PMID- 34871089 OWN - NLM STAT- MEDLINE DCOM- 20220322 LR - 20220322 IS - 1098-6596 (Electronic) IS - 0066-4804 (Print) IS - 0066-4804 (Linking) VI - 66 IP - 2 DP - 2022 Feb 15 TI - Phase 2 Open-Label Study of Long-Term Safety, Tolerability, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive Adolescents Living with HIV-1. PG - e0091621 LID - 10.1128/AAC.00916-21 [doi] LID - e00916-21 AB - This phase 2 study investigated long-term safety and efficacy of rilpivirine (RPV) plus two investigator-selected nucleos(t)ide reverse transcriptase inhibitors (NRTIs) in HIV-1-infected antiviral therapy-naive adolescents. Participants (>/=12 to <18 years of age) were treated with RPV at 25 mg once daily (q.d.) plus 2 NRTIs and entered the treatment extension period for up to 240 weeks, with visits every 3 months. Long-term safety (analysis of adverse events [AEs] and laboratory results), efficacy (virologic response and outcome for patients with viral loads of <50 and <400 by time to loss of virologic response [TLOVR] and FDA Snapshot methods, as well as CD4(+) cell count), and adherence (by pill count) for up to 240 weeks are presented. Twenty-four of 36 participants entered the treatment extension period, and 21 completed week 240. At week 240, a viral load of <50 copies/mL was achieved by 14/32 (43.8%) participants; virologic response by TLOVR was higher in participants with a baseline viral load of 100,000 copies/mL (28.6%). By FDA Snapshot, a viral load of <50 copies/mL at week 240 was found in 53.1% (17/32) of participants with a baseline viral load of 95% and a baseline viral load of /=1 treatment-emergent NRTI RAM. No serious AEs after week 48, no discontinuations due to AEs between week 48 and week 240, and no new safety signals were observed. RPV did not affect pubertal development or adolescent growth. At the 5-year follow-up, efficacy was low in adolescents, particularly those with poor adherence and/or a high baseline viral load of >100,000 copies/mL. To limit the risk of virologic failure, RPV is restricted to patients with a baseline VL of