Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Switching to Oral Rilpivirine in Combination With Other Antiretroviral Therapy in Virologically Suppressed Children Living With HIV-1 Infection: Forty-eight-week Results From the Phase 2, Open-label, Single-arm, PICTURE Study
Por:
Lombaard, J, Ssali, F, Moolasart, V, Guarino, A, Badolato, R, Bernardi, S, Tavares, M, Fortuny-Guasch C, Aurpibul, L, Rungmaitree, S, Van Solingen-Ristea, R, Van Eygen, V, Van Hemelryck, S, Russu, A, Kurosawa, K, Shibuya, M, Vanveggel, S and Van Landuyt, E
Publicada:
1 nov 2025
Resumen:
Background: PICTURE (NCT04012931) was a phase 2, open-label, single-arm, multicenter study evaluating pharmacokinetics (PK), safety, tolerability and antiviral activity of oral rilpivirine in combination with other antiretroviral therapy (ART) in children living with HIV-1 with virologic suppression. Methods: Children (>= 2 to <12 years, >= 10 kg) living with HIV-1, virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ART were enrolled. Weight-based rilpivirine [25 mg once-daily (qd) for >= 25 kg, 15 mg (6 x 2.5 mg) qd for 20 kg to <25 kg and 12.5 mg (5 x 2.5 mg) qd for 10 to <20 kg in film-coated or investigational dispersible tablet formulations] was administered orally in combination with background ART for 48 weeks. The primary objectives were evaluation of rilpivirine steady-state PK, determination of an appropriate weight-based dose, and safety and tolerability when combined with other ARTs. Results of the primary (week 24) and final (week 48) analyses are presented. Results: Of 40 participants screened, 26 (65%) were enrolled and treated with rilpivirine. All participants completed the week 48 visit and were included in the final analysis. PK parameters were observed to be in the target range for all rilpivirine weight-based doses. Through week 48, 19/26 (73.1%) participants had >= 1 adverse event; all grade 1-2 and none were treatment related. All 26 participants (100%) receiving rilpivirine in combination with ART remained virologically suppressed at both weeks 24 and 48. Adherence to treatment was 98.99%. Conclusion: Rilpivirine in combination with background ART was well-tolerated and maintained virologic suppression from baseline through week 48 in the studied population of children living with HIV-1. Rilpivirine exposure was within the target range for all doses.
Filiaciones:
Lombaard, J:
Josha Res, Bloemfontein, South Africa
Ssali, F:
Joint Clin Res Ctr, Kampala, Uganda
Moolasart, V:
Minist Publ Hlth, Bamrasnaradura Infect Dis Inst, Nonthaburi, Thailand
Guarino, A:
Azienda Osped Univ Federico II, Naples, Italy
Badolato, R:
Univ Brescia, Inst Mol Med Angelo Nocivelli, Asst Spedali Civili Brescia, ERN RITA, Brescia, Italy
Bernardi, S:
IRCCS Osped Pediat Bambino Gesu, Rome, Italy
Tavares, M:
Hosp Sao Joao, CHSJ, Porto, Portugal
Fortuny-Guasch C:
Hosp St Joan Deu, Barcelona, Spain
Aurpibul, L:
Res Inst Hlth Sci, Chiang Mai, Thailand
Rungmaitree, S:
Mahidol Univ, Siriraj Hosp, Bangkok, Thailand
Van Solingen-Ristea, R:
Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium
Van Eygen, V:
Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium
Van Hemelryck, S:
Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium
Russu, A:
Johnson & Johnson, Milan, Italy
Kurosawa, K:
Johnson & Johnson, Tokyo, Japan
Shibuya, M:
Johnson & Johnson, Tokyo, Japan
Vanveggel, S:
Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium
Van Landuyt, E:
Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium
hybrid
|