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

Olav Dalgard; Ola Weiland; Geir Noraberg; Lars Karlsen; Lars Heggelund; Martti Färkkilâ; Ulla Balslev; Erika Belard; Anne Øvrehus; Mette Skalshøi Kjær; Henrik Krarup; Birgit Thorup Røge; Sofie Hallager; Lone G Madsen; Alex Lund Laursen; Martin Lagging; Nina Weis

doi:10.1371/journal.pone.0179764

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

Olav Dalgard, Ola Weiland, Geir Noraberg, Lars Karlsen, Lars Heggelund, Martti Färkkilâ, Ulla Balslev, Erika Belard, Anne Øvrehus, Mette Skalshøi Kjær, Henrik Krarup, Birgit Thorup Røge, Sofie Hallager, Lone G Madsen, Alex Lund Laursen, Martin Lagging, Nina Weis

Institut for Klinisk Medicin

18 Citationer (Scopus)

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Abstract

BACKGROUND AND AIMS: Chronic hepatitis C virus (HCV) genotype 3 infection with advanced liver disease has emerged as the most challenging to treat. We retrospectively assessed the treatment outcome of sofosbuvir (SOF) based regimes for treatment of HCV genotype 3 infections in a real life setting in Scandinavia.

METHODS: Consecutive patients with chronic HCV genotype 3 infection were enrolled at 16 treatment centers in Denmark, Sweden, Norway and Finland. Patients who had received a SOF containing regimen were included. The fibrosis stage was evaluated by liver biopsy or transient liver elastography. The following treatments were given according availability and local guidelines: 1) SOF + ribavirin (RBV) for 24 weeks, 2) SOF + daclatasvir (DCV) +/-RBV for 12-24 weeks, 3) SOF + pegylated interferon alpha (peg-IFN-α) + RBV for 12 weeks or 4) SOF/ledipasvir (LDV) + RBV for 12-16 weeks. The primary endpoint was sustained virological response (SVR) assessed at week 12 (SVR12) after end of treatment.

RESULTS: We included 316 patients with a mean age of 55 years (range 24-79), 70% men, 49% treatment experienced, 58% with compensated cirrhosis and 12% with decompensated cirrhosis.In the modified intention to treat (mITT) population SVR12 was achieved in 284/311 (91%) patients. Among 26 treatment failures, five had non-response, 3 breakthrough and 18 relapse. Five patients were not included in the mITT population. Three patients died from reasons unrelated to treatment and two were lost to follow-up. The SVR12 rate was similar for all treatment regimens, but lower in men (p = 0.042), and in patients with decompensated liver disease (p = 0.004).

CONCLUSION: We found that sofosbuvir based treatment in a real-life setting could offer SVR rates exceeding 90% in patients with HCV genotype 3 infection and advanced liver disease.

Originalsprog	Engelsk
Artikelnummer	e0179764
Tidsskrift	PloS one
Vol/bind	12
Udgave nummer	7
Antal sider	8
ISSN	1932-6203
DOI	https://doi.org/10.1371/journal.pone.0179764
Status	Udgivet - 13 jul. 2017

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10.1371/journal.pone.0179764Licens: CC BY

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Dalgard, O., Weiland, O., Noraberg, G., Karlsen, L., Heggelund, L., Färkkilâ, M., Balslev, U., Belard, E., Øvrehus, A., Skalshøi Kjær, M., Krarup, H., Thorup Røge, B., Hallager, S., Madsen, L. G., Lund Laursen, A., Lagging, M., & Weis, N. (2017). Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections-A Scandinavian real-life study. PloS one, 12(7), [e0179764]. https://doi.org/10.1371/journal.pone.0179764

Dalgard, O, Weiland, O, Noraberg, G, Karlsen, L, Heggelund, L, Färkkilâ, M, Balslev, U, Belard, E, Øvrehus, A, Skalshøi Kjær, M, Krarup, H, Thorup Røge, B, Hallager, S, Madsen, LG, Lund Laursen, A, Lagging, M & Weis, N 2017, 'Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections-A Scandinavian real-life study', PloS one, bind 12, nr. 7, e0179764. https://doi.org/10.1371/journal.pone.0179764

