 73
Interim resistance analysis of long-acting lenacapavir in treatment-naïve people with HIV at 28 weeks
Investigational Long-Acting HIV Prevention Research (Lenacapavir)
Poster 848
Approaches to optimize recruitment of historically underrepresented Black and Hispanic/Latinx MSM, transgender, and gender non-binary individuals into the lenacapavir for PrEP (PURPOSE 2) trial
HIV Prevention Research
Poster 854
Long-term outcomes of participants on F/TAF for pre-exposure prophylaxis: Results for 144 weeks of follow-up in the DISCOVER trial
Poster 855
Persistence on F/TAF versus F/TDF for HIV pre-exposure prophylaxis: A real- world evidence analysis in the United States
Poster 866
Adherence to F/TDF for PrEP in dried blood spots and HIV infection rates: A pooled analysis of global PrEP studies
For more information, including a complete list of abstracts, please visit https://idweek.org/program/.
Please see below for U.S. Indication and Important Safety Information for Veklury. Please also see below for U.S. Indication and Important Safety Information, including Boxed Warnings, for Biktarvy and Descovy for PrEP®.
Veklury is the first and only U.S. Food & Drug Administration (FDA) approved antiviral treatment for adults and pediatric patients at least 12 years of age and weighing at least 40 kg requiring hospitalization for COVID-19 in the United States. Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide. Currently, multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of COVID-19, in different patient populations, and in combination with other therapies.
Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use; its safety and efficacy are not established. The FDA has granted Priority Review designation to Gilead’s new drug applications (NDAs) for lenacapavir for the treatment of multi-drug resistant HIV-1 infection in heavily treatment-experienced (HTE) patients in combination with other antiretroviral agents. The investigational, long-acting HIV-1 capsid inhibitor has been given a Prescription Drug User Fee Act (PDUFA) action date of February 28, 2022, accelerating the review goal from ten months to six months from the day of filing acceptance. Gilead also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lenacapavir as a potential treatment for HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. As announced in August 2021, the MAA has been fully validated and is now under evaluation with the EMA.
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.
U.S. Indication for Veklury
Veklury® (remdesivir 100 mg for injection) is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
U.S. Important Safety Information for Veklury
Contraindication
Warnings and precautions
Adverse reactions
Drug interactions
Dosage and administration
Pregnancy and lactation
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
Contraindications
Warnings and precautions
Adverse reactions
Drug interactions
Dosage and administration
Pregnancy and lactation
U.S. Indication for Descovy for PrEP
Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.
Limitation of Use:
U.S. Important Safety Information and Indication for Descovy for PrEP
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Contraindication:
Comprehensive management to reduce risks:
Warnings and precautions:
Adverse reactions:
Drug interactions:
Dosage and administration:
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. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Forward-Looking Statements
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 Veklury, Biktarvy, Descovy for PrEP and lenacapavir; 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 as a result, lenacapavir may never be successfully commercialized; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA and EMA approvals of lenacapavir, 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 June 30, 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.
U.S. full Prescribing Information for Veklury, and U.S. Prescribing Information for Biktarvy and Descovy, including BOXED WARNINGS, are available at www.gilead.com.
Veklury, Biktarvy, Descovy, Descovy for PrEP, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s).
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.
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