China clears ViiV, J&J injectable HIV treatment

ViiV Healthcare and Johnson & Johnson have been granted approval in China for a long-acting HIV therapy that frees patients from the need to take daily pills to keep the virus at bay.

China’s National Medical Products Administration (NMPA) has cleared the use of ViiV’s integrase inhibitor Vocabria (cabotegravir) given in combination with J&J’s non-nucleoside reverse transcriptase inhibitor (RTI) Rekambys (rilpivirine), an all-injectable regimen that can be delivered either six or 12 times a year.

ViiV, which is a joint venture with GSK as a majority shareholder, and Pfizer and Shionogi holding minority interests, said the new regimen becomes an option for treating HIV-1 infection in adults who are able to control the virus using standard oral antiretroviral therapy (ART) and have no evidence of resistance to integrase inhibitors.

The regimen – sold as Cabenuva in other markets, including the US and Europe – is an important component of ViiV’s plans to build sales of its HIV franchise to £7 billion ($8.5 billion) in 2026 from £5.7 billion last year.

Cabenuva contributed £303 million in sales in the first half of this year and is central to ViiV’s plans to offset the loss of patient protection for older integrase inhibitor Tivicay (dolutegravir) before the end of the decade.

China is a big part of ViiV’s growth plans, given that it has more than a million people living with HIV and more than 100,000 new cases diagnosed every year, and the company said this morning that expanding treatment options is “critical to reduce the scale of the epidemic in the country.”

While acknowledging that regular clinic visits for injections may not be feasible or desirable for some patients, ViiV and J&J are hoping their treatment could help those who struggle to remember to take oral ART, run the risk of discrimination if their status is revealed, or simply don’t want a daily reminder of their HIV status.

Earlier this year, ViiV and J&J reported data from a head-to-head trial of Cabenuva and oral ART using rival Gilead Sciences’ big-selling Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), which found that 90% of patients preferred the once-monthly injection regimen.

“The approval of cabotegravir injection and rilpivirine long-acting injection marks a step forwards in helping to change the treatment experience for some people living with HIV in China who may have challenges with daily HIV therapies,” said ViiV's chief executive, Deborah Waterhouse.

“We look forward to working closely with our partners in China to make this treatment available to those who could benefit from a long-acting regimen, part of our commitment to ensuring no person living with HIV is left behind.”