Bictegravir

MONDAY, March 9, 2026 -- For patients with HIV -1 with virologic suppression on complex multipill regimens, the bictegravir- lenacapavir single-tablet regimen (STR) is noninferior to complex regimens, according to a study published online Feb. 25 in The Lancet . Chloe Orkin, M.D., from Queen Mary University of London, and colleagues conducted a randomized, noninferiority phase 3 trial involving people with HIV-1 with virologic suppression on complex regimens. Participants were randomly assigned to switch to once-daily oral bictegravir-lenacapavir 75-mg/50-mg STRs or a continued complex regimen (371 and 186, respectively). The researchers found an HIV-1 RNA viral load of 50 copies/mL or higher in three and two participants receiving bictegravir-lenacapavir and a complex regimen, respectively, at week 48 (both 1 percent; difference −0.3 percent [95.002 percent confidence interval, −2.3 to 1.8], meeting the noninferiority margin). There was no resistance. The groups had similar adverse event rates. Due to adverse events, six and one (2 and 1 percent) participants discontinued bictegravir-lenacapavir and their complex regimen, respectively. Five deaths occurred in the bictegravir–lenacapavir group, none of which were related to the study drug. After switching to bictegravir-lenacapavir, participants reported increased treatment satisfaction. "This STR could present the first opportunity to optimize treatment while maintaining virological suppression in people taking complex regimens who have not benefited from available STRs due to antiretroviral resistance or other reasons," the authors write. Several authors disclosed ties to biopharmaceutical companies, including Gilead Sciences, which manufactures bictegravir-lenacapavir and funded the study. Abstract/Full Text

ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Credit: GSK GSK-backed ViiV Healthcare’s VH184 and VH499 show potential for twice-yearly HIV injections, offering long-acting, therapy with improved resistance Recent developments in HIV treatment highlight promising advances in long-acting antiretroviral therapy. ViiV Healthcare, the global specialist HIV company majority owned by GSK with Pfizer and Shionogi as shareholders, has reported encouraging early data for two investigational agents, VH184 and VH499. These therapies aim to reduce the frequency of dosing from daily regimens to potentially twice-yearly injections. The findings suggest both improved potency and tolerability, representing a significant step toward more convenient HIV management. HIV is not a solved problem A third-generation integrase inhibitor VH184, the first third-generation integrase strand transfer inhibitor (INSTI) in development, demonstrated potential for twice-yearly dosing in a phase 1 study of adults without HIV . Administered as a single subcutaneous or intramuscular injection, both formulations maintained drug levels for extended periods, with one sustaining steady concentrations through seven months. Early tolerability data show mostly mild injection site reactions, consistent with approved INSTIs, suggesting VH184 could offer a safe, long-acting alternative to daily therapies. In vitro studies further support VH184’s potential clinical advantages. Compared with bictegravir, VH184 retained activity against a broad spectrum of resistant HIV strains, including viruses with multiple INSTI-associated mutations. This enhanced resistance profile indicates a higher barrier to resistance, a critical consideration for long-term HIV management. ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. Credit: GSK Together with its pharmacokinetic profile, these findings position VH184 as a promising candidate for ultra long-acting HIV therapy. An investigational capsid inhibitor VH499, an investigational capsid inhibitor, also showed potential for twice-yearly dosing in phase 1 studies. Single intramuscular or subcutaneous injections maintained stable drug levels for prolonged periods, supporting ultra long-acting (ULA) dosing intervals of up to six months. The treatment was generally well tolerated, with the most common adverse effects being mild to moderate injection site reactions and no serious adverse events or study withdrawals due to side effects. “Our R&D efforts are built around delivering best-in-class, long-acting therapies that challenge the status quo and help make HIV treatment a smaller, less frequent part of people’s lives,” says Kimberly Smith, M.D., MPH, Head of Research & Development and Senior Vice President at ViiV Healthcare. Kimberly Smith, M.D., MPH, Head of Research & Development and Senior Vice President at ViiV Healthcare “The data we’re presenting on VH184, our third-generation INSTI, indicate a potential high barrier to resistance and twice-yearly dosing intervals. “Early results for VH499, a capsid inhibitor, point to its potential for dosing every six months. “These data underscore how ViiV Healthcare is working to define the future of HIV care through ultra long-acting options designed to address the needs and preferences of people living with HIV and will inform our plans to introduce the first INSTI-based, twice-yearly regimen for people with HIV.” Implications for future HIV care Together, VH184 and VH499 represent a shift toward longer-acting, less frequent HIV therapies. These early-stage results lay the groundwork for further clinical studies to optimise dosing schedules and confirm safety and efficacy in people living with HIV. As part of ViiV Healthcare’s broader pipeline, these agents underscore the company’s commitment to expanding treatment options that minimise the daily burden of HIV management and improve quality of life for patients. Company portals GSK ViiV Healthcare Executives Kimberly Smith Head of Research & Development and Senior Vice President