Infectious Disease

The FDA approves the primary long-acting injectable routine for HIV

January 22, 2021

2 min read

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Disclosure:
Farley does not report any relevant financial information. Volberding reports on advising Gilead Sciences and chairing a data protection and oversight committee for Merck.

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The FDA approved the first long-acting injectable regimen for HIV treatment, Cabenuva, which contains cabotegravir and rilpivirine only once a month.

In clinical studies, the regimen has been shown not to be inferior to the daily three-drug oral regimes. It was approved as a replacement for current antiretroviral therapies in HIV patients who are virologically suppressed after stable therapy, have not had treatment failures, and have no suspected or known resistance to cabotegravir (ViiV Healthcare) or rilpivirine (Janssen Pharmaceuticals).

Volberding HIV quote

“The development of HIV drugs has made convenience and safety a priority. We have come a long way since the inception of triple therapy, with a handful of pills taken several times a day and often with significant side effects to the current single-pill multidrug regimens, “said Infectious Disease News chief medical editor Paul A. Volberding, MD, Professor of medicine and director of the AIDS Research Institute at the University of California, San Francisco, said Healio.

“We now have another option that is preferred by many patients, once a month on a two-drug injectable, long-acting regimen,” said Volberding. “This has been shown to maintain full virus suppression with minimal side effects and is an important addition to our treatment options. This is good news for people living with HIV. “

Patients prescribed the new regimen are initially given a month-long daily oral induction consisting of ViiV’s Vocabria (cabotegravir in tablet form) – which has also been approved by the FDA – and oral rilpivirine to ensure that the drugs are well tolerated.

After that, they’ll get a one-time dose of 600 mg of cabotegravir and 900 mg of rilpivirine at a cost of $ 5,940, a ViiV spokesman told Healio. Subsequent monthly injections of 400 mg cabotegravir and 600 mg rilpivirine cost $ 3,960.

The spokesman said the monthly two-shot therapy cost is “in the upper range” of daily oral therapies on the market.

The FDA initially denied approval of Cabenuva in 2019 because of concerns about chemistry, manufacturing, and controls, but not safety.

The approval is based on data from the ATLAS and FLAIR phase 3 studies, in which a total of more than 1,100 patients in 16 countries participated. The injectable regimen was found to be just as effective in maintaining virus suppression as continuing a three-drug oral regimen. Additionally, nine out of ten patients preferred Cabenuva over daily oral therapy.

The most common side effects in both studies were pyrexia, fatigue, injection site reactions, headache, nausea, musculoskeletal pain, difficulty sleeping, rash, and dizziness.

“This approval allows some patients to receive injections once a month instead of daily oral treatment.” John Farley, MD, MPH, The director of the Infectious Disease Office at the FDA Center for Drug Evaluation and Research said in a statement. “The availability of this treatment to some patients offers an alternative treatment for this chronic condition.”

In November, the FDA named long-acting cabotegravir a breakthrough therapy for HIV-PrEP after data from multiple studies showed it was effective in preventing infection in transgender women, men who have sex with men, and cisgender women.

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Melanie A. Thompson, MD)

Melanie A. Thompson, MD

This new treatment option is celebrated by a subset of people living with HIV who, for whatever reason, have difficulty taking daily pills and who have the ability to successfully come to the clinic for monthly injections. Although the efficacy and safety of Cabenuva has been proven in clinical studies, the devil of implementation lies in the details that have yet to be sorted out, especially for large, understaffed clinics that are now also dealing with COVID-19. The tiny implementation attitudes survey study doesn’t even address real-world challenges. Many people need transportation and reminders to ensure visits are within the treatment window. This increases the complexity and the cost. We can only hope the FDA will give a positive assessment of the ATLAS 2M data, which supports injections every 8 weeks. Bimonthly injections could also cut annual costs significantly if the dose price stays the same. Long-term therapies of many types are definitely the future, and a small piece of that future is finally with us now.

Melanie A. Thompson, MD

HIV doctor and researcher

Atlanta

Disclosure: Thomspon reports that he served as a lead investigator for Bristol Myers Squibb, Cepheid, CytoDyn, Frontier Biotechnology, Gilead Sciences, Merck, Sharp & Dohme, Taimed and ViiV Healthcare.

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