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

Glaxo Wellcome is offering an expanded access program for abacavir (Ziagen, formerly 1592) to HIV-positive patients who are not benefiting from their current combination therapy. In a dramatic departure from the usual entry criteria, the abacavir eligibility criteria require no specific CD4 cell count or viral load. To qualify, volunteers must be on a failing regimen, unable to tolerate standard therapies, and a physician must verify that another drug combination would not be viable. Patients are urged to switch to a regimen of at least two new drugs based on U.S. government treatment guidelines. Similar programs are available for the anti-HIV drugs efavirenz (Sustiva) and adefovir dipivoxil (Preveon). People using abacavir, a nucleoside analog, may experience side effects such as headache, nausea, and vomiting. If a hypersensitivity reaction develops, patients must stop the treatment. Taking the drug after experiencing an adverse reaction can be life threatening.
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PMID:Glaxo opens broad expanded access program for abacavir (Ziagen). 1136 71

Glaxo Wellcome has expanded its access program for the nucleoside analog abacavir (Ziagen). Currently there are no CD4 count or viral load requirements and the program is open to patients over age 13 who have failed standard treatments. Pregnant and breastfeeding women are excluded from the study. Patients must take Ziagen with at least one other new anti-HIV drug. In a previous trial, approximately three percent of people taking abacavir developed a severe hypersensitivity reaction that forced interruption of treatment. After suspension of treatment, initial symptoms subside, however, the syndrome could reappear in life-threatening proportions should treatment be resumed. Physicians have a limited window to enroll patients in the expanded program because abacavir is anticipated to get clearance from the Food and Drug Administration (FDA) in the fall.
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PMID:Abacavir at last. 1136 94

The FDA Antiviral Advisory Committee has recommended the approval of abacavir (Ziagen), a nucleoside analog that is produced by Glaxo Wellcome. Abacavir will be the thirteenth HIV drug to win approval. Glaxo applied under the FDA's accelerated approval statutes, which allow for conditional approval of lifesaving drugs. This approval is based on preliminary data, and can only be applied for when no other feasible treatment alternative exists. Results from the early tests are presented, along with toxicity data. Abacavir is a relatively safe drug, however, approximately 3 percent of people taking abacavir, have suffered from severe allergic reactions. Pricing information is included.
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PMID:Abacavir's trials and tribulations. 1136 5

An advisory committee of the Food and Drug Administration (FDA) has recommended accelerated approval for abacavir (ABC, Ziagen). The approval decision was not unanimous due to concerns of drug toxicity. Three percent of those taking the drug have developed severe allergic reactions, and at least eight people have died of complications related to the allergic reaction. Abacavir works by attacking the viral enzyme reverse transcriptase (RT), and it is related to other drugs such as AZT, 3TC, d4T, ddI, and ddC. Abacavir should be taken twice daily, in combination with other anti-HIV medications.
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PMID:Abacavir gets green light from FDA advisory board. Food and Drug Administration. 1136 24

Abacavir (Ziagen), a newly approved nucleoside analog, could be one of the most potent antiretrovirals available. Most of the clinical trials on abacavir have focused on patients who have never been treated for HIV, and they have responded well to the drug. The drug is not expected to be as effective in patients who have exhausted treatment options, as was demonstrated by Glaxo study CNA2007. The most common side effect of abacavir was skin rash. Some participants also reported systemic flu-like symptoms. Abacavir shows promise in intensification therapies where a drug is added to an established regimen that is not working, and in salvage therapies where patients have few treatment options remaining.
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PMID:Abacavir for salvage or intensification. 1136 11

The Food and Drug Administration (FDA) announced accelerated approval of Glaxo-Wellcome's abacavir (Ziagen, 1592) in combination with other antiretrovirals. Abacavir is in the same nucleoside analog class as AZT, but abacavir has stronger effects against HIV. Use of the drug requires caution, because it can cause a serious hypersensitivity or allergic reaction in 5 percent of patients. If abacavir is stopped and restarted, the hypersensitivity can be more fatal. Little is known about long-term use of the drug or its effects when in combination with other anti-HIV medications other than AZT plus 3TC.
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PMID:Ziagen (abacavir) approved: caution essential. 1136 48

More antiretroviral drugs are becoming available, increasing potential treatment regimens but also increasing the complexity of HIV treatment. The 4 newest of the 15 available antiretroviral agents are described: efavirenz (Sustiva, EFV), abacavir (Ziagen, ABC), adefovir (Preveon, ADV), and amprenavir (Agenerase, APV). Information on dosing, side effects, and interactions with other drugs is provided.
Hopkins HIV Rep 1999 Jan
PMID:The new drugs and how to use them. 1136 60

Ribavirin (Rebetol) is Schering Corporation's newly approved drug. It is used in combination with interferon for treatment of chronic hepatitis C in patients whose compensated liver disease has not been treated or who have relapsed after interferon monotherapy. Results of clinical trials are summarized, and dosing options and side effects are detailed. Similar information is provided for abacavir (Ziagen), Glaxo-Wellcome's new nucleoside analog reverse transcriptase inhibitor (NRTI) that is used in combination therapy to treat HIV.
Hopkins HIV Rep 1999 Mar
PMID:Product information. 1136 50

Abacavir sulfate (Ziagen) received accelerated approval for treatment of HIV infection from the Food and Drug Administration (FDA). It is the fifteenth approved anti-HIV drug. Abacavir, manufactured by Glaxo Wellcome, is currently the most powerful of the nucleoside analogue reverse transcriptase inhibitors (NRTIs). Side effects include nausea, vomiting, fatigue, headache, and diarrhea. A serious hypersensitivity reaction occurs in approximately 5 percent of patients taking the drug. Patients who experience this reaction can never take the drug again, because subsequent reactions can be fatal. Drug interactions may be minimal, as abacavir is not metabolized by the same enzymes that metabolize several other anti-retrovirals. Resistance is also discussed and clinical data from studies are presented.
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PMID:Abacavir sulfate (Ziagen). 1136 89

Federal HIV treatment guidelines will soon include recommendations about selecting salvage therapy and will provide advice on understanding the increasingly complex science of cross-resistance and HIV mutations. The increasing number of HIV drugs makes selecting a salvage therapy more difficult. The guidelines will upgrade the nucleoside analog reverse transcriptase inhibitor abacavir (Ziagen) to an alternative treatment. In addition, hypersensitivity to abacavir and the differences in progression of HIV disease between women and men are described.
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PMID:Next HIV guidelines likely to include salvage therapy. 1136 17


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