Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections—A Scandinavian real-life study

Dalgård, Olav; Weiland, Ola; Noraberg, Geir; Karlsen, Lars Normann; Heggelund, Lars; Färkkilä, M.; Balslev, Ulla; Belard, Erika; Øvrehus, Anne; Kjær, Mette; Krarup, Henrik; Røge, Birgit Thorup; Hallager, Sofie; Madsen, Lone Galmstrup; Laursen, Alex Lund; Lagging, Martin; Weis, Nina

doi:10.1371/journal.pone.0179764

Cited by 31 publications

(27 citation statements)

References 23 publications

(33 reference statements)

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“…Therefore our data underscores the importance of prolonging treatment duration to 24 weeks, as well as adding RBV when feasible, to obtain an improvement in SVR. These findings are supported by and consistent with other three reports in abstract form from other Italian regions [10][11][12] and two European studies [13,14]. The beneficial role of RBV in treating G3 cirrhotic patients is in fact suggested by improved virological rates in RBV-containing regimens also in the UK EAP study though the total number of patients treated without RBV was small and robust conclusion cannot be drawn [13].…”

Section: Discussionsupporting

confidence: 86%

“…The beneficial role of RBV in treating G3 cirrhotic patients is in fact suggested by improved virological rates in RBV-containing regimens also in the UK EAP study though the total number of patients treated without RBV was small and robust conclusion cannot be drawn [13]. Similar results are reported in the Scandinavian study where the addition of RBV even for 12 weeks' treatment showed a trend toward higher SVR12 [14]. However, our results are in contrast with a sub-analysis of an heterogeneous French early access program study by Hezode et al, which showed a lower SVR rates in 205 G3 cirrhotic patients treated for 24 weeks with the same regimens: SOF + DCV had 86% SVR12, while SOF + DCV + RBV had 82% SVR12 [15].…”

Section: Discussionsupporting

confidence: 63%

“…RBV was added based on physician's discretion, which can represent a possible bias. However RBV administration was discretionary by the treating clinician in all published studies of cirrhotic patients, due to variability of residual liver function across Child-Pugh classes and safety concerns regarding risk of decompensation [13][14][15]. The selection of patients who can benefit from RBV must take into account both pre-treatment SVR likelihood as well predicted tolerability.…”

Section: Discussionmentioning

confidence: 99%

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Daclatasvir, Sofosbuvir With or Without Ribavirin for 24 Weeks In Hepatitis C Genotype 3 Cirrhosis: A Real-Life Study

Lionetti

Piccolo

Lenci

et al. 2018

Annals of Hepatology

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Introduction and aim: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks’ treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics . Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. Materials and methods: 106 consecutive cirrhotics (70.8% males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2%) based expected tolerability, at a mean dose of 964±202 mg/day. Baseline Child-Pugh class was A 91.5%, B 6.6%, C 1.9%; mean baseline MELD was 8.5±2.7. Results: All patients completed 12-week follow-up post-treatment, and 104 (98.1%) obtained sustained virologcal response (100% in ribavirin -treated patients vs 90.4% without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). Conclusion: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100% efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 63%

Section: Discussionmentioning

confidence: 99%

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Daclatasvir, Sofosbuvir With or Without Ribavirin for 24 Weeks In Hepatitis C Genotype 3 Cirrhosis: A Real-Life Study

Lionetti

Piccolo

Lenci

et al. 2018

Annals of Hepatology

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“…The EVR and ETR rates are almost equal in patients with different liver textures. Dalgard et al. (2017) administered Sofosbuvir plus Ribavirin therapy to hepatitis C virus genotype 3 patients in Scandinavian countries and reported SVR12 of 90% in compensated cirrhotic patients compared with 100% in non-cirrhotic patients.…”

Section: Discussionmentioning

confidence: 99%

Effect of Sofosbuvir plus Ribavirin therapy on hepatitis C patients in Pakistan: a retrospective study

