Lenacapavir

Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24

Retrieved on: 
Wednesday, March 6, 2024

These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ).

Key Points: 
  • These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ).
  • At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA
  • The potent antiviral activities, along with pharmacokinetic profiles of islatravir and lenacapavir, support their development as an investigational once-weekly oral combination regimen.
  • No participants in the Biktarvy group had a viral load of more than 50 copies/mL at Week 24.

Gilead’s Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health

Retrieved on: 
Tuesday, March 5, 2024

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline.
  • “The latest findings across our HIV pipeline showcase the potential of multiple candidates to help transform HIV management,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
  • It is estimated that up to 10% of people with HIV take a complex treatment regimen, defined as 2 or more pills each day.
  • Results showed that all three treatment groups had robust virologic suppression at six months, with consistently low viral loads throughout the study.

Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024

Retrieved on: 
Monday, February 26, 2024

Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.

Key Points: 
  • Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.
  • Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented.
  • Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV).
  • Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

New Data Presented at EACS 2023 Further Demonstrate Strong Clinical Profile of Twice-Yearly Sunlenca® for Adults With Multi-Drug Resistant HIV

Retrieved on: 
Friday, October 20, 2023

Gilead Sciences, Inc. (Nasdaq: GILD) presented new data today supporting Sunlenca® (lenacapavir) as an important treatment option for adults with multi-drug resistant (MDR) HIV who have extensive treatment history.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) presented new data today supporting Sunlenca® (lenacapavir) as an important treatment option for adults with multi-drug resistant (MDR) HIV who have extensive treatment history.
  • The data were presented at the 19th European AIDS Conference ( EACS 2023 ) in Warsaw, Poland, from October 18-21.
  • “The bar is rightly now set high for the efficacy and safety of HIV treatment across a diverse range of people living with the virus.
  • Respondents reported that Sunlenca has strong potential to improve clinical outcomes and health-related quality of life for heavily treatment-experienced adults.

Gilead Sciences Announces New Clinical Trial in Europe to Assess Lenacapavir for HIV Prevention as Part of Landmark Purpose Program

Retrieved on: 
Wednesday, October 18, 2023

Gilead Sciences, Inc. (Nasdaq: GILD) today announced PURPOSE 5, the first Phase 2 clinical trial to evaluate an investigational long-acting HIV prevention option in Europe.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced PURPOSE 5, the first Phase 2 clinical trial to evaluate an investigational long-acting HIV prevention option in Europe.
  • HIV continues to be a public health threat across Europe, where in 2022 more than 100,000 people were newly diagnosed with HIV.
  • PURPOSE 1-5 is the most comprehensive and diverse program for an investigational HIV PrEP program ever conducted.
  • The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

Gilead Demonstrates the Impact of Global Collaboration in Advancing HIV Research and Health Equity at EACS 2023

Retrieved on: 
Monday, October 16, 2023

As a leader in HIV innovation, Gilead will provide an update on its signature initiatives, key collaborations and share new scientific data from its HIV research and development programs.

Key Points: 
  • As a leader in HIV innovation, Gilead will provide an update on its signature initiatives, key collaborations and share new scientific data from its HIV research and development programs.
  • Additional lenacapavir data presented at EACS 2023 will provide insight into the therapy’s resistance profile.
  • The mental health outcomes reported by participants in BICSTaR over a two-year period will also be presented at EACS 2023.
  • Mental health impairments can further increase the risk of negative health outcomes at every stage of the HIV care continuum.

Gilead to Present Latest Innovative Virology Data on Current and Potentially Transformative Therapies Across HIV and COVID-19 at IDWeek 2023

Retrieved on: 
Tuesday, October 3, 2023

These latest data demonstrate the company’s ongoing efforts to address the unmet medical needs of people and communities affected by HIV and COVID-19.

Key Points: 
  • These latest data demonstrate the company’s ongoing efforts to address the unmet medical needs of people and communities affected by HIV and COVID-19.
  • Gilead will be presenting 16 abstracts, including real-world evidence, as the company continues to pursue the next wave of scientific discovery in virology.
  • “At IDWeek 2023, we look forward to sharing our latest data with the broader community and discussing potential implications for the treatment of COVID-19 among some of the most vulnerable populations.
  • At IDWeek 2023, Gilead will present data that reinforces the ongoing role Veklury® (remdesivir) plays as the antiviral standard of care for the treatment of hospitalized patients with COVID-19.

Twice-Yearly Lenacapavir Demonstrates Sustained Impact on Health-Related Quality of Life in People With HIV

Retrieved on: 
Tuesday, July 25, 2023

In CALIBRATE, in a missing equals excluded analysis, 100% of all participants at Week 10, 20, and 30 were virologically suppressed (77/77; 58/58; 5/5, respectively).

Key Points: 
  • In CALIBRATE, in a missing equals excluded analysis, 100% of all participants at Week 10, 20, and 30 were virologically suppressed (77/77; 58/58; 5/5, respectively).
  • One CAPELLA participant who missed two non-consecutive oral lenacapavir doses did not maintain virologic suppression during OB.
  • Overall, OB demonstrated a consistent safety and tolerability profile, with treatment-emergent adverse events (AEs) similar to subcutaneous lenacapavir.
  • The use of twice-yearly lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

Gilead Showcases Latest HIV Pipeline Progress and the Impact of Global Collaboration on Health Equity Efforts at IAS 2023

Retrieved on: 
Wednesday, July 19, 2023

As the leader in HIV innovation, Gilead will provide updates on its signature initiatives and key collaborations while sharing new scientific data from its research and development programs.

Key Points: 
  • As the leader in HIV innovation, Gilead will provide updates on its signature initiatives and key collaborations while sharing new scientific data from its research and development programs.
  • Gilead is committed to continuous scientific discovery to meet the evolving needs of people affected by HIV.
  • At IAS 2023, 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.
  • Gilead scientists will also contribute to three IAS-hosted satellite sessions to further advance scientific dialogue on key issues including:

Global HIV Treatment Market Analysis Report 2023: A $25+ Billion Market by 2030 - Focus on Combination Therapies Gaining Momentum - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 29, 2023

The "Global HIV Treatment Market: Analysis By Product, By Region Size and Trends with Impact of COVID-19 and Forecast up to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global HIV Treatment Market: Analysis By Product, By Region Size and Trends with Impact of COVID-19 and Forecast up to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global HIV treatment market in 2022 stood at US$22.38 billion, and is likely to reach US$25.49 billion by 2030.
  • The global HIV treatment market is projected to grow at a CAGR of 1.42% during the forecast period of 2023-2030.
  • These ongoing efforts are instrumental in shaping the future of the global HIV treatment market.