FDA Approves HIV Injectable Cabenuva Initiation Without Oral Lead-in

Heidi Splete


March 29, 2022

Initiating treatment may become easier for adults living with HIV. The US Food and Drug Administration has approved a label update that allows adults living with HIV to begin treatment with Cabenuva (ViiV Healthcare), a combination injectable, without a lead-in period of oral tablets, according to a press release from Janssen Pharmaceuticals.

Cabenuva combines rilpivirine and cabotegravir. The change offers patients and clinicians an option for a streamlined entry to treatment without the burden of daily pill taking, according to the release.

Cabenuva injections may be given as few as six times a year to manage HIV, according to Janssen. HIV patients with viral suppression previously had to complete an oral treatment regimen before starting monthly or bimonthly injections.

The injectable combination of cabotegravir, an HIV-1 integrase strand transfer inhibitor, and rilpivirine, an HIV-1 nonnucleoside reverse transcriptase inhibitor, is currently indicated as a complete treatment regimen to replace the current antiretroviral regimen for adults with HIV who are virologically suppressed," according to the press release.

"Janssen and ViiV are exploring the future possibility of an ultra-long-acting version of Cabenuva, which could reduce the frequency of injections even further, according to the press release.

Access May Improve, but Barriers Persist

"Despite advances in HIV care, many barriers remain, particularly for the most vulnerable populations," Lina Rosengren-Hovee, MD, of the University of North Carolina at Chapel Hill, told Medscape Medical News in an interview.

"Care engagement has improved with the use of bridge counselors, rapid ART initiation policies, and contact tracing," she said. "Similarly, increasing access to multiple modalities of HIV treatment is critical to increase engagement in care.

"For patients, removing the oral lead-in primarily reduces the number of clinical visits to start injectable ART," Rosengren-Hovee added. "It may also remove adherence barriers for patients who have difficulty taking a daily oral medication."

But Rosengren-Hovee (who has no financial connection to the manufacturers) pointed out that access to Cabenuva may not be seamless. "Unless the medication is stocked in clinics, patients are not likely to receive their first injection during the initial visit," she noted. "Labs are also required prior to initiation to ensure there is no contraindication to the medication, such as viral resistance to one of its components. Cost and insurance coverage are also likely to remain major obstacles," she added.

Rosengren-Hovee has disclosed no relevant financial relationships.

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