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https://www.arca.fiocruz.br/handle/icict/30149
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Embargo date
2025-08-30
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- INI - Artigos de Periódicos [3645]
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A REVIEW OF THE SAFETY AND TOLERABILITY PROFILE OF THE NEXT-GENERATION NNRTI ETRAVIRINE
Drug-Related Side Effects and Adverse Reactions
Exanthema
HIV Infections
Humans
Pyridazines
Time Factors
Treatment Outcome
Withholding Treatment
Author
Affilliation
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of Turín. Turín, Italy.
Kaiser Permanente. Los Angeles, California, USA.
Tibotec BVBA. Mechelen, Belgium.
Tibotec BVBA. Mechelen, Belgium.
Tibotec BVBA. Mechelen, Belgium.
University of Turín. Turín, Italy.
Kaiser Permanente. Los Angeles, California, USA.
Tibotec BVBA. Mechelen, Belgium.
Tibotec BVBA. Mechelen, Belgium.
Tibotec BVBA. Mechelen, Belgium.
Abstract
The next-generation nonnucleoside reverse transcriptase inhibitor (NNRTI) etravirine (TMC125) has demonstrated durable virologic efficacy in clinical trials involving >1000 treatment-experienced, NNRTI-resistant, HIV-1-infected patients. In this clinical safety review, we show etravirine to be well tolerated with a proven safety record. The nature and magnitude of adverse events observed during treatment suggest that etravirine may offer improved tolerability over existing antiretrovirals, including NNRTIs. Notably, adverse events reported with etravirine treatment are generally mild to moderate in severity. Rash has been shown to occur with a higher incidence in etravirine-treated patients versus placebo, but cases are generally mild to moderate, occur within the first few weeks, and resolve with continued use. In addition, the rate of adverse event-related discontinuations is low with etravirine. In summary, the safety and tolerability profile of etravirine, combined with its virologic efficacy, suggest that the drug may be a valuable option for treatment-experienced patients with HIV-1 infection.
Keywords
Anti-HIV AgentsDrug-Related Side Effects and Adverse Reactions
Exanthema
HIV Infections
Humans
Pyridazines
Time Factors
Treatment Outcome
Withholding Treatment
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