Egyptian Ancestry

Design

Objective– SVR12 (HCV RNA < 25 IU/ml), with 95% CI

SOF 400 mg qd + RBV

SOF 400 mg qd + RBV

Randomised1 : 1

Open-label

Egyptian Ancestry Study: SOF + RBV for HCV genotype 4

W12

≥ 18 years1st generation egyptian

Chronic HCV infection, genotype 4HCV RNA ≥ 10,000 IU/ml

Treatment-naïve or experiencedCirrhosis* allowed

No HBV or HIV co-infection

* by liver biopsy, or Fibrotest® ≥ 0.75 + APRI > 2

N = 29

N = 31

W24

RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg)

Ruane P. J. Hepatology 2015;62:1040-6

SOF + RBV12 weeks

N = 31

SOF + RBV24 weeks

N = 29

Mean age, years 53 55

Female 29% 34%

HCV RNA, log10 IU/ml, mean 6.0 6.0

IL28B CC genotype 13% 21%

Cirrhosis 23% 24%

Treatment naïve 45% 48%

Treatment experienced 55% 52%

Past treatment categoryRelapseNon responseOther (intolerance, unknown response)

29%59%12%

7%67%26%

Completed treatment 31 29

Completed W12 of follow-up post-treatment 22 28

Baseline characteristics and patient disposition

Egyptian Ancestry

Egyptian Ancestry Study: SOF + RBV for HCV genotype 4

Ruane P. J. Hepatology 2015;62:1040-6

31 14 17 4 27 11 20 24 7 29 14 15 6 23 15 14 22 70

25

50

75

100

68

79

59

100

63

91

55

75

43

93100

87

10091 93 93 91

100

SVR12 (HCV RNA < 25 IU/ml)

Alln

Naïve Expe-rienced

CC NonCC

< 800K ≥ 800K No Yes All Naïve Expe-rienced

CC NonCC

< 800K ≥ 800K No Yes

Egyptian Ancestry

Egyptian Ancestry Study: SOF + RBV for HCV genotype 4

Ruane P. J. Hepatology 2015;62:1040-6

%

BaselineHCV RNA,

IU/ml

IL28B Cirrhosis BaselineHCV RNA,

IU/ml

IL28B Cirrhosis

SOF + RBV 12W SOF + RBV 24W

Adverse events, N (%)SOF + RBV 12W, N = 31 SOF + RBV 24W, N = 29

Adverse event leading to discontinuation 0 0

Serious adverse event 0 3

AE in ≥ 20 % of patientsHeadacheInsomniaFatigueCoughIrritabilityDizzinessPruritusOropharyngeal painDyspneaAbdominal distensionPainRashMyalgiaNauseaPalpitationsDiarrhea

58%52%45%19%19%16%23%16%16%13%13%3%6%6%6%3%

66%48%52%45%34%31%24%28%24%21%21%31%21%21%21%21%

Egyptian Ancestry

Egyptian Ancestry Study: SOF + RBV for HCV genotype 4

Ruane P. J. Hepatology 2015; 62:1040-6

Summary

– In this phase II, open-label study, 24 weeks of treatment with SOF and RBV resulted in high rates of SVR12 in treatment-naive and previously treated patients with genotype 4 HCV infection.

• SVR12 rates were notably high in patients with characteristics historically associated with poor response : cirrhosis, high baseline viral load, non-CC IL28B genotype, and prior non-response to HCV treatment

– Limitations• Small sample size• Small number (12 = 20%) of patients infected with non-4a HCV

Egyptian Ancestry

Egyptian Ancestry Study: SOF + RBV for HCV genotype 4

Ruane P. J. Hepatology 2015;62:1040-6