Infectious Diseases Department
St Antoine Hospital
Karine Lacombe, MD, PhD, has disclosed that she has received consulting fees from AbbVie, Gilead Sciences, and Janssen.
In France, despite broad access to HCV screening and direct-acting antiviral (DAA) therapy fully reimbursed by national health services, it was estimated that 110,000 individuals chronically infected with HCV remained to be treated in early 2018. Approximately 58,000-69,000 of these individuals were unaware of their HCV status. Given that healthcare-associated HCV infection has been eliminated in the modern era, this undiagnosed population largely draws now from 3 key risk groups: persons who inject drugs (PWID), men who have sex with men (MSM) and engage in high-risk sexual behaviors combined with drug use (called “chemsex”), and individuals emigrating from countries with a high prevalence of HCV. Recognizing these source populations, how can we effectively identify and treat these patients—thereby preventing further transmission of HCV?
HCV Treatment in France: Then and Now
Historically, one of the greatest barriers to linkage to care was the requirement for patients to undergo liver assessment and HCV treatment in hospital settings. Furthermore, the ability to prescribe treatment was restricted to liver, internal medicine, or infectious diseases specialists. These burdensome requirements inhibited our most vulnerable and tenuously linked patients from seeking care for fear of stigmatization.
Then, in May 2018, the French Ministry of Health launched a new era in HCV care and management in France: DAAs could now be purchased from pharmacies outside of hospital settings. In early 2019, it was planned that general practitioners and addiction specialists would be able to prescribe DAAs. Although these new initiatives are not fully implemented as of April 2019, clinicians in primary care and opioid substitution centers are preparing to soon provide HCV screening and treatment to those most in need.
These new initiatives will aid in effectively implementing the HCV “treatment as prevention” model. As already demonstrated in the context of HIV infection, treating to prevent transmission is the cornerstone of microelimination in groups at high risk of infection and reinfection. Shortening the time between positive screening and treatment initiation is a crucial step toward success. Thus, point-of-care molecular tests are being implemented in the clinic whenever possible. The French Association for the Study of the Liver (AFEF) has also published a simplified algorithm for liver assessment and HCV treatment, based on the identification of patients with easy-to-treat infections who do not require specialized HCV management in tertiary care centers.
Translating Guidelines Into Practice
How do these new initiatives and guidelines translate into daily clinical practice? First, all individuals should be offered a one-time opportunity for HCV screening, along with screening for HBV and HIV infections, as recommended by national guidelines. In my patients who have a positive HCV screen, I then confirm HCV replication with point-of-care nucleic acid amplification testing (NAAT). I rule out cirrhosis using portable FibroScan and carefully assess the patient’s medical history for other comorbidities. Although active drug use or alcohol consumption do not preclude HCV treatment, I reinforce counseling around adherence when addiction issues are present.
Regarding which DAA regimen to use, genotyping is no longer necessary in the setting of a first HCV infection. Within 2 days to 1 week after HCV diagnosis, I start the patient on one of 2 recommended first-line regimens, sofosbuvir/velpatasvir or glecaprevir/pibrentasvir. At 12 weeks after the end of treatment, I check for cure with point-of-care NAAT. This strategy of “treating all and early” also applies to those presenting with acute HCV infection. I anticipate that when this simplified strategy is widely implemented, France should be on track to eliminate HCV by 2025!
What have been your greatest challenges in counseling and treating PWID, MSM engaging in high-risk sexual practices, and other groups at high risk for HCV infection? I invite you to share your experiences in the comments box.