On Oct. 21, 2020, ViiV Healthcare, majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. When missed visits occurred due to the pandemic, the analysis showed they were manageable and successfully mitigated primarily by switching patients onto short periods of daily oral therapy of cabotegravir and rilpivirine, with good tolerability and no virologic failure or emerging resistance. These findings were presented at the 2020 Infectious Diseases Society of America (IDSA) IDWeek^TM

The pooled analysis examined 1,744 participants across 16 countries currently taking long-acting cabotegravir and rilpivirine as part of the regimen’s ongoing global clinical development programme of six studies, which includes the phase IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE clinical trials. While the majority of participants (93%, 1,615) maintained their routine dosing schedule from December 2019 through the analysis end point of September 15, 2020, 129 participants (7%) in the ongoing clinical trials had a planned injection visit that was impacted by COVID-19.

To date, there have been no suspected or confirmed virologic failures observed for any participants whose planned injection visit schedules were impacted by COVID-19. Treatment interruption was prevented among impacted participants primarily by switching participants onto daily oral therapy with cabotegravir and rilpivirine (94 participants, 73%) or the daily oral standard of care antiretroviral therapy (27 participants, 21%). Seven participants (5%) were able to reschedule their long-acting injection visit. Of the participants who experienced an impact to their visit, 54 (42%) were due to clinic closure or staffing constraints, 11 (9%) were due to self-quarantine, 18 (14%) were due to confirmed or suspected COVID-19, and 46 (36%) were attributed to other reasons, including COVID-19-related travel restrictions.

One hundred ten of the 121 participants (91%) who transitioned to temporary oral therapy because of a COVID-impacted injection visit have since restarted therapy with long-acting cabotegravir and rilpivirine. Of those participants who transitioned back to injectables, the median duration of oral therapy was 51 days. Participants identified as impacted by COVID-19 will continue to be followed and data collected from that group is expected to be presented at a future medical meeting.

The long-acting regimen of cabotegravir and rilpivirine was approved by Health Canada in March 2020 and is currently under review by the US Food and Drug Administration and other global regulatory authorities. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) recently issued a positive opinion recommending marketing authorisation for long-acting cabotegravir and rilpivirine in both injectable and tablet formulations. The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which has the authority to approve medicines for use throughout the European Union.