Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0019693 (HIV)
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The Food and Drug Administration (FDA) approved two new protease inhibitors for treatment of AIDS. Ritonavir (Norvir) and indinavir (Crixivan) have been approved for both monotherapy and combination therapy, and appear to have relatively few side effects. Reports on clinical trials of both drugs are reported. Saquinavir (Invirase) also has FDA approval, but currently has a low absorption rate; better formulations are expected to increase absorption. Early trials indicate that triple drug combinations may suppress HIV replication to very low levels.
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PMID:FDA approves 2 new protease inhibitors: ritonavir (Norvir) and Crixivan (Indinavir sulfate). Food and Drug Administration. 1136 92

The Food and Drug Administration (FDA) approved two new protease inhibitors--ritonavir and indinavir--for the treatment of HIV infection in adults. Ritonavir (Norvir), developed by Abbott Laboratories, received full approval for use alone or in combination with nucleoside analogue medications in patients with advanced HIV disease. Two encouraging studies on ritonavir are described. An ongoing phase III trial showed mortality to be 43 percent lower than for patients receiving standard therapy alone. In a separate study, untreated HIV-infected individuals who were given a triple combination of ritonavir plus AZT and ddC showed significant increases in CD4+ T cells counts and decreases in viral load for at least six months. Indinavir (Crixivan), developed by Merck, received accelerated approval for monotherapy and combination therapy for the treatment of HIV infection in adults when therapy is warranted. New data on indinavir showed decreases in levels of HIV in 22 out of 25 patients who had taken a triple combination of indinavir, AZT and 3TC. In another study of patients taking a combination of indinavir, ddI, and AZT, 60 percent of the patients' HIV levels were reduced to undetectable levels. In addition to ritonavir and indinavir, saquinavir (Invirase, Hoffmann-La Roche) is another protease inhibitor approved for use in conjunction with nucleoside analogues for the treatment of HIV infection.
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PMID:Two new protease inhibitors approved by FDA. Food and Drug Administration. 1136 99

The revised HIV Adult Standard of Care guidelines, produced by ACT UP/Philadelphia, are printed. The extensive table summarizes the minimum standard of care needed for individuals with HIV infection to maximize their quality and length of life. Divided into sections by T4 cell count, the table includes diagnostic tests and exams that patients may wish to have done at certain times in their disease progression. Treatment options are suggested for HIV disease, opportunistic infections, and other AIDS-related symptoms. Highlights of the many discussions on protease inhibitors at the 11th International AIDS Conference in Vancouver are described. Saquinavir has the lowest bioavailability of the three approved protease inhibitors and is awaiting new formulation. Ritonavir works to raise CD4 counts, drop viral load and decrease morbidity and mortality. However, it is poorly tolerated in about half of all users who describe gastrointestinal trauma. Indinavir has been shown to decrease viral loads to undetectable levels for 48 weeks, and shows promise for sustaining that measure for longer periods. Nelfinavir will likely be approved in early 1997. In addition, viral load monitoring has become a significant measure in guiding the efficacy of combination therapies, when used in conjunction with CD4 tests. The Philadelphia Water and Health Departments are suggesting that individuals not boil their water, despite outbreaks among people with AIDS of cryptosporidium. Filtered and bottled water are safer alternatives until there is a resolution.
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PMID:HIV adult standard of care. ACT UP. 1136 24

The metabolic action of the liver is described, including how it breaks down and processes drugs. Nucleoside analog drugs are not broken down by the liver but travel through the kidneys where the liver sometimes combines them with other chemicals so they can be dissolved and passed out in the urine. The cytochrome p450 system, a group of enzymes, breaks down drugs before they are metabolized by the liver. Some drugs, such as rifampin, are inducers, increasing the p450 levels and resulting in less of the drug getting to the rest of the body. Drug interaction can occur when an HIV treatment drug is taken with an inducer drug. Drug interaction can also occur when different drugs compete to be broken down by the same enzyme, resulting in too high levels of one drug in the body. Ritonavir can both induce and compete, and can block the metabolism of the recreational drug ecstasy, causing toxic effects. Patients need to inform every doctor of all of their medications, including herbal medicines and dietary supplements, to avoid unwanted drug interactions.
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PMID:Drugs and the liver. 1136 25

The 1998 Retrovirus Conference in Chicago presented what is known about specific dual-protease inhibitor (PI) therapies. The effectiveness of the following therapies are highlighted: ritonavir/saquinavir, nelfinavir/saquinavir, ritonavir/indinavir, indinavir/saquinavir, amprenavir in dual-protease inhibitor combinations, and ABT-378/ritonavir. Growing evidence supports the use of dual PIs in treating HIV disease. Effectiveness is enhanced when they are combined with reverse transcriptase inhibitors. Ritonavir/saquinavir is the therapy of choice so far, particularly for salvage therapy. Less support is found for nelfinavir/saquinavir, following the failure of other PIs. Failure on dual PI therapy is likely to cause extensive cross-resistance within the PI class. Therefore, caution is warranted in using dual PI therapy in patients who have problems with adherence.
Hopkins HIV Rep 1998 May
PMID:A review of dual protease inhibitor therapy. 1136 90

