Efficacy

Rukobia (fostemsavir) Efficacy in HIV/AIDS

Rukobia, the brand name for fostemsavir, is a novel antiretroviral medication approved for the treatment of HIV/AIDS. It is specifically indicated for adults with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen. Fostemsavir acts as an attachment inhibitor, targeting the initial stage of HIV-1 entry into host cells, thus providing a unique mechanism of action compared to other antiretroviral agents.

The efficacy of Rukobia was primarily demonstrated in the Phase 3 BRIGHTE study, which consisted of heavily treatment-experienced adults with multidrug-resistant HIV-1. The results showed that a significant proportion of participants achieved and maintained viral suppression when Rukobia was added to an optimized background therapy. At Week 96, the study reported that a majority of patients in the randomized cohort sustained viral suppression, highlighting Rukobia's potential as an effective treatment component for this challenging patient population.

Apretude (cabotegravir extended-release injectable suspension) Efficacy in HIV/AIDS

Apretude is the brand name for cabotegravir extended-release injectable suspension, a long-acting form of the integrase strand transfer inhibitor (INSTI) cabotegravir. It is approved for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents. Apretude is administered as an injection once every two months, offering an alternative to daily oral PrEP medications.

The efficacy of Apretude was established through two pivotal clinical trials, HPTN 083 and HPTN 084, which compared the injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for PrEP. In HPTN 083, Apretude was found to be more effective than daily oral FTC/TDF in preventing HIV acquisition among men who have sex with men and transgender women. Similarly, HPTN 084 showed that Apretude was superior to daily oral FTC/TDF in preventing HIV in cisgender women. These findings suggest that Apretude is highly efficacious in reducing the risk of HIV infection across diverse populations when used as directed.