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Query: UMLS:C0019693 (HIV)
 170,526 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee met February 27 to March 1, 1996. At the meeting, the FDA granted full approval of ritonavir for the treatment of advanced AIDS. Ritonavir manufacturer, Abbott Laboratories, characterized the drug as generally well-tolerated, with the most common side effects being nausea, vomiting, and diarrhea. The committee also recommended accelerated approval of Merck's protease inhibitor, indinavir. Results of several clinical studies and protocols are presented. The committee voted against somatropin (Serostim), the recombinant human growth hormone, for treatment of AIDS-related wasting syndrome. They cited too many gaps in the research data. The manufacturer, Serono, is currently negotiating with the FDA on the best way to pursue approval. The committee also unanimously recommended that ddI (Videx) be indicated as a first-line treatment for HIV. The drug appears to be superior to AZT in delaying disease progression and death.
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PMID:Highlights from the FDA antiviral drug advisory committee meetings, February 27-March 1, 1996. 1136 21

Much of the information presented at the Fifth European Conference on Clinical Aspects and Treatment of HIV Infection dealt with HIV protease inhibitors. Pharmacologic, pharmacokinetic, and therapeutic aspects of ritonavir, saquinavir, and indinavir, given individually, were assessed by both viral load testing and CD4 counts. Ritonavir, used in combination with ddC and AZT, reduced HIV RNA and increased CD4 count, with minimal adverse effects. The development of HIV resistance and cross resistance to these protease inhibitors was discussed, with an examination of the number of mutations needed to render the HIV virus resistant. When to begin treatment with these drugs was also a topic of discussion.
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PMID:Protease inhibitors: implications for HIV research and treatment. 1136 25

A New Drug Application for ritonavir, an HIV protease inhibitor manufactured by Abbott Laboratories, has been submitted to the Food and Drug Administration (FDA) as an HIV infection treatment. Results of randomized clinical trials demonstrated the efficacy of ritonavir alone and in combination with AZT. The trials showed a decrease in mean average viral RNA level and statistically significant increases in CD4 count. Another study combining ritonavir with AZT and ddC also showed favorable results. Ritonavir was generally well tolerated.
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PMID:Abbott laboratories files New Drug Application for ritonavir. 1136 29

Saquinavir, a protease inhibitor, received Food and Drug Administration (FDA) approval. Ritonavir and indinavir are likely to receive FDA approval by mid-1996, and three others are currently in clinical trials. Clinicians who treat HIV-positive patients will be faced with conflicting test results and multiple choices in drug therapy. All tests currently show that protease inhibitors are most effective in combination with nucleoside analog reverse transcriptase inhibitors. The issue of cross-resistance is controversial, with differing opinions on whether these treatments reduce the effectiveness of later treatments with other compounds. For the most effective treatment, patients should begin therapy with the maximum tolerated dosage of any of these drugs. A chart summarizes each of the six drugs' developmental statuses. Clinicians are cautioned to consider variables other than viral load in determining which drugs to prescribe; side effects, cost, drug interactions, tissue distribution and palatability are also important factors to consider. Test results of the six drugs are reviewed.
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PMID:The rolling uncertainties of antiprotease prescribing. 1136 41

Reports from the Third Conference on Retroviruses detailed extraordinary antiviral and clinical effects when protease inhibitors were used in combination with nucleoside analogs. These treatments will be considerably more effective than the anti-HIV therapies of the past. Abbott is the first to demonstrate that its drug, ritonavir, extends survival and delays opportunistic infections. Merck's indinavir, used in combination with AZT/3TC, dramatically reduces viral loads. Agouron's nelfinavir, used in combination with d4T, reduces viral load by 99 percent after 45 days. However, while the effects of protease inhibitors are profound, there are no long-term studies to show that they will remain effective. The only long-term study, which covers 60 weeks, is from indinavir. Each of the drugs have significant side effects which may limit their use. Ritonavir is the least well tolerated due to severe gastrointestinal side effects. Indinavir's side effects, kidney stones and elevated bilirubin levels, do not seem to cause patients to stop therapy. Nelfinavir causes grade I/II diarrhea. Only one new compound, Ciba-Geigy's CGP 61755, is nearing clinical trials. Initial indications are that it may cause cross-resistance problems with ritonavir and indinavir.
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PMID:Protease inhibitors come of age. 1136 82

The Food and Drug Administration's (FDA) Drug Advisory Committee made significant changes to the way HIV infections are treated at its February 28 to March 1, 1996 meetings. As a result, AZT is no longer considered to be the centerpiece of first-line anti-HIV therapy, and CD4 cell counts are no longer the primary laboratory standards used to judge the effectiveness of a drug. The FDA recommended the approval of two older nucleoside analogs (ddI and ddC) and two new protease inhibitors (ritonavir and indinavir). Serono Laboratories' application for approval of its human growth hormone was rejected, largely because of the poor way the company presented its findings. Ritonavir demonstrated an ability to extend survival and delay the onset of new opportunistic infections in people with advanced HIV disease. Although ritonavir is more effective than AZT, the combination of the two drugs was no better than ritonavir monotherapy. There is no long-term data available on the safety of ritonavir. The committee recommended indinavir after the manufacturer, Merck, provided impressive safety and surrogate marker data for the drug alone and in combination with AZT. Charts are included to summarize the drugs' regimen. There is a growing conviction within the FDA that four-drug combination therapy will be the most effective means of treating HIV. However, treatment success will vary on an individual basis.
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PMID:Three days that shook the world. 1136 88

Ritonavir (Norvir), a protease inhibitors, was approved for HIV treatment by the Food and Drug Administration (FDA). Studies have shown that ritonavir helps people live longer and delays the progression of the illness. One study showed that the death rate for the treated group was half that of the group taking a placebo. Ritonavir should be taken with meals. Many people cannot tolerant the side effects, including nausea, vomiting, weakness, diarrhea, elevated liver enzymes, and numbing around the mouth. Ritonavir affects the way other drugs are absorbed by the body, and its use should be closely monitored for toxic reactions.
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PMID:Ritonavir (Norvir). 1136 97

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

Study data are presented on the use of protease inhibitors. Indinavir shows particularly potent antiviral activity and a modest side effect profile. Three indinavir studies are highlighted. Ritonavir appears to be effective in people with advanced HIV disease by helping to stem the progression of disease. Highlights from two ritonavir studies are presented. Two small studies involving nelfinavir are discussed, showing potent antiviral activity with high doses of the drug, and better performance when used in combination with d4T. It is cautioned that use of these drugs requires careful strategic thinking.
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PMID:Update on protease inhibitors. 1136 12

Ritonavir is the first protease inhibitor to demonstrate prolonged survival in advanced HIV disease. The Food and Drug Administration (FDA) approved ritonavir in 72 days. Ritonavir's development and clinical testing results are described. Clinical data include ritonavir's use in triple combination therapy with ddC and ZDV, as well as a comparison of its use in monotherapy against ZDV monotherapy and in combination with ZDV. Evidence shows that the use of ritonavir increases the duration of patient survival. The potential for cross-resistance to ritonavir and a synergistic interaction with saquinavir are highlighted.
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PMID:Ritonavir: first to prolong survival. 1136 17


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