Navigation Links
Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
Date:10/5/2007

the studies examined treatment response, defined as a confirmed 1 log10 or greater decrease in the amount of HIV in the blood, or viral load, at 48 weeks versus a comparator group in which patients received one of several marketed ritonavir-boosted PIs. Investigators selected a comparator PI (CPI/r) that offered patients the best opportunity for treatment response based on resistance testing. The comparator PIs were lopinavir, indinavir, saquinavir and amprenavir. In addition, patients in both arms received an optimized background regimen of other antiretroviral drugs. Patients were treatment-experienced and the majority (85.1%) were at least possibly resistant to the comparator PI chosen.

Analysis of the primary endpoint at week 48 demonstrated that more than twice the percentage of patients (33.8%) treated with APTIVUS/r achieved a treatment response compared to those patients treated with a CPI/r (14.9%). The median change from baseline in HIV-1 viral load at the last measurement up to week 48 was -0.64 log10 copies/mL in APTIVUS/r patients versus -0.22 log10 copies/mL in CPI/r patients.

Secondary endpoints included reduction in viral load to less than 400 copies/mL or 50 copies/mL and increase in CD4+ cell count. Through 48 weeks of treatment, more than twice the percentage of patients in the APTIVUS/r arm achieved a viral load of less than 400 copies/mL (30.3%) compared to the CPI/r arm (13.6%). Regarding a viral load of less than 50 copies/mL, 22.7% of APTIVUS/r patients achieved this level compared to 10.2% of CPI/r patients. The median change from baseline in CD4+ cell count at the last measurement up to week 48 was +23 cells/mm3 in APTIVUS/r patients (n=740) versus +4 cells/mm3 in CPI/r patients (n=727).

According to HIV treatment guidelines, achieving and maintaining an undetectable viral load -- less than 50 copies/mL of blood -- is the goal of HIV therapy.(1)

The APTIVUS labeling includes boxed warnings for reports of:

