Safety of Switching Nevirapine Twice Daily to Nevirapine Once Daily in Virologically Suppressed Patients

Podzamczer, Daniel; Olmo, Montserrat; Sanz, José; Boix, Vicente; Negredo, Eugènia; Knobel, Hernando; Domingo, Peré; Pineda, Juan A.; Viladés, Consuelo; Quero, José Hernández; Force, Lluís; Lahoz, J. González; Muñoz, Pepa; Llibre, Josep M; Mariño, Ana; Ortega, Enrique; Dalmau, David; Gatell, Josep M.; Antón, Esperanza; Sola, Julio; Galindo, Marı́a José; Pedrol, Enric; Sanz, Jesús; Lima, Javier Torre de; Flores, Juan

doi:10.1097/qai.0b013e318198a0cc

Cited by 19 publications

(8 citation statements)

References 15 publications

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“…Moreover, liver toxicity associated with the use of ARV drugs is usually somewhat higher in patients coinfected with HCV [4]. Most cases of NVP-associated hepatotoxicity appear during the first 2 to 3 months of therapy and manifest as a hypersensitivity reaction [14][15][16][17]. This clinical syndrome seems to be more frequent in patients with certain genetic markers [14], and is mainly driven by the presence of high CD4 counts (>400 cells/μL in men and >250 cells/μL in women), mostly in patients with detectable viral load [17][18][19].…”

Section: Discussionmentioning

confidence: 99%

Long-Term Benefits of Nevirapine-Containing Regimens: Multicenter Study with 506 Patients, Followed-Up a Median of 9 Years

Podzamczer

Tiraboschi²,

Mallolas³

et al. 2012

CHR

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Section: Discussionmentioning

confidence: 99%

Long-Term Benefits of Nevirapine-Containing Regimens: Multicenter Study with 506 Patients, Followed-Up a Median of 9 Years

Podzamczer

Tiraboschi²,

Mallolas³

et al. 2012

CHR

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“…The risk of hepatotoxicity with 400-mg once-daily dosing appears to be low when CD4 T-cell thresholds (see below) and 14-day dosage escalation guidelines are followed [5]. One study showed safety of switching from 200 mg twice daily to 400 mg once daily after at least 12 to 18 weeks of therapy [6]. With the ER formulation, 400 mg once daily should begin immediately after the aforementioned 14-day lead in.…”

Section: Overview Of Nevirapine and Its Pharmacologymentioning

confidence: 99%

Clinical Perspectives on Human Genetic Screening to Prevent Nevirapine Toxicity

Haas

Mootsikapun

Ruxrungtham

et al. 2012

Personalized Medicine

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Nevirapine is one of the most extensively prescribed antiretroviral drugs worldwide. However, a concern is increased risk for severe toxicity when antiretroviral-naive individuals with higher CD4 T-cell counts initiate nevirapine-containing regimens. Several genetic variants are associated with nevirapine toxicities. The authors used data from a previous study to anticipate potential consequences of genetic screening to prevent nevirapine adverse events. That study enrolled cohorts of African, Asian and European descent in 11 countries, including 276 patients who had experienced severe cutaneous and/or hepatic adverse events with nevirapine-containing regimens and 587 matched nevirapine-tolerant controls. Associations were identified with HLA-Cw*04, HLA-B*35, HLA-DRB*01 and CYP2B6 516G>T (rs3745274); however, positive predictive values for these genetic markers were low, and most nevirapine-associated adverse events occurred in patients without these markers. Unless better genetic predictors are identified, nevirapine toxicity is best avoided by continuing to follow current prescribing guidelines that are based largely on CD4 T-cell criteria.

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“…Se demostró también, que la formulación de liberación sostenida mantuvo concentraciones constantes entre las dosis. Estaría indicada en adultos que están recibiendo nevirapina por más de 12 a 18 semanas 26,27 .…”

Section: Nevirapina (Nvp)unclassified

Nuevos y viejos anti-retrovirales en pediatría: Nuevas dosis, presentaciones y asociaciones

B¹

2010

Rev. chil. infectol.

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Of the 25 antiretroviral drugs available in the market, only 16 are allowed for prescription in the pediatric patients. The antiretroviral, pertaining to the first three families, used for two decades, remain valid and are important components of antiretroviral therapy in naive children. We describe doses, presentations and current associations for these drugs in children, and also discuss new co-formulations that will reduce the number of doses, improve tolerance and therefore achieve better adherence of pediatric patients.

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Safety of Switching Nevirapine Twice Daily to Nevirapine Once Daily in Virologically Suppressed Patients

Abstract: In patients on standard twice daily NVP-containing regimens for at least 12-18 weeks, per protocol analysis showed that switching to once daily NVP was not inferior to continued twice daily NVP in terms of the predefined noninferiority margin of 10% for hepatotoxicity.

Cited by 19 publications

References 15 publications

Long-Term Benefits of Nevirapine-Containing Regimens: Multicenter Study with 506 Patients, Followed-Up a Median of 9 Years

Long-Term Benefits of Nevirapine-Containing Regimens: Multicenter Study with 506 Patients, Followed-Up a Median of 9 Years

Clinical Perspectives on Human Genetic Screening to Prevent Nevirapine Toxicity

Nuevos y viejos anti-retrovirales en pediatría: Nuevas dosis, presentaciones y asociaciones

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