POZ - XVI International AIDS Conference (2006) : IAC: 48-Week Prezista POWER Results Presented - by Tim Horn

POZ - Health, Life and HIV
Subscribe to:
POZ magazine
E-newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join
Username:
Password:

Back to home » Conference Coverage » XVI International AIDS Conference (2006)

emailrssprint

IAC: 48-Week Prezista POWER Results Presented
by Tim Horn

August 15, 2006 (AIDSmeds)—Additional results from two ongoing clinical trials of Prezista™ (darunavir), Tibotec, Inc.’s protease inhibitor approved by the U.S. Food and Drug Administration (FDA) in June, suggest that the drug offers prolonged treatment effects for HIV-positive people with limited treatment options.  The new data, reflecting 48 weeks of follow up from the clinical trials, were reported today at the XVI International AIDS Conference (IAC) in Toronto.

Prezista was approved by the FDA based largely on early results from two phase IIb clinical trials called POWER 1 and POWER 2. The two studies enrolled 588 HIV-positive people who had previously been treated with at least one protease inhibitor, one non-nucleoside reverse transcriptase inhibitor(NNRTI), and one nucleoside reverse transcriptase inhibitor (NRTI). Patients also needed have evidence, by way of drug-resistance testing, of one or more HIV mutation known to contribute to resistance to older protease inhibitor options.

The study participants were randomized to one of two groups. In the first group, 131 patients are taking Norvir® (ritonavir)-boosted Prezista (600mg plus 100mg Norvir) twice daily plus an optimized background regimen (OBR). In the second group – the control group – 124 patients are taking an approved Norvir-boosted protease inhibitor plus OBR.

Twenty-four week data from both studies combined, which were reviewed by the FDA and used to support accelerated approval of the drug, demonstrated that patients in POWERs’ Prezista groups were more likely to achieve undetectable viral loads and experience increases in CD4 cell counts compared to control patients in the study.

After 24 weeks of follow up, 45% of patients in the Prezista groups had viral loads below 50, compared to 12.1% of patients in the control groups.

The combined 48-week data from the studies were reported at IAC by Sharon Walmsley, MD, a POWER researcher and Senior Scientist at the Toronto General Research Institute. She reported data involving 110 patients who had reached 48 weeks of treatment in the Prezista groups and 120 patients who reached 48 weeks of treatment in the control groups.

According to Dr. Walmsley, 61% of patients taking a Prezista-based regimen had viral loads that were at least 1 log below their pre-study levels. In the control groups, only 15% had a similar viral load response after 48 weeks of treatment. As for undetectable viral loads, 46% of the Prezista-treated patients had viral loads below 50 after 48 weeks, compared to 10% of the control patients.

Encouraging CD4 count data were reported as well. After almost a year of treatment, Prezista-treated patients experienced, on average, a 102-cell increase, compared to an approximate 19-cell increase in the control groups.

Thus far, the most common side effects in the Prezista-treated patients, compared to those in the control group, include diarrhea (20% in the Prezista group vs. 28% in the control group), nausea (18% vs. 13%), headache (15% vs. 20%), and fatigue (12% vs. 17%). Dr. Walmsley noted that while increases in cholesterol and triglycerides have been noted in patients participating in the studies, these increases do not appear to be any more common in the Prezista-treated patients compared to those in the control groups.

The POWER researchers plan to publish final data from POWER 1 and POWER 2 based on 96-week follow-up results. However, Dr. Walmsley and her group will follow patients for a total of 144 weeks—approximately three years of effectiveness and safety data.

emailrssprint


[Go to top]

POZ Exclusives

What’s Your Long-term Risk of Transmitting HIV?

'Midsummer Night Drinks' Benefits God’s Love We Deliver

Gay Shamelessness, Beyond the Crystal Meth Crisis

» More

What's That Mean?
(just double-click it!)

NEW! If you don't understand one of the words in this article, just double-click it. A window will open with a definition from mondofacto's On-line Medical Dictionary. If the double-click feature doesn't work in your browser, you can enter the word below:


What You're Talking About

Mouth Full of Problems: A Crisis in HIV Dental Care (24)

Sex Crime (23)

HPV Vaccine for Boys: Public Comments Welcome (18)

Sir Elton John Denied Request to Adopt HIV-Positive Ukrainian Child (13)

HIV-Positive Sailor Sentenced for Consensual, Unprotected Sex (8)

Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

15 Years Ago In POZ



Join POZ Facebook Twitter Google+ MySpace YouTube Tumblr Flickr
Quick Links
Current Issue

HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
HIV 101
Disclosing Your Status
Starting Treatment
Help Paying for Meds
Search for the Cure
POZ Stories
POZ Opinion
POZ Exclusives
Read the Blogs
Visit the Forums
Job Listings
Events Calendar


    adorableone
    New York
    New York


    oceanblue65
    louisiana
    Louisiana


    youngbloodlatino
    Columbia
    Maryland


    daino1972
    Columbus
    Ohio
Click here to join POZ Personals!
Ask POZ Pharmacist

Talk to Us
Poll
Will decriminalizing injection drug use help end the global HIV epidemic?
Yes
No

Survey
PrEP Course

more surveys
Contact Us
We welcome your comments!
[ about Smart + Strong | about POZ | POZ advisory board | partner links | advertising policy | advertise/contact us | site map]
© 2014 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.