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Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study.
Chamorro-de-Vega, Esther; Gimenez-Manzorro, Alvaro; Rodriguez-Gonzalez, Carmen-Guadalupe; Escudero-Vilaplana, Vicente; De Lorenzo-Pinto, Ana; Iglesias-Peinado, Irene; Herranz-Alonso, Ana; Sanjurjo Saez, Maria.
Afiliação
  • Chamorro-de-Vega E; a Pharmacy Department , Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón , Madrid , Spain.
  • Gimenez-Manzorro A; a Pharmacy Department , Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón , Madrid , Spain.
  • Rodriguez-Gonzalez CG; a Pharmacy Department , Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón , Madrid , Spain.
  • Escudero-Vilaplana V; a Pharmacy Department , Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón , Madrid , Spain.
  • De Lorenzo-Pinto A; a Pharmacy Department , Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón , Madrid , Spain.
  • Iglesias-Peinado I; b Faculty of Pharmacy , Universidad Complutense de Madrid , Madrid , Spain.
  • Herranz-Alonso A; a Pharmacy Department , Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón , Madrid , Spain.
  • Sanjurjo Saez M; a Pharmacy Department , Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón , Madrid , Spain.
Expert Opin Drug Saf ;17(3): 235-241, 2018 Mar.
ArtigoemInglês |MEDLINE | ID: mdl-29325476
ABSTRACT

OBJECTIVE:

To explore the effectiveness and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV) for 12 weeks without ribavirin in adults with chronic HCV genotype 1b infection and compensated cirrhosis.

METHODS:

Observational study of a prospective cohort of adult patients with HCV genotype 1b infection and compensated cirrhosis who received 12 weeks of OBV/PTV/r and DSV without ribavirin. Effectiveness was assessed by recording the percentage of patients achieving sustained virological response at week 12 post-treatment (SVR12). Safety outcomes were based on the incidence of adverse events.

RESULTS:

Seventy-eight patients were included. The SVR12 rate was 96.1% (95%CI 89.2-99.2). Adverse events were recorded in 78.0% of patients. Of these, 97.7% were grade 1/2. One patient discontinued treatment prematurely owing to adverse events. Eighty-six interactions were detected in 43 patients (55.1%). Overall, 81.4% of interactions required close monitoring, alteration of drug dosage, or timing of administration. In 7.0% of cases, the interactions arose from contraindications that required the suspension of the concomitant drug. In 11.6% of cases, medicinal plants or foods were withdrawn.

CONCLUSIONS:

The simplified regimen of OBV/PTV/r+DSV administered for 12 weeks is effective and safe in patients with chronic HCV genotype 1b infection and compensated cirrhosis. No adverse reactions related to drug-drug interactions were recorded.
Assuntos


Texto completo:Disponível Coleções:Bases de dados internacionais Base de dados:MEDLINE Assunto principal:Antivirais /Hepacivirus /Hepatite C Crônica /Cirrose Hepática Tipo de estudo:Estudo de etiologia /Estudo de incidência /Estudo observacional /Fatores de risco Idioma:Inglês Revista:Expert Opin Drug Saf Assunto da revista:Farmacologia /Terapia por Medicamentos Ano de publicação:2018 Tipo de documento:Artigo País de afiliação:Espanha

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Texto completo:Disponível Coleções:Bases de dados internacionais Base de dados:MEDLINE Assunto principal:Antivirais /Hepacivirus /Hepatite C Crônica /Cirrose Hepática Tipo de estudo:Estudo de etiologia /Estudo de incidência /Estudo observacional /Fatores de risco Idioma:Inglês Revista:Expert Opin Drug Saf Assunto da revista:Farmacologia /Terapia por Medicamentos Ano de publicação:2018 Tipo de documento:Artigo País de afiliação:Espanha
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