Análisis comparativo de la seguridad de la triple terapia con telaprevir entre pacientes monoinfectados por VHC y coinfectados por VIH

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Objetivo: Conocer las posibles diferencias en cuanto al perfil de toxicidad de la triple terapia con telaprevir entre pacientes monoinfectados y coinfectados. Método: Estudio observacional retrospectivo (Enero 2012-Noviembre 2013) de los pacientes con VHC genotipo 1, tanto monoinfectados como coinfectados por VIH, que hubieran finalizado las 12 semanas de tratamiento con telaprevir. Se recogieron las variables necesarias para caracterizar a los pacientes, y aquellas referentes al tratamiento recibido. La clasificación de la toxicidad se realizó según criterios de la División del SIDA v.1.0. Se realizó un análisis estadístico descriptivo y comparativo empleando el programa SPSS v.15.0. Resultados: Se incluyeron 100 pacientes, 41% coinfectado con el VIH. Se observó una tasa de cirrosis hepática superior en pacientes coinfectados (97,6% vs 52,5% p < 0,001). Toxicidad: mayor incidencia hiperbilirrubinemia en coinfectados (51,2% vs 27,1% p = 0,012). Toxicidad por grados: no se observaron diferencias en la toxicidad leve-moderada entre ambos grupos, mientras que la hiperbilirrubinemia grave fue mayor en los pacientes coinfectados (26,8% vs 3,4% p = 0,001). Se observó mayor empleo de eritropoyetina exógena (39,9% vs 12,2% p = 0,003), y de ajuste de dosis de ribavirina (64,4% vs 26,8% p < 0,001) en pacientes monoinfectados. Conclusiones: Se evidencia un perfil de toxicidad similar entre ambos grupos a excepción de la hiperbilirrubinemia que aparece en mayor grado en los pacientes coinfectados (posiblemente relacionada con el uso de atazanavir), y al menor empleo de eritropoyetina exógena y de reducción de dosis de ribavirina en los mismos.

Translated abstract

Purpose: To know the possible differences in the toxicity profile of triple therapy with telaprevir between monoinfected and coinfected patients. Method: A retrospective observational study (January 2012-November 2013) of patients with HCV genotype 1, both monoinfected and coinfected with HIV, who had completed 12 weeks of treatment with telaprevir. The necessary variables were collected to characterize patients and the treatment received. The classification was made according to the toxicity criteria of the Division of AIDS v.1.0. A descriptive and comparative statistical analysis using the SPSS v.15.0 software was performed. Results: 100 patients were included, 41% coinfected with HIV. Cirrhosis rate was observed at higher coinfected patients (97.6% vs 52.5%, p < 0.001). Toxicity: increased incidence in coinfected hyperbilirubinemia (51.2% vs 27.1% p = 0.012). Toxicity grades: no differences in mild-moderate toxicity were observed between the two groups, while severe hyperbilirubinemia was higher in coinfected (26.8% vs 3.4% p = 0.001). Increased use of exogenous erythropoietin (39.9% vs 12.2% p = 0.003) was observed, and dose adjustment of ribavirin (64.4% vs 26.8% p < 0.001) in monoinfected patients. Conclusions: The study shows a similar toxicity profile between the two groups except for hyperbilirubinemia appears greater in coinfected patients (possibly related to the use of atazanavir) and less use of exogenous erythropoietin and dose reduction of ribavirin in them.

Related collections

Most cited references 20

Record: found
Abstract: found
Article: not found

Telaprevir for retreatment of HCV infection.

Stefan Zeuzem, Pietro Andreone, Stanislas Pol … (2011)

Up to 60% of patients with hepatitis C virus (HCV) genotype 1 infection do not have a sustained virologic response to therapy with peginterferon alfa plus ribavirin. In this randomized, phase 3 trial, we evaluated the addition of telaprevir to peginterferon alfa-2a plus ribavirin in patients with HCV genotype 1 infection who had no response or a partial response to previous therapy or who had a relapse after an initial response. A total of 663 patients were assigned to one of three groups: the T12PR48 group, which received telaprevir for 12 weeks and peginterferon plus ribavirin for a total of 48 weeks; the lead-in T12PR48 group, which received 4 weeks of peginterferon plus ribavirin followed by 12 weeks of telaprevir and peginterferon plus ribavirin for a total of 48 weeks; and the control group (PR48), which received peginterferon plus ribavirin for 48 weeks. The primary end point was the rate of sustained virologic response, which was defined as undetectable HCV RNA 24 weeks after the last planned dose of a study drug. Rates of sustained virologic response were significantly higher in the two telaprevir groups than in the control group among patients who had a previous relapse (83% in the T12PR48 group, 88% in the lead-in T12PR48 group, and 24% in the PR48 group), a partial response (59%, 54%, and 15%, respectively), and no response (29%, 33%, and 5%, respectively) (P<0.001 for all comparisons). Grade 3 adverse events (mainly anemia, neutropenia, and leukopenia) were more frequent in the telaprevir groups than in the control group (37% vs. 22%). Telaprevir combined with peginterferon plus ribavirin significantly improved rates of sustained virologic response in patients with previously treated HCV infection, regardless of whether there was a lead-in phase. (Funded by Tibotec and Vertex Pharmaceuticals; REALIZE ClinicalTrials.gov number, NCT00703118.).