Background Boceprevir and telaprevir are two new drugs approved by the European Medicines Agency for the treatment of hepatitis C genotype 1. They are used in combination with ribavirin and peg-interferon to increase the response to treatment.
Purpose To analyse the evolution of the viral load and the adverse effects of boceprevir and telaprevir, at week 12 of treatment.
Materials and Methods We undertook a prospective observational study from November 2011 to October 2012 of patients who started treatment with boceprevir and telaprevir. Patients were monitored for 12 weeks after initiation of triple therapy. We also analysed the incidence of adverse effects during treatment. The data collected were: age, sex, grade of fibrosis, type of patient, baseline viral load, and viral load at weeks 4, 8 and 12. The data were consulted in the medical records of patients through the IMDHv.50 programme.
Results A total of 31 patients were followed up, eight treated with boceprevir and 23 with telaprevir. The median of age was 60 years. Regarding the type of patient, 10 were treatment naïve, 5 were relapsers, 7 non-responders, 4 presented side effects in previous treatment and 5 were partial non-responders. The median viral load was 2,682,000 IU/ml. At week 12, undetectable viral load was found in 26 (83.8%) patients (6 in the boceprevir group and 20 in the telaprevir group). Five patients (16.1%) had to discontinue treatment, four (12.9%) had >1000 IU/ml at week 12 and one (3%) due to pancreatitis. Adverse events observed during treatment are shown in the table.
Conclusions The data show an early decrease in the viral load of patients treated with triple therapy, becoming undetectable by week 12 in most cases. The side effects differed from those described in clinical trials, so more studies and post-marketing pharmacovigilance are needed.
No conflict of interest.
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