@article{0d468b4cbf79407980ae94fff53f5af6,

title = "Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections-A Scandinavian real-life study",

abstract = "BACKGROUND AND AIMS: Chronic hepatitis C virus (HCV) genotype 3 infection with advanced liver disease has emerged as the most challenging to treat. We retrospectively assessed the treatment outcome of sofosbuvir (SOF) based regimes for treatment of HCV genotype 3 infections in a real life setting in Scandinavia.METHODS: Consecutive patients with chronic HCV genotype 3 infection were enrolled at 16 treatment centers in Denmark, Sweden, Norway and Finland. Patients who had received a SOF containing regimen were included. The fibrosis stage was evaluated by liver biopsy or transient liver elastography. The following treatments were given according availability and local guidelines: 1) SOF + ribavirin (RBV) for 24 weeks, 2) SOF + daclatasvir (DCV) +/-RBV for 12-24 weeks, 3) SOF + pegylated interferon alpha (peg-IFN-α) + RBV for 12 weeks or 4) SOF/ledipasvir (LDV) + RBV for 12-16 weeks. The primary endpoint was sustained virological response (SVR) assessed at week 12 (SVR12) after end of treatment.RESULTS: We included 316 patients with a mean age of 55 years (range 24-79), 70% men, 49% treatment experienced, 58% with compensated cirrhosis and 12% with decompensated cirrhosis.In the modified intention to treat (mITT) population SVR12 was achieved in 284/311 (91%) patients. Among 26 treatment failures, five had non-response, 3 breakthrough and 18 relapse. Five patients were not included in the mITT population. Three patients died from reasons unrelated to treatment and two were lost to follow-up. The SVR12 rate was similar for all treatment regimens, but lower in men (p = 0.042), and in patients with decompensated liver disease (p = 0.004).CONCLUSION: We found that sofosbuvir based treatment in a real-life setting could offer SVR rates exceeding 90% in patients with HCV genotype 3 infection and advanced liver disease.",

keywords = "Adult, Aged, Antiviral Agents, Drug Therapy, Combination, Female, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Imidazoles, Interferon-alpha, Male, Middle Aged, Retrospective Studies, Ribavirin, Scandinavian and Nordic Countries, Sofosbuvir, Sustained Virologic Response, Treatment Outcome, Journal Article, Multicenter Study",

author = "Olav Dalgard and Ola Weiland and Geir Noraberg and Lars Karlsen and Lars Heggelund and Martti F{\"a}rkkil{\^a} and Ulla Balslev and Erika Belard and Anne {\O}vrehus and {Skalsh{\o}i Kj{\ae}r}, Mette and Henrik Krarup and {Thorup R{\o}ge}, Birgit and Sofie Hallager and Madsen, {Lone G} and {Lund Laursen}, Alex and Martin Lagging and Nina Weis",

year = "2017",

month = jul,

day = "13",

doi = "10.1371/journal.pone.0179764",

language = "English",

volume = "12",

journal = "PLoS Computational Biology",

issn = "1932-6203",

publisher = "Public Library of Science",

number = "7",

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TY - JOUR

T1 - Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections-A Scandinavian real-life study

