scholarly journals Real-world Efficacy of Direct-Acting Antiviral Therapy for HCV Infection Affecting People Who Inject Drugs Delivered in a Multidisciplinary Setting

2018 ◽  
Vol 5 (6) ◽  
Author(s):  
Arshia Alimohammadi ◽  
Julie Holeksa ◽  
Astou Thiam ◽  
David Truong ◽  
Brian Conway
Keyword(s):  
Real World ◽  
People Who Inject Drugs ◽  
Hcv Rna ◽  
World Population ◽  
Model Of Care ◽  
Hcv Treatment ◽  
Direct Acting Antiviral ◽  
Hcv Therapy ◽  
Direct Acting ◽  
Multidisciplinary Model

Abstract Background Many clinicians and insurance providers are reluctant to embrace recent guidelines identifying people who inject drugs (PWID) as a priority population to receive hepatitis C virus (HCV) treatment. The aim of this study was to evaluate the efficacy of direct-acting antiviral (DAA) HCV therapy in a real-world population comprised predominantly of PWID. Methods A retrospective analysis was performed on all HCV-infected patients who were treated at the Vancouver Infectious Diseases Centre between March 2014 and December 2017. All subjects were enrolled in a multidisciplinary model of care, addressing medical, psychological, social, and addiction-related needs. The primary outcome was achievement of sustained virologic response (undetectable HCV RNA) 12 or more weeks after completion of HCV therapy (SVR-12). Results Overall, 291 individuals were enrolled and received interferon-free DAA HCV therapy. The mean age was 54 years, 88% were PWID, and 20% were HCV treatment experienced. At data lock, 62 individuals were still on treatment and 229 were eligible for evaluation of SVR by intent-to-treat (ITT) analysis. Overall, 207 individuals achieved SVR (90%), with 13 losses to follow-up, 7 relapses, and 2 premature treatment discontinuations. ITT SVR analysis show that active PWID and treatment-naïve patients were less likely to achieve SVR (P = .0185 and .0317, respectively). Modified ITT analysis of active PWID showed no difference in achieving SVR (P = .1157) compared with non-PWID. Conclusion Within a multidisciplinary model of care, the treatment of HCV-infected PWID with all-oral DAA regimens is safe and highly effective. These data justify targeted efforts to enhance access to HCV treatment in this vulnerable and marginalized population.

scholarly journals Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol)

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029538 ◽  
Author(s):  
Matthew Hickman ◽  
John F Dillon ◽  
Lawrie Elliott ◽  
Daniela De Angelis ◽  
Peter Vickerman ◽  
...  
Keyword(s):  
Drug Treatment ◽  
People Who Inject Drugs ◽  
Scale Up ◽  
Treatment As Prevention ◽  
Hcv Treatment ◽  
Direct Acting Antiviral ◽  
Link Type ◽  
Hcv Prevalence ◽  
Chronic Hcv ◽  
Direct Acting

IntroductionHepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40% among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90%) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV ‘Treatment as Prevention’ (TasP) in PWID.Methods and analysisWe plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome – chronic HCV prevalence in PWID – is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a ‘virtual cohort’ of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes.Ethics and disseminationExtending HCV community care pathways is covered by ethics (ERADICATE C,ISRCTN27564683, Super DOT C Trial clinicaltrials.gov:NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.

scholarly journals High Rates of Hidden HCV Infections among Hospitalized Patients Aged 55–85

Pathogens ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 695
Author(s):  
Annarita Valeria Piazzolla ◽  
Giulia Paroni ◽  
Francesca Bazzocchi ◽  
Mauro Cassese ◽  
Antonio Cisternino ◽  
...  
Keyword(s):  
Antiviral Agents ◽  
Laboratory Data ◽  
Clinical History ◽  
Hcv Infection ◽  
High Rate ◽  
Hcv Rna ◽  
Hcv Treatment ◽  
Direct Acting Antiviral ◽  
Hcv Screening ◽  
Direct Acting

