Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 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

The Illinois Department of Public Health and the General Assembly canceled funding for 82 AIDS drugs in order to cover saquinavir costs for residents who lack health insurance. Medicines that will no longer be covered under the Illinois assistance program include all antibiotics and drugs that control diarrhea and nausea. As of July 1, 1996, clients who need to switch from saquinavir to a different protease inhibitor will have to pay for the prescription themselves. For some of these patients, the only alternative will be to resign from their jobs, shrink their assets, and apply for Medicaid and government income assistance programs.
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PMID:Illinois cancels 82 AIDS drugs to pay for one protease inhibitor. 1136 76

Ritonavir, Abbott Laboratories protease inhibitor, has been associated with nausea as a side effect. Abbott claims that the nausea subsides after several weeks of treatment. Taking the drug with a fat-rich meal may decrease nausea. Instructions on how to take the protease inhibitor to prevent gastrointestinal upset are provided.
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PMID:Starting ritonavir. 1136 7

A combination of two protease inhibitors, saquinavir (Invirase) and ritonavir (Norvir), may produce a median drop in viral load of 99.9 percent. Several dosage variations were tested. The most common side effects of the combination regimen included tingling around the mouth, diarrhea, fatigue, and nausea. A low level of toxicity was found. This combination may be used for people who have failed other protease inhibitor therapy or have developed a resistance to nucleoside analogues.
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PMID:Saquinavir plus ritonavir reduce viral load by 99.9 percent. 1136 83

Agenerase (amprenavir), the first of a new generation of protease inhibitors, manufactured by Glaxo Wellcome, promises to be a powerful drug for salvage therapy and for use in treatment-naive patients. It is the first protease inhibitor to be approved by the Rockville, MD-based Food and Drug Administration in 2 years. The drug does not elevate glucose or triglyceride levels as much as some of the other protease inhibitors do, and resistance to this drug is different from that of other protease inhibitors. Some adverse effects include nausea, diarrhea, and rash, and one percent of patients may experience severe and life-threatening skin conditions. Agenerase has been studied in 1,400 patients, and costs about $6,100 per year.
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PMID:Study: new drug doesn't display cross-resistance. 1136 18

The FDA has approved amprenavir (Agenerase), the fifth protease inhibitor (PI) to be approved and the first PI approved in 2 years. When used in triple combination therapy, amprenavir is effective in viral suppression in treatment-naive patients and some patients who have taken NRTIs and NNRTIs. The drug has also been shown to be effective in about half of the patients who are resistant to other PIs. The standard dose for amprenavir is eight large capsules taken twice a day. Levels of amprenavir may be affected by the concurrent use with efavirenz (Sustiva). Common side effects of amprenavir include nausea, vomiting, diarrhea, and numbness and tingling around the mouth.
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PMID:Amprenavir approved. 1136 53

The FDA has approved Agenerase (generic name amprenavir), a new protease inhibitor which costs about $6,500 per year. Eight 150mg gelatin capsules, twice a day, can be taken without food restrictions. Potential side effects include nausea, fatigue, and headache. About 20 percent of patients developed a rash, that was life-threatening in 1 percent. Early data indicate that the drug does not cause lipodystrophy. Drug interactions are possible with some antihistamines, sedatives, and anti-fungal agents. Website contact information is provided.
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PMID:New protease inhibitor. 1136 64

ABT-378, a new drug from Abbott Laboratories, may hold promise for patients who are infected with drug-resistant HIV. ABT-378 made in a combination pill with ritonavir can suppress HIV viral loads to fewer than 400 copies/mL in 78 percent of protease inhibitor-experienced patients and 95 percent of treatment-naive patients. It is well tolerated, with the most common side effects being diarrhea, nausea, asthenia, and headaches. It is taken twice a day in a single pill; researchers are evaluating the effectiveness of taking it only once a day.
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PMID:Drug works in treatment-naive, experienced patients. 1136 88

