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DOI: 10.1055/s-0035-1551766
Shortening overall treatment to 12 weeks of SIMEPREVIR plus pegylated-interferon/ribavirin according to early virologic response in treatment-naïve patients with chronic HCV genotype 4 infection and mild-to-moderate fibrosis
Aims: HCV genotype 4 (GT4) is highly prevalent in the Middle East and Sub-Saharan Africa, and is expanding in Europe. To prevent disease progression, short and effective regimens are needed for these patients. This study aims to assess whether treatment with simeprevir+Peg-IFN/ribavirin can be shortened to 12 weeks, based on early viral kinetics, in patients with mild-to-moderate fibrosis.
Design: Phase-3, open-label study, including treatment-naïve patients in Europe and Saudi Arabia with HCV GT4. In patients with HCV-RNA < 25IU/mL (detectable/undetectable in IL28B CC, undetectable in CT/TT [Roche COBAS® Taqman®] at Week 2, and undetectable at Weeks 4 and 8, all treatments were stopped at Week 12. Otherwise, Peg-IFN/ribavirin was continued to Week 24. On-treatment and SVR4 data from the European patients are presented.
Results: 50 patients were enrolled (male: 72%, white: 83%, GT4a/d/other: 36/40/24%, METAVIR F0-F1/F2: 78/22%, IL28B non-CC: 84%). 46 patients completed simeprevir; three discontinued due to an AE; one met a virologic stopping rule. 24/50 were eligible for 12 weeks of treatment. 14/26 patients extending to 24 weeks are currently ongoing with Peg-IFN/ribavirin. Treatment with simeprevir+Peg-IFN/ribavirin was well tolerated: SAE (n = 1); grade 3/4 AE: 26%/0%.
Of the 24 patients eligible for 12 weeks (Table), none discontinued or relapsed to date. Among initial patients evaluable, SVR4 was 94% (16/17; one patient missing SVR4 data).
n/N (%) |
|
Total |
|
Met 12-week criteria |
24/50 (48) |
Did not meet 12-week criteria |
24/50 (48) |
Not classifiable |
2/50 (4) |
GT4a |
|
Met 12-week criteria |
8/18 (44) |
Did not meet 12-week criteria |
9/18 (50) |
Not classifiable |
1/18 (6) |
GT4 d |
|
Met 12-week criteria |
10/20 (50) |
Did not meet 12-week criteria |
9/20 (45) |
Not classifiable |
1/20 (5) |
GT4 other |
|
Met 12-week criteria |
6/12 (50) |
Did not meet 12-week criteria |
6/12 (50) |
IL28B CC |
|
Met 12-week criteria |
8/8 (100) |
IL28B CT |
|
Met 12-week criteria |
12/33 (36) |
Did not meet 12-week criteria |
19/33 (58) |
Not classifiable |
2/33 (6) |
IL28B TT |
|
Met 12-week criteria |
4/9 (44) |
Did not meet 12-week criteria |
5/9 (56) |
Conclusions: 48% of GT4 patients met the criteria for stopping treatment at Week 12. Of these patients, preliminary SVR4 rates are promising in GT4a/d, with SVR12/24 data and SVR data in Saudi Arabian patients forthcoming.