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: Several studies have been published on a rare side effect of severe venous thrombosis at unusual sites and thrombocytopenia after vaccination against SARS-CoV- 2, referred to as vaccine-induced immune thrombocytopenia and thrombosis (VITT). Aim(s): To identify new cases of acute splanchnic vein thrombosis (SVT) or Budd-Chiari Syndrome (BCS) who presented following SARS-CoV- 2 vaccination in the Vascular Liver Disease Group (VALDIG) network, and to evaluate the incidence of VITT. Method(s): We conducted a prospective international cohort study between May 1st, 2021 and January 10th, 2022, on consecutive patients with acute SVT or BCS who presented within 6 weeks following any type or dose of SARS-CoV- 2 vaccination. Anonymous data were collected including baseline characteristics, risk factors, treatment and survival. Cases were identified as definite VITT, probable VITT or possible VITT or unlikely VITT as defined by Pavord et al (NEJM 2021). Result(s): 25 patients with acute (N = 24) or recurrent (N = 1) SVT or BCS were collected from 14 centers in 4 countries (after ChAdOx1 nCoV-19 N = 11, BNT162b2 N = 9, Ad26.COV2.S N = 1, mRNA-1273 N = 1). Median time after vaccination to symptoms was 10 days (2-40). Median age was 52.5 years (21-66), 52% were female. Three patients (12%) fulfilled criteria for definite VITT, 6 (24%) for probable VITT, 2 (8%) for possible VITT, 14 (56%) for unlikely VITT. Thrombosis was located in the portal vein (N = 20), hepatic vein(s) (N = 9), mesenteric vein (N = 18) or splenic vein (N = 9). Concomitant extra-abdominal thrombosis was seen in 5 patients (20%). Patients were treated with LMWH (60%), DOACs (24%) or VKA (40%). Six (2/3 with definite VITT) received IVIG. Thrombophilia was found in 5 patients and 3 had a myeloproliferative neoplasm. Conclusion(s): 25 cases of acute SVT or BCS following SARS-CoV- 2 vaccination were identified. Although definite VITT was rare (12%), no underlying disorder was identified in the majority of patients, contrary to 'typical' cases of SVT and BCS.