A substantial body of evidence provides support (but not definitive proof of efficacy) for the use of antiretroviral agents as postexposure prophylaxis for occupational exposures to HIV in the healthcare workplace. Despite the lack of definitive evidence of the efficacy of these agents in this setting, over the past decade this intervention has become the standard of care for healthcare workers who sustain occupational exposures to HIV. Administration of these agents--even for a relatively short 28-day postexposure course--is often fraught with difficulty. All of the agents currently used for postexposure prophylaxis regimens have substantial adverse effects, and significant adverse effects occur in more than two-thirds of individuals electing prophylaxis. This manuscript reiterates current US Federal Government guidelines for the administration of postexposure prophylaxis, specifically noting that zidovudine plus lamivudine (with or without a protease inhibitor) remains the recommended regimen. The paper summarises the significant toxicities associated with nucleoside reverse transcriptase inhibitors (primarily nausea, vomiting, diarrhoea and bone marrow suppression), non-nucleoside reverse transcriptase inhibitors (rash, fever, gastrointestinal symptoms and hepatitis, including hepatic decompensation necessitating liver transplantation) and protease inhibitors (nausea, vomiting, diarrhoea, abdominal pain, hyperglycaemia, hyperlipidaemia, headache and anorexia). As a class, the antiretroviral agents have an extraordinary number of drug interactions. The non-nucleoside reverse transcriptase inhibitors and the protease inhibitors are metabolised through the cytochrome P450 pathway, and the effects of concomitant administration of protease inhibitors with other agents in the same class are discussed, as well as the effects of concomitant administration of protease inhibitors with non-nucleoside agents. The potential for numerous and medically risky drug interactions emphasises the importance of planning antiretroviral prophylaxis in consultation with practitioners or clinical pharmacists who are skilled in the use of these agents and knowledgeable about the potential for significant drug interactions that could either reduce the benefit of prophylaxis or increase the potential for toxicity. Another common problem encountered by individuals managing postexposure prophylaxis programmes relates to the administration of chemoprophylaxis to a pregnant healthcare worker who has sustained an occupational exposure to HIV. We address what is known about the potential for toxicity and emphasise the recently published warning concerning the deaths of pregnant women and their offspring from lactic acidosis while receiving regimens containing stavudine and didanosine.
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PMID:Tolerability of postexposure antiretroviral prophylaxis for occupational exposures to HIV. 1148 Apr 91

The objective of our randomized, multicentre, double-blind, placebo-controlled study was to investigate the safety, tolerability, and antiretroviral and immunological effect of double and triple combination therapy regimens. A total of 105 antiretroviral therapy-naive patients were randomized to receive either zidovudine (300 mg twice per day) plus lamivudine (150 mg twice per day) plus nelfinavir placebo (three times per day) (n=52), or zidovudine/lamivudine (dose as before) plus nelfinavir (750 mg three times per day) (n=53) for 28 weeks. After this time, patients were allowed to switch to open-label zidovudine/lamivudine/nelfinavir. The overall log10 reduction from baseline in plasma HIV-1 RNA was significantly greater in the zidovudine/lamivudine/nelfinavir group than the zidovudine/lamivudine group (P=0.001; median treatment difference, -1.01 log10 copies/ml; 95% confidence interval -1.23 to -0.79), as measured by the average area under the curve minus baseline over 28 weeks. Increases from baseline in CD4 cell counts were statistically significantly greater in the zidovudine/ lamivudine/nelfinavir group (101.5 cells/ml) than the zidovudine/lamivudine group (47.0 cells/ml; P=0.027) at week 28. Of note, the addition of nelfinavir from weeks 28-52 led to an increase in the proportion of subjects with plasma HIV-1 RNA <400 copies/ml from 17% (9/52 patients on zidovudine/lamivudine) to 50% (13/26 patients who switched to zidovudine/lamivudine/nelfinavir). Incidence of drug-related adverse events was similar in the two groups, except for nausea (more common in zidovudine/lamivudine group; 40 versus 17%) and diarrhoea (more common in zidovudine/lamivudine/nelfinavir group; 45 versus 14%). In conclusion, our study confirms the efficacy of triple combination therapy with two nucleoside analogues and a protease inhibitor compared with double-nucleoside therapy. Interestingly, the addition of nelfinavir to zidovudine/lamivudine, even after 6 months of double nucleoside therapy, led to a substantial virological benefit that was sustained over 24weeks in a subset of patients.
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PMID:AVANTI 3: a randomized, double-blind trial to compare the efficacy and safety of lamivudine plus zidovudine versus lamivudine plus zidovudine plus nelfinavir in HIV-1-infected antiretroviral-naive patients. 1149 17


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