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Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden.

https://arctichealth.org/en/permalink/ahliterature301752
Source
Infect Dis (Lond). 2019 Feb; 51(2):131-139
Publication Type
Clinical Trial, Phase III
Journal Article
Multicenter Study
Date
Feb-2019
Author
Vasily Isakov
Vladimir Chulanov
Dzhamal Abdurakhmanov
Eduard Burnevich
Elena Nurmukhametova
Galina Kozhevnikova
Natalya Gankina
Sergey Zhuravel
Svetlana Romanova
Robert H Hyland
Sophia Lu
Evguenia S Svarovskaia
John McNally
Diana M Brainard
Vladimir Ivashkin
Vyacheslav Morozov
Igor Bakulin
Martin Lagging
Konstantin Zhdanov
Ola Weiland
Author Affiliation
a 1 Department of Gastroenterology and Hepatology , Institute of Nutrition , Moscow , Russia.
Source
Infect Dis (Lond). 2019 Feb; 51(2):131-139
Date
Feb-2019
Language
English
Publication Type
Clinical Trial, Phase III
Journal Article
Multicenter Study
Keywords
Adolescent
Adult
Aged
Antiviral Agents - administration & dosage - therapeutic use
Carbamates - administration & dosage - therapeutic use
Drug Therapy, Combination
Female
Hepatitis C - drug therapy
Heterocyclic Compounds, 4 or More Rings - administration & dosage - therapeutic use
Humans
Male
Middle Aged
Russia
Sofosbuvir - administration & dosage - therapeutic use
Sweden
Young Adult
Abstract
In both Russia and Sweden, the dominant hepatitis C virus (HCV) is genotype 1, but around one-third of patients have genotype 3 infection. For such countries, HCV genotype testing is recommended prior to therapy. An effective pangenotypic therapy may potentially eliminate the need for genotyping. In this study, we evaluated the efficacy and safety of sofosbuvir/velpatasvir for 12 weeks in patients from Russia and Sweden.
In an open-label, single-arm phase-3 study, patients could have HCV genotype 1-6 infection and were treatment-naïve or interferon treatment-experienced. All patients received sofosbuvir/velpatasvir, once daily for 12 weeks. The primary endpoint was sustained virologic response 12 weeks post-treatment (SVR12).
Of 122 patients screened, 119 were enrolled and treated. Overall, half (50%) were male, 18% had cirrhosis, and 24% had failed prior interferon-based therapy. In total, 66% of patients were infected with HCV genotype 1 (59% 1b and 7% 1a), 6% with genotype 2, and 29% with genotype 3. The overall SVR12 rate was 99% (118/119, 95% confidence interval 95-100%). One treatment-experienced patient infected with HCV genotype 3 experienced virologic relapse after completing treatment. The most common adverse events were headache (16%) and fatigue (7%). Serious adverse events were observed in four patients, but none were related to treatment. No patients discontinued treatment due to adverse events.
Sofosbuvir/velpatasvir as a pangenotypic treatment for 12 weeks was highly effective in patients from Russia and Sweden infected with HCV genotypes 1, 2, or 3. Sofosbuvir/velpatasvir was safe and well-tolerated. Clinical trial number: ClinicalTrials.gov NCT02722837.
PubMed ID
30499360 View in PubMed
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Summary of available surveillance data on hepatitis C virus infection from eight Arctic countries, 2012 to 2014.

https://arctichealth.org/en/permalink/ahliterature295354
Source
Euro Surveill. 2018 Oct; 23(40):
Publication Type
Journal Article
Date
Oct-2018
Author
Prabhu P Gounder
Anders Koch
Ginger Provo
Astrid Lovlie
Josefine Lundberg Ederth
Maria Axelsson
Chris P Archibald
Brendan Hanley
Angie Mullen
Myrna Matheson
David Allison
Henrik Trykker
Thomas W Hennessy
Markku Kuusi
Vladimir Chulanov
Brian J McMahon
Author Affiliation
Arctic Investigations Program, Division of Preparedness and Emerging Infections, National Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and Prevention (CDC), Anchorage, Alaska, USA.
Source
Euro Surveill. 2018 Oct; 23(40):
Date
Oct-2018
Language
English
Publication Type
Journal Article
Abstract
We summarised available hepatitis C virus (HCV) surveillance data for 2012-14 from Arctic/sub-Arctic countries/regions. We sent a HCV data collection template by email to public health authorities in all jurisdictions. Population statistics obtained from census sources for each country were used to estimate rates of reported acute and chronic/undifferentiated HCV cases. Seven countries with Arctic regions (Canada, Denmark, Finland, Greenland, Norway, Sweden and the United States, represented by the state of Alaska), including three Canadian territories and one province, as well as 11 Russian subnational Arctic regions, completed the data collection template. Data on acute HCV infection during 2014 was available from three Arctic countries and all Russian Arctic regions (rate range 0/100,000 population in Greenland, as well as Nenets and Chukotka Automous Okrugs (Russian subnational Arctic regions) to 3.7/100,000 in the Russian Republic of Komi). The rate of people with chronic/undifferentiated HCV infection in 2014 ranged from 0/100,000 in Greenland to 171.2/100,000 in Alaska. In most countries/regions, the majority of HCV-infected people were male and aged 19-64 years. Differences in surveillance methods preclude direct comparisons of HCV surveillance data between Arctic countries/regions. Our data can inform future efforts to develop standardised approaches to HCV surveillance in the Arctic countries/regions by identifying similarities/differences between the surveillance data collected.
Notes
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PubMed ID
30301489 View in PubMed
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