Abstract
Background and aimsChronic 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.MethodsConsecutive 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.ResultsWe 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).ConclusionWe 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.
Highlights
We included 316 patients with a mean age of 55 years, 70% men, 49% treatment experienced, 58% with compensated cirrhosis and 12% with decompensated cirrhosis.In the modified intention to treat population SVR12 was achieved in 284/311
We found that sofosbuvir based treatment in a real-life setting could offer sustained virologic response (SVR) rates exceeding 90% in patients with hepatitis C virus (HCV) genotype 3 infection and advanced liver disease
100,000 individuals are infected with hepatitis C virus (HCV) in Scandinavia (Denmark, Finland, Norway, Sweden) of whom 50% have genotype 3 [1, 2]
Summary
100,000 individuals are infected with hepatitis C virus (HCV) in Scandinavia (Denmark, Finland, Norway, Sweden) of whom 50% have genotype 3 [1, 2]. In vitro studies with the NS5A inhibitor daclatasvir (DCV) indicated high efficacy against all genotypes including genotype 3 [8]. In the ALLY-3 study SOF+DCV without RBV was given for 12 weeks and yielded SVR12 in 94% in non-cirrhotic genotype 3 patients but only in 63% of those with cirrhosis [9]. In the ALLY-3+ study, SOF+DCV+RBV was given for 12 or 16 weeks, to treatment naïve and experienced patients with stage F3-F4 fibrosis, and SVR was achieved in 31/36 (86%) of F4 patients with no improvement with treatment prolonged to 16 weeks [10]. 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
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