LONDON - ViiV Healthcare, the specialist HIV company majority-owned by GlaxoSmithKline (NYSE:GSK), with Pfizer (NYSE:PFE) and Shionogi as shareholders, is set to present pivotal data at the 25th International AIDS Conference in Munich, Germany.
The conference, scheduled from July 22 to 26, will feature 25 abstracts from ViiV's portfolio and pipeline, including a head-to-head study of the two-drug regimen Dovato against the three-drug regimen Biktarvy.
The study, sponsored by the SEIMC-GeSIDA Foundation, is a randomized clinical trial comparing the efficacy, safety, and weight gain impact of Dolutegravir/Lamivudine (DTG/3TC) versus Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in virologically suppressed adults.
Preliminary findings at 48 weeks indicate non-inferiority between the regimens, with additional insights into weight changes experienced by participants.
Further studies to be presented include the DYAD and SOUND studies, assessing the switch from BIC/FTC/TAF to DTG/3TC, as well as data on cabotegravir long-acting (LA) for pre-exposure prophylaxis (PrEP) during pregnancy from the HPTN 084 trial. Moreover, phase I results of a third-generation integrase inhibitor (INSTI) with potential for ultra long-acting applications will be shared.
Real-world evidence will also be highlighted, with several studies on the complete long-acting HIV treatment regimen of cabotegravir + rilpivirine long-acting (CAB+RPV LA), including patient adherence and outcomes from the BEYOND, CARLOS, and COMBINE-2 studies.
ViiV Healthcare's Chief Medical Officer, Dr. Harmony P. Garges, emphasized the company's leadership in developing long-acting and two-drug regimens, aiming to offer more personal treatment choices for HIV care.
The information in this article is based on a press release statement from ViiV Healthcare.
In other recent news, GlaxoSmithKline (GSK (LON:GSK)) has seen significant developments in its business operations. The company recently secured exclusive rights to develop, manufacture, and commercialize mRNA vaccines for influenza and COVID-19 from CureVac. The deal involves an upfront payment of €400 million with potential future payments totaling €1.05 billion, based on various milestones.
In addition, GSK reported a 100% response rate in a rectal cancer study with Jemperli, a potential new treatment option that could lead to complete tumor regression. However, GSK is also facing a lawsuit from Valisure over allegations related to the concealment of cancer risks associated with its heartburn medication Zantac.
Citi adjusted its price target for GSK shares to GBP 19.00, down from the previous GBP 21.20, following a decision by the Advisory Committee on Immunization Practices (ACIP) that has impacted the market prospects for GSK's Arexvy vaccine. The ACIP's decision has significantly narrowed the eligible age group for Arexvy, leading to a lowered sales expectation for the vaccine.
Goldman Sachs (NYSE:GS) has initiated coverage on GSK, issuing a Neutral rating and highlighting the company's transition to focus on specialty medicines and vaccines. Lastly, the CDC's recent decision to limit the use of RSV vaccines to a narrower age group could potentially impact the projected market for GSK's Arexvy RSV vaccine, according to analysts at JPMorgan (NYSE:JPM).
InvestingPro Insights
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