Bristol-Myers Squibb released results from a long-term European cohort study that included 1,294 antiretroviral (ARV)-experienced patients from Germany, France and Sweden.
In a gender-specific sub-analysis, boosted REYATAZ(R) (atazanavir sulphate) (ATV/ritonavir)-based regimens demonstrated no difference in time to virologic failure in women compared to men over a follow-up period of up to five years.
Nearly 16 million women are living with HIV, most of them of childbearing age. HIV has become the leading cause of disease and death among women of reproductive age worldwide. In Europe, women account for 35% of new HIV diagnoses. However, data on efficacy, safety and tolerability on antiretrovirals (ARVs) in women are limited, as they are under-represented in clinical trials.
This retrospective, observational study collected data from three European databases (France, DatAids; Germany, KompNet; Sweden, InfCare). All participants were ARV-treatment experienced patients; 336 female (median age of 40 years) and 958 male (median age of 44 years). The present sub-analysis evaluated the effect of gender on long-term outcomes of ATV/r-based regimens.
The results revealed no gender-based differences in time to virological failure, defined as two consecutive HIV RNA more than or equal to 50 c/mL or one HIV RNA more than or equal to 50 c/mL followed by discontinuation.
After three years of follow-up, the probability of not having virological failure was 59% for women (95% CI 52-65%) and 63% for men (95% CI 59-67%). Female gender was associated with increased risk of treatment discontinuation but not with a significantly higher risk of virologic failure.
The cohort results also showed that REYATAZ/ritonavir is a well-tolerated therapeutic option for treatment-experienced patients of either gender. The safety profile was comparable among men and women and similar to that previously described in clinical trials. Among women, diarrhea was reported in 2%, nausea in < 1%, jaundice in < 1%, lipodystrophy in 5% and bone density abnormalities in < 1% of the cases.
The results reported in this gender-specific sub-analysis are consistent with those previously reported in clinical trials (i.e CASTLE study gender analysis) in which boosted REYATAZ showed durable viral suppression and favorable safety and tolerability profiles, irrespective of gender.