Implementing and scaling up HCV treatment services for people who inject drugs and other high risk groups in Ukraine: An evaluation of programmatic and treatment outcomes

Abstract

Background

HCV prevalence estimates among people who inject drugs (PWID) in Ukraine is high (60–90%), yet barriers to HCV treatment and care remain substantial including limited access to direct acting antiviral (DAA) medications. A feasibility scale-up project implemented HCV treatment in community-based settings to improve access to DAA treatment for key populations in this context.

Methods

Using program-level data and verified medical records, we describe the development, implementation processes and outcomes for HCV treatment for PWID and other risks groups. Most participants (76%) received a combination of sofosbuvir, pegylated interferon, and ribavirin for 12 weeks. Treatment enrollment started in June 2015; the first two waves are reported. Data on demographics, HIV characteristics, HCV genotype and RNA levels, including sustained virologic response (SVR) were obtained from verified medical records. We used logistic regression to examine the independent correlates of achieving a SVR.

Results

The project was implemented in 19 healthcare institutions from 16 regions of Ukraine, mainly within AIDS specialty centers. Our analytical sample included 1126 participants who were mostly men (73%) and the majority were HIV co-infected (79%). Treatment retention was 97.7%; the proportions of participants who achieved SVR for the overall sample and for those with complete data (N = 1029) were 86.2% (95% CI 84.08–88.19%) and 94.3% (95% CI 92.8–95.7%) respectively. The analysis of data restricted to only those with SVR data available showed that PWID who were currently injecting had comparable SVR rates (89.2%, 95% CI 81.5–94.5%) to PWID not injecting (94.4%, 95% CI 92.4–96.1), PWID on methadone (94.4%, 95%CI 92.4–96.1), and ‘other’ risk groups (95.2%, 95% CI 91.3–97.7). Independent factors associated with achieving a SVR were female sex (AOR: 3.44, 95% CI 1.45–8.14), HCV genotype 3 (AOR: 4.57, 95% CI 1.97–10.59) compared to genotype 1. SVR rates in PWID actively injecting did not differ significantly from any other group.

Conclusion

Both patient-level and structural factors influence HCV treatment scale-up in Ukraine, but patient-level outcomes confirm high levels of achieving SVR in PWID, irrespective of injection and treatment status.

Introduction

Worldwide, 71 million people are infected with hepatitis C virus (HCV) (Blach et al., 2017). Since 1990, HCV associated disability-adjusted life years have more than doubled and mortality continues to increase (Stanaway et al., 2016). People who inject drugs (PWID) account for most HCV cases in Eastern Europe and Central Asia with global prevalence of HCV among PWID exceeding 60% (Degenhardt et al., 2016).

Several prospective trials confirm high levels of efficacy and safety of treating HCV using direct-acting antiviral (DAA) medications in PWID receiving opioid agonist therapies (OAT) (Dore et al., 2016, Grebely, Dore et al., 2016, Grebely, Mauss et al., 2016), with sustained virological responses (SVR) approaching 96% (Grebely, Dore et al., 2016). These studies suggest that active drug use during HCV treatment did not impact treatment outcomes (Grebely, Mauss et al., 2016). Similarly, findings from longitudinal studies in real-world settings confirm these findings with no evidence of association between drug use and treatment non-adherence (Boglione et al., 2017, Mason et al., 2017, Read et al., 2017).

Despite evidence that HCV testing and treatment worldwide are increasing (Milne et al., 2015; Smith, Combellick, Jordan, & Hagan, 2015), PWID continue to lack access to effective treatment in low and middle-income settings (LMIC) (Harris, Albers, & Swan, 2015; Milne et al., 2015). Numerous system-level barriers continue to prevent PWID from receiving HCV treatment, including treatment cost, criminalization of drug use, restrictive treatment protocols, and stigma and discrimination in healthcare settings (Wolfe et al., 2015). To address such obstacles, several strategies have been recommended, including clinical training, outreach support, integrated and flexible treatment services, reduced medication costs, elimination of laws and regulations limiting PWID’s treatment access and retention (Bruggmann and Grebely, 2015, Wolfe et al., 2015).

Non-governmental organizations (NGOs) in Ukraine have been central to increasing access to HIV treatment, scaling-up HIV prevention and overcoming system-level barriers (Dutta, Wirtz, Baral, Beyrer, & Cleghorn, 2012; Dutta et al., 2013, Vitek et al., 2014), becoming a model for program development geared toward increasing access to HCV among PWID. Previous data also support the integration of HCV treatment within prevention and treatment services for PWID (Grebely et al., 2015; Sylla, Bruce, Kamarulzaman, & Altice, 2007), which has been crucial for overcoming barriers to HIV treatment.

Examination here describes the implementation process and assesses the treatment outcomes in an ongoing pilot project designed to expand access and overcome barriers to HCV treatment in Ukraine for the highest risk groups, focusing on several groups of PWID, including active and inactive injectors, those on OAT and other high risk groups.