Early Look at Two New Hepatitis C Pangenotypic Therapies

Digestive Disease Week (DDW) 2017

Nancy S. Reau, MD


June 13, 2017

Screening Efforts

Despite the incredible evolution in hepatitis C (HCV) therapeutics, much remains to be done to affect the incidence, prevalence, and morbidity caused by this silent but curable disease. Several presentations at the recent Digestive Disease Week (DDW) meeting offer new perspectives in screening, reinfection, and therapy.

Risk-based screening was the primary way to identify individuals with chronic HCV until 2012, when the Centers for Disease Control and Prevention released recommendations to screen Americans born between 1945 and 1965, the birth cohort with the highest prevalence of chronic HCV and the most chronically infected with advanced fibrosis.

This update was not meant to replace risk-based screening but rather to augment the testing. Still, many chronically infected individuals remain unaware of their disease. Some guilt can be laid at the feet of providers who may not ask questions to identify high-risk behaviors or fail to screen those in the aforementioned birth cohort. Because the disease is frequently without symptoms, patients also may not realize that they are infected until they advance to end-stage liver disease or develop malignancy.

Udompap and colleagues[1] proposed a new algorithm for screening based on standard labs that highlight risk for advanced liver disease. The authors stratified participants in the National Health and Nutrition Examination Survey 1999-2012 by FIB-4 and APRI scores as abnormal (FIB-4 >1.45 and APRI >0.5) or high (FIB-4 >3.25 and APRI >1.5). Prevalence of HCV was much higher in both the birth cohort and non-baby boomer birth cohort with abnormal values. The authors concluded that up to 66% of the non-birth cohort could be diagnosed if testing for HCV was performed in those with abnormal ALT or APRI.

Our goal is to identify and cure HCV prior to advanced fibrosis, as this offers the best reduction in liver-related mortality/morbidity.

Again, this should not replace birth cohort screening. Our goal is to identify and cure HCV prior to advanced fibrosis, as this offers the best reduction in liver-related mortality/morbidity.

Disrupting Transmission

As we work toward using treatment to decrease the health-related consequences of HCV, we also focus on its ability to disrupt transmission. Key to this end is treating individuals who engage in injection drug use.

C-EDGE CO-STAR is a 3-year study that first demonstrated high efficacy (sustained virologic response [SVR], 91%-96%) in participants on opioid agonist therapy. Researchers presented the 6-month interim results of an anticipated 3-year follow-up.[2] Of 199 participants, 21% reported injecting drugs in the past 30 days. Although none reported needle sharing, 42% shared other injecting equipment, a practice that also can facilitate HCV transmission. During this 6-month period, there were eight reinfections, of which three spontaneously cleared.

Although many payers limit access of therapy on the basis of active drug use and may not reimburse for re-treatment, 2.5 reinfections per 100 patient-years supports therapy in this population.


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