RESUMO
AIM: To determine the safety profile of new hepatitis C virus (HCV) treatments in liver transplant (LT) recipients with recurrent HCV infection. METHODS: Forty-two patients were identified with recurrent HCV infection that underwent LT at least 12 mo prior to initiating treatment with a Sofosbuvir-based regimen during December 2013-June 2014. Cases were patients who experienced hepatic decompensation and/or serious adverse events (SAE) during or within one month of completing treatment. Controls had no evidence of hepatic decompensation and/or SAE. HIV-infected patients were excluded. Cumulative incidence of decompensation/SAE was calculated using the Kaplan Meier method. Exact logistic regression analysis was used to identify factors associated with the composite outcome. RESULTS: Median age of the 42 patients was 60 years [Interquartile Range (IQR): 56-65 years], 33% (14/42) were female, 21% (9/42) were Hispanic, and 9% (4/42) were Black. The median time from transplant to treatment initiation was 5.4 years (IQR: 2.1-8.8 years). Thirteen patients experienced one or more episodes of hepatic decompensation and/or SAE. Anemia requiring transfusion, the most common event, occurred in 62% (8/13) patients, while 54% (7/13) decompensated. The cumulative incidence of hepatic decompensation/SAE was 31% (95%CI: 16%-41%). Risk factors for decompensation/SAE included lower pre-treatment hemoglobin (OR = 0.61 per g/dL, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate (OR = 0.95 per mL/min per 1.73 m(2), 95%CI: 0.90-0.99, P = 0.01), and higher baseline serum total bilirubin (OR = 2.43 per mg/dL, 95%CI: 1.17-8.65, P < 0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases. CONCLUSION: Sofosbuvir/ribavirin will continue to be used in the post-transplant population, including those with HCV genotypes 2 and 3. Management of anemia remains an important clinical challenge.
Assuntos
Antivirais/efeitos adversos , Doença Hepática Terminal/cirurgia , Hepacivirus/efeitos dos fármacos , Hepatite C/tratamento farmacológico , Falência Hepática/induzido quimicamente , Transplante de Fígado/efeitos adversos , Sofosbuvir/efeitos adversos , Adulto , Idoso , Anemia/induzido quimicamente , Quimioterapia Combinada , Doença Hepática Terminal/diagnóstico , Doença Hepática Terminal/virologia , Feminino , Hepacivirus/patogenicidade , Hepatite C/diagnóstico , Hepatite C/virologia , Humanos , Estimativa de Kaplan-Meier , Falência Hepática/diagnóstico , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Recidiva , Ribavirina/efeitos adversos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ativação Viral/efeitos dos fármacosRESUMO
Telaprevir, a protease inhibitor, was recently approved for management of Chronic Hepatits C (CHC) due to HCV genotype 1. Various RCTs have demonstarted increased incidence of cutaneous adverse effects with use of Telaprevir. Herein, we report two cases of drug rash with eosinophilia and systemic symptoms (DRESS) secondary to Telaprevir use.
