Background The approval for the clinical use of direct-acting antivirals in 2011 (boceprevir [BOC] and telaprevir [TLV], viral NS3 protease inhibitors) has increased recovery rates by up to 70%. However follow-up of these patients is necessary due to adverse effects (AEs) and the high cost of the treatment.
Purpose To follow up the pharmacotherapy in chronic hepatitis C virus genotype-1.
(VHC-1) patients treated with triple therapy (TT): BOC or TLV, ribavirin and peg-interferon.
To evaluate the efficacy of the treatment and describe the pharmacological handling of severe AEs.
Materials and Methods Prospective study (from 01/01 to 30/9/2012) was carried out in the Pharmacy Department. VHC-1 patients who started TT were included. All of them had at least one viral load (VL) determination (BOC at week 8 and TLV at week 4).
A hospital pharmacist interviewed the patient at the first day treatment and provided oral and written information about how to take the drugs and their potential AEs.
Later, we analysed the compliance of the treatment to the guidelines of Spanish Agency for Drugs. Patient data (age, sex, basal LV at week 4 and week 8, previous treatment response, fibrosis and haemoglobin levels) were collected from electronic clinical histories and outpatient software.
Results 35 patients were included (22 TLV and 13 BOC), 28 had initial VL > 800000 IU/mL. 34 patients had fibrosis grade ≥3.13 patients were treatment-naive, 22 had been treated previously (9 non-responders, 8 relapsers, 5 partial responders). 2 BOC patients obtained fast viral response vs. 4 TLV patients, and 7 BOC patients had undetectable VL at the week 8 cheque-up vs. 16 TLV patients at week 4 cheque-up.
5 patients (4 with BOC) discontinued treatment, one due to severe toxicity and 4 due to lack of efficacy. TT was effective and adhered to the guidelines in 84% patients.
The most frequent AEs were asthenia, anaemia and dermatological reactions (mainly with TLV). 9 patients presented grade 3 anaemia and were treated with erythropoiesis-stimulating agents (EEAs) (31% BOC vs. 23% TLV).
Conclusions The safety profiles of BOC and TLV found in our study were similar to those published in clinical trials. Despite not being a comparative study, we observed that more people in the TLV group reached undetectable VL after 4 or 8 weeks (91% TLV vs. 69% BOC). Patients treated with BOC had earlier suspended the TT because of lower effectiveness and higher occurrence of grade 3 anaemia that required EAAs.
No conflict of interest.
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