OHP-022 Evaluation of efficacy and safety of hepatitis C virus treatment with the new direct acting antivirals in the clinical practice of a regional hospital

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Abstract

Background

Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide. Clinical care for patients with HCV related liver disease has progressed considerably over the past years, thanks to improvements in pharmacological treatment, especially with the new direct acting antivirals (DAAs).

Purpose

To evaluate the efficacy and safety of treatment of HCV with the new DAAs in clinical practice.

Material and methods

This was a prospective, descriptive and observational study carried out in a regional hospital from May 2015 to July 2016 in HCV patients. In this area, there are approximately 447 cases of positive HCV. Treatment with DAAs included sofosbuvir, simeprevir±ribavirina; ledipasvir+sofosbuvir±ribavirina; daclastavir+sofosbuvir±ribavirina; ombitasvir+paritaprevir+ritonavir+dasabuvir±ribavirina and sofosbuvir±ribavirina. Variables studied were age, sex, hepatic fibrosis stage, HCV genotype, treatment duration, HCV-RNA level at weeks 4, 12, post-12 (sustained virological response, SVR) and adverse events.

Results

The study included 50 patients with HCV treated with DAAs, 36 (72%) men with a mean age of 58.3 (43–78) years. Only 4 (8%) were HIV coinfected. 35 (70%) patients had grade 4 fibrosis (F4) with compensated cirrhosis and 11 (22%) had grade F3. Genotype distribution was genotype 1b (50%), 1a (16%), 4 (10%), 3 (12%), 1ab (6%), 1 (2%), 1ac (2%) and 2 (2%). 22 (44%) patients were treated with the combination sofosbuvir+simeprevir±ribavirin (2 HIV coinfected); 12 (24%) with ledipasvir+sofosbuvir±ribavirina (1 HIV coinfected); 6 (12%) with daclastavir+sofosbuvir±ribavirina (1 HIV coinfected), 9 (18%) with ombitasvir+paritaprevir+ritonavir+dasabuvir±ribavirina and 1 (2%) with sofosbuvir±ribavirina. 28 (56%) patients achieved undetectable HVC-RNA at week 4. At the end of the treatment, 96% of patients reached SVR. The only adverse event detected was a case of photosensitivity skin reaction that was attributed to simeprevir. No patient had to stop treatment because of adverse effects.

Conclusion

Treatment of patients with HCV with new DAAs is considered a highly effective and safe therapy, obtaining SVR of 96%. Only one adverse event was observed. Although the endpoint of therapy is undetectable HCV-RNA 12 weeks post-treatment, in this study 28 (56%) patients reached SVR at week 4.

Conclusion

No conflict of interest

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