Long-term safety and efficacy of rilpivirine in combination with nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected patients: 336-week rollover study of phase 2b and 3 clinical studies

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dc.contributor.authorMolina, Jean-Michel
dc.contributor.authorEne, Liliana
dc.contributor.authorCahn, Pedro
dc.contributor.authorFätkenheuer, Gerd
dc.contributor.authorVan Wijngaerden, Eric
dc.contributor.authorLombaard, Johannes
dc.contributor.authorZakharova, Natalia
dc.contributor.authorVan Eygen, Veerle
dc.contributor.authorVanveggel, Simon
dc.contributor.authorVan Solingen-Ristea, Rutger
dc.date.accessioned2024-05-23T18:53:36Z
dc.date.available2024-05-23T18:53:36Z
dc.date.issued2021
dc.description.abstractBackground: To evaluate the long-term safety and efficacy of rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in human immunodeficiency virus (HIV)-infected patients. Methods: RPV-treated HIV-infected patients from phase 2b or 3 studies rolled-over into this phase 3, open-label study and received RPV 25 mg once daily (QD) with choice of two NRTIs. Adverse events (AEs), plasma viral load, CD4+ cell count, and antiviral resistance were evaluated. Results: Of the 482 patients treated, 437 (>90%) patients discontinued study treatment; 371 (77%) had switched to commercially available RPV, 14 (2.9%) discontinued due to AEs, and 6 (1.2%) had virologic failure. In this rollover study, patients were followed up to week 336, although data was limited beyond 288 weeks. Forty-five (9.3%) patients were still undergoing treatment at the time of data cut-off for the current analysis (8 February 2018). The most frequently reported AEs were pregnancy in 7 (1.5%) patients and syphilis in 5 (1.0%) patients. Grade 3-4 AEs were reported in 17 (3.5%) patients, and AEs possibly related to RPV in 23 (4.8%) patients. Over 288 weeks of treatment, 80.1% (95% CI: 74.9%; 84.3%) of patients maintained virologic suppression (HIV-1 RNA <50 copies/mL). The absolute CD4+ cell count increased over time until week 192 and remained constant thereafter. Conclusions: RPV 25 mg QD in combination with an investigator-selected background regimen of two NRTIs demonstrated sustained long-term virologic suppression. The treatment was well-tolerated with no new safety findings.
dc.identifier.citationMolina JM, Ene L, Cahn P, Fätkenheuer G, Van Wijngaerden E, Lombaard J, Zakharova N, Van Eygen V, Vanveggel S, Van Solingen-Ristea R. Long-term safety and efficacy of rilpivirine in combination with nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected patients: 336-week rollover study of phase 2b and 3 clinical studies. Antivir Ther. 2021 Nov;26(6-8):95-105. doi: 10.1177/13596535211062388. Epub 2021 Nov 26. PMID: 35485339.
dc.identifier.otherdoi: 10.1177/13596535211062388
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1148
dc.relation.ispartofseriesAntiviral Therapy
dc.subjectLong-term safety
dc.subjectefficacy
dc.subjectRilpivirine
dc.subjectNucleoside/nucleotide reverse transcriptase inhibitors
dc.subjectHIV-1 infected patients
dc.subject336-week rollover study
dc.subjectPhase 2b and 3 clinical studies
dc.titleLong-term safety and efficacy of rilpivirine in combination with nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected patients: 336-week rollover study of phase 2b and 3 clinical studies

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