Background In clinical trials, direct-acting antiviral (DAA) drugs stop hepatitis C virus (HCV) proliferation with efficacy rates near 100% in F0–F1 patients.
Purpose To describe and analyse the effectiveness and safety profiles of DAA drugs in patients with F0–F1 fibrosis stage in a university hospital.
Material and methods A retrospective, observational study. All patients with F0–F1 fibrosis stage who had initiated their treatment with DAA drugs between August 2015 and March 2018 were included. The variables collected from electronic clinical history were: demographics (age, sex), virus genotype, previous antiviral treatment, DAA agent and duration of the treatment, HIV coinfection, adverse events (AE) reported by patients and sustained viral response at week 12 (SVR12) defined as a viral load in blood less than 15UI/ml 12 weeks after having completed the treatment.
Results One-hundred and sixty-five patients were included: the median age was 53.5 years (48.5–60.5), 70 (42.4%) were males and 16 (9.7%) HIV-coinfected.
The most common virus was genotype 1 HCV, with 135 (81.8%) infected patients. Sixteen (9.7%) were infected with genotype 4, 10 (6.1%) with genotype 3 and four (2.4%) with genotype 2 HCV.
ne-hundred and forty-eight patients (89.7%) were treatment-naive. Of the total, 48 (29.1%) were treated with ledipasvir/sofosbuvir, 40 (24.2%) with elbasvir/grazoprevir and 32 (19.4%) with ombitasvir/paritaprevir/ritonavir/dasabuvir, 19 (11.5%) with glecaprevir/pibrentasvir, 14 (8.5%) with velpatasvir/sofosbuvir, seven (4.2%) with ombitasvir/paritaprevir/ritonavir and five (3.0%) with other sofosbuvir-based regimens.
The effectiveness rate was 95.8%: 158 patients achieved the SVR12. One patient (0.6%) abandoned the treatment, and three (1.8%) completed it but were lost to medical follow-up before determining SVR12. Three patients (1.8%) had undetectable viral load during the treatment, but they did not achieve SVR12. Further analysis confirmed mutations of the virus genotypes, which had made them resistant to treatment.
Seventy-seven patients (46.7%) were cured after only 8 weeks of antiviral treatment, 78 (47.3%) after 12 and three (1.8%) after 16 week treatment.
No patient left the treatment because of AE. During the treatment, 37 (22.4%) felt more tired, 21 (12.7%) had headaches, eight (4.8%) had gastrointestinal AE and seven (4.2%) experienced itching.
Conclusion Our real-world data coroborates clinical trials. The high effectiveness rates and good safety profiles of DAA permits the treatment of F0–F1 patients, which may help to eradicate HCV infection, a public health problem.
References and/or acknowledgements No conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.