A 44-year-old man diagnosed with HIV in 1992 has become 3TC-resistant, has had adverse effects to ddI, and most likely will have the same adverse effects to d4T and ddC. The Ritonavir, Saquinavir, and Nevirapine combination he was switched to did not reduce his viral load, however, the patient was clinically stable without wasting or opportunistic infections, and his CD4 count was 220 cells/mm3. Based on past responses to medication and to the available NNRTIs, it is believed that the patient is currently cross-resistant to all first-generation protease inhibitors. It was suggested that the patient, now categorized as having virologic failure but clinical/immunologic success, is unlikely to achieve durable suppression, even with the new drugs becoming available. Mega-HAART therapy, which uses up to eight drugs, may work temporarily but appears to be intolerable in the long term for most patients. It is not known how long the patient's clinical/immunologic stability will last, but it is unlikely to continue indefinitely in the presence of high viral replication. In the case of worsening conditions, it is suggested that a phenotypic analysis be done to guide salvage therapy. In the absence of a phenotypic analysis, it is suggested to try a combination of ddI plus d4T plus Hydroxyurea plus Nelfinavir plus efavirenz.
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PMID:A patient with no options? 1136 84

Two new diagnostic tests which evaluate a patient's HIV resistance to antiviral drugs were scheduled to be on the market in July. The tests are being marketed under the trademarks Antivirogram, by Laboratory Corporation of America, and VircoGEN by VIRCO. Both companies say that when the tests are used together, they will predict which drugs a patient will respond to, leading to more effective treatment decisions. Studies were conducted to predict the effectiveness of Ritonavir/Saquinavir therapy, and the results were very promising.
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PMID:Predicting drug effectiveness. 1136 96

To augment the limited antiviral treatments available for children, new therapies to treat children are being investigated. On recommendation from Federal guidelines, many treatment regimens approved for adults are being prescribed for children, but these have little information available about dosing and long-term effects. Ritonavir in different combinations and dose levels has shown good short-term results, and it is believed that the long-term outcomes will mirror the adult outcomes. The Pediatric AIDS Clinical Trials Group study 338 indicated that the three- drug combinations used had a similar impact on viral load when compared to the adult studies. An additional study of Ritonavir, given as a salvage therapy to children with high viral loads, illustrates that pediatric trials should use the experiences learned from adult trials to formulate beneficial regimens. Descriptions of studies for children utilizing Nelfinavir, Saquinavir, and abacavir describe the triple drug combinations that were most successful, the side effects that were experienced, and the need for liquid formulations of the drugs for easier administration. Critical issues that need to be addressed are: adherence to treatment, modifications of side effects, toxicity, and appropriate dosing. A summary of current Federal guidelines for treating children and adolescents with HIV is included.
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PMID:Antivirals and children. 1136 46

Highly active antiretroviral therapies (HAART) that do not incorporate a protease inhibitor (PI) have received much attention in attempts to find effective treatment alternatives. HAART without PIs can extend the future options of some patients, to allow switching to a PI therapy later in treatment, or to avoid unpleasant side effects reported with some PIs. A study of combination therapy employing efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI) showed encouraging results, as did a similar study employing abacavir. However, researchers are cautious about the ability of these drugs to sustain high antiviral activity over a long-term period. As a potent alternative to HAART, NNRTI's offer easier dosing and appear to have similar results, albeit in the short-term. Studies of Hydroxyurea have reported a positive antiviral response. However, one study indicated that the positive response came with significant side effects. The use of anti-HIV therapy in pregnant women and their newborns is the subject of another study, that assessed the safety of treatment and the possible side effects. Comparisons of protease inhibitor-containing regimens are also reviewed. Alternative two-drug combinations of Indinavir and Ritonavir, and abacavir and amprenavir are explored.
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PMID:Antivirals update. 1136 49

Efavirenz and abacavir, two recently approved drugs, have simplified HIV treatment. They are taken less often than some other drugs, and fewer pills are required. Results are reported from studies which have evaluated different dosing schedules and the effectiveness of new drug combinations. The studies have involved AZT, Combivir, d4T, amprenavir, Indinavir, Ritonavir, and Delavirdine. Researchers hope that the results of these studies may provide alternatives to three times a day dosing schedules.
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PMID:Antiviral therapy: how simple can you get? 1136 6


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