The Food and Drug Administration has given a thumbs-down to a long-acting injectable therapy for HIV that is administered once per month.
ViiV Healthcare said Saturday that the FDA cited chemistry manufacturing and controls issues in issuing a complete response letter for its long-acting injectable regimen, cabotegravir and rilpivirine. ViiV said it would work with the FDA to determine the next steps and noted there were not any safety issues raised, but did not provide further details about what the manufacturing issues were. London-based GlaxoSmithKline owns a majority stake in ViiV, while Pfizer and Shionogi each own a minority stake.
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Although antiretroviral therapy for HIV has enabled patients to achieve normal lifespans while virtually eliminating their risk of transmitting the virus to others, the current treatment regimens of daily dosing, often with multiple medications, can create a significant burden, with adherence being another problem.
ViiV originally filed with the FDA for approval in April, based on results of the Phase III ATLAS and FLAIR studies, and the FDA gave it a priority review, with a targeted action date of Dec. 29. Results of ATLAS demonstrated that cabotegravir and rilpivirine was non-inferior to an oral three-drug regimen of two nucleoside reverse transcripterase inhibitors and a third drug. FLAIR compared the injectable drug combination with ViiV’s Triumeq (abacavir, dolutegravir, lamivudine), showing also that virologic suppression rates were similar between the two arms.
In July, ViiV started a clinical trial called CUSTOMIZE, which is designed to find approaches to implementing the therapy into clinical practice, with initial results anticipated to be available by the end of this year. The one-year study – taking place at university hospitals, private and public clinics in several major cities across the U.S., involves handing out educational items, training aids, treatment and resource planning tools, appointment reminders and patient-facing materials to participating centers. Sites determine how to use the materials and can also develop their own, while surveys and interviews with providers, patients and administrators will seek to identify best practices and barriers to successful delivery of the drug.
Photo: GSK