[TuPeB4455] Are there differences between men and women in their response to HAART?

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Are there differences between men and women in their response to HAART?

[AUTHOR(S):] E.H. Bijleveld¹, K. Squires²

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. TuPeB4455

[ABSTRACT:] Objective: To establish whether gender differences exist in toxicity and virologic response in patients treated with highly active antiretroviral treatment (HAART).

METHODS: The Atlantic Study was designed to compare the safety, activity and durability of d4T/ddI/3TC, d4T/ddI/nevirapine (NVP), and d4T/ddI/indinavir (IDV). This was a multicenter, open-label study, recruiting HIV-1 infected ARV-naïve patients with ³200 CD4 cells/mm³ and plasma HIV-1 RNA ³500 c/mL; the follow-up period for this analysis was 96 weeks.

RESULTS: The study recruited 59 women (f) and 239 men (m). Significant differences at baseline between the sexes were found for age (f=33, m=36 years, p=.03)and baseline log HIV-1 RNA (f=4.1, m=4.4 c/ml, p=.002). No significant differences were found in the clinical adverse events reported, nor in the number of patients with a grade 3 or 4 adverse event (f=20%, m=12%, p=.08). However, there was a significant difference in the number of patients with laboratory toxicities (f=17%, m=35%, p=.008), especially patients with liver toxicities (f=2%, m=17%, p=.001). No differences in dose reduction or discontinuation rates were found. Logistic regression analysis revealed no differences in treatment response between the 2 sexes.

CONCLUSIONS: Differences in pretreatment characteristics were observed between women and men enrolled in this clinical trial. No evidence was found for gender differences with respect to treatment response. Laboratory abnormalities were more prevalent in men; however there were no significant differences observed in the occurrence of more severe toxicities. Gender has only been studied in a few clinical trials; these studies have yielded conflicting information regarding gender differences in anti viral response or toxicity of HAART. Gender should therefore be included as a standard variable in the analysis of clinical trials.

Presenting author: Engelien Bijleveld

1International Antiviral Therapy Evaluation Center, IATEC T1-120, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

2Rand Schrader Clinic, LAC and USC Medical Center, Los Angeles, United States.

020708
TuPeB4455