ABSTRACT
Background: In France, prescribing authorization for hepatitis C virus (HCV) treatment has been expanded to all physicians including non-specialists working in addiction and psychiatric centers and in jails. Patient management includes a Test and Treat approach (TnT) to expedite treatment initiation and a pathway for severe patients followed-up by specialists. This is a descriptive, interim analysis of an ongoing study to assess the efficacy and safety of Sofosbuvir/Velpatasvir (SOF/VEL) for 12 weeks after prescription expansion in patients treated by specialists and non-specialists. Method(s): Included patients are HCV-infected adults following SOF/VEL-based regimens prescribed by primary care physicians and specialists. Data collected from available information in medical records include patient characteristics, number of days between positive PCR/fibrosis assessment and start of therapy, and proportion of patients with sustained virologic response (SVR) 12 weeks after treatment end. Qualitative variables are described as number and percentage (%);quantitative measures as mean (standard deviation;SD) or median (range) as indicated. Result(s): Table) As of January 2022, 286 patients had received at least one dose of SOF/VEL treatment;217 were managed by specialists and 69 by non-specialists. Median patient age was 53.14 years (19.8-88.7), 80 (28%) were F3/F4 and 185 (64.7%) were male. Occasional and excessive consumption of alcohol was reported in 43 (62.3%) and 87 (40.8 %) patients managed by specialists and non-specialists respectively. Current recreational drug use was reported more frequently in 37 patients (53.6%) managed by non-specialists and 40 patients (18.6%) managed by specialists. Mean number of days between SOF/VEL initiation and fibroscan and Fib 4 were 62.16 +/- 306.39 and 40.35 +/- 60.24, respectively. Median number of days between positive PCR and start of therapy was 89.19 +/- 311.17 and 60.65 +/- 80.71 for patients managed by specialists and non-specialists respectively, and only 2 were lost to follow-up. Among 167 eligible patients who achieved an SVR12, 124 (97.6%) [93.28;99.19] were managed by specialists and 40 (100.0%) [91.24;100.00] by non-specialists;according to fibrosis stage, 107 F0-F2 patients (100.0%) and 39 F3-F4 (92.9%) achieved SVR12. Overall, at least one adverse event was observed in 34 patients (11.9%), of which only 2 (0.7%) lead to drug withdrawal. Conclusion(s): This interim analysis describes a French study population benefiting from SOF/VEL in real world use after treatment prescription expansion. SVR12 rates were high, regardless of the type of patient management and stage of fibrosis suggesting that HCV patients could be treated by SOF/VEL for 12 weeks by non-specialists. Despite the COVID 19 situation this study suggested that HCV patient pathway could be more optimized regarding fibrosis assessment or genotype determination.
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.