Patient-Reported Symptoms During and After Direct Acting Antiviral Therapy for HCV

From a real-world study, researchers observed that patients with hepatitis C who received direct-acting antiviral medications did not experience significant changes in symptoms during treatment, except in 1346 patients who were cured and reported improvements in fatigue; sleep disturbance; and functional well-being, including pain and depression.

In real-world clinical practice, heterogeneous patient experiences occur during and after direct acting antiviral (DAA) therapy, and symptom improvement is often more pronounced in younger patients, according to a multicenter observational study published in the Journal of Hepatology.1

Patients with hepatitis C virus (HCV) infection often report various symptoms such as neuropsychiatric, somatic, and gastrointestinal symptoms that they attribute to the virus infection.2-4 Studies have demonstrated that health-related quality of life and other patient-reported outcomes improve during DAA therapy,5-7 but a comprehensive analysis of changes in symptoms and functioning during and after DAA therapy for chronic HCV has not been conducted for patients treated in real-world clinical settings. Therefore, researchers in the United States evaluated patient-reported outcomes in a diverse cohort of 1564 patients with HCV treated with commonly-prescribed DAAs (63% were prescribed sofosbuvir/ledipasvir; 21%, sofosbuvir/velpatasvir; 11%, grazoprevir/elbasvir; and 5%, paritaprevir/ombitasvir/ritonavir+dasabuvir).1 Overall, they found that these patients did not experience significant changes in baseline symptoms during treatment. However, they observed a full range of experiences, with some patients experiencing substantial symptom improvement, others experiencing less improvement, and some even experiencing a worsening of symptoms. Of these patients, 1346 were cured of HCV and experienced improvements in fatigue, sleep disturbance, and functional well-being and trends for improvement in pain and depression. However, 64 patients were not cured and experienced minimal improvement.

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“This comprehensive assessment of changes in neuropsychiatric, somatic and gastrointestinal symptoms, and functional well-being during and after therapy with all-oral DAA therapies provides new insights relevant to patients, clinicians and other stakeholders,” concluded the authors.1

1. Evon DM, Sarkar S, Amador J, et al. Patient-reported symptoms during and after direct acting antiviral therapies for chronic hepatitis C: The PROP UP Study [published online May 13, 2019]. J Hepatol. doi: 10.1016/j.jhep.2019.04.016.

2. Kleinman L, Mannix S, Yuan Y, Kummer S, L’Italien G, Revicki D. Review of patient-reported outcome measures in chronic hepatitis C. Health Qual Life Outcomes. 2012;10:92.

3. Lang CA, Conrad S, Garrett L, et al. Symptom prevalence and clustering of symptoms in people living with chronic hepatitis C infection. J Pain Symptom Manage. 2006;31:335-344.

4. Ferri C, Ramos-Casals M, Zignego AL, et al. International diagnostic guidelines for patients with HCV-related extrahepatic manifestations. A multidisciplinary expert statement. Autoimmun Rev. 2016;15:1145-1160.

5. Younossi ZM, Stepanova M, Zeuzem S, et al. Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: The VALENCE study. J Hepatol. 2014;61:228-234.

6. Younossi Z, Henry L. Systematic review: patient-reported outcomes in chronic hepatitis C – the impact of liver disease and new treatment regimens. Aliment Pharmacol Ther. 2015;41:497-520.

7. Younossi ZM, Stepanova M, Feld J, et al. Sofosbuvir/velpatasvir improves patient-reported outcomes in HCV patients: Results from ASTRAL-1 placebo-controlled trial. J Hepatol. 2016;65:33-39.