Universität zu Köln

Molina, Jean Michel, Ene, Luminita, Cahn, Pedro, Faetkenheuer, Gerd, Van Wijngaerden, Eric, Lombaard, Johan, Zakharova, Natalia, Van Eygen, Veerle, Vanveggel, Simon and Van Solingen-Ristea, Rodica (2021). 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., 26 (6-8). S. 95 - 106. LONDON: SAGE PUBLICATIONS LTD. ISSN 2040-2058

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Abstract

Background 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Molina, Jean Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Ene, Luminita UNSPECIFIED UNSPECIFIED UNSPECIFIED Cahn, Pedro UNSPECIFIED UNSPECIFIED UNSPECIFIED Faetkenheuer, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Wijngaerden, Eric UNSPECIFIED UNSPECIFIED UNSPECIFIED Lombaard, Johan UNSPECIFIED UNSPECIFIED UNSPECIFIED Zakharova, Natalia UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Eygen, Veerle UNSPECIFIED UNSPECIFIED UNSPECIFIED Vanveggel, Simon UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Solingen-Ristea, Rodica UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-598160
DOI:	10.1177/13596535211062388
Journal or Publication Title:	Antivir. Ther.
Volume:	26
Number:	6-8
Page Range:	S. 95 - 106
Date:	2021
Publisher:	SAGE PUBLICATIONS LTD
Place of Publication:	LONDON
ISSN:	2040-2058
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TREATMENT-NAIVE; ANTIRETROVIRAL THERAPY; HIV; EFAVIRENZ; ECHO Multiple languages Infectious Diseases; Pharmacology & Pharmacy; Virology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59816