-- C
'/>"/>

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Allos Therapeutics PDX Granted Orphan Medicinal Product Designation by the European Commission
2. Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients
3. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/18/2013)... 18, 2013 Apama Medical, a privately ... of next-generation atrial fibrillation technologies, today announced the ... US Patent and Trademark Office (USPTO), titled "Low ... assemblies for use on expandable structures such as ... procedures. "We are grateful to the ...
(Date:6/18/2013)... Calif. , June 18, 2013  Isis Pharmaceuticals, Inc. ... today announced that management will present a general corporate update ... Open House on Tuesday, June 25 at 2:10 p.m. Pacific ... The agenda for the meeting is as follows: 2:00 p.m. ... of record as of April 26, 2013) 2:10 p.m. – ...
(Date:6/17/2013)... , June 17, 2013 Velplex, LLC announced ... a technology platform that connects buyers and sellers of ... an industry leader. Why? It,s because ... are intimately familiar with the dental industry. They have ... and have diligently worked to negotiate some of the ...
Breaking Medicine Technology:Isis Pharmaceuticals to Present a General Corporate Update at its 2013 Annual Meeting of Stockholders and Open House 2TopProdeals.com Rises to Top as Discount Dental Supply Leader 2
(Date:6/18/2013)... 19, 2013 oBand Surgery Centers, a ... holding complimentary weight loss seminars in Los Angeles this ... be accessed at their official website. oBand Surgery Centers ... time. Their highly skilled panel of surgeons and dedicated ... , A senior executive working with oBand Surgery Centers ...
(Date:6/18/2013)... As a sponsor of the 2013 Fourth of July Splash, ... Chiropractic want you to get out and celebrate! Dr. Saggau ... are excited to be involved. “My husband and I have lived ... to the Kent Splash event. It's a tradition that our kids ... support this fun day.” , The 2013 Fourth of ...
(Date:6/18/2013)... Chicago, IL (PRWEB) June 18, 2013 Exposed ... is helping thousands of acne suffers of all ages finally ... Unlike other acne treatment products, this new acne clearing system ... current acne, and prevent new acne from forming. ... , ExposedSkinCareReview.org believes these products are some of the most ...
(Date:6/18/2013)... FL (PRWEB) June 19, 2013 "What ... minutes a day could boost your health and well-being? ... Heshelow, founder of Sublime Beauty®. "It is called ... for centuries but became a lost art. Now, people ... know about Skin Brushing, and so do certain health ...
(Date:6/18/2013)... June 19, 2013 Recent studies linking bullying ... bullying-related suicide among young people, led the Centers ... an expert panel to focus on these issues. ... complex relationship between youth involvement in bullying and ... youth is a significant public health problem, with ...
Breaking Medicine News(10 mins):Health News:oBand Surgery Centers Will Hold Complimentary Weight Loss Seminars in Los Angeles in June 2Health News:Lake Meridian Chiropractic of Kent, WA to Sponsor the Fireworks Finale at 15th Annual Fourth of July Splash 2Health News:Exposed Skin Care Review Released by ExposedSkinCareReview.org 2Health News:Exposed Skin Care Review Released by ExposedSkinCareReview.org 3Health News:The Easiest Way to Contribute to Better Health and Well-Being Starting Today and for Under $20, Says Sublime Beauty® 2Health News:Bullying and suicide among youth is a public health problem 2
... PBCC Announces availability of conference scholarships ... PA Breast Cancer Coalition Annual Conference , , ... to announce the availability of scholarships and travel grants for the 2009 PA Breast ... & Towers on Wednesday, October 14, 2009. , , ...
... , , , ... of octuplets Nadya Suleman and "Jon & Kate Plus 8" has ... in-vitro fertilization (IVF). The recent e.p.t((R)) /BabyCenter ((R)) Fertility ... surveyed believe that public visibility of large families and multiple births ...
... HOUSTON, July 20 What will healthcare look like in the future? ... to learn more and have an opportunity to make your opinions known, please ... a Federal Health Board: The Impact on Texas." , ... 1401 St. Joseph Parkway in Houston, Texas on Wednesday, July 22. All ...
... , SEOUL, South Korea, July 20 ... to announce that its wholly owned subsidiary, VASKA, a ... institutional, and consumer markets, has successfully turned the first major commercial ... Royal Laundry of South San Francisco is the largest ...
... , , , CARY, ... a specialty pharmaceutical company focused on acquiring, developing and commercializing ... that David Price, Executive Vice President, Finance, and Chief Financial ... of the Year in the Small Public Business category. ...
... , , CARLSBAD, Calif., July 20 ... manufacturer, recently introduced a new advanced lens design for ... takes advantage of the best features of the hybrid ... comfort. The patent-pending design is optimized to vault the ...
Cached Medicine News:Health News:Scholarships Available for PA Breast Cancer Coalition Annual Conference 2Health News:New e.p.t.(R)/BabyCenter(R) Fertility Report Reveals 70 Percent of Moms Want Tighter Regulation on In-Vitro Fertilization 2Health News:New e.p.t.(R)/BabyCenter(R) Fertility Report Reveals 70 Percent of Moms Want Tighter Regulation on In-Vitro Fertilization 3Health News:New e.p.t.(R)/BabyCenter(R) Fertility Report Reveals 70 Percent of Moms Want Tighter Regulation on In-Vitro Fertilization 4Health News:Building a Federal Health Board - Impact on Texas 2Health News:HepaHope Korea Subsidiary VASKA Introduces Green Chemicals to U.S. Commercial Laundry Industry 2Health News:Cornerstone Therapeutics' David Price Named 2009 Chief Financial Officer of the Year by the Triangle Business Journal 2Health News:SynergEyes, Inc. Launches New Hybrid Lens Design for Keratoconus Patients 2Health News:SynergEyes, Inc. Launches New Hybrid Lens Design for Keratoconus Patients 3
... The Clariflex® Intraocular Lens is indicated ... years of age or older in whom ... IOL is a third-generation IOL design made ... is designed both to reduce internal reflections ...
... Lenses: The Bausch & Lomb PMMA Posterior Chamber ... primary implantation for the visual correction of aphakia ... where a cataractous lens has been removed by ... be placed in the ciliary sulcus or capsular ...
... USIOL lenses are manufactured using ... processes. Perspex CQ UV PMMA ... multi-piece and single piece lenses. ... in both nonphaco and phaco ...
... II is a sterile nonpyrogenic, transparent viscoelastic ... II contains 12 mg/ml of high molecular ... hyaluronate dissolved in physiological saline. In the ... is 105,000 cps (105 Pa s) at ...
Medicine Products: