(ROME, 20 July 2011) – 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® (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.1 However, data on efficacy, safety and tolerability on antiretrovirals (ARVs) in women are limited, as they are under-represented in clinical trials.5
"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 ≥ 50 c/mL or one HIV RNA ≥ 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,6,7 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.
Developed by Bristol-Myers Squibb, REYATAZ (atazanavir sulfate) is an antiviral drug used in combination with other medicines to treat individuals infected with the human immunodeficiency virus-1 (HIV-1).7 REYATAZ was the first once-daily protease inhibitor launched in Europe.8,9
About Bristol-Myers Squibb Company
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
Annie Simond, office: + 33 01 58 83 65 66
Joanna Ritter, office: + 33 01 58 83 65 09
1. World Health Organisation: "Annual rate of newly diagnosed HIV infections in Europe more than doubled," December 2009. Available at http://www.euro.who.int/en/what-we-publish/information-for-the-media/sections/press-releases/2009/12/annual-rate-of-newly-diagnosed-hiv-infections-in-europe-more-than-doubled. Accessed February 2011.
2. Sonnerborg A., et al. Long-term gender-based outcomes for Atazanavir/Ritonavir (ATV/r)-based regimens in HIV-1 positive treatment-experienced patients in a clinical setting. Poster MOPE223 accepted to IAS 2011.
3. UNAIDS. Press statement: "International Women's Day 2011," March 2011. Available at http://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2011/march/20110308psiwd/. Accessed June 2011.
4. BBC News: "UN Warns HIV/AIDS Leading Cause of Death in Women." Available at: http://news.bbc.co.uk/2/hi/health/8546655.stm. Accessed March 2010.
5. Wilkin, T. HIV-positive women in clinical trials: Important, but underrepresented. The Body. 2003. Available at http://www.thebody.com/content/art15069.html. Accessed June 2011.
7. Squires KE et al. Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 86 weeks in the CASTLE study.JAntimicrob Chemother 2011;66:363-370
8. European Medicines Agency. REYATAZ: EPAR Summary for the public. Updated March 2009. Available at http://www.ema.europa.eu/humandocs/PDFs/EPAR/reyataz/H-494-en1.pdf. Accessed 26 May 2010.
9. The Body, Switching Antiretroviral Therapy. Available at http://www.thebody.com/content/art38572.html. Accessed 25 May 2010.