CP-126 Effectiveness and safety assessment of direct acting antiviral in the treatment of chronic hepatitis C virus infection

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Abstract

Background

Direct acting antivirals (DAA) have become the elective treatment for chronic hepatitis C virus (HCV) infection but definitive data regarding routine medical practice are still limited.

Purpose

To assess the effectiveness and safety of DAA in the treatment of chronic HCV infection in a 300 bed general hospital.

Material and methods

This was an observational, retrospective, descriptive study conducted from December 2014 to February 2016. Inclusion criteria: HCV patients who started treatment with dasabuvir+paritaprevir–ombitasvir–ritonavir (DAS+OMBI/PARI/r), simeprevir (SIM), sofosbuvir+daclatasvir (SOF+DACL) or sofosbuvir–ledipasvir (SOF/LD) during the study period. Exclusion criteria: patients not achieving 12 weeks of treatment during the study period. Effectiveness variables: gender and age, genotype, fibrosis degree (F1–F4), HIV coinfection, basal viral load (VL), fast virologic response (FVR, VL ≤15 IU/mL) at week 4, VL at the end of treatment and sustained virological response (SVR) at week 12 post-treatment. Safety variables: adverse drug reactions (ADRs) and detected drug–drug interactions (DIs). Data were collected from the pharmaceutical managing programme, Farmatools, and from clinical reports, and were analysed using the SPSS statistical package.

Results

40 patients were included (30 men). Mean age: 55±2.36 years. 15 naïve patients (37.5%), 14 (35%) were HIV coinfected. Fibrosis degree: 21 F4 (52.5%), 11 F3 (27.5%) and 8 F1–F2. HCV genotype: 29 genotype 1 (72.5%), 6 genotype 4 (15%) and 5 genotype 3 (12.5%). 23 patients were treated with SOF/LDV (57.5%), 6 with DAS+OMBI/PARI/r (15%), 8 with SOF+DACL (20%) and 3 with SIM (7.5%). Effectiveness: 28 patients (70%) had basal VL >800 000 IU/mL. 31 patients (77.8%) achieved FVR. 100% achieved undetectable VL at the end of treatment. 34 (85%) patients maintained undetectable VL at 12 week post-treatment, 5 patients did not have VL determined and 1 rebounded (VL >800 000 IU/mL, HIV coinfected). 34 patients (85%) had no ADRs, 4 had gastrointestinal ADRs, 3 had asthenia, 2 had a mild allergic reaction and 1 had dizziness. DIs were detected with home medication in 17 patients: 12 with proton pump inhibitors, 5 with statins and 2 with oral antidiabetics and digoxin.

Conclusion

DAAs represent a great advance in HCV treatment. In our study, 100% of patients achieved undetectable VL at the end of the treatment and a high rate of SVR at week 12. DAAs are well tolerated but they require pharmacist intervention to avoid DIs.

Conclusion

No conflict of interest

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