Abstract
Objective
Due to a high efficacy in clinical trials, sofosbuvir (SOF) and
ribavirin (RBV) for 12 or 16 weeks is recommended for treatment
of patients with HCV genotype (GT) 2
infection. We investigated safety and effectiveness of these regimens
for GT2 in HCV-TARGET
participants.
Design
HCV-TARGET, an international, prospective observational study evaluates
clinical practice data on novel antiviral therapies
at 44 academic and 17 community
medical centres in North America and Europe. Clinical data were
centrally abstracted from
medical records. Selection of
treatment regimen and duration was the investigator's choice. The
primary efficacy outcome was
sustained virological response
12 weeks after therapy (SVR12).
Results
Between December 2013 and April 2015, 321 patients completed 12 weeks
(n=283) or 16 weeks (n=38) of treatment with SOF and
RBV. Prior treatment experience and
cirrhosis was more frequent among patients in the 16-week regimen
compared with 12 weeks
(52.6% vs 27.6% and 63.2% vs 21.9%,
respectively). Overall, SVR12 was 88.2%. The SVR12 in patients without
cirrhosis was 91.0%
and 92.9% for 12 or 16 weeks of
therapy, respectively. In patients with cirrhosis treated for 12 or
16 weeks, SVR12 was 79.0%
and 83%. In the multivariate
analysis, liver cirrhosis, lower serum albumin and RBV dose at baseline
were significantly associated
with SVR12. Common adverse events
(AEs) included fatigue, anaemia, nausea, headache, insomnia, rash and
flu-like symptoms.
Discontinuation due to AEs occurred
in 2.8%.
Conclusions In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection.
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