Brief Report: Durable Suppression and Low Rate of Virologic Failure 3 Years After Switch to Dolutegravir plus Rilpivirine 2-Drug Regimen: 148-Week Results From the SWORD-1 and SWORD-2 Randomized Clinical Trials

Wyk, Jean van; Orkin, Chloe; Rubio, Rafael; Bogner, Johannes; Baker, David; Khuong-Josses, Marie-Aude; Parks, David; Angelis, Konstantinos; Kahl, Lesley P.; Matthews, Jessica; Wang, Ruolan; Underwood, Mark; Wynne, Brian; Nascimento, Maria-Claudia; Vandermeulen, Kati; Gartland, Martin und Smith, Kimberly Y. (2020): Brief Report: Durable Suppression and Low Rate of Virologic Failure 3 Years After Switch to Dolutegravir plus Rilpivirine 2-Drug Regimen: 148-Week Results From the SWORD-1 and SWORD-2 Randomized Clinical Trials. In: Jaids-Journal of Acquired Immune Deficiency Syndromes, Bd. 85, Nr. 3: S. 325-330

Abstract

Background: The SWORD trials showed that in participants who achieved virologic suppression taking 3-drug or 4-drug regimens, switching to the 2-drug regimen dolutegravir plus rilpivirine was noninferior in maintaining HIV-1 RNA <50 copies/mL at the week 48 primary endpoint. We present pooled week 148 analysis results from both studies. Setting: SWORD-1: 65 centers, 13 countries;SWORD-2: 60 centers, 11 countries. Methods: SWORD-1 and SWORD-2 are identical, open-label, phase III studies. Participants with screening HIV-1 RNA <50 copies/mL for >= 6 months;no prior virologic failure;and no documented resistance-associated major protease inhibitor, integrase inhibitor, nucleoside reverse transcriptase inhibitor (NRTI), or non-NRTI mutations or integrase resistance-associated substitution R263K were randomly assigned 1:1 to switch to once-daily dolutegravir 50 mg plus rilpivirine 25 mg on day 1 (early-switch group) or to continue their current antiretroviral regimen and, if virologically suppressed at week 48, switch to dolutegravir plus rilpivirine at week 52 (late-switch group) until week 148. Results: Using snapshot algorithm at week 148, 432 of 513 (84%) early-switch participants (148 weeks of exposure) and 428 of 477 (90%) late-switch participants (96 weeks of exposure) maintained HIV-1 RNA <50 copies/mL. Eleven participants (1%) on dolutegravir plus rilpivirine met the confirmed virologic withdrawal criterion through week 148 (early-switch group, n = 8;late-switch group, n = 3) with no integrase resistance identified. Non-NRTI resistance-associated mutations were identified in 6 participants (<1%). Drug-related adverse events (grades 2-4) were observed in 31 (6%) early-switch and 16 (3%) late-switch participants. Significant improvements in bone biomarkers were observed. Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre-switch. Conclusion: Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1525-4135
• Sprache: Englisch