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FDA approves first long-acting HIV treatment

The FDA in the US approved CABENUVA as the first once-monthly, long-acting injectable (LAI) for the treatment of HIV-1 infection in adults. CABENUVA consists of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare Ltd.), for treating HIV-1 infection in adults.

Photo by Hakan Nural from Unsplash.com

The FDA in the US approved CABENUVA as the first once-monthly, long-acting injectable (LAI) for the treatment of HIV-1 infection in adults. CABENUVA consists of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare Ltd.), for treating HIV-1 infection in adults.

Before proceeding with the news (and dampening the good news), here’s an FYI: As quoted by NBC News, ViiV Healthcare Ltd. stated that the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward.

According to the FDA, the safety and efficacy of CABENUVA were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with CABENUVA. The patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed (https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv).

In first trial, the ATLAS study, CABENUVA was said to have met the primary endpoint for noninferiority (or the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter [c/mL] at Week 48), with a comparable number of patients receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ≥50 c/mL. Two percent of patients receiving the long-acting injectable and 1% of patients receiving CAR had an HIV-1 RNA level ≥50 c/mL at Week 48 (Treatment difference 0.7%; 95% CI: -1.2%, 2.5%).

In second trial, the FLAIR study, a comparable number of patients receiving either CABENUVA or daily oral dolutegravir/abacavir/lamivudine therapy had an HIV-1 RNA count ≥50 c/mL, meeting noninferiority criteria. Two percent of patients in both treatment arms had an HIV-1 RNA count ≥50 c/mL at Week 48 (Treatment difference -0.4%; 95% CI: -2.8%, 2.1%).

Rilpivirine and cabotegravir are able to act as a complete regimen for people with HIV, allowing it to replace the antiretroviral regimen for those who are virologically suppressed with HIV-1 RNA at less than 50 copies per milliliter [c/mL], have no history of treatment failure, and are not known or suspected to have any resistance to either cabotegravir or rilpivirine.

To administer the therapy, a provider would conduct a once-monthly administration that would consist of two individual intramuscular injections in the buttocks.

Added the FDA: The most common adverse reactions with CABENUVA were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter).

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In a press release, Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson said: “With the approval of CABENUVA, we’re proud to bring a new treatment option to people living with HIV that removes the burden of taking a daily pill… While much more remains to be done to make HIV history, today’s milestone reminds us how far medical innovation has come since the first reported cases of the virus almost 40 years ago.”

Now, and realistically, with newer HIV medicines like rilpivirine and cabotegravir not even widely offered in countries like the Philippines yet, the even newer injectables may sound promising but remain stuff of dreams…

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