Minireviews
Copyright ©The Author(s) 2015.
World J Hepatol. May 18, 2015; 7(8): 1133-1141
Published online May 18, 2015. doi: 10.4254/wjh.v7.i8.1133
Table 1 Sustained virological response rates for cirrhotic patients who were treated with direct-acting antiviral agents against hepatitis C virus including peginterferon and ribavirin
Ref. (name of trial)Regimen; genotype; No. of patients (n)Tx historySVR rates
SVR rates for P + R
Cirrhosis vs Non-cirrhosis
Jacobson et al[10] (ADVANCE)TVR + P + R; G1; n = 363: P + R; n = 361-62% vs 78%133% vs 47%
Sherman et al[11] (ILLUMINATE)TVR + P + R; G1; n = 540-63% vs 75%1
Zeuzem et al[12] (REALIZE)TVR + P + R; G1; n = 530: P + R; n = 132+Relapse; 84%-85% vs 83%-90%112% vs 38%
PR; 40%-44% vs 70%-75%10% vs 18%
Null; 22%-28% vs 31%-50%5% vs 6%
Poordad et al[13] (SPRINT-2)BOC + P + R; G1; n = 734: P + R; n = 363-41%-52% vs 67%138% vs 38%
Bacon et al[14] (RESPOND-2)BOC + P + R; G1; n = 299: P + R; n = 76+; relapse or PR35%-77% vs 64%-66%0% vs 24%
Jacobson et al[17]SMV + P + R; G1; n = 521: P + R; n = 264-60% vs 84%2334% vs 55%
Manns et al[18] (QUEST1/2)
Forns et al[19] (PROMISE)SMV + P + R; G1; n = 260: P + R; n = 133+; relapse74% vs 82%2326% vs 41%
Zeuzem et al[20] (ASPIRE)SMV + P + R; G1; n = 199: P + R; n = 66+Relapse; 73% vs 95%0% vs 56%2
PR; 82% vs 79%0% vs 8%
Null; 31% vs 66%0% vs 23%
Lawitz et al[25] (NEUTRINO)SOF + P + R; G1, 4-6; n = 327-80% vs 92%3
Table 2 Safety data of antiviral treatments for cirrhotic patients infected with hepatitis C virus
Ref. (name of trial)Regimen; genotypes; No. of patients (n)Patient characteristicsAE (serious AE) rate;
cirrhosis vs non-cirrhosis
Kumada et al[27] (AI447026)ASV + DCV; G1; n = 222IFN-intolerant/IFN-ineligible or IFN-non-responders(9% vs 6%)
Forns et al[19] (PROMISE)SMV + P/RBV; G1; n = 260Treatment experienced; relapse100% vs 92%-93% (1% vs 1%)1
Jacobson et al[30] (POSITRON, FUSION)SOF + RBV; G2-3; n = 408IFN-ineligible/IFN-intolerant (POSITRON); IFN-failure (FUSION)97% vs 88% (7% vs 5%)
12-wk regimen86% vs 91% (11% vs 2%)
16-wk regimen88% vs 88% (6% vs 2%)
Lawitz et al[35] (COSMOS)SMV + SOF ± RBVF0-2; non-responders87% vs 88% (5% vs 0%)
for 12 or 24 wk; G1; n = 167F3-4; non-responders or naïve
Table 3 Sustained virological response rates for cirrhotic patients who were treated with interferon-free regimens
Ref. (name of trial)Regimen; genotypes; No. of patients (n)Patient characteristicsSVR rates: cirrhosis
vs non-cirrhosis
Kumada et al[27] (AI447026)ASV + DCV; G1; n = 222IFN-intolerant/IFN-ineligible91% vs 87%
IFN-non-response191% vs 79%
Manns et al[28] (HALLMARK-DUAL)ASV + DCV; G1; n = 645Treatment naïve91% vs 89%3
IFN-non-response187% vs 80%
IFN-intolerant/IFN-ineligible79% vs 84%
Lawitz et al[32] (LONESTAR)SOF + LDV ± RBV; G1; n = 40Treatment experienced291% vs 100%34
100% vs 100%5
Osinusi et al[29]SOF + RBV; G1; n = 50Treatment naïve38% vs 65%6
Lawitz et al[26] (FISSION)SOF + RBV; G2-3; n = 256Treatment naïve; 12-wk regimenG2; 83% vs 97%3
G3; 34% vs 61%3
Jacobson et al[30] (POSITRON, FUSION)SOF + RBV; G2-3; n = 408IFN-ineligible/IFN-intolerantG2; 94% vs 92%3
(POSITRON); 12-wk regimenG3; 21% vs 68%3
IFN-failure7 (FUSION)
12-wk regimenG2; 60% vs 96% (90%)
G3; 19% vs 37%
16-wk regimenG2; 78% vs 100% (92%)
G3; 61% vs 63%
Zeuzem et al[31] (VALENCE)SOF + RBV; G2-3; n = 323Treatment-naïve
12-wk regimenG2; 100% vs 97%3
24-wk regimenG3; 92% vs 93%3
Treatment-experienced
12-wk regimenG2; 88% vs 91%
24-wk regimenG3; 60% vs 85%
Lawitz et al[35] (COSMOS)SMV + SOF ± RBV for 12 or 24 wk; G1; n = 167F0-2; non-respondersF0-2; 90%3
F3-4; non-responders or naiveF3-4; 94%
Poordad et al[36] (TURQUOISE-II)Paritaprevir, ritonavir, ombitasvirTreatment-naïve94%38
+ dasabuvir + RBV 12 or 24 wk; G1; n = 380Treatment-experienced
Relapse98%
Partial response96%
Null response91%