Cabotegravir superior to oral standard of care for HIV prevention in women

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Cabotegravir superior to oral standard of care for HIV prevention in women

The investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women, ViiV Healthcare announced in November 2020. Interim analysis from the HPTN 084 clinical trial demonstrated that the long-acting injectable cabotegravir administered every two months is 89 percent more effective than daily pills in preventing HIV acquisition in women. 

An independent data safety monitoring board (DSMB) recommended the early unblinding of the HIV Prevention Trials Network (HPTN) 084 study. Following a pre-specified interim analysis, the DSMB indicated that cabotegravir met the primary objective of showing superiority versus the current standard of care for women, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets. The clinical trial demonstrated cabotegravir was 89 percent more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP).

“It’s thrilling to collaborate with the NIH and the Bill & Melinda Gates Foundation to conduct such an important study in HIV prevention in women and deliver ground-breaking results confirming the superior efficacy of long-acting cabotegravir for PrEP,” commented Kimberly Smith, M.D., MPH, head of research & development at ViiV Healthcare . “Women need more effective choices for HIV prevention. If approved, long-acting cabotegravir will provide an option that reduces the number of annual dosing days from 365 to six. In addition, long-acting cabotegravir can be discretely administered and may empower women to reduce their risk of HIV acquisition without the need for negotiation with their sexual partner. The results of HPTN 084 confirm long-acting cabotegravir’s potential as an HIV prevention option that can meet these needs.”

The investigational integrase inhibitor cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV. Cabotegravir is being tested as a long-acting formulation for intramuscular injection and additionally as a once-daily oral tablet for use as a lead-in, to establish the tolerability of cabotegravir before long-acting injection.

The Food and Drug Administration granted Breakthrough Therapy Designation for cabotegravir for HIV PrEP in November based on efficacy and safety results from the Phase IIb/III randomized, multicenter, double-blind study HPTN 083.