AU - Dalgard, Olav

AU - Weiland, Ola

AU - Noraberg, Geir

AU - Karlsen, Lars

AU - Heggelund, Lars

AU - Färkkilâ, Martti

AU - Balslev, Ulla

AU - Belard, Erika

AU - Øvrehus, Anne

AU - Skalshøi Kjær, Mette

AU - Krarup, Henrik

AU - Thorup Røge, Birgit

AU - Hallager, Sofie

AU - Madsen, Lone G

AU - Lund Laursen, Alex

AU - Lagging, Martin

AU - Weis, Nina

PY - 2017/7/13

Y1 - 2017/7/13

N2 - BACKGROUND AND AIMS: Chronic hepatitis C virus (HCV) genotype 3 infection with advanced liver disease has emerged as the most challenging to treat. We retrospectively assessed the treatment outcome of sofosbuvir (SOF) based regimes for treatment of HCV genotype 3 infections in a real life setting in Scandinavia.METHODS: Consecutive patients with chronic HCV genotype 3 infection were enrolled at 16 treatment centers in Denmark, Sweden, Norway and Finland. Patients who had received a SOF containing regimen were included. The fibrosis stage was evaluated by liver biopsy or transient liver elastography. The following treatments were given according availability and local guidelines: 1) SOF + ribavirin (RBV) for 24 weeks, 2) SOF + daclatasvir (DCV) +/-RBV for 12-24 weeks, 3) SOF + pegylated interferon alpha (peg-IFN-α) + RBV for 12 weeks or 4) SOF/ledipasvir (LDV) + RBV for 12-16 weeks. The primary endpoint was sustained virological response (SVR) assessed at week 12 (SVR12) after end of treatment.RESULTS: We included 316 patients with a mean age of 55 years (range 24-79), 70% men, 49% treatment experienced, 58% with compensated cirrhosis and 12% with decompensated cirrhosis.In the modified intention to treat (mITT) population SVR12 was achieved in 284/311 (91%) patients. Among 26 treatment failures, five had non-response, 3 breakthrough and 18 relapse. Five patients were not included in the mITT population. Three patients died from reasons unrelated to treatment and two were lost to follow-up. The SVR12 rate was similar for all treatment regimens, but lower in men (p = 0.042), and in patients with decompensated liver disease (p = 0.004).CONCLUSION: We found that sofosbuvir based treatment in a real-life setting could offer SVR rates exceeding 90% in patients with HCV genotype 3 infection and advanced liver disease.

AB - BACKGROUND AND AIMS: Chronic hepatitis C virus (HCV) genotype 3 infection with advanced liver disease has emerged as the most challenging to treat. We retrospectively assessed the treatment outcome of sofosbuvir (SOF) based regimes for treatment of HCV genotype 3 infections in a real life setting in Scandinavia.METHODS: Consecutive patients with chronic HCV genotype 3 infection were enrolled at 16 treatment centers in Denmark, Sweden, Norway and Finland. Patients who had received a SOF containing regimen were included. The fibrosis stage was evaluated by liver biopsy or transient liver elastography. The following treatments were given according availability and local guidelines: 1) SOF + ribavirin (RBV) for 24 weeks, 2) SOF + daclatasvir (DCV) +/-RBV for 12-24 weeks, 3) SOF + pegylated interferon alpha (peg-IFN-α) + RBV for 12 weeks or 4) SOF/ledipasvir (LDV) + RBV for 12-16 weeks. The primary endpoint was sustained virological response (SVR) assessed at week 12 (SVR12) after end of treatment.RESULTS: We included 316 patients with a mean age of 55 years (range 24-79), 70% men, 49% treatment experienced, 58% with compensated cirrhosis and 12% with decompensated cirrhosis.In the modified intention to treat (mITT) population SVR12 was achieved in 284/311 (91%) patients. Among 26 treatment failures, five had non-response, 3 breakthrough and 18 relapse. Five patients were not included in the mITT population. Three patients died from reasons unrelated to treatment and two were lost to follow-up. The SVR12 rate was similar for all treatment regimens, but lower in men (p = 0.042), and in patients with decompensated liver disease (p = 0.004).CONCLUSION: We found that sofosbuvir based treatment in a real-life setting could offer SVR rates exceeding 90% in patients with HCV genotype 3 infection and advanced liver disease.

KW - Adult

KW - Aged

KW - Antiviral Agents

KW - Drug Therapy, Combination

KW - Female

KW - Genotype

KW - Hepacivirus

KW - Hepatitis C, Chronic

KW - Humans

KW - Imidazoles

KW - Interferon-alpha

KW - Male

KW - Middle Aged

KW - Retrospective Studies

KW - Ribavirin

KW - Scandinavian and Nordic Countries

KW - Sofosbuvir

KW - Sustained Virologic Response

KW - Treatment Outcome

KW - Journal Article

KW - Multicenter Study

U2 - 10.1371/journal.pone.0179764

DO - 10.1371/journal.pone.0179764

M3 - Journal article

C2 - 28704381

SN - 1932-6203

VL - 12

JO - PLoS Computational Biology

JF - PLoS Computational Biology

IS - 7

M1 - e0179764

ER -

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

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