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Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection
The New England Journal of Medicine ( IF 70.670 ) Pub Date : 2020-03-19 , DOI: 10.1056/nejmoa1909512
Chloe Orkin; Keikawus Arasteh; Miguel Górgolas Hernández-Mora; Vadim Pokrovsky; Edgar T. Overton; Pierre-Marie Girard; Shinichi Oka; Sharon Walmsley; Chris Bettacchi; Cynthia Brinson; Patrick Philibert; Johan Lombaard; Marty St. Clair; Herta Crauwels; Susan L. Ford; Parul Patel; Vasiliki Chounta; Ronald D’Amico; Simon Vanveggel; David Dorey; Amy Cutrell; Sandy Griffith; David A. Margolis; Peter E. Williams; Wim Parys; Kimberly Y. Smith; William R. Spreen

Background Long-acting injectable regimens may simplify therapy for patients with human immunodeficiency virus type 1 (HIV-1) infection. Methods We conducted a phase 3, randomized, open-label trial in which adults with HIV-1 infection who had not previously received antiretroviral therapy were given 20 weeks of daily oral induction therapy with dolutegravir–abacavir–lamivudine. Participants who had an HIV-1 RNA level of less than 50 copies per milliliter after 16 weeks were randomly assigned (1:1) to continue the current oral therapy or switch to oral cabotegravir plus rilpivirine for 1 month followed by monthly injections of long-acting cabotegravir plus rilpivirine. The primary end point was the percentage of participants who had an HIV-1 RNA level of 50 copies per milliliter or higher at week 48 (Food and Drug Administration snapshot algorithm). Results At week 48, an HIV-1 RNA level of 50 copies per milliliter or higher was found in 6 of 283 participants (2.1%) who received long-acting therapy and in 7 of 283 (2.5%) who received oral therapy (adjusted difference, −0.4 percentage points; 95% confidence interval [CI], −2.8 to 2.1), a result that met the criterion for noninferiority for the primary end point (margin, 6 percentage points). An HIV-1 RNA level of less than 50 copies per milliliter at week 48 was found in 93.6% who received long-acting therapy and in 93.3% who received oral therapy (adjusted difference, 0.4 percentage points; 95% CI, −3.7 to 4.5), a result that met the criterion for noninferiority for this end point (margin, −10 percentage points). Of the participants who received long-acting therapy, 86% reported injection-site reactions (median duration, 3 days; mild or moderate severity, 99% of cases); 4 participants withdrew from the trial for injection-related reasons. Grade 3 or higher adverse events and events that met liver-related stopping criteria occurred in 11% and 2%, respectively, who received long-acting therapy and in 4% and 1% who received oral therapy. Treatment satisfaction increased after participants switched to long-acting therapy; 91% preferred long-acting therapy at week 48. Conclusions Therapy with long-acting cabotegravir plus rilpivirine was noninferior to oral therapy with dolutegravir–abacavir–lamivudine with regard to maintaining HIV-1 suppression. Injection-site reactions were common. (Funded by ViiV Healthcare and Janssen; FLAIR ClinicalTrials.gov number, NCT02938520.)
更新日期:2020-03-19

 

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