fyi. FORTOVASE recommended as first line therapy by DHHS. The lack of such designation for Invirase (Roche's saquinavir in hard gel capsule formulation) was a drawback in its market acceptance ... this will help in the marketability of FORTOVASE, as all the other marketed PIs have this designation.
AIDS Experts Designate Newest Protease Inhibitor FORTOVASE as Preferred' Treatment
- Department of Health and Human Services Panel Revises Federal Government's
AIDS Treatment Guidelines -
WASHINGTON, March 12 /PRNewswire/ -- In a video conference broadcast held nationwide last week, a panel of experts convened by the Department of Health and Human Services (HHS) announced its decision to designate FORTOVASE(TM) (saquinavir) as "preferred" therapy in revised federal government AIDS treatment guidelines soon to be released on the world wide web ( hivatis.org ). According to the recommendations, Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, FORTOVASE, when taken with two nucleoside analogues, demonstrates "strong evidence of clinical benefit and sustained suppression of plasma viral load."
"Nationally renowned AIDS experts have classified FORTOVASE as a 'preferred' protease inhibitor because of its clinically proven efficacy," said Sandra Palleja, M.D., medical director, Hoffmann-La Roche. "Physicians and other health care professionals who rely on these treatment recommendations now have a significant new addition to the arsenal of available AIDS therapies."
The guidelines were developed to provide physicians and other health care providers with recommendations for the clinical use of antiretroviral therapy in people infected with HIV. The changes to the guidelines, which were first issued on June 19, 1997, reflect scientific discoveries and advances in medical treatments for HIV infection. The expert panel is comprised of AIDS specialists from the National Institutes of Health, the Centers for Disease Control, and Department of Health and Human Services' Office of HIV/AIDS Policy, as well as leading AIDS practitioners and treatment activists.
FORTOVASE(TM) (saquinavir) received marketing clearance on November 7, 1997. FORTOVASE is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection. This indication is based on studies which have shown increased saquinavir concentrations and improved antiviral activity for FORTOVASE 1200 mg tid compared to INVIRASE(R) (saquinavir mesylate) 600 mg tid. Introduced in 1995, INVIRASE was the first protease inhibitor to become available to people with HIV and AIDS.
"FORTOVASE(TM) (saquinavir) is a more potent formulation of the original formulation of saquinavir, INVIRASE, as it delivers a more powerful dose of drug to patients," said Dr. Palleja. "The result is a drug that provides greater antiviral activity while maintaining excellent tolerability to benefit a broad range of patients."
FORTOVASE has been generally well tolerated in clinical trials. The safety of FORTOVASE was studied in more than 500 patients who received the drug either alone or in combination with other antiretroviral agents. The majority of treatment-related adverse events were of mild intensity. The most frequently reported treatment-emergent adverse events among patients receiving FORTOVASE in combination with other antiretroviral agents were nausea (17.8%), diarrhea (15.6%), abdominal discomfort (13.3%), and dyspepsia (8.9%).
An exacerbation of chronic liver dysfunction has been reported in patients taking FORTOVASE. There have also been reports of hyperglycemia or diabetes, and spontaneous bleeding in patients with hemophilia associated with the use of protease inhibitors.
About Hoffmann-La Roche Inc.
Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that discovers, develops, manufactures and markets numerous important prescription drugs that improve, prolong and save the lives of patients with serious illnesses. Among the company's areas of therapeutic interest are virology, including HIV and AIDS, infectious diseases, cardiology, oncology, transplantation, dermatology and obesity.
The company provides a wide range of medications in the United States through its marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in Nutley, N.J., both companies are members of the Basel, Switzerland-based Group, a global leader in health care with principal businesses in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors.
For further information about FORTOVASE, Patients can call: 800-910-4687, Healthcare Professionals, 800-526-6367, Roche HIV Therapy Assistance Program: 800-282-7780, or FORTOVASE Web site: fortovase.com
FORTOVASE(TM) is a trademark of Hoffmann-La Roche Inc.
INVIRASE(R) is a trademark of Hoffmann-La Roche Inc.
SOURCE Hoffmann-La Roche Inc.
CO: Hoffmann-La Roche Inc.
ST: District of Columbia, New Jersey
IN: MTC
SU: PDT
03/12/98 11:21 EST prnewswire.com |
