Tag: Gilead

 

Gilead Presents New Data from Antiviral Development Programs at IDWeek 2020

Gilead Sciences, Inc. (Nasdaq: GILD) today 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

Gilead questions WHO study that cast doubts on drug’s COVID-19 benefits

By Deena Beasley and Vishwadha Chander

(Reuters) – Gilead Sciences Inc has questioned the findings of a World Health Organization (WHO) study that concluded its COVID-19 drug remdesivir does not help patients who have been admitted to hospital.

The American company told Reuters the data appeared inconsistent, the findings were premature and that other studies had validated the drug’s benefits.

In a blow to one of the few drugs being used to treat people with COVID-19, the WHO said on Thursday its “Solidarity” trial had concluded that remdesivir appeared to have little or no effect on 28-day mortality or length of hospital stays among patients with the respiratory disease.

The antiviral medication was one of the drugs used to treat U.S. President Donald Trump’s coronavirus infection, and has been shown in previous studies to have cut time to recovery, though the European Union is investigating it for possible kidney injury.

The WHO trial was conducted in 11,266 adult patients in more than 30 countries. The evidence was conclusive, the WHO said.

Gilead said other trials of remdesivir, including with 1,062 patients that compared it with a placebo, showed the treatment cut COVID-19 recovery time.

“The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir,” Gilead told Reuters.

Gilead said it was “unclear if any conclusive findings can be drawn” given what it called differences in how the trial was conducted from site to site and between the patients who received the medicine.

In April, the top U.S. infectious disease official, Anthony Fauci, predicted remdesivir would become “the standard of care”.

Companies such as Gilead are racing to find a treatment for COVID-19. Some 1.1 million people have died and 39.1 million have been reported infected in the pandemic, and the global economy has been thrown into chaos.

Remdesivir was developed for Ebola, which causes fever, bleeding, vomiting and diarrhoea and spreads among humans through bodily fluids.

It was quickly repurposed and has offered some hope for patients, though the WHO’s findings may shift the focus of the search for a vaccine to new monoclonal antibodies being developed by companies including Regeneron.

The Solidarity trial also evaluated hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon, and concluded that they, like remdesivir, did little to help patients survive or leave the hospital more quickly.

The WHO trial’s results are yet to be reviewed and were uploaded on the preprint server medRxiv. (https://bit.ly/3nViYIf)

“PREMATURE”

Gilead say the Solidarity conclusions, lacking scrutiny from other scientists, were premature.

“We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design,” it said.

Remdesivir got emergency use authorization from the U.S. Food and Drug Administration on May 1, and has been authorized for use in several countries.

During the Solidarity study, trials of hydroxychloroquine and lopinavir/ritonavir were stopped in June after