ABSTRACT
Plain language summary Achievement of elimination of HCV as a major public health threat requires focus on vulnerable populations such as people in prison. The prison population is at high risk of HCV infection but their treatment is complicated by social issues such as mental health disorders and drug use. Simple and effective treatment regimens are required to increase access to treatment and improve cure rates. This real-world analysis across Europe and Canada analyzed data from 20 prison populations. HCV-infected individuals were treated with sofosbuvir/velpatasvir, a once daily treatment which requires minimal monitoring. This regimen achieved high cure rates in the prison population despite the existence of complicating social issues. Background: People in prison are at high risk of hepatitis C virus (HCV) infection and often have a history of injection drug use and mental health disorders. Simple test-and-treat regimens which require minimal monitoring are critical. Methods: This integrated real-world analysis evaluated the effectiveness of once daily sofosbuvir/velpatasvir (SOF/VEL) in 20 prison cohorts across Europe and Canada. The primary outcome was sustained virological response (SVR) in the effectiveness population (EP), defined as patients with a valid SVR status. Secondary outcomes were reasons for not achieving SVR, adherence and time between HCV RNA diagnosis and SOF/VEL treatment. Results: Overall, 526 people in prison were included with 98.9% SVR achieved in the EP (n = 442). Cure rates were not compromised by drug use or existence of mental health disorders. Conclusion: SOF/VEL for 12 weeks is highly successful in prison settings and enables the implementation of a simple treatment algorithm in line with guideline recommendations and test-and-treat strategies.
ABSTRACT
Background: New data collection in established longitudinal population studies provides an opportunity for studying the risk factors and sequelae of the novel coronavirus disease 2019 (COVID-19), plus the indirect impacts of the COVID-19 pandemic on wellbeing. The Extended Cohort for E-health, Environment and DNA (EXCEED) cohort is a population-based cohort (N>11,000), recruited from 2013 in Leicester, Leicestershire and Rutland. EXCEED includes consent for electronic healthcare record (EHR) linkage, spirometry, genomic data, and questionnaire data.
ABSTRACT
Background: The treatment of high priority populations, including patients actively using intravenous drugs (active PWID), must be prioritized to accomplish the WHO HCV elimination goals by 2030. Simplification of the treatment cascade is key to reaching this goal, even more so in the COVID-19 era Sofosbuvir/velpatasvir (SOF/VEL) is a protease inhibitor-free, pangenotypic, panfibrotic, single duration, single tablet regimen, to be taken without regards to food and with limited drug-drug interactions This real-world analysis evaluates SOF/VEL as a simple strategy to implement a testand- treat approach in HCV-infected active PWID Methods: Adult active PWID treated for HCV with 12 weeks SOF/VEL in different clinical settings were included from 25 cohorts in 6 countries Patients with a history of decompensation or prior NS5A-inhibitor exposure were excluded The endpoints were HCV cure (undetectable HCV RNA ≥12 after the end of therapy, SVR12) and time-to-treatment (TT) between most recent HCV RNA measurement and SOF/VEL treatment start Results: Analysis included 340 patients, mean age 44±10years, 84% male, 15% compensated cirrhotic (CC) and 8% treatment-experienced, with 43% genotype (GT) 1 and 41% GT3 73% of patients were diagnosed with a mental disorder, 27% were homeless and 21% incarcerated Of patients with TT available (n=334), 10% were treated the same day of diagnosis, 16% within 1 week, 39% within 1 month, and 69% within 3 months Treatment adherence below 90% was observed in 24 patients (8%) SVR12 is available for 254 patients (75%), as non-virological or unknown cause of failure was documented in 86 patients (25%), 79% due to lost-to-follow-up (LTFU) SVR12 was 98% overall (249/254), 98% (80/82) in non-cirrhotic and 95% (20/21) in CC patients Active PWID with mental disorders showed 97% SVR12 (181/186) Of active PWID with GT3 infection, 96% (104/180) were cured, including 95% (20/21) of those with CC Of 31 patients starting treatment within 1 week of diagnosis, all achieved SVR12 compared to 126/129 (98%) starting within 3 months of diagnosis Conclusion: SOF/VEL is a simple HCV treatment resulting in high cure rates in active PWID, including patients with multiple complicating factors LTFU remains a challenge in this population The simplicity of the SOF/VEL approach allowing for shortening of the patient care cascade and rapid treatment starts with high cure rates may help address this important issue.
ABSTRACT
Background: Stigma and poor linkage to care, amplified in the setting of the COVID-19 pandemic, are significant barriers for treating hepatitis C (HCV) in vulnerable patients, reducing our ability to implement a rapid test and treat (TnT) strategy with minimal monitoring within a simple patient cascade, as currently available HCV therapies would allow us to do This real-world analysis evaluates our ability to implement this approach in both general (GP) and vulnerable (VP) populations Methods: HCV-infected patients from 32 clinical cohorts in 8 countries treated with sofosbuvir/ velpatasvir without a history of decompensation or prior NS5A-inhibitor exposure were included in this analysis The VP included prisoners, homeless patients and patients with mental disorders Time to treatment (TT) between the most recent HCV RNA measurement and treatment initiation was estimated based on available data Results: A total of 2449 patients were included, 937 in GP (58% males), 1512 (72% males) in VP (59% with mental disorders, 31% homeless, 10% imprisoned) Mean age [standard deviation] was 55 [14] and 50 [14] years in GP and VP respectively Genotype 3 was observed in 35% and 33% respectively, compensated cirrhosis confirmed in 20% and 18% of GP versus VP. The median TT [MTT, interquartile range] was 55 days [23- 107] in GP and 60 days [27-132] in VP The longest MTT of 66 days [32-134] was observed in patients with mental disorders MTT was 63 days [29-149] in prisoners and 27 days [13-71] among the homeless Only 13% of GP and 8% of VP were treated the same day of diagnosis, and 70% of GP and 63% of VP were treated within 3 months In patients with mental disorders only 4% were treated the same day of diagnosis Cure rates were high and consistent with previously reported cure rates Conclusion: MTT varies across HCV patient groups, from over 6 months to 1 day This analysis shows that a quick treatment start is possible, both in general population and in vulnerable populations, supporting the feasibility of a TnT approach in all populations New strategies should be considered to engage patients with mental disorders in this model of care more effectively.