Popis: |
Background and importance Over the last few years there have been remarkable advances in chronic hepatitis C virus (HCV) drug development, and the goals of most new regimens have been increasing sustained viral response rates (SVR), improving tolerability and shortened treatment duration. Aim and objectives To describe the use of glecaprevir/pibrentasvir in the treatment of HCV patients, as well as to evaluate efficacy and safety. Material and methods This was an observational retrospective study in all adult HCV patients who received treatment with glecaprevir/pibrentasvir between December 2017 and December 2018. Variables collected were age, sex, genotype, degree of fibrosis, type of patient (naive, relapsed or non-respondent), prior treatment, treatment duration, basal viral load (VL), VL at 12 weeks after finishing treatment and adverse reactions. As an indicator of effectiveness, SVR was used. Results A total of 37 patients (70.27% men) were analysed with a median age of 54 years (range 20–81). Six patients (16.22%) had genotype 1a, 10 (27.03%) had genotype 1b, 1 (2.70%) had genotype 2, 10 (27.03%) had genotype 3 and 10 (27.03%) had genotype 4. Regarding the degree of fibrosis, 7 patients (18.92%) were F0, 10 (27.03%) were F1, 9 (24.32%) were F2, 2 (5.41%) were F3, 3 (8.11%) were F4, and the degree of fibrosis was not determined in 6 patients (16.22%). Thirty (81.08%) were treatment naive patients, 4 (10.81%) failed prior treatment with interferon+ribavirin, 2 (5.40%) were non-responders to treatment with direct acting antivirals (DAA) and 1 (2.70%) was a non-responder to both interferon and DAA. Treatment duration was 8 weeks in 28 patients (75.68%), 12 weeks in 6 (16.22%) and 16 weeks in 3 (8.11%). Median baseline VL was 1 506 164 IU/mL (range 19 800–49 033 584), with 23 patients (62.16%) having >800 000 IU/mL. SVR was achieved in 33 patients (89.19%). VL was not determined in three patients, although two of them presented undetectable VL at the end of treatment and one patient died before reaching 12 weeks post treatment. Regarding safety, six patients suffered at least one adverse reaction: nausea (2), fatigue (2), gastrointestinal discomfort (2), gas (1), night sweats (1), dry mouth (1), diarrhoea (1) and headache (1). Conclusion and relevance Glecaprevir/pibrentasvir represents an effective pangenotypic therapeutic option for naive, non-responding and relapsing HCV patients due to the high percentage of patients who achieved SVR. Most of the adverse reactions reported were similar to those described in clinical trials, all of them being mild, and did not require interruption of treatment. References and/or acknowledgements No conflict of interest. |