Gilead to present new data from their HIV and COVID-19 treatments

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The FINANCIAL — Gilead Sciences, Inc. announced the presentation of 18 abstracts spanning the company’s HIV treatment and prevention and COVID-19 clinical development programs during the virtual IDWeek 2020 conference from October 21-25. The breadth of data reflects Gilead’s commitment to advancing antiviral innovation aiming to help end the HIV epidemic and to addressing the treatment needs of patients with COVID-19.

“The global HIV epidemic and the COVID-19 pandemic are two of the most complex public health challenges of our time,” explained Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “The data presented at IDWeek reflect the latest progress in Gilead’s antiviral drug discovery and development and underscore our commitment to supporting the global health community to quickly and effectively respond to devastating viral outbreaks worldwide.”

At IDWeek 2020, Gilead will present results from the ongoing DISCOVER multi-center randomized clinical trial, evaluating the safety and efficacy of Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP® and a new analysis leveraging a novel statistical method to estimate the background HIV incidence rate in DISCOVER. Separate data from DISCOVER will provide insight into the impact of age and comorbidities on renal outcomes for study participants. In addition to new data from the DISCOVER trial, the key findings from an analysis examining real-world patterns of persistence with Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for PrEP® in at-risk populations will be presented in an oral presentation.

Gilead also will present new data on the efficacy and safety of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in certain populations of people living with HIV that have historically been underrepresented in HIV clinical research. The latest data from Gilead’s HIV treatment research program to be presented include an oral presentation on 48-week outcomes from the landmark community-based and designed BRAAVE study evaluating the safety and efficacy of switching to Biktarvy among Black American adults living with HIV who are virally suppressed. Findings on the efficacy of Biktarvy in people living with HIV who are virologically suppressed with end-stage renal disease and requiring chronic hemodialysis will also be presented.

Data on Gilead’s investigational antiviral Veklury® (remdesivir) for injection (100 mg) administered by intravenous infusion for the treatment of COVID-19 include two oral presentations examining the safety and efficacy of Veklury in hospitalized patients with moderate COVID-19 and global geographical disparities in clinical outcomes of hospitalized patients with severe COVID-19 treated with Veklury in Gilead’s open-label, Phase 3 SIMPLE studies.

Select accepted abstracts are as follows:

HIV prevention research

  • Oral 103: Persistence on Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for HIV Pre-Exposure Prophylaxis: Insights From Real-World Evidence
  • Poster 999: Using the Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Adherence-Efficacy Relationship to Calculate Background HIV Incidence: Results From the DISCOVER trial
  • Poster 985: Impact of Age and Medical Comorbidities on Renal Outcomes in the DISCOVER Trial
  • Poster 995: Safety and Efficacy of Emtricitabine/Tenofovir Alafenamide (F/TAF) and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for PrEP in DISCOVER Participants Taking F/TDF for PrEP at Baseline

HIV treatment research

  • Oral 109: Pre-Existing Resistance and Week 48 Virologic Outcomes After Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in African American Adults With HIV
  • Late Breaker 7: Weight Change in Suppressed People With HIV (PWH) Switched From Either Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) to Tenofovir Alafenamide (TAF)
  • Poster 1046: Week 48 Outcomes From the BRAAVE 2020 Study: A Randomized Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in African American Adults With HIV
  • Poster 1002: A Daily Single Tablet Regimen (STR) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed Adults Living With HIV and End Stage Renal Disease on Chronic Hemodialysis
  • Poster 1028: Long-term Follow-up After a Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir/Abacavir/Lamivudine
  • Poster 1448: Forgiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF): In Vitro Simulations of Intermittent Poor Adherence Find Limited HIV-1 Breakthrough and High Barrier to Resistance
  • Poster 633: Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Efficacy in Participants With Pre-Existing Primary Integrase Inhibitor Resistance Through 48 Weeks of Phase 3 Clinical Trials

COVID-19 treatment research

  • Oral 72: Remdesivir vs. Standard Care in Patients With Moderate COVID -19
  • Oral 73: Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated With Remdesivir
  • Poster 561: Safety of Remdesivir vs. Standard Care in Patients With Moderate COVID-19
  • Poster 557: Impact of Concomitant Hydroxychloroquine Use on Safety and Efficacy of Remdesivir in Moderate COVID-19 Patients

There is no cure for HIV or AIDS.

Veklury has not been approved by the U.S. Food and Drug Administration (FDA) for any use, and its safety and efficacy have not been established. Gilead submitted a new drug application for Veklury on August 7, 2020; the NDA is currently under FDA review. Veklury is currently authorized for temporary use under an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with COVID-19, including patients with moderate to severe disease, regardless of the need for supplemental oxygen. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of Veklury and mandatory requirements of the EUA in the U.S., 

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