Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0019693 (HIV)
 170,526 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Hoffman LaRoche and Merck have agreed to expand enrollment in their Invirase and Crixivan programs if the drug availability increases. The Roche program offers Invirase to HIV-positive individuals with CD4 cell counts under 300. The Merck program provides Crixivan to people with AIDS who have fifty or fewer CD4 cells. Originally, both programs were open only to individuals who were intolerant to, or had failed, standard treatments for HIV infection.
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PMID:Roche and Merck begin expanded access programs for protease inhibitor drugs. 1136 90

New data presented at the Fourth HIV Drug Resistance Workshop in Italy suggest that treatment with Invirase (saquinavir) does not cause cross-resistance to other protease inhibitors, including Merck, Abbott, and Vertex compounds. In addition, HIV resistance to Invirase develops at a slower rate than seen with all other anti-HIV drugs, even after prolonged combination therapy with Invirase plus AZT. Data indicate monotherapy with Invirase does not threaten the efficacious use of other protease inhibitors now in development. Used in combination with other anti-HIV drugs, Invirase may also help reduce the emergence of resistant strains of HIV. Phase I/II studies are showing that L90M and G48V are the only mutations consistently found after a year of treatment with Invirase monotherapy, Invirase plus AZT, or the triple combination of Invirase, AZT, and ddC.
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PMID:Roche investigators say Invirase does not cause cross-resistance to other protease inhibitors. 1136 95

Protease inhibitors (PRIs) are a diverse group of drugs which block an HIV-1 enzyme needed for the production of new viruses. PRIs stop the production of HIV in newly- or chronically-infected cells. There are currently six PRIs in clinical phase I or II trials: ritonavir, indinavir, Invirase, AG1343, U-103017, and VX 478; and there are four newly-identified PRIs soon to begin clinical trials: CGP 53 437, CGP 57 817, KNI-272, and A-80978. Eleven monotherapy studies of PRIs presented at the 35th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) are described.
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PMID:Protease inhibitors. 1136 81

Hoffman-LaRoche's saquinavir (Invirase) is the first protease inhibitor to be granted approval by the Food and Drug Administration (FDA). The drug can be marketed for use in people with advanced HIV disease in combination with approved nucleoside analogs, such as AZT and ddC. Invirase has relatively minor side effects. The improvement in CD4 counts is small and short-lived, and it performs no better alone than does ddC. Saquinavir's main advantage is the relatively benign way it has of boosting the mediocre performance of nucleoside analogs. Its primary disadvantage is the retail price of $7,200 per year.
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PMID:A kinder, gentler ddC... for $7,200 a year. 1136 96

The Food and Drug Administration (FDA) has granted accelerated approval of the 3TC (Epivir)/AZT (Retrovir) combination as a first-line therapy for treatment of HIV infection and AIDS in adults and children. It has also approved saquinavir (Invirase), a protease inhibitor, for treatment of HIV infection (when taken in combination with nucleoside analog drugs) in adults with advanced HIV disease. Epivir is now available in U.S. pharmacies with a doctor's prescription, but the combination is costly. Medicaid will cover 3TC costs, and most third party insurers are expected to reimburse for the combination regimen. Invirase is also expensive, particularly at the higher dosage levels. Its manufacturer, Hoffmann-LaRoche, is expected to develop a stronger version in 1996. Because there is little known about protease inhibitor drug resistance, forestalling invirase use until it is clearly needed is recommended.
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PMID:FDA approves 3TC and saquinavir. Food and Drug Administration. 1136 11

Saquinavir, developed by Hoffmann-LaRoche under the trade name Invirase, is the first protease inhibitor to be approved by the Food and Drug Administration (FDA) for use in combination with one or more unspecified nucleoside analogs. Rifampin should not be taken with saquinavir, and rifabutin should be only cautiously used in combination with saquinavir. Protease inhibitors have shown T-cell increases and viral load reductions similar to AZT when taken at the present low dosage. Research is being done on a new formulation which would deliver more effective amounts. The cost of saquinavir and other new drugs may be prohibitive, especially as the standard treatment changes from one drug (AZT) to combinations of drugs. Physicians and patients should call the Roche HIV Therapy Assistance Program for more information.
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PMID:Saquinavir (Invirase): first protease inhibitor approved--reimbursement, information hotline numbers. 1136 73

Hoffmann-La Roche received accelerated approval from the Food and Drug Administration (FDA) for its protease inhibitor, saquinavir (Invirase), when used in combination with nucleoside analogues. This is the quickest review of any AIDS drug made by the FDA. Accelerated approval is generally based on laboratory markers, such as CD4 counts. Clinically significant viral load changes in saquinavir trials have not been shown yet. Saquinavir has not been combined in tests with nucleoside analogues other than AZT and ddC. The wholesale cost of saquinavir for the recommended dose of 600 mg 3 times per day is $15.89. The Roche HIV Therapy Assistance Program provides saquinavir to patients waiting for insurance coverage and to those who cannot afford the drug.
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PMID:Saquinavir gets accelerated approval. 1136 35

Saquinavir, the first of the protease inhibitors on the market, is a product of both an innovative product design and a growing dissatisfaction with the other anti-HIV products on the market. Saquinavir received Food and Drug Administration (FDA) approval in record time, 97 days. The design process for the drug is detailed, including specifications. Saquinavir, sold under the Hoffman-LaRoche label, Invirase, was computer-designed because of its ability to cleave to a protease site. Large-scale studies are currently underway, and the manufacturer has made the drug available through a compassionate treatment program since April 1994. Saquinavir's limited availability due to manufacturing problems appears to be resolved, and Hoffman-LaRoche reports that the synthesis process now takes less than a year.
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PMID:Saquinavir: newest weapon in the antiviral arsenal. 1136 36

Saquinavir (Invirase) is the first protease inhibitor to gain Food and Drug Administration (FDA) approval for treatment of HIV. It works by blocking a part of the HIV called protease, causing HIV to make copies of itself that cannot infect new cells. It is most effective when prescribed in conjunction with one of the nucleoside analog drugs--AZT, ddI, ddC, d4T, or 3TC. HIV can become resistant to saquinavir, which may also make HIV resistant to other protease inhibitors. Saquinavir is not well absorbed by the body, and is very expensive when prescribed in doses high enough to be very effective. It is absorbed better when taken with food, and grapefruit juice may increase the levels in the body. The drug seems to have few side effects other than gastrointestinal upset.
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PMID:Saquinavir (Invirase). 1136 96

The recent approval of three protease inhibitors introduces a welcome element of choice into HIV treatment programs. Ritonavir (Norvir), indinavir (Crixivan), and saquinavir (Invirase) all prevent HIV from replicating, leading to lower viral loads and a slower disease progression. However, patients must continue taking the drugs once they begin therapy; stopping the treatment or reducing the dosage can lead to resistance. Long term data is not yet available on toxicity or drug interactions. All three drugs are most effective when used in combination therapy.
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PMID:Freedom of choice. 1136 32


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