Jamil

Waheed

Malik

et al. 2018

PeerJ

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BackgroundThe annual global deaths from viral hepatitis is 1.4 million. Pakistan has the second highest burden of hepatitis C in the world. There is dire need to evaluate the response of new direct acting antivirals for the treatment of hepatitis C patients in Pakistan. World Health Organization has developed a strategy to treat 80% of HCV patients by 2030. In Pakistan, HCV treatment rate is 1%. The aim of the study was to analyze the effect of Sofosbuvir plus Ribavirin therapy on HCV patients in Pakistan.MethodsAn observational study was conducted at Fauji Foundation Hospital Rawalpindi from November-2016 to July-2017. All the drugs were administered according to the guidelines of Asia Pacific Association for the Study of Liver (APASL) for the treatment of HCV patients. A total 327 chronic HCV patients were enrolled in the study and 304 completed the treatment. Patients belonged to three different groups including treatment: Naïve patients (n = 107), Non-Responder patients (n = 126) and patients who relapsed to Interferon therapy (n = 71). All the patients were given Sofosbuvir plus Ribavirin therapy for 24 weeks and the early virological response (EVR) and end treatment response (ETR) was calculated. Different parameters including patient age, viral load, viral genotype, blood picture, ultrasound findings and liver function tests were also studied.ResultsOut of 304 patients, 301 (99%) achieved EVR and 300 achieved ETR (98.7%). End treatment response was 95.6% in HCV genotype 1 and 98.9% in HCV genotype 3 patients. ETR was 99.06% in treatment Naïve, 99.20% in non-responders and 97.18% in previously relapsed patients. We did not find the association of any host and viral factor in the determination of EVR and ETR.ConclusionThe Sofosbuvir plus Ribavirin treatment is highly effective, safe and cost-effective for the treatment of hepatitis C patients in Pakistan.

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“…Early virological response was achieved with DAAs in short duration that was not achieved by interferon therapy after long time. In Scandinavian countries, [3] injected DAAs to HCV genotype 3 patients and noted Sustained virological response in cirrhotic and non-cirrhotic patients that was 90% and 100. We have 932 patients under treatment for HCV genotype 3, the 29 cases with same Hepatitis C Virus genotype and 3 with other HCV genotypes in interferon base therapy.…”

Section: Discussionmentioning

confidence: 99%

Recurrence of Hepatitis C Virus after treatment with Pegylated Interferon and Direct Acting Antivirals in Punjab, Pakistan.

Raza

Sughra

Zeeshan

2020

Preprint

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Background Although increased response rates concomitant in hepatitis C virus but relapse after treatment is threatened. Therefore, it is terrible requirement to evaluate the response of Pegylated interferon and direct acting antivirals in Pakistan.Methods This study conducted at Department of Pathology, Nawaz Sharif Medical College Gujrat, while treatment effects monitored in different Government and Private Hospitals of Punjab, Pakistan from July 2017 to January 2019. Total 973 patients administered the recommended dose that divided in two groups (i) Interferon based therapy (ii) direct acting antivirals (DAAs).Other parameters like ALT and viral load studied.Results The 374 patients given interferon therapy and 32 of 374 were positive after 24 weeks of treatment. Among these 29 patients have same genotype and recurrence was present .While 3 patients were re-infected with different HCV strains. In case of DAAs, only 27 patients were positive among 558 patients after 2 weeks and only one patient re-infected with different genotype. Early and sustained virologic response noted in DAAs. ALT and viral load decreased faster with DAAs that not achieved after 4 weeks with pegylated interferon.Conclusion SVR appears in DAAs and recurrence rate was high in interferon-based therapy as compared to DAAs. Therefore, reinfection has implications for correct treatment efficiency and to select optimal strategies for retreatment cases.

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Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections—A Scandinavian real-life study

Cited by 31 publications

References 23 publications

Daclatasvir, Sofosbuvir With or Without Ribavirin for 24 Weeks In Hepatitis C Genotype 3 Cirrhosis: A Real-Life Study

Daclatasvir, Sofosbuvir With or Without Ribavirin for 24 Weeks In Hepatitis C Genotype 3 Cirrhosis: A Real-Life Study

Effect of Sofosbuvir plus Ribavirin therapy on hepatitis C patients in Pakistan: a retrospective study

Recurrence of Hepatitis C Virus after treatment with Pegylated Interferon and Direct Acting Antivirals in Punjab, Pakistan.

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