ROME, July 20, 2011 /PRNewswire/ --

Boosted REYATAZ shows durable viral suppression in antiretroviral-experienced women living with HIV, in a gender-specific sub-analysis of a large retrospective cohort study(1)

Bristol-Myers Squibb Company announced results from a long-term, retrospective, European cohort study, which included 1,294 antiretroviral (ARV)-experienced patients (336 female and 958 male) from Germany, France and Sweden, that were presented today at the Sixth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011).

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.(2)

Approximately 30 years into the AIDS epidemic, nearly 16 million women are living with HIV, and most of them are of childbearing age.(3) HIV has become the leading cause of disease and death among women of reproductive age worldwide.(4) In Europe, women account for 35% of new HIV diagnoses.(5)However, data on efficacy, safety and tolerability on antiretrovirals (ARVs) in women are limited, as they are under-represented in clinical trials.(6)

"More clinical data, especially long-term data, evaluating ARV response in women with HIV are needed to improve their management; in this way, the results presented today give us as physicians relevant and valuable information," said Prof. Dr Norbert H. Brockmeyer, Germany.

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).(2) 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%). As seen in several other recent studies,(7,8) female gender was associated with increased risk of treatment discontinuation but not with a significantly higher risk of virologic failure.(2)

The cohort results also showed that REYATAZ/ritonavir is a well-tolerated therapeutic option for treatment-experienced patients of either gender.(2) Overall, the safety profile was comparable among men and women and similar to that previously described in clinical trials. Among women, diarrhoea was reported in 2%, nausea in < 1%, jaundice in < 1%, lipodystrophy in 5% and bone density abnormalities in < 1% of the cases.(2)

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 favourable safety and tolerability profiles, irrespective of gender.

More about the Study Design

This real-life long-term study was a non-comparative, retrospective, observational study that collected data from three European databases (France - DatAids; Germany - KompNet; Sweden - InfCare). Clinical data from 1,294 ARV-experienced adult patients who started an ATV/RTV-based regimen between October 2004 and March 2007 were collected every six months (maximum follow-up of five years). For the main study, the primary endpoint was time to treatment discontinuation, and the secondary endpoints were reasons for discontinuation, time to virological failure, and long-term safety.

The present sub-analysis evaluated the effect of gender on long-term outcomes (efficacy, measured as time to virological failure, and safety) of ATV/RTV-based regimens in this cohort.