Background New direct antiviral agents have caused marked evolution in the treatment of hepatitis C. However, it is necessary to demonstrate that this new therapeutic achieves higher response rates, lower complexity and better tolerability than older regimens in clinical practice.
Purpose To analyse the viral response and tolerability of direct antiviral agents in clinical practice in patients with hepatitis C.
Material and methods This was a prospective observational study conducted at the pharmaceutical care outpatient unit. All patients receiving treatment with new free interferon treatment from January 2015 to April 2016 were included. We evaluated analytical and clinical data: type of patient and treatment, degree of fibrosis, side effects, and viral load on completion of treatment and 24 weeks after completion of treatment. The information was obtained from the pharmacotherapeutic history, patient interview and laboratory register. Results are expressed as percentages and side effects as median (IQR)
Results 229 patients were included (72% men; 51% naïve; 22% coinfected): 10.6% had been treated with daclatasvir/sofosbuvir, 19.4% with ombitasvir/paritaprevir/ritonavir ± dasabuvir, 42.7% with ledipasvir/sofosbuvir and 27.3% with simeprevir/sofosbuvir. In 59.9% of cases, these treatments were combined with ribavirin. Degree of fibrosis: 0.9% F0, 6.1% F1, 22.5% F2, 22.5% F3 and 55.1% F4. Duration of treatment was 12 weeks for 86.7% of patients and 24 weeks for the reminder. When the treatment was finished, 89.7% obtained undetectable viral load, 0.4% detectable viral load, 6.6% unknown viral load and 1.3% death before the finish. At 24 weeks after the finished treatment, 95.8% obtained undetectable viral load: 100% of patients treated with daclatasvir/sofosbuvir, 91.4% treated with simeprevir/sofosbuvir, 98.1% treated with ledipasvir/sofosbuvir and 100% treated with ombitasvir/paritaprevir/ritonavir ± dasabuvir. Regarding side effects, 23.4% of patients had asthenia, 17.5% had skin reactions, 12.9% had gastrointestinal reactions and 22.6% other reactions. The median number of side effects was 1 (0–7).
Conclusion New drugs show a high rate of response and are well tolerated. However, follow-up and pharmaceutical care in these patients has contributed to better management of side effects, resulting in better adherence and effectiveness.
No conflict of interest
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