Test-and-treat approach with Epclusa effective for HCV in prisons

A real-world analysis has shown that a test-and-treat approach coupled with treatment with Epclusa is feasible and results in high cure rates among incarcerated patients with hepatitis C.

“We know that persons who are incarcerated worldwide represent a very high-risk group for HCV infection and that engagement and treatment of this patient population is critical to achieve WHO elimination targets for HCV by 2030,” Alexander Wong, MD, FRCPC, from the University of Saskatchewan in Canada, said during a virtual poster presentation at The Liver Meeting Digital Experience. “The key principles to achieving better outcomes in this patient population is simplifying the cascade of care and initiating treatment as quickly as possible, ideally via a test-and-treat approach.”

Wong and colleagues assessed data from 20 clinical cohorts across six different countries to evaluate the effectiveness of Epclusa (sofosbuvir/velpatasvir, Gilead) in incarcerated adults with HCV. Patients were included in the analysis if they completed their treatment course before February 2020 while incarcerated. Exclusion criteria included history of hepatic decompensation, prior NS5A inhibitor exposure, hepatocellular carcinoma or treatment with a regimen that contained ribavirin.

The researchers also considered two study populations. The full study population included 526 people and the effectiveness population included all persons who had sustained virologic response 12 or 24 weeks after the end of treatment. Eighty-four patients, or 16%, of the full study population did not have SVR data available, most of whom were lost to follow-up.

Study endpoints included SVR at 12 and 24 weeks, adherence to therapy as evaluated by the treating physician and time between HCV RNA diagnosis and initiation of treatment with sofosbuvir/velpatasvir.

The majority of patients were men and had fibrosis stage between F0 and F2. Approximately 85% were treatment-naive and nearly 90% of all patients were genotype 1 or genotype 3, according to Wong. Many patients also had a history of or ongoing recreational drug use as well as concurrent mental health disorders, such as anxiety, depression and bipolar disorder.

For the approximately 90% of patients with available information on adherence, 98.5% had greater than 90% adherence to therapy as deemed by their treating physician, Wong said. The researchers also noted a wide distribution of time to initiation from HCV RNA diagnosis, with slightly more than 60% being treated within 3 months of diagnosis and nearly 80% within 6 months of diagnosis.

The efficacy of sofosbuvir/velpatasvir in the population for which SVR data were available was extremely high — nearly 100% — regardless of fibrosis stage, genotype or concurrent complicating characteristics, such as injection drug use, mental health disorder and use of antipsychotic drugs. There was also no difference in cure rates among patients who initiated treatment at different time points relative to diagnosis, according to Wong.

“This real-world dataset of sofosbuvir/velpatasvir utilized in correctional settings around the world showed that a test-and-treat approach for persons in corrections is feasible and that sofosbuvir/velpatasvir is effective when used in this setting, regardless of baseline characteristics, such as advanced fibrosis, mental health concerns or active injection drug use,” Wong said.

“We expect that sofosbuvir/velatasvir will be used successfully in settings around the world to continue to treat HCV in persons who are incarcerated.”