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Long-Acting HIV Regimen Approved in Europe


The approval of injectable drug Vocabria sets up a treatment regimen that can be taken once a month or even every other month.

The European Union has approved a new long-acting treatment for HIV.

The E.U.’s European Medicines Agency announced approval Monday of Vocabria from Viiv Healthcare. Vocabria is a cabotegravir injection and works by blocking an essential step in HIV replication cycle. Vocabria was approved for use in Europe in combination with Rekambys injections and Edurant tablets, both of which are forms of rilpivirine and are made by Janssen Pharmaceuticals.

This marks the first time people living with HIV in Europe will be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase, according to a Viiv press release. The injections of Vocabria and Rekambys could be delivered once a month or once every two months. The treatment is appropriate for adults who have achieved HIV suppression and have shown no resistance to integrase inhibitors or nonnuncleoside reverse transcriptase inhibitors.

The hope is that people will follow their treatment regimen more diligently when they have to take their meds only once a month or every other month. Less frequent treatment will also mean fewer reminders of their condition.

“Daily antiretrovirals have transformed the lives of people living with HIV,” Dr. Antonio Antela of the University Hospital in Santiago de Compostela, Spain, said in the release. “However, taking daily medication can pose challenges for some people; it may act as a constant reminder of HIV or be a cause of fear that their HIV status will be disclosed.” Vocabria has the potential to reduce treatment days from 365 per year to 12 or even as few as six.

In clinical trials, the regimen using injectables performed just as well as therapies already in use, Antela added. “The long-acting regimen of cabotegravir and rilpivirine was as effective as treatment with current daily antiviral therapy in the clinical trials in maintaining viral suppression, is generally well tolerated, and could change the treatment experience for some people living with HIV that may have challenges with daily HIV therapies,” he said.

Viiv Healthcare CEO Deborah Waterhouse noted patients in clinical trials overwhelmingly preferred Vocabria over daily treatments.

“We saw from the patient-reported outcomes in our pivotal clinical trials that approximately nine out of 10 people who switched to the long-acting regimen preferred this over their previous daily oral tablets,” she said in the release.

The question now is when this treatment will be approved for use in the United States. Testing has been under way since last year, but there is still no word on when its approval will come through.

Viiv Healthcare is majority-owned by GlaxoSmithKline; Pfizer and Shionogi are minority shareholders. Janssen Pharmaceuticals is owned by Johnson & Johnson.

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