Background Recently, new direct acting antivirals (DAAs) for chronic hepatitis C have been licensed. These drugs achieve a virologic sustained response (SVR) above 90% in clinical trials. SVR is defined as undetectable HCV RNA 12 weeks after treatment completion (SVR12).
Purpose To evaluate the effectiveness of treatment with new DAAs for chronic hepatitis C in real medical practice.
Material and methods Observational retrospective study that included patients with chronic hepatitis C treated with new DAAs, who had finished treatment and had results for HCV RNA levels 12 weeks post-treatment. We considered that the drug was effective if the patient achieved SVR12.
Data collected were: age, gender, HIV coinfection, prior treatment experience, genotype, hepatic fibrosis stage, DAA regimen and HCV RNA level.
Results We included 86 patients; 66% were males. Median age was 57 years (29–84). 31 (36%) patients were HIV coinfected. Regarding previous treatment, 38 (44%) patients were naïve, 26 (30%) non-responders, 13 (15%) relapsers, 7 (8%) partial responders and 2 (2.33%) patients had no data. The most frequent genotype was 1b (62%). The hepatic fibrosis stage was F4 in 55 (64%) patients, F3 in 19 (22%), F2 in 11 (13%) and 1 (1.16%) patient had no data. The treatment regimens were:
dasabuvir+paritaprevir/ritonavir+ombitasvir+ribavirine 12 weeks: 22 (25.58%) patients.
sofosbuvir+ledipasvir 8–12 weeks: 22 (25.58%) patients.
simeprevir+PegIFN+ribavirine 24 weeks: 5 (5.81%) patients.
sofosbuvir+daclatasvir 24 weeks: 7 (8.14%) patients.
sofosbuvir+daclatasvir+ribavirine 12–24 weeks: 6 (6.98%) patients.
sofosbuvir+simeprevir+ribavirine: 12 weeks: 13 (15.12%) patients and 24 weeks 4 (4.65%) patients.
sofosbuvir+simeprevir: 24 weeks, 4 (4.65%) and 12 weeks, 1 (1.6%) patient.
sofosbuvir+ribavirine 16 weeks: 1 (1.16%) patient.
paritaprevir/ritonavir+ombitasvir+ribavirine 12 weeks: 1 (1.16%) patient.
81 (94%) patients achieved RVS12.
Patients did not achieve RVS12 with: sofosbuvir+daclatasvir 24 weeks (2 patients), simeprevir+PegIFN+ribavirine 24 weeks (2 patients) and dasabuvir+paritaprevir/ritonavir+ombitasvir+ribavirine 12 weeks (1 patient).
Conclusion The RVS12 rate achieved with the new DAAs in this study matches the results obtained in published clinical trials. These results are very good but now we have to face the challenge of how to treat patients who have not responded to these therapies and look for possible causes, such as low adherence and resistance.
References and/or Acknowledgements
European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol 2015;63:199–236
References and/or AcknowledgementsNo 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.