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), al- though 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 discontinu- ation due to pregnancy concerns. However, we observed a higher risk of dolutegravir discontinuation for toxicity in women.

Long-term outcome of dolutegravir-containing regimens according to sex: data from the ICONA Study / A. D'ARMINIO MONFORTE, M. Puoti, A. Tavelli, A. Saracino, S. Rusconi, S. Antinori, M. Sala, A. Mondi, B. MAURIZIO CELESIA, A. Cozzi-Lepri, L. Taramasso, A. Antinori. - In: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY. - ISSN 0305-7453. - (2023 Feb 13), pp. dkad026.1-dkad026.13. [Epub ahead of print] [10.1093/jac/dkad026]

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

A. D'ARMINIO MONFORTE
Primo
;
S. Rusconi;S. Antinori;M. Sala;L. Taramasso
Penultimo
;
2023

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), al- though 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 discontinu- ation due to pregnancy concerns. However, we observed a higher risk of dolutegravir discontinuation for toxicity in women.
Settore MED/17 - Malattie Infettive
13-feb-2023
Article (author)
File in questo prodotto:
File Dimensione Formato  
DTG regimens outcome by sex_ICONA_JAC Feb 2023 .pdf

accesso riservato

Descrizione: Article
Tipologia: Publisher's version/PDF
Dimensione 912.36 kB
Formato Adobe PDF
912.36 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/952909
Citazioni
  • ???jsp.display-item.citation.pmc??? 0
  • Scopus 4
  • ???jsp.display-item.citation.isi??? 3
social impact