Extended duration therapy with pegylated interferon and ribavirin for patients with genotype 3 hepatitis C and advanced fibrosis: Final results from the STEPS trial

Shoeb, D.; Dearden, Janet; Weatherall, A.; Bargery, C.; Moreea, Sulleman; Alam, Syed M.; White, Edward; Vila, Xavier Sánchez; Freshwater, D; Ryder, Stephen; Mills, Peter R.; Alexander, Graeme; Forton, Daniel; Foster, Graham R.

doi:10.1016/j.jhep.2013.11.011

Cited by 15 publications

(14 citation statements)

References 18 publications

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“…This rate is lower than other reports from tertiary medical centers, referral centers, and clinical trials, where SVR rates have been reported to range between 72% and 89%. [11][12][13][14][15][16]24 One potential reason for the low SVR rate was the high relapse rate (23.5%) in our patient population compared with rates reported by others. Relapse rates in the range of 10% to 15% for genotype 3 are generally reported in the literature.…”

Section: ■■ Discussionmentioning

confidence: 96%

“…For example, others have reported that patients with various degrees of liver disease, such as cirrhosis, advanced fibrosis, steatosis, and obesity, have lower SVR rates in genotype 3. [11][12][13][14][15][16]25 Age less than 45 years has been associated with improved SVR outcomes in genotype 3. 16 It is increasingly reported that HCV genotype 3 is more difficult to treat than previously thought and is associated with higher rates of complications than most other genotypes.…”

Section: ■■ Discussionmentioning

confidence: 99%

“…In an effort to the 72%-89% range are reported for genotype 3 HCV patients treated with PegINF and ribavirin. [11][12][13][14][15][16][17][18] However, these SVR results are from clinical trials or from patients treated at tertiary medical centers, university hospitals, and referral centers. [11][12][13][14][15][16][17][18] There is little information confirming these rates of SVR response in population-based studies.…”

Section: Datamentioning

confidence: 99%

“…The relapse rate of 23.5%, found in this study, is also higher than the relapse rates reported by others, which generally range from 10% to 15%. 11,13,[15][16][17][18] Sofosbuvir was approved for use with ribavirin at the end of the study window, and patients treated with this new combination are only now completing therapy. Clinical studies suggest that the combination of sofosbuvir and ribavirin are equivalent or better than PegINF and ribavirin.…”

Section: Sustained Virologic Response and Failure Outcomesmentioning

confidence: 99%

See 3 more Smart Citations

Factors Associated with Failure to Achieve SVR in Hepatitis C Genotype 3 Patients Within an Integrated Care Delivery System

Cheetham¹,

Niu²,

Chiang³

et al. 2015

JMCP

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Section: ■■ Discussionmentioning

confidence: 96%

Section: ■■ Discussionmentioning

confidence: 99%

Section: Datamentioning

confidence: 99%

Section: Sustained Virologic Response and Failure Outcomesmentioning

confidence: 99%

See 2 more Smart Citations

Factors Associated with Failure to Achieve SVR in Hepatitis C Genotype 3 Patients Within an Integrated Care Delivery System

Cheetham¹,

Niu²,

Chiang³

et al. 2015

JMCP

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“…Multiple randomized controlled trials [15][16][17][18][19][20], detailed in Table 1, have demonstrated moderate rates of efficacy to pegylated interferon (PEG)-based therapy. Overall, SVR rates range from 42 to 93 % across these studies.…”

Section: Treatmentmentioning

confidence: 99%

Hepatitis C genotype 3 disease

et al. 2016

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Hepatitis C genotype 3 (GT-3) infection comprises up to 30 % of all HCV infections worldwide, with roughly 54.3 million cases concentrated in South and Southeast Asia. Longitudinal studies have demonstrated significantly increased rates of steatosis, fibrosis, and hepatocellular carcinoma in GT-3 disease, thus distinguishing this genotype as both the most difficult and urgent to treat. However, novel direct-acting antiviral agents currently approved have not demonstrated the uniform potency seen in GT-1 disease for GT-3. This review outlines (1) the epidemiology and natural history, (2) phase II and III clinical trials demonstrating effective treatment options, and (3) current and future therapeutic issues in the quest to eradicate hepatitis C genotype 3 disease.

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Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection

et al. 2015

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on behalf of the VITAL-1 study teamAlisporivir is a cyclophilin inhibitor with pan-genotypic anti-hepatitis C virus (HCV) activity and a high barrier to viral resistance. The VITAL-1 study assessed alisporivir as interferon (IFN)-free therapy in treatment-na€ ıve patients infected with HCV genotype 2 or 3. Three hundred forty patients without cirrhosis were randomized to: arm 1, alisporivir (ALV) 1,000 mg once-daily (QD); arm 2, ALV 600 mg QD and ribavirin (RBV); arm 3, ALV 800 mg QD and RBV; arm 4, ALV 600 mg QD and pegylated IFN (Peg-IFN); or arm 5, Peg-IFN and RBV. Patients receiving IFN-free ALV regimens who achieved rapid virological response (RVR) continued the same treatment throughout, whereas those with detectable HCV RNA at week 4 received ALV, RBV, and Peg-IFN from weeks 6 to 24. Overall, 300 patients received ALV-based regimens. In arm 1 to arm 4, the intent-to-treat rates of sustained virological response (SVR) 24 weeks after treatment (SVR24) were from 80% to 85%, compared with 58% (n 5 23 