FDA Approves Rilpivirine, Cabotegravir as the First Long-Acting Regimen for HIV Treatment


The FDA has approved cabenuva, which consists of rilpivirine and cabotegravir, for treating HIV-1 infection in adults. This therapy is the first once-monthly, long-acting injectable to be approved for the treatment of HIV.

The FDA has approved cabenuva, which consists of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare), for treating HIV-1 infection in adults. This therapy is the first once-monthly, long-acting injectable (LAI) to be approved for the treatment of HIV.

Rilpivirine and cabotegravir are able to act as a complete regimen for patients, allowing it to replace the antiretroviral regimen for patients 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.

For the administration of the therapy, a provider would conduct a once-monthly administration that would consist of 2 individual intramuscular injections in the buttocks.

“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,” said Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, in a press release. “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.”

The approval of rilpivirine and cabotegravir by the FDA was based on 2 recent studies, the phase 3 Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study and First Long-Acting Injectable Regimen (FLAIR) study. Both studies had approximately 1100 patients from 16 countries included in the cohorts and demonstrated the efficacy of the treatment as a daily, oral 3-drug regimen that was able to maintain viral suppression during a 48-week period.

In the ATLAS study, rilpivirine and cabotegravir were able to meet the primary endpoint for noninferiority, which was set as the proportion of participants with plasma HIV-1 RNA ≥50 c/mL at week 48. The researchers gave patients either rilpivirine and cabotegravir or their current daily antiretroviral regimen (CAR) with an HIV-1 RNA level ≥50 c/mL. They observed that 2% of patients who received the LAI and 1% of patients who received CAR showed an HIV-1 RNA level ≥50 c/mL at week 48.

In the FLAIR study, patients were given either rilpivirine and cabotegravir or a daily oral dolutegravir/abacavir/lamivudine therapy. By week 48, patients demonstrated an HIV-1 RNA count ≥50 c/mL, which met the established noninferiority criteria. Additionally, 2% of patients in both treatment arms had an HIV-1 RNA count ≥50 c/mL at week 48.

During the studies, adverse events (AEs) of at least grade 2 severity were observed in patients treated with rilpivirine and cabotegravir or CAR, with the AEs including, respectively: injection site reactions (37%, 0), pyrexia (2%, 0), fatigue (1%, <1%), headache (<1%, <1%), musculoskeletal pain (1%, 0), nausea (<1%, 0), sleep disorders (<1%, 0), dizziness (<1%, 0), and rash (<1%, 0).

“This is an exciting new option for patients and providers, as it provides an alternative strategy for effective HIV treatment,” said Susan Swindells, MBBS, professor in the Department of Internal Medicine at the University of Nebraska Medical Center, in the press release. “Cabenuva once-monthly injections showed comparable efficacy to daily oral antiretroviral treatment in maintaining viral suppression—a first in the treatment paradigm.”

The regimen works by combining the non-nucleoside reverse transcriptase inhibitor rilpivirine with the integrase strand transfer inhibitor cabotegravir in order to inhibit the replication of HIV through the prevention of viral DNA’s integration with T cells. In order for HIV to persist as a chronic infection, this replication is necessary, meaning the inhibition of the cycle is critical for a successful, long-term treatment response.

“For more than 25 years, we have been committed to changing the course of the HIV epidemic through the pursuit of innovative treatments and effective prevention,” said Mathai Mammen, MD, PhD, the global head of Janssen Research & Development at Johnson & Johnson, in the press release. “This new treatment option for people living with HIV brings us one step closer toward alleviating this global health threat.” 


Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV. Titusville, NJ: Janssen Pharmaceutical Companies; January 21, 2021. https://www.janssen.com/janssen-announces-us-fda-approval-cabenuva-rilpivirine-and-cabotegravir-first-long-acting-regimen. Accessed January 22, 2021.


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