ViiV Healthcare’s Cabenuva will be available in the U.S. in February

FDA cleared Cabenuva, the first and only compete long-acting regimen to treat HIV-1 in adults, according to pharma maker ViiV Healthcare.

Cabenuva is provided as a co-pack with two injectable medicines, ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine. The prescription calls for it to be administered once monthly, and it is an option that can replace the current antiretroviral (ARV) regimen in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine, ViiV said in a press release.

Related: FDA clears first-in-class HIV-1 treatment

Notably, Cabenuva reduces the treatment dosing days from 365 days to 12 days per year, according to ViiV’s Lynn Baxter. The approval “represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” Baxter said in press releae

Lynn Baxter

ViiV Healthcare says it will begin shipping Cabenuva to wholesalers and specialty distributors in the U.S. in February.

Cabenuva’s approval was based on a phase 3 studies that included more than 1,100 patients from 16 countries.

Related: Gilead snags approval for second HIV-1 prevention drug

The new treatment was preferred by nine out of 10 patients over their previous daily oral therapy, according to ViiV.

In both studies, the most common adverse reactions (Grades 1 to 4) observed in ≥ 2% of clinical trial participants receiving Cabenuva were injection site reactions, pyrexia (fever), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Serious adverse events occurred in 4% of patients taking Cabenuva, and 3% (17/591) of adverse events led to withdrawal from the study.

Read more: FDA clears first 2-drug HIV-1 regimen