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FDA CLEARS FIRST IN NEW CLASS OF AIDS DRUGS CALLED HIV PROTEASE INHIBITORS

         INVIRASE Will Be Available To Patients Within 48 Hours


NUTLEY, N.J., Dec. 7 /PRNewswire/ -- To respond to the immediate needs of people with AIDS The People With AIDS (PWA) Self-Empowerment Movement was a movement of those diagnosed with AIDS and grew out of San Francisco. The PWA Self-Empowerment Movement believes that those diagnosed as having AIDS should "take charge of their own life, illness, and care, and to minimize , Roche Laboratories announced today that Invirase(TM) (saquinavir mesylate) capsules, the first in a new class of drugs called HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  protease inhibitors, will be on pharmacy shelves within 48 hours. The FDA has cleared Invirase for use in combination with nucleoside analogues such as AZT AZT or zidovudine (zīdō`vydēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called  and HIVID(R) (ddC) for selected individuals with advanced HIV disease.

To ensure that every patient in the U.S. who can benefit from Invirase gets immediate and sustained access to the drug, irrespective of their financial situation, Roche has established the Roche HIV Therapy Assistance Program. This important program will make supplies of Invirase available to patients who are waiting to be approved for coverage and reimbursement through their existing insurance sources, and to patients who are uninsured and cannot afford to pay for the drug.

The decision to release Invirase for marketing was based on increases in CD4 counts (a measure of the immune system) in patients who initiated Invirase together with either AZT (in previously untreated patients) or HIVID (in patients previously treated with prolonged AZT therapy). Studies indicate that patients treated with combinations including Invirase have greater increases in CD4 counts and greater reduction of virus in the blood than patients given the same treatments without Invirase.

The clinical significance of changes in viral load has not been established. At this time, there are no data available from clinical trials evaluating the activity of Invirase in combination with nucleoside analogues other than AZT and HIVID. There are also no results available from clinical trials confirming the clinical benefit of regimens containing Invirase on survival or the clinical progression of HIV infection.

In clinical studies Invirase was well tolerated by most patients and reported adverse events were mostly of mild intensity. The most frequently reported adverse events, at least possibly related to Invirase treatment, and of at least moderate intensity included diarrhea (3.8 percent), abdominal discomfort (1.3 percent) and nausea (1.9 percent). Invirase does not appear to alter the pattern, frequency, or severity of adverse events associated with the use of HIVID and/or AZT. Invirase should not be administered concomitantly with rifampin rifampin (rĭfăm`pĭn), antibiotic used in the treatment of tuberculosis. It is also used to eliminate the meningococcus microorganism from carriers and to treat leprosy, or Hansen's disease.  and caution should be used when considering concomitant use of Invirase with rifabutin or other similar drugs. Physicians may consider using alternatives to such drugs when a patient is taking Invirase.

"The fact that there's a drug to be used in combination -- that is completely different -- is encouraging for people with AIDS, especially since it's a treatment with less side effects," said Gabriel Torres, M.D., medical director of the AIDS Center at St. Vincent's Hospital Hospital:
  • St. Vincent's Hospital, Birmingham, Alabama
  • St. Vincent's Hospital, Indianapolis, Indiana
  • St. Vincent's Hospital, Melbourne, Australia
  • St Vincent's Hospital, Sydney, Australia
  • St. Vincent's Hospital, New York City
  • St.
 in New York.

Access for People With AIDS

"Access is a critical issue for AIDS physicians. We need to make new treatments available to our patients at the earliest opportunity, and to feel confident that patients will continue to have access to them in the longer term," said Dr. Torres.

The Roche HIV Therapy Assistance Program is available to health care providers and patients in the U.S. through the ASSIST Reimbursement Program. Services will include:

-- information about national and local insurance coverage for

Invirase;

-- contact with insurers to determine a specific patient's coverage

and benefits for Invirase;

-- informing payers, including Medicaid, commercial insurers and

AIDS Drug Assistance Programs (ADAPs) about Invirase;

-- helping callers with their insurance coverage by verifying and

explaining prior authorization and other procedures;

-- helping customers resolve denied or underpaid claims for Invirase

and assisting with appeals;

-- screening and enrolling eligible patients in the Medical Needs

Program (for patients without insurance or financial means) for

Invirase.

For more information about this program, patients are advised to speak with their physician or contact a local AIDS service organization AIDS service organizations are community based that provide community support. While their primary function is to provide needed services to individuals with HIV, they also provide support services for their families and friends as well as conduct prevention efforts. .

The cost of Invirase will be $15.89 per day (wholesaler acquisition cost) at the recommended dose of 600 mg taken orally three times daily. Full prescribing information for Invirase is available upon request to Roche Laboratories.

About Roche

Roche Laboratories of Nutley, N.J., is the pharmaceutical sales and marketing division of Hoffmann-La Roche Inc., and has a long history in the area of HIV which includes HIVID, Cytovene(TM), Roferon-A(R), and Bactrim(TM) as well as HIV diagnostics. Hoffmann-La Roche is a research-based health care company that is a member of the Roche Group with headquarters in Basel, Switzerland. Roche is a leading health care company dedicated to the research, development and delivery of diagnostic tests, treatments and services for people with life- threatening diseases.
    -0-                              12/7/95


/CONTACT: Joy Schmitt of Hoffmann-La Roche, 201-562-2202/

CO: Roche Laboratories; Hoffmann-La Roche Inc. ST: New Jersey IN: MTC mtc - A Modula-2 to C translator.

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Date:Dec 7, 1995
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