Bottlenecks are slowing switch to GSK's long-acting HIV injectable Cabenuva: clinician

Supply bottlenecks linked to centralized distribution are slowing the pace at which patients are switching to GlaxoSmithKline’s long-acting HIV injectable Cabenuva, according to a U.S.-based expert clinician.

The clinician shared thoughts on Cabenuva with analysts from Jefferies. The analysts learned that 1% of 2% of patients are now receiving the monthly injectable Cabenuva, but there is a long list of patients waiting to switch, mainly from branded oral regimens. The expert blamed supply issues for the length of the waiting list.

“Uptake has been hindered by the COVID-19 pandemic, with patients currently wishing to avoid monthly clinic visits, but more importantly, supply bottlenecks owing to the centralized distribution, which has prevented the clinic securing adequate supply to meet demand. It is not clear if centralized distribution is temporary, with expert noting it to be unusual,” the analysts wrote in their summary of the chat.

ViiV Healthcare, GSK's majority-owned specialist HIV company, put its side across in a statement. "There are no issues with supply availability of Cabenuva to meet the demand. ViiV Healthcare recognizes that bringing innovation to HIV treatment with the first and only complete long-acting regimen requires new processes for providers regarding product acquisition. We work to educate and provide appropriate support to HCPs and office staff as they implement the necessary changes to bring this innovation to their patients," a spokesperson said.

The Jefferies analysts expect the recent approval of a version of Cabenuva that is given every two months to help to ease the bottleneck identified by the clinician, although the need for in-clinic administration of the large-volume intramuscular injection by a healthcare professional may limit uptake. While the expert expects most patients to favor the less frequent dosing schedule, they see monthly dosing as the preferred option in people who are at risk for non-adherence pending real-world resistance data.

The current restrictions on the pace at which patients are switching to Cabenuva may ultimately be a blip in a long-term success story. The expert expects long-acting regimens to claim more than half of the HIV market over the next decade, while cautioning that drugs given at most every two months and products suitable for self-administration may be needed to drive broad adoption.

Sales of Cabenuva totaled 38 million pounds sterling ($50 million) in 2021, its first year on the market. As GSK works to increase that figure, it may face competition from Gilead Sciences, although the long-acting oral program it is working on with Merck ran into problems last year that precipitated a pause in enrollment.