US FDA approves ViiV Healthcare’s Cabenuva as complete long-acting regimen for HIV treatment

ViiV Healthcare, a specialist HIV company majority-owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.

Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.

Lynn Baxter, Head of North America, ViiV Healthcare, said, “Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.”

The approval of Cabenuva is based on the phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included over 1,100 patients from 16 countries. Prior to initiating treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine (lead-in) was administered for approximately one month to assess the tolerability of each therapy. In these studies, Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks once a month throughout the 48-week study period. In both studies, the most common adverse reactions (Grades 1 to 4) observed in ≥ 2 per cent of clinical trial participants receiving Cabenuva were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Serious adverse events occurred in three per cent (24/591) of patients taking Cabenuva, and three per cent (17/591) of adverse events led to withdrawal.

Cabenuva was preferred by nine out of 10 patients over their previous daily oral therapy in these pivotal studies. Patient preference data was collected from clinical trial participants who received Cabenuva. In a pooled exploratory analysis of this Intent-to-Treat Exposed (ITT-E) population, 532 patients completed a single-item question at Week 48 (59 patients did not) and 88 per cent (523/591) preferred Cabenuva compared with two percent (9/591) who preferred their previous ARV treatment. The results were descriptive in nature and are not intended to imply clinical significance.

To support the successful delivery of the once-monthly regimen to people living with HIV (PLHIV), ViiV Healthcare sponsored the CUSTOMIZE trial, the first-ever, pre-approval implementation science study to identify and evaluate approaches to integrate Cabenuva into clinical practices in the US. Interim findings presented at AIDS2020 demonstrated that at four months, the majority of clinical staff participants continued to perceive the implementation of Cabenuva as highly acceptable, feasible and appropriate for PLHIV, and clinical staff had a substantial decrease in what they thought would be barriers to implementation of the injectable regimen.

ViiV Healthcare will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February 2021.

The New Drug Application for Vocabria (cabotegravir) 30 milligram (mg) oral tablets was also approved by the FDA. Vocabria is indicated, in combination with rilpivirine tablets, as a complete regimen for short-term treatment of HIV-1 infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as an oral lead-in to assess tolerability of cabotegravir prior to initiating Cabenuva and as an oral therapy for patients who will miss planned injection dosing of Cabenuva.