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Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection.

Orkin, Chloe; Arasteh, Keikawus; Górgolas Hernández-Mora, Miguel; Pokrovsky, Vadim; Overton, Edgar T; Girard, Pierre-Marie; Oka, Shinichi; Walmsley, Sharon; Bettacchi, Chris; Brinson, Cynthia; Philibert, Patrick; Lombaard, Johan; St Clair, Marty; Crauwels, Herta; Ford, Susan L; Patel, Parul; Chounta, Vasiliki; D'Amico, Ronald; Vanveggel, Simon; Dorey, David; Cutrell, Amy; Griffith, Sandy; Margolis, David A; Williams, Peter E; Parys, Wim; Smith, Kimberly Y; Spreen, William R.
N Engl J Med; 382(12): 1124-1135, 2020 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-32130806

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 (11) 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.).
Selo DaSilva