- ViiV Healthcare, majority-owned by GSK Plc GSK, Pfizer Inc PFE, and Shionogi Limited, announced 12-month findings from the SOLAR Phase 3b study of the long-acting injectable regimen Cabenuva (cabotegravir, rilpivirine [CAB+RPV LA]) compared against complete daily oral regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]).
- Biktarvy is Gilead Sciences Inc GILD product.
- Study findings showed that CAB+RPV LA dosed every two months achieved the primary endpoint of non-inferior virologic efficacy versus daily oral BIC/FTC/TAF.
- The 670-participant study found that rates of virologic suppression were similar between treatment arms.
- 90% of participants who switched to CAB+RPV LA from BIC/FTC/TAF and who completed a survey (n=425) preferred the long-acting regimen.
- Switching to CAB+RPV LA from BIC/FTC/TAF during the SOLAR study was efficacious, well-tolerated, and improved treatment satisfaction from baseline.
- Confirmed virologic failure (CVF) was infrequent.
- Treatment with CAB+RPV LA and BIC/FTC/TAF were both well-tolerated.
- In March last year, the FDA approved Cabenuva (cabotegravir, rilpivirine) for HIV-1 in virologically suppressed adolescents on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.
- Price Action: GSK stock is down 1.54% at $35.19, and PFE shares are down 0.31% at $42.25 during the premarket session on the last check Thursday.
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