Gilead Sciences (GILD) to Present Latest Antiviral Research and Development Data at CROI


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Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new data from the company’s HIV and COVID-19 research and development programs at the 29th Retroviruses and Infections Conference. opportunists (virtual conference CROI 2022) which will take place from February 12 to 16. The data reflects Gilead’s enduring dedication to advancing global health through scientific innovation by tackling some of the world’s toughest viruses. Gilead’s commitment to inclusive research facilitates the discovery and development of person-centered treatment options that meet the changing needs of a wide range of individuals.

“The HIV and COVID-19 pandemics continue to challenge the global community, requiring unprecedented coordination and collaboration from scientists, industry and community partners to accelerate antiviral research and development. At Gilead, we will continue to apply our long-standing expertise in virology to advance human-centered innovation to meet these pressing global needs,” said Frank Duff, MD, Senior Vice President, Head of Domain Virology Therapeutics, Gilead Sciences. “We are excited to present our latest data at CROI 2022 from across our research and development programs, as we work to advance therapies to help different populations affected by COVID-19 and HIV.

HIV research

Gilead is committed to pursuing scientific innovation to provide solutions to the changing needs of people affected by HIV around the world, with the goal of ending the HIV epidemic for everyone, everywhere. At CROI 2022, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s ongoing search for a cure for HIV.

HIV treatment research and development data include one-year results from the CALIBRATE and CAPELLA trials evaluating the efficacy and virologic suppression, in combination with other antiretrovirals, of investigational lenacapavir in treatment-naïve people and heavily pretreated people with multidrug-resistant HIV. Lenacapavir is Gilead’s first potential long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. If approved, lenacapavir would be the only HIV-1 treatment option given twice a year.

The cumulative results over five years of 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 (PLHIV) will also be presented. These results demonstrate Biktarvy’s long-term safety and tolerability profile, as well as sustained efficacy with a high barrier to resistance in participants who started treatment with the guideline-recommended single-pill regimen. .

Data presented as part of Gilead’s Cure Research Program Uncovers Insights to Expand the Collective Scientific Understanding of Potential Pathways to Achieve a Functional Cure or Long-Term Viral Remission in the Absence of Treatment antiretroviral for PLHIV.

Additionally, at CROI 2022, Gilead will present new prevention research using data from the DISCOVER trial to evaluate the performance of different recency tests to calculate background HIV incidence, or the number of new infections. to HIV that occur in an area. Recency testing has been proposed as the main methodology to assess the efficacy of new PrEP agents in next-generation PrEP clinical trials.

COVID-19 Research

Gilead will present data that supports the role of Veklury® (remdesivir) in meeting the needs of adult and pediatric, hospitalized and non-hospitalized patients with COVID-19. New interim results will be presented from an ongoing Phase 2/3 trial evaluating the safety, tolerability and pharmacokinetics of Veklury in children hospitalized with COVID-19.

In addition, Gilead will present PINETREE Phase 3 data for a three-day course of Veklury IV for non-hospitalized patients with mild to moderate COVID-19 at high risk of disease progression. This research led to the recent FDA approval for the use of Veklury in non-hospitalized patients and the updated National Institutes of Health (NIH) treatment guidelines for COVID-19 recommending the use of Veklury in appropriate outpatient settings. These updates come amid an increase in COVID-19 cases and reduced susceptibility to several anti-SARS-CoV-2 monoclonal antibodies (mAbs) due to the Omicron variant. In contrast, Veklury targets the highly conserved viral RNA polymerase, thereby retaining its activity against existing SARS-CoV-2 variants of concern. in vitro. Laboratory tests show that Veklury retains activity against the Omicron variant.

Accepted abstracts are:

COVID-19 Research

Outpatient remdesivir improves biomarkers of COVID-19 progression

Safety of remdesivir versus placebo in non-hospitalized patients with COVID-19

Population Pharmacokinetics of Remdesivir in Pediatric COVID-19 Patients

Remdesivir treatment of COVID-19 in hospitalized children: interim results from CARAVAN

Experimental research on long-acting HIV treatment (lenacapavir)

Long-acting lenacapavir in people with multidrug-resistant HIV-1: results at week 52

Lenacapavir as part of combination therapy in treatment-naïve HIV-infected people: results at week 54

Absence of cross-resistance to lenacapavir in isolates resistant to HIV entry inhibitors

Pharmacokinetics of lenacapavir, a novel first-in-class selective HIV-1 capsid function inhibitor, in participants with severe renal impairment

Assessing Potential Drug Interactions Between Islatravir and Lenacapavir

HIV treatment research

Biktarvy (B/F/TAF) results at five years in treatment-naïve adults

HIV Cure Research

HIV envelope diversity and bNAb susceptibility across acute and early stages of HIV

Viral and biomarker outcomes of an altered bNAb in participants on antiretroviral therapy

Identification of predictive biomarkers for HIV rebound time in virologic controllers

Immunogenicity and prophylactic efficacy of arenavirus-based SIV (simian immunodeficiency virus) vaccine in macaques

Therapeutic efficacy of combined active and passive immunization in SHIV+ macaques

Efficacy of AD26/MVA + ENV + vesatolimod therapeutic vaccination in rhesus macaques

HIV prevention research

Assessment of HIV-1 recency testing among prospectively observed HIV-1 seroconversions

Long-acting lenacapavir protects against intravenous challenge with simian-tropic HIV

For more information, including a full list of abstracts, please visit https://www.croiconference.org/croi-2022/

Please see the US indication and important safety information for Veklury below. Please also see the US indication and important safety information, including boxed warning, for Biktarvy below.

Lenacapavir and vesatolimod are investigational compounds and are not approved anywhere in the world. Their safety and effectiveness have not been established.

There is currently no cure for HIV or AIDS.

US indication for Biktarvy

Biktarvy is indicated as a comprehensive therapy 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 history of antiretroviral therapy or to replace current antiretroviral therapy in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on stable antiretroviral therapy with no history of treatment failure and no known substitutions associated with resistance to individual components of Biktarvy.


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