ViiV Healthcare announces first global regulatory approval of CABENUVA; the first complete, long-acting, regimen for the treatment of HIV
London, 20 March 2020 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that Health Canada has approved CABENUVA, the first and only once-monthly, complete long-acting regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]). VOCABRIA oral tablets, to be used for short time periods in conjunction with CABENUVA, have also been approved by Health Canada. These approvals are the first for CABENUVA and VOCABRIA anywhere in the world.
CABENUVA allows virologically suppressed adults living with HIV to maintain viral suppression while reducing their dosing schedule from 365 days to 12 days per year. VOCABRIA and CABENUVA should not be used in patients with known or suspected resistance to cabotegravir or rilpivirine. A kit with two injectable medicines—ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine— CABENUVA was co-developed as part of a collaboration with Janssen and builds on ViiV Healthcare’s industry-leading portfolio centered on delivering innovative medicines for the HIV community.
Deborah Waterhouse, CEO, ViiV Healthcare, said: “Today’s approval marks a monumental step in the treatment of HIV and is a true testament to ViiV Healthcare’s R&D innovation. With CABENUVA, people living with HIV who are virologically suppressed now have an option to maintain that suppression with 12 treatments a year thereby positively impacting their lives.”
The approval of CABENUVA is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 participants 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 cabotegravir and rilpivirine. The studies demonstrated that CABENUVA, when injected intramuscularly in the buttocks, once a month, was as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression throughout the 48-week study period.
In both studies, the most common adverse reactions (Grades 1 to 4) observed in ≥ 2% of participants receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash, and diarrhoea. Over the 48-week study period, a total of 4% of participants discontinued CABENUVA due to adverse events.3 The New England Journal of Medicine published the 48-week results of these studies in its March 4, 2020 issue.
CABENUVA was preferred over their previous daily oral therapy by approximately 9 out of 10 patients who switched to cabotegravir and rilpivirine long-acting in ATLAS and FLAIR studies. Treatment preference data was collected from ATLAS and FLAIR clinical trial participants who received CABENUVA. In a pooled exploratory analysis of this Intent-to-Treat Exposed (ITT-E) population, 532 participants completed a single-item question at Week 48 (59 participants did not) and 88% (523/591) preferred CABENUVA compared with 2% (9/591) who preferred their previous ARV treatment. The results were descriptive in nature and are not intended to infer clinical significance.
Chloe Orkin, M.D., Consultant Physician and Clinical Professor at Queen Mary University of London and FLAIR principal investigator, said: “CABENUVA, an injectable treatment, has the potential to transform HIV care by offering monthly instead of daily treatment to suitable patients. It reduces the frequency of dosing and is as effective as daily, oral, three-drug regimens in maintaining viral suppression among adults living with HIV. Most participants in the clinical trials preferred it over their prior oral daily regimens.”
Cabotegravir and rilpivirine complete long-acting regimen for the treatment of HIV-1 infection therapy is under review by the European Medicines Agency (EMA) and regulatory authorities in Switzerland and Australia. Further regulatory authority submissions are planned in the coming months. ViiV Healthcare is working closely with the FDA to determine the appropriate next steps for a New Drug Application in the US.
About CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) and VOCABRIA (cabotegravir tablets)
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL). CABENUVA is administered intramuscularly as two individual injections in the buttocks once a month by a healthcare provider.
VOCABRIA is indicated, in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL) as an oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA and as an oral bridging therapy for missed CABENUVA injections.
VOCABRIA and CABENUVA should not be used in patients with known or suspected resistance to cabotegravir or rilpivirine.
The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC. Each of these medicines are also approved as once-daily oral tablets. Once-daily oral cabotegravir and rilpivirine tablets may be used as a lead-in, to establish the tolerability of cabotegravir and rilpivirine prior to CABENUVA injection as well as for up to two months to replace monthly injectable CABENUVA therapy when injectable doses are missed.
INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies. EDURANT is owned by or licensed to Janssen Sciences Ireland UC.