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Observational Study
. 2017 Oct;66(10):1844-1852.
doi: 10.1136/gutjnl-2016-311609. Epub 2016 Jul 13.

Effectiveness and Safety of Sofosbuvir Plus Ribavirin for the Treatment of HCV Genotype 2 Infection: Results of the Real-World, Clinical Practice HCV-TARGET Study

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Free PMC article
Observational Study

Effectiveness and Safety of Sofosbuvir Plus Ribavirin for the Treatment of HCV Genotype 2 Infection: Results of the Real-World, Clinical Practice HCV-TARGET Study

Tania M Welzel et al. Gut. .
Free PMC article

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.

Trial registration number: NCT01474811.

Keywords: CLINICAL TRIALS; GENOTYPE; HEPATITIS C.

Conflict of interest statement

Competing interests: TMW: Consultancies/speaker for Abbvie, Bristol-Myers Squibb, Gilead, Janssen. DRN: Grant funding from AbbVie, Gilead, BMS, Janssen, Merck, GSK. GM: Grant funding from AbbVie, BMs, Gilead, Merck, Janssen, Vertex, Idenix, Conatus and Salix. ADB: Grant funding from Gilead, AbbVie and BMS. Consultant for Gilead, AbbVie and BMS. Expert testimony/advisory board from Gilead, AbbVie and BMS. RKR: Grant funding from AbbVie, Merck, Gilead, Janssen, Vertex (Money paid to Pennsylvania). Expert testimony/advisory board from AbbVie Merck, Gilead, BMS, Janssen. AK: Grant funding from Gilead. JKL: Grant funding from BMS, Gilead, Janssen, Hologic (All to institution). Consultant to BMS, Gilead, Janssen. JD: Grant funding and consulting from BMS. PP: Grant funding from Gilead, BMS, AbbVie, Merck, Janssen. Consultant for Gilead, BMS, AbbVie, Merck and Janssen. Sponsored lectures/Honoraria from Gilead, BMS, AbbVie, Janssen. JSG: Grant funding from Merck and Gilead. Sponsored lectures/Honoraria from Gilead Speakers Bureau. LMF: Grant funding and consulting from Gilead, AbbVie, Janssen and Merck. SA: Grant funding from Gilead, AbbVie and Merck. Consultant for Gilead, AbbVie, Merck and Janssen. Sponsored Lectures/Honoraria from Gilead and AbbVie. MSS: Grant funding from AbbVie, BMS, Gilead, Janssen and Merck. (Paid to Johns Hopkins University, NIH/NDA K24DA034621). Consultant for AbbVie, CoCrystal Pharma, Gilead, Janssen, Merck and Trek. MV: No Disclosures. LA: No Disclosures. MWF: Grant funding from Merck, Janssen, Gilead, BMS, AbbVie and research grants from NIH. Consultant for Merck, AbbVie, Gilead and BMS. SZ: Consultant for AbbVie, BMS, Gilead, Janssen and Merck. Sponsored Lectures/Honoraria from AbbVie, BMS, Gilead, Janssen and Merck.

Figures

Figure 1
Figure 1
Patient disposition. DAA, direct-acting antiviral; f/u, follow-up; OLT, orthotopic liver translantation; SVR12, sustained virological response 12 weeks after therapy.
Figure 2
Figure 2
Probability of sustained virological response 12 weeks after therapy (SVR12) by baseline ribavirin (RBV) dose per kg bodyweight (BW; mg/kg). CL, confidence limit.
Figure 3
Figure 3
Predictors of sustained virological response (SVR) among genotype 2 (GT2)-infected patients who were treated with sofosbuvir (SOF)+ribavirin (RBV) and had an available virological outcome (n=307). *Patients who discontinued due to adverse events or were lost to follow-up are excluded. N, number observed; OR, 95% CI (CL, confidence limit; LCL, lower confidence limit; UCL, upper confidence limit) and p value. **Estimated with logistic regression with the predictor of interest, age and gender in the model. BW, bodyweight; INR, international normalised ratio; MELD, model for end-stage liver disease.

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