DI-082 Efficacy in clinical practice of new direct acting antivirals for the treatment of hepatitis C virus

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Abstract

Background

Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide. New direct acting antivirals (DAAs) have been licensed in the EU since 2014 and represent an improvement in effectiveness and safety of HCV treatment.

Purpose

To analyse the efficacy of DAAs and review possible factors, such as adherence and interactions, that may have been responsible in those patients where therapy was not effective. Compare sustained virological response (SVR) of our population with results from clinical trials.

Material and methods

A prospective observational study (October 2014–September 2016) was conducted in HCV patients who had completed treatment with DAAs and had SVR12 data. Protocols were reviewed, collecting for each patient: demographic data, genotype, fibrosis, prior treatment, viral load, treatment prescribed, concomitant treatment and interactions, adherence and SVR12.

Results

203 patients were enrolled (mean age 58 years, 61.6% men, 22.2% coinfected) Baseline characteristics: genotype: 1b, 53.2%; 1a, 19.2%; 1a/b, 2.9%; 3, 11.3%; 4, 10.9%; and others, 2.5%. Cirrhosis: 56.6%. Treatment experienced: 38.4%.

Results

SVR12 was 94.1% (91.6% in cirrhosis and 96.9% in non-cirrhosis). SVR12 was not 100%: genotype 1a non-cirrhotic (91.7% with ledipasvir/sofosbuvir); 1b non-cirrhotic (96.7% with ombitasvir/paritaprevir/ritonavir/dasabuvir) and cirrhotic (92.9% with ledipasvir/sofosbuvir and 97.2% with ombitasvir/paritaprevir/ritonavir/dasabuvir); 3 non-cirrhotic (69.2% with daclatasvir/sofosbuvir) and cirrhotic (90% with daclatasvir/sofosbuvir) and 4 cirrhotic (0% sofosbuvir/simeprevir/interferon and 92.8% with sofosbuvir/ledipasvir). 12 patients did not achieved SVR12 (41.6% coinfected, 75% naive). In 1 patient, adherence was <90% and 2 patients were taking drugs that could interact with DAAs (ledipasvir/sofosbuvir with omeprazole).

Conclusion

DAAs have proved highly effective in our population although slightly lower than expected according to clinical trials (SVR12 94–98% ledipasvir/sofosbuvir in genotype 1 and 4; 99–100% ombitasvir/paritaprevir/ritonavir/dasabuvir in genotype 1b; 97% daclatasvir/sofosbuvir in non-cirrhotic genotype 3), especially in genotypes 3 and 4, although this could be explained by the low number of patients in both. Most patients without SVR12 were adherents. In general, there were no interactions, and in those cases where interactions were detected, we recommended a regimen of the drug to avoid it, but if patient did not follow our recommendation, it could have affected the efficacy of DAAs.

References and/or acknowledgements

EASL recommendations on treatment of hepatitis C2015.

References and/or acknowledgements

No conflict of interest

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