COMMENTARY
Hepatitis C: Let's Get 'Real'
Digestive Disease Week (DDW) 2016
William F. Balistreri, MD
June 24, 2016
Hepatitis C virus (HCV) infection remains a significant problem worldwide, with risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. The good news is that with the development and validation of a spate of new direct-acting antiviral (DAA) drugs and novel treatment strategies, a significant proportion of patients can be cured of HCV infection.
Current highly successful strategic treatment approaches have achieved high sustained virologic response (SVR) rates in clinical trials. However, the question remains: Can this degree of success be replicated in a real-world application of these strategies? And will this level of success apply to all patients? Research presented at this year's Digestive Disease Week (DDW) discussed real-world outcomes and the prospects for ensuring the best outcome for all patients with chronic hepatitis C, including certain patient populations—those with cirrhosis or decompensated liver disease and those who failed to respond to treatment—who may require enhanced strategies such as a longer duration of therapy, the addition of ribavirin, or the use of new ribavirin-free combinations. There are also new possibilities, therapeutic agents that will soon be available to add to the expanding armamentarium of DAAs and combination regimens. For example, the next-generation investigational pangenotypic once-daily combination tablet containing 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) was granted priority review designation from the US Food and Drug Administration (FDA) and is scheduled for approval this quarter. A key area of concern is the possibility of treatment failure due to the existence and emergence of resistant variants of the virus. Investigators discussed the potential impact and use of regimens that offer non-overlapping resistance profiles.
Curative treatment has clear advantages compared with the management of end-stage disease, yet treatment costs and access to treatment for HCV infection are ongoing issues, even though increased competition among pharmaceutical manufacturers may ultimately reduce the price of DAA regimens.
Some of the relevant presentations from DDW 2016 in which investigators shed light on these important issues are highlighted herein.
Current highly successful strategic treatment approaches have achieved high sustained virologic response (SVR) rates in clinical trials. However, the question remains: Can this degree of success be replicated in a real-world application of these strategies? And will this level of success apply to all patients? Research presented at this year's Digestive Disease Week (DDW) discussed real-world outcomes and the prospects for ensuring the best outcome for all patients with chronic hepatitis C, including certain patient populations—those with cirrhosis or decompensated liver disease and those who failed to respond to treatment—who may require enhanced strategies such as a longer duration of therapy, the addition of ribavirin, or the use of new ribavirin-free combinations. There are also new possibilities, therapeutic agents that will soon be available to add to the expanding armamentarium of DAAs and combination regimens. For example, the next-generation investigational pangenotypic once-daily combination tablet containing 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) was granted priority review designation from the US Food and Drug Administration (FDA) and is scheduled for approval this quarter. A key area of concern is the possibility of treatment failure due to the existence and emergence of resistant variants of the virus. Investigators discussed the potential impact and use of regimens that offer non-overlapping resistance profiles.
Curative treatment has clear advantages compared with the management of end-stage disease, yet treatment costs and access to treatment for HCV infection are ongoing issues, even though increased competition among pharmaceutical manufacturers may ultimately reduce the price of DAA regimens.
Some of the relevant presentations from DDW 2016 in which investigators shed light on these important issues are highlighted herein.
Index
Hepatitis C: Let's Get 'Real'
Efficacy and Impact of Treatment
New Strategies
Special Populations
Can We Improve Outcomes?
Cost and Access
In The Journals
Access to Treatment Regimens in Chronic HCV Patients
Journal of Viral Hepatitis, June 24, 2016
Access to Treatment Regimens in Chronic HCV Patients
Journal of Viral Hepatitis, June 24, 2016
The Direct-acting Antiviral Era in HCV Cirrhosis
Alimentary Pharmacology & Therapeutics, June 24, 2016
HCV Transmission Associated With a CAM Injection Therapy
Morbidity & Mortality Weekly Report, June 23, 2016
Direct Acting Antiviral Therapy After Liver Transplantation
Current Opinion in Gastroenterology, June 22, 2016
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