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Long-term outcome of dolutegravir-containing regimens according to sex: data from the ICONA study

Monforte, Antonella D'arminio; Tavelli, Alessandro; Sala, Matteo; Mondi, Annalisa; Rusconi, Stefano; Antinori, Spinello; Puoti, Massimo; ... Cozzi-Lepri, Alessandro; + view all (2023) Long-term outcome of dolutegravir-containing regimens according to sex: data from the ICONA study. Journal of Antimicrobial Chemotherapy , 78 (4) pp. 933-945. 10.1093/jac/dkad026. Green open access

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Abstract

OBJECTIVES: To compare the long-term risk of treatment failure of dolutegravir-based ART in men and women in a real-life setting. PATIENTS AND METHODS: Persons living with HIV (PLWH) from the ICONA cohort were included if they had started dolutegravir in a two- or three-drug regimen as ART-naive or as virologically controlled ART-experienced. The primary endpoint was time to treatment failure (virological/clinical failure or dolutegravir discontinuation). Secondary endpoints were: time to dolutegravir discontinuation due to toxicity and to neuropsychiatric adverse events; and time to virological failure. Cox regression analyses focused on differences in outcomes by sex. RESULTS: A total of 2304 PLWH (15% women) initiated dolutegravir-based therapy from ART-naive, and 1916 (19.8% women) while experienced. After a median follow-up of 2.2 (IQR: 0.9-3.9) years in ART-naive and 2.4 (IQR: 1.1-4.3) years in experienced, the 4-year cumulative probability of treatment failure was 33% (95% CI 30.5-35.1) and 20% (95% CI 17.8-22.3), respectively. In the multivariable analyses, in ART-naive the risk of treatment failure was higher for women, but not different after excluding women discontinuing dolutegravir for pregnancy concerns. We also observed a higher risk of discontinuation for toxicity in women (ART-naives: Adjusted Hazard Ratio (AHR): 1.56%; 95% CI: 1.03-2.37; ART-experienced: AHR: 1.53%; 95% CI: 1.01-2.32), although the absolute 4-year probability was low: 7.7% (95% CI 6.5-9.2) in ART-naive and 8.3% (95% CI 6.9-9.9) in experienced. CONCLUSIONS: In our cohort of PLWH treated with dolutegravir-based regimens and followed up for up to 4 years, we observed a low risk of treatment failure and no evidence for a difference by sex, after excluding discontinuation due to pregnancy concerns. However, we observed a higher risk of dolutegravir discontinuation for toxicity in women.

Type: Article
Title: Long-term outcome of dolutegravir-containing regimens according to sex: data from the ICONA study
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1093/jac/dkad026
Publisher version: https://doi.org/10.1093/jac/dkad026
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Science & Technology, Life Sciences & Biomedicine, Infectious Diseases, Microbiology, Pharmacology & Pharmacy, ADVERSE EVENTS, OPEN-LABEL, DISCONTINUATION, INHIBITORS, EFFICACY, COHORT, WOMEN
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
URI: https://discovery.ucl.ac.uk/id/eprint/10168674
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