Background and Aims: The WHO has solicited all countries to eliminate HCV by 2030. The Italian government started routine screening for HCV infection in January 2021, initially targeting subjects born between 1969 and 1989. With the aim of achieving micro-elimination, we designed a hospital-wide project focusing on inpatients born from 1935 to 1985 and conducted it in our institution. Method: All inpatients aged 35 to 85, admitted from 10 February 2020 to 9 February 2021 for many different diseases and conditions underwent HCV antibody (HCVAb) testing by third-generation ELISA. When positive, reflex HCV RNA testing and genotyping were performed. Clinical history, fibrosis diagnosis, laboratory data and concomitant medications were available for all. Results: The HCV screening rate of inpatients was 100%. In total, 11,748 participants were enrolled, of whom 53.50% were male. The HCVAb positivity rate was 3.03%. The HCVAb rate increased with age and was higher for patients born between 1935 and 1944 (4.81%). The rate of HCV RNA positivity was 0.97%. The vast majority (80.70%) of HCV RNA-positive participants were 55 or older; in about 40% of cases, HCV RNA-positive patients were unaware of their infection. Although 16 patients died after HCV chronic infection diagnosis (two due COVID-19) or HCV treatment prescription (one due to COVID-19), 74.56% of patient HCV diagnoses were linked to HCV treatment, despite their co-morbidities. All patients older than 65 who died had an active HCV infection. Conclusion: The present study revealed a rate of active HCV infections among inpatients lower than what has been reported in the past in the general population; this appears to be a result of the widespread use of pangenotypic direct-acting antiviral agents (DAAs). The overall rate of active infection was lower than the rate observed in the 1935–1954 cohort. The high rate of inpatients unaware of HCV infections and the high number of deaths among subjects with an active HCV infection born from 1935 to 1954, suggest that, at least in southern Italy, targeted screening of this birth cohort may be required to reduce the number of undiagnosed cases and hidden infections.

scholarly journals Incidence and Impact of Persistent Viremia on SVR Rates in Patients Receiving Direct-Acting Antiviral Therapy

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Alicia B Carver ◽  
Autumn D Zuckerman ◽  
Joshua DeClercq ◽  
Leena Choi ◽  
Cody A Chastain
Keyword(s):  
Antiviral Therapy ◽  
Real World ◽  
Sustained Virologic Response ◽  
Response Rates ◽  
Virologic Response ◽  
Direct Acting Antiviral ◽  
Rapid Virologic Response ◽  
Persistent Viremia ◽  
Direct Acting ◽  
High Sustained Virologic Response

Abstract Rates of persistent viremia (PV) while on direct-acting antiviral therapy were low (5.7%) in a real-world cohort of 983 patients. High sustained virologic response rates were achieved both in patients with PV (92.9%) and those with rapid virologic response (96.5%), without significant differences.

scholarly journals Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study

2020 ◽  
Author(s):  
Kristina M Brooks ◽  
Jose R Castillo-Mancilla ◽  
Mary Morrow ◽  
Samantha MaWhinney ◽  
Sarah E Rowan ◽  
...  
Keyword(s):  
Drug Use ◽  
Linear Models ◽  
Virologic Response ◽  
Directly Observed Therapy ◽  
Hcv Treatment ◽  
Open Label ◽  
Direct Acting Antiviral ◽  
Intention To Treat ◽  
Adherence Data ◽  
Direct Acting

Abstract Background HCV treatment in persons who use drugs (PWUD) is often withheld due to adherence and reinfection concerns. Here, we report treatment outcomes, technology-based adherence data, and adherence predictors in PWUD and/or alcohol. Methods INCLUD was a prospective, open-label study of ledipasvir/sofosbuvir for 12 weeks in PWUD aged 18-70 years. Participants were randomized to wireless (WOT, Wisepill®) or video-based directly observed therapy (vDOT, Emocha®). Drug use was assessed every 2 weeks. Sustained virologic response (SVR) was examined by intention-to-treat and as-treated. Factors associated with missing ≥1 dose(s) between visits were examined using generalized linear models. Results Sixty participants received ≥1 ledipasvir/sofosbuvir dose (47 HIV/HCV, 13 HCV only; 78% male; 22% Black; 25% cirrhotic). Substance use occurred at 94% of person-visits: 60% marijuana, 56% alcohol, 37% methamphetamine, 22% opioids, 17% cocaine, and 20% injection drug use. SVR by intention-to-treat was 86.7% (52/60) and as-treated was 94.5% (52/55). Confirmed failures included 1 relapse, 1 reinfection, and 1 unknown (suspected reinfection). Median (IQR [range]) total adherence was 96% (85-100% [30-101%]) and between-visit adherence was 100% (86-100% [0-107%]). Odds [95% CI] of missing ≥1 dose between visits increased with HIV coinfection (2.94 [1.37, 6.32], p=0.006), Black race (4.09 [1.42, 11.74], p=0.009), methamphetamine use (2.51 [1.44, 4.37], p=0.0.001) and cocaine use (2.12 [1.08, 4.18], p=0.03), and decreased with marijuana use (0.34 [0.17, 0.70], p=0.003) and vDOT (0.43 [0.21, 0.87], p=0.02). Conclusions PWUD achieved high SVR rates with high, but variable, ledipasvir/sofosbuvir adherence using technology-based methods. These findings support efforts to expand HCV treatment in PWUD.

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