FDA Updates Raltegravir (Isentress) Label with New Information on Severe Skin and Hypersensitivity Reactions
“Updates to the Isentress (raltegravir) package insert were approved on November 2, 2011 to include a new subsection in the Warnings and Precautions section and update the postmaketing experience section. Specifically, the following subsection was added to section 5 Warnings and Precautions:
“5.1 Severe Skin and Hypersensitivity Reactions
“Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure. Discontinue ISENTRESS and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping ISENTRESS treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.
“In Section 6 Adverse Reactions, subsection 6.2 Postmarketing Experience, cerebellar ataxia and drug rash with eosinophilia and systemic symptoms was added.
“The Patient Counseling Information section and the patient labeling was also revised to incorporate these changes.”
The updated label will be available at the FDA Web site.
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More Than 700 HIV/AIDS-Related Terms Defined in New Edition of AIDSinfo Glossary
AIDSinfo is pleased to introduce the English-language 7th edition of the popular AIDSinfo Glossary of HIV/AIDS-Related Terms. The glossary provides people affected by HIV/AIDS with a comprehensive guide to the vocabulary used to describe HIV/AIDS, including its treatment, prevention, and ongoing research.
From absolute contraindication to X4-tropic virus, the updated glossary contains definitions for more than 700 HIV/AIDS-related terms. Definitions, developed on the basis of health information from trusted government sources, are presented in concise, easy-to-understand language.
Highlights of the 7th edition of the glossary include the following:
- 151 new terms and accompanying definitions.
- Addition of several new terms and changes to existing terms on the basis of the most recent updates to medical practice guidelines on the use of antiretroviral HIV drugs in adults, adolescents, children, and pregnant women.
- A revamped resources section that includes a more comprehensive listing of federal agencies that provide HIV/AIDS-related resources.
- A new appendix that lists all FDA-approved antiretroviral HIV drugs, which are classified according to drug class and identified by generic name, brand name, and acronym.
The glossary is available on the AIDSinfo Web site in Web- and printer-friendly formats and also on the AIDSinfo mobile site. The online version of the glossary includes an audio feature providing users with the pronunciation for each term. In the coming year, the updated glossary will also be available in Spanish and as iPhone and Android apps.
To order copies of the glossary, contact the AIDSinfo call center by e-mail (ContactUs@aidsinfo.nih.gov), phone (800-448-0440), or Live Chat.
Study Examines Efficacy of Darunavir/Ritonavir Plus Raltegravir in Treatment-Naive HIV-Infected People
“[The objective of the study is to] explore darunavir/ritonavir (DRV/r) plus raltegravir (RAL) combination therapy in antiretroviral-naive patients. …
“One hundred and twelve antiretroviral-naive, HIV-1-infected patients received DRV/r 800/100mg once daily and RAL 400mg twice daily. Primary endpoint was virologic failure by week 24. Virologic failure was defined as confirmed viral load of 1000copies/ml or more at week 12, or an increase of more than 0.5log10copies/ml in viral load from week 4 to 12, or a confirmed viral load of more than 50copies/ml at or after week 24. …
“Virologic failure rate was 16% [95% confidence interval (CI) 10-24] by week 24 and 26% (95% CI 19-36) by week 48 in an intent-to-treat analysis. Viral load at virologic failure was 51-200copies/ml in 17/28 failures. Adjusting for age and sex, virologic failure was associated with baseline viral load of more than 100000copies/ml [hazard ratio 3.76, 95% CI (1.52-9.31), P=0.004] and lower CD4 cell count [0.77 per 100cells/μl increase (95% CI 0.61-0.98), P=0.037]. When trough RAL concentrations were included as a time-varying covariate in the analysis, virologic failure remained associated with baseline viral load more than 100000copies/ml [hazard ratio=4.67 (95% CI 1.93-11.25), P<0.001], whereas RAL level below detection limit in plasma at one or more previous visits was associated with increased hazard [hazard ratio=3.42 (95% CI 1.41-8.26), P=0.006]. All five participants with integrase mutations during virologic failure had baseline viral load more than 100000copies/ml. …
“DRV/r plus RAL was effective and well tolerated in most patients, but virologic failure and integrase resistance were common, particularly in patients with baseline viral load more than 100000copies/ml.”
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