Table 7Trials of triple therapy with pegylated interferon alfa-2b, ribavirin, and telaprevir

Author
Country
Study Name
N
Quality
Population CharacteristicsTelaprevir Dose/DurationWeekly Pegylated interferon DoseDaily Ribavirin DoseOverall Duration of Therapy (weeks)Sustained Virologic Response
Hezode, 200985
Europe

N=323

Quality: Fair
A vs. B vs. C vs. D
Age (median): 46 vs. 44 vs. 45 vs. 45 years
Female: 33% vs. 40% vs. 45% vs. 44%
Non White race: 7% vs. 7% vs. 1% vs. 7%
Genotype 1: 100%
Cirrhosis: 0% vs. 0% vs. 1% vs. 0%
Minimal or no fibrosis: 43% vs. 37% vs. 40% vs. 34%
Elevated transaminases: Not reported
A. 750 mg tid weeks 1–12
B. 750 mg tid weeks 1–12
C. 750 mg tid weeks 1–12
D. placebo
Alfa-2a 180 mcgA. 1000–1200 mg
B. 1000–1200 mg
C. placebo
D. 1000–1200 mg
A. 12
B. 24
C. 12
D. 48
A. 69%
B. 60%
C. 36%
D. 46%
Jacobson, 201151
Worldwide

N=1088

Quality: Good
A vs. B vs. C
Age (median): 49 vs. 49 vs. 49 years
Female: 41% vs. 42% vs. 42%
Non White race: 10% vs. 13% vs. 12%
Genotype 1: 100%
Cirrhosis: 6% overall
Minimal or no fibrosis: 28% overall
Elevated transaminases: Not reported
A. 750 mg tid weeks 1–8
B. 750 mg tid weeks 1–12b
C. placebo
Alfa-2a 180 mcg1000–1200 mgA. 24/48a
B. 24/48a
C. 48
A. 69%
B. 75%b
C. 44%
Kumada,
201286
Japan

N=189

Quality: Fair
A vs. B
Age (mean): 53 vs. 55
Female: 48% vs. 48%
Non White: Not reported (conducted in Japan)
Minimal or no fibrosis: Not reported
Elevated transaminases: Not reported
A. 750 mg tid weeks 1–12
B. placebo
Alfa-2b 1.5 mcg/kg600–1000 mgA. 24
B. 48
A. 73%
B. 49%
Marcellin, 201159
Europe

N=161

Quality: Fair
A vs. B vs. C vs. D
Age (median): 47 vs. 46 vs. 40 vs. 49 years
Female: 50% vs. 52% vs. 48% vs. 51%
Non White race: 10% vs. 10% vs. 10% vs. 8%
Genotype 1: 100%
Cirrhosis: 2.5% vs. 2.4% vs. 0 vs. 5.1%
Minimal or no fibrosis: 39% overall
Elevated transaminases: Not reported
A. 750 mg tid weeks 1–12
B. 750 mg tid weeks 1–12
C. 1125 mg bid weeks 1–12
D. 1125 mg bid weeks 1–12
A. Alfa-2a 180 mcg
B. Alfa-2b 1.5 mcg/kg
C. Alfa-2a 180 mcg
D. Alfa-2a 1.5 mcg/kg
A. 1000–1200 mg
B. 800–1200 mg
C. 1000–1200 mg
D. 800–1200 mg
24/48cA. 85%
B. 81%
C. 83%
D. 82%
McHutchison, 200931
U.S.
PROVE1

N=250

Quality: Fair
A vs. B vs. C vs. D
Age (median): 49 vs. 50 vs. 49 vs. 49 years
Female: 32% vs. 39% vs. 29% vs. 43%
Non White race: 24% vs. 24% vs. 24% vs. 21%
Cirrhosis: 0%
Minimal or no fibrosis: 31% (overall)
Elevated transaminases: Not reported
A. 750 mg tid weeks 1–12
B. 750 mg tid weeks 1–12
C. 750 mg tid weeks 1–12
D. placebo
Alfa-2a 180 mcg1000–1200 mgA. 12
B. 24
C. 48
D. 48
A. 35%
B. 61%
C. 67%
D. 41%
Sherman, 201187
U.S.
Name: ILLUMINATE

N=322d

Quality: Fair
A vs. B
Age (median): 51 vs. 50 years
Female: 36% vs. 39%
Non White race: 17% vs. 18%
Cirrhosis: 11% vs. 8%
Minimal or no fibrosis: 27% (overall)
Elevated transaminases: Not reported
A. 750 mg tid weeks 1–12
B. 750 mg tid weeks 1–12
Alfa-2a 180 mcg1000–1200 mgA. 24
B. 48
A. 92%
B. 88%

bid = two times daily; eRVR = extended rapid virologic response; HCV = hepatitis C virus; NA = not applicable; TCP = telaprevir; tid = three times daily

Note: Cirrhosis=METAVIR F4, Ishak 5–6, or equivalent. Minimal or no fibrosis=METAVIR F0–F1, Ishak 0–2, or equivalent.

a

Response-guided duration: 24 weeks of pegylated interferon/ribavirin if HCV-RNA negative from week 4 through week 12. Patients not meeting these criteria continued until week 48.

b

Dosing regimen recommended by the U.S. Food and Drug Administration for telaprevir.

c

Response-guided duration: 24 weeks of pegylated interferon/ribavirin if HCV-RNA negative from week 4 through week. Patients not meeting these criteria continued until week 48.

d

Patients with undetectable HCV RNA at week 4 and week 12 randomized to either 24 or 48 weeks of dual therapy.

From: Results

Cover of Treatment for Hepatitis C Virus Infection in Adults
Treatment for Hepatitis C Virus Infection in Adults [Internet].
Comparative Effectiveness Reviews, No. 76.
Chou R, Hartung D, Rahman B, et al.

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