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January 22, 2026AIDS

Durable efficacy of dolutegravir/rilpivirine switch in subjects with HIV RNA <50 copies/ml and history of K103N mutation

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Authors

GMGraeme MoyleLALambert AssoumouNCNathalie De Castro

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Overview

Randomized trial demonstrates sustained virological suppression after switching to dolutegravir and rilpivirine in HIV-1 with prior K103N mutations, indicating durable two-drug regimen efficacy.

Key Points

  • To evaluate the 96-week efficacy, safety, and patient-reported outcomes of switching to dolutegravir plus rilpivirine in virologically suppressed adults with HIV-1 harboring historic K103N resistance mutations.
  • Open-label, parallel, two-arm randomized trial conducted across 32 sites in seven European countries (WISARD trial).
  • Enrolled 140 treatment-experienced participants with HIV-1 RNA <50 copies/ml and documented K103N mutations, randomized 2:1 to immediate switch (DTG/RPV-I, n=95) or deferred switch at week 48 (DTG/RPV-D, n=45).
  • Virological suppression at week 96 was 84.2% in the immediate switch group versus 73.3% in the deferred switch group (difference +10.9%, 95% CI -4 to +25.8; P = 0.168).
  • Confirmed virological failure occurred in 8 participants through week 96 (4 by week 48, 4 between weeks 48 and 96); only one sample successfully amplified, showing no emergent DTG- or RPV-associated resistance mutations.
  • Serious adverse events were infrequent with none attributed to study medication, and health-related quality of life, treatment satisfaction, and sleep quality remained stable over time in both groups.

Cite This Study

Moyle et al. (2026) studied this question.

synapsesocial.com/papers/6aacfc65b488817de87c5d51https://doi.org/10.1097/qad.0000000000004451
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