Published online Jul 27, 2022. doi: 10.4254/wjh.v14.i7.1495
Peer-review started: April 3, 2022
First decision: May 12, 2022
Revised: May 26, 2022
Accepted: June 22, 2022
Article in press: June 22, 2022
Published online: July 27, 2022
Hepatitis C virus (HCV) infection has an incidence of around 1.1% worldwide, making it one of the main issues in the area of public health. Direct-Acting Antivirals (DAAs) have demonstrated a high response rate as an anti-HCV treatment, resulting in effective curative therapy in 95%-96% of cases, and is an affordable and cost-effective treatment. In Italy, approximately 50% of the population receiving assistance for substance use disorder (SSUDs) is positive for HCV infection. These services in Italy could be considered a “hot spot” for HCV screening and treatment because they avoid the typical health care pattern, create a dedicated link to a care strategy for patient retention, curing the condition, and improving adherence to therapy and follow-up.
To prospectively describe the experience of our HCV-dedicated multidisciplinary program at the SSUD of Trento (Northeast Italy), which focuses on providing anti-HCV therapy in infected "people who inject drugs" (PWIDs) with an active or past history of substance abuse.
To show the efficacy of our dedicated program in terms of therapy completion and PWIDs’ adherence to post-treatment controls. Secondary endpoints included HCV eradication, the rate of HCV reinfection after treatment, and DAA-related toxicity.
This study included: PWIDs attending our SSUD in Trento, with HCV-antibodies and HCV-RiboNucleic Acid (RNA) > 15 UI/mL, with history of substance abuse. In October 2020, a dedicated team was set up at the SSUD in Trento to provide opioid agonist therapy and DAA therapy to HCV RNA-positive to these patients. The team provided health education program, including counseling, planning of blood tests and visits. Indications for DAA therapy followed the World Health Organization criteria. The HCV genotype was assessed before treatment start and the stage of liver disease by transient elastography or Fibrosis 4 Score”, as recommended by the EASL Guidelines. The treatment regimen was based on the standard 12 wk oral schedule with Sofosbuvir/Velpatasvir or an 8 wk oral Glecaprevir/Pibrentasvir regimen. Treatment efficacy was evaluated by negative HCV RNA at the end of treatment and after 12 wk (SVR12), or by “delayed SVR” (SVR evaluated at any time after 12 wk).
Forty patients were included in the study, with active or past history of drug consumption and other psychoactive substances (i.e., benzodiazepines), and 37.5% with history of alcohol consumption. Twenty-eight patients (70.0%) were treated with Sofosbuvir/Velpatasvir, 12 (30.0%) received Glecaprevir/Pibrentasvir. The therapy cycle was completed by 40 patients (100%). All tested patients presented a negative viral load at the end of treatment and a sustained virologic response was observed in 92.5% (SVR12 + delayed SVR). Therapy was well-tolerated, except in two cases where the patients temporarily discontinued treatment and refused subsequent lab tests. Another patient elected to only be tested for HCV RNA at the end of treatment but refused all post-therapy controls. No significant drug interactions with commonly used psychiatric treatments or side effects were observed. One patient died of an overdose and another of cirrhosis complications following HCV eradication. One reinfection was observed ten months after SVR12.
In conclusion, targeted anti-HCV programs involving vulnerable infected patients, such as PWIDs, can be effective at improving patient compliance and eradicating infection with good tolerability. However, a larger prospective study is required to definitively confirm the efficacy of this initiative.
Despite the strength of a real-world setting and prospective design, this study has a major limitation. The findings are the result of intensive and time-consuming work, with the program having been applied to a small population on a local scale thus far. The question then becomes whether this type of model could be scaled up to a larger and more complex field while maintaining reasonable costs and demand for human resources. Based on the encouraging results achieved thus far, our next step will be to apply this multidisciplinary anti-HCV program to a larger PWID population and validate it in a larger-scale real-world setting.