GlaxoSmithKline’s (GSK; NYSE: GSK) subsidiary, ViiV Healthcare, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for both cabotegravir tablets and cabotegravir injection. These medications are intended for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents weighing at least 35kg who are at risk of HIV infection, marking a significant advancement in HIV prevention as the first therapy that can prevent HIV infection without daily medication.
The approvals were granted based on the successful outcomes of the HPTN 083 and HPTN 084 trials. These were multi-center, randomized, double-blinded, positive-controlled Phase IIb/III studies aimed at evaluating the safety and efficacy of long-term injections of cabotegravir for HIV prevention in HIV-1 negative individuals involved in male same-sex sexual intercourse, transgender women, and cisgender women. The HPTN 083 study demonstrated that cabotegravir injections were associated with a 68% reduced risk of HIV infection compared to the daily oral administration of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). Meanwhile, the HPTN084 study showed that the long-acting injection group experienced a 91% reduced risk of HIV infection compared to the TDF/FTC oral tablet group.- Flcube.com
