HCV Treatment as Prevention in Italy: Overcoming Regulatory Barriers

Alessio Aghemo, MD, PhD

Associate Professor of Gastroenterology
Department of Biomedical Sciences
Humanitas University
Division of Internal Medicine and Hepatology
Department of Gastroenterology
Humanitas Research Hospital
Milan, Italy

Alessio Aghemo, MD, PhD, has disclosed that he has received consulting fees and fees for non-CME/CE services from AbbVie, Gilead Sciences, Intercept, and Merck; has received funds for research support from AbbVie; and has ownership interest in Aimmune Therapeutics.

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Released: August 2, 2019

With direct-acting antivirals (DAAs) now available in Italy, it is possible for patients with HCV to achieve SVR, thereby mitigating HCV-associated liver complications and halting HCV transmission. This beneficial effect of DAAs on HCV transmission underlies the treatment as prevention (TasP) model. By implementing TasP, we can cure HCV in Italian populations at high risk of transmission, thereby decreasing the incidence of new cases and benefiting public health. However, we currently face multiple barriers to successfully implementing TasP in Italy.

Epidemiology of HCV in Italy
To design effective TasP programs, we must first identify populations in which HCV transmission is more common. The epidemiology of HCV in Italy differs from that of other European countries, in that many older Italians have HCV due to the common medical practice of reusing needles after World War II, which spread HCV through unsafe blood transfusions and other medical procedures. The national pattern of HCV transmission changed in the 1970s and 1980s, with HCV being mainly acquired through illicit drug injection with nonsterile needles. Following the discovery of HCV in 1989, the annual incidence rate of infection in Italy dramatically decreased—from 3.0 cases per 100,000 individuals in 1989 to 0.2 cases per 100,000 in 2016—with most newly diagnosed infections having been acquired either nosocomially or by drug injection.

Given that many new infections are associated with injection drug use, HCV treatment in people who inject drugs (PWID) is key to implementing TasP in Italy. HCV prevalence in Italian PWID is estimated to be 10% to 30%, with higher rates in people receiving opioid substitution therapy (OST), which is delivered through public drug addiction service units called SerDs managed by addiction specialists.

Barriers to TasP in Italy
Successfully implementing TasP requires rapidly diagnosing HCV in high-risk populations and efficiently linking individuals to treatment. Unfortunately, the diagnostic rate in Italy is still relatively low, with up to 40% of the HCV-infected general population remaining undiagnosed.

Although DAA treatment is universal in Italy, several barriers stand in the way of PWID receiving therapy. First, pretreatment characterization is unnecessarily complex for the DAA era, requiring HCV genotyping, FibroScan, and multiple biochemical assessments. Second, treatment administration is restricted to specialists and hospital units, meaning that SerDs cannot directly prescribe treatment. Finally, treatment is administered monthly by hospital pharmacies, meaning that regular follow-up visits need to be performed to receive DAAs.

As a clinician and member of national scientific societies focusing on liver diseases, it is my duty to fight for abolition of these barriers using scientific evidence. Indeed, most of these restrictions are not based on current evidence, but rather were introduced as cost-containing measures (eg, restricting treatment administration to specialists and hospital units) or are legacies from the interferon era (eg, complex pretreatment assessment and on-treatment monitoring). In the modern DAA era, pretreatment assessment can be limited to proof of HCV replication, disease stage assessment, and drug–drug interaction analysis. On-treatment monitoring can be abandoned, as it provides no clinical benefit. Last, treatment can be administered by nonspecialists without compromising SVR rates, as has been shown in multiple countries inside and outside of the European Union.

If Italy is to eliminate HCV infection, there is a strong need to change these regulatory barriers. Physicians and patients must work together to provide decision makers with data supporting the public and personal health benefits of TasP.

Your Thoughts?
What policies or restrictions surrounding HCV treatment would you change to more effectively implement TasP in your practice? Please share your thoughts in the comments box or read about progress toward HCV elimination in France, Germany, and Spain.

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