• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Boosted REYATAZ proves effective in men and women

Boosted REYATAZ proves effective in men and women

July 22, 2011
CenterWatch Staff

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.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing