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J Antimicrob Chemother. 2019 Jun 24. pii: dkz254. doi: 10.1093/jac/dkz254. [Epub ahead of print]

Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316).

Author information

1
Hospital Ramón y Cajal, IRYCIS, Infectious Diseases, Madrid, Spain.
2
Instituto de Salud Carlos III, Madrid, Spain.
3
Hospital Universitari Vall d'Hebron, Barcelona, Spain.
4
Hospital Clínico Universitario de Valencia, Valencia, Spain.
5
Hospital Álvaro Cunqueiro, Vigo, Spain.
6
Hospital Universitario La Princesa, Madrid, Spain.
7
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain.
8
Hospital Costa del Sol, Marbella, Spain.
9
Hospital Virgen de Valme, Sevilla, Spain.
10
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
11
Hospital Universitario y Politécnico La Fe, Valencia, Spain.
12
Hospital General Universitario de Alicante, Alicante, Spain.
13
Hospital Clinic de Barcelona, Barcelona, Spain.
14
Hospital Sont Llatzer, Mallorca, Spain.
15
Complejo Hospitalario de Toledo, Toledo, Spain.
16
Hospital Infanta Leonor, Madrid, Spain.

Abstract

BACKGROUND:

Few women have been included in darunavir/cobicistat clinical development studies, and hardly any of them were antiretroviral experienced or treated with anything other than triple-based therapies.

OBJECTIVES:

Our aim was to increase our knowledge about women living with HIV undergoing darunavir/cobicistat-based regimens.

METHODS:

A multicentre (21 hospitals), retrospective study including a centrally selected random sample of HIV-1 patients starting a darunavir/cobicistat-based regimen from June 2014 to March 2017 was planned. Baseline characteristics, 24 and 48 week viral load response (<50 copies/mL), CD4+ lymphocyte count increase, time to change darunavir/cobicistat and adverse event occurrence were all compared by sex. The study was approved by each of the 21 ethics committees, and patients signed informed consent.

RESULTS:

Out of 761 participants, 193 were women. Similar characteristics were found for both sexes, except that the women had a longer duration of HIV infection (P = 0.001), and were less frequently pre-treated with darunavir/cobicistat in their previous regimen (P = 0.02). The main reason for using a darunavir/cobicistat-based regimen was simplification, without differences by sex, while monotherapy seems to be more frequently prescribed in women than in men (P = 0.067). The main outcomes, HIV viral load response, CD4+ lymphocyte count increase at 24 or 48 weeks, occurrence of adverse events, main reasons for changing and time to the modify darunavir/cobicistat regimen, did not show differences between the sexes.

CONCLUSIONS:

No sex disparities were found in the main study outcomes. These results support the use of a darunavir/cobicistat-based regimen in long-term pre-treated women. Clinical Trial.gov No. NCT03042390.

PMID:
31236601
DOI:
10.1093/jac/dkz254

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