Tuesday, April 16, 2024

China Approves Long-Acting Injectable HIV Treatment by ViiV Healthcare and Johnson & Johnson

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In a significant development for HIV treatment, China’s National Medical Products Administration (NMPA) has approved a long-acting HIV therapy co-developed by ViiV Healthcare and Johnson & Johnson. This therapy eliminates the necessity for daily pill intake to manage the virus, offering a more convenient treatment option for patients.

The approved therapy combines ViiV’s integrase inhibitor Vocabria (cabotegravir) with J&J’s non-nucleoside reverse transcriptase inhibitor (RTI) Rekambys (rilpivirine). This innovative regimen can be administered via injection either six or 12 times a year, revolutionizing the approach to HIV treatment.

ViiV Healthcare, a joint venture majority-owned by GSK, with Pfizer and Shionogi as minority stakeholders, considers this regimen a valuable addition for treating HIV-1 infection in adults who can effectively control the virus using standard oral antiretroviral therapy (ART) and have no resistance to integrase inhibitors.

Known as Cabenuva in other markets, including the US and Europe, this regimen plays a crucial role in ViiV’s strategy to boost sales of its HIV franchise from £5.7 billion to £7 billion by 2026. In the first half of this year alone, Cabenuva contributed £303 million in sales, making it central to ViiV’s plans to offset the anticipated loss of patient protection for the older integrase inhibitor Tivicay (dolutegravir) before the decade’s end.

China represents a significant growth opportunity for ViiV, with over a million people living with HIV and more than 100,000 new cases diagnosed annually. Expanding treatment options is deemed essential to curbing the epidemic’s scale in the country.

While acknowledging that regular clinic visits for injections may not be suitable for every patient, ViiV and J&J believe their treatment can greatly benefit individuals who struggle to adhere to oral ART regimens, face discrimination if their HIV status is disclosed, or simply prefer not to be reminded of their HIV status daily.

Earlier this year, ViiV and J&J conducted a head-to-head trial comparing Cabenuva with oral ART, including Gilead Sciences’ popular Biktarvy. The results showed that 90% of patients preferred the convenience of the once-monthly injection regimen.

ViiV’s CEO, Deborah Waterhouse, emphasized the significance of this approval, stating it marks a step forward in enhancing the treatment experience for some individuals living with HIV in China, particularly those facing challenges with daily therapies. The company is committed to ensuring that no person living with HIV is left behind in accessing this innovative long-acting regimen.

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