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Multicenter Study
. 2017 Jul 13;12(7):e0179764.
doi: 10.1371/journal.pone.0179764. eCollection 2017.

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

Olav Dalgard  1   2 , Ola Weiland  3 , Geir Noraberg  4 , Lars Karlsen  5 , Lars Heggelund  6 , Martti Färkkilâ  7 , Ulla Balslev  8 , Erika Belard  8 , Anne Øvrehus  9 , Mette Skalshøi Kjær  10 , Henrik Krarup  11 , Birgit Thorup Røge  12 , Sofie Hallager  13 , Lone G Madsen  14 , Alex Lund Laursen  15 , Martin Lagging  16 , Nina Weis  13   17
Affiliations
Multicenter Study

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

Olav Dalgard et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: Olav Dalgard: Research grants Gilead, Abbvie and Merck. Paid lectures Abbvie, Merck and Gilead. Chair of committee writing Norwegian national guidelines for HCV treatment in Norway. Nina Weis: Clinical investigator, speaker and advisory board member for Abbvie, Bristol Myers Squibb and Merck Sharp & Dohme; speaker and advisory board member for Gilead. Lars Karlsen: Advisory boards: Merck, Abbvie, Gilead, Bristol-Myers Squibb. Member of the committee that write national guidelines for HCV treatment in Norway Clinical expert in HCV for The Norwegian Medicines Agency Martti Färkkila: Study grant: Gilead. Speaker and consultation fee, MSD Finland, Janssen, BMS, Takeda, Pfizer, Cook Ireland, Intercept Ola Weiland: Consultancies: AbbVie, BMS, Gilead, Janssen, Medivir, Roche and MSD/Merck. Speaker’s bureau: AbbVie, BMS, Gilead, Janssen, Medivir, Roche and MSD/Merck Lone Madsen: Lecture fees from: BMS and Medivir. Advisory Board member: AbbVie and BMS. Mette Kjær: Speakers fee from Abbvie. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Sustained virological response (SVR) 12 weeks after end of treatment, according to different sofosbuvir based treatment regimens and stage of liver disease in patients with chronic HCV genotype 3 infection (n = 311).
*Data on 24 patients with cirrhotic patients is not included due to missing CP score.
Fig 2
Fig 2. Sustained virological response (SVR) according to liver elasticity levels in patients with chronic HCV genotype 3 infection, treated with a sofosbuvir based.
See this image and copyright information in PMC

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