Lenacapavir, a long-acting injectable HIV medication, may soon be a promising option for those starting HIV treatment. The latest findings from the CALIBRATE study, which tracked patients for up to 132 weeks, show that twice-yearly injections of lenacapavir helped nearly all participants maintain viral suppression. This development suggests lenacapavir could be part of a combination regimen for people newly diagnosed with HIV.
This long-acting treatment approach offers several advantages. By reducing the frequency of administration to just twice a year, lenacapavir could encourage better adherence to treatment, improve convenience for patients, and provide a more discreet option compared to daily pills. However, it still requires a daily antiretroviral partner, as there are no other equally long-lasting options available at this time.
Lenacapavir works as a capsid inhibitor, which is distinct from other HIV medications. This allows it to remain effective even against resistant strains of the virus. Initially approved by the FDA in 2022 as part of a treatment regimen for multidrug-resistant HIV, lenacapavir has since been studied for its use as pre-exposure prophylaxis (PrEP) to prevent HIV. The FDA also recently approved it for this purpose under the brand name Yeztugo.
The CALIBRATE study involved 183 participants who were previously untreated for HIV. Over the course of the trial, four different treatment regimens were tested, with groups receiving either lenacapavir injections every six months combined with daily pills or entirely oral regimens. After two years, the study reported high rates of viral suppression, with participants in groups receiving lenacapavir injections showing impressive results. By 132 weeks, more than 98% of those in the lenacapavir groups maintained undetectable viral loads.
While these results are promising, the need for daily medication alongside lenacapavir remains a limitation. The only other approved long-acting HIV regimen, Cabenuva, requires injections every other month and is only available for those switching from daily treatment. Researchers are now investigating the potential for fully long-acting combinations, such as pairing lenacapavir with other long-acting injectables like cabotegravir or exploring additional options like broadly neutralizing antibodies (bnAbs).
The progress in this area signals hope for the future of HIV treatment, potentially revolutionizing how the disease is managed and providing a better quality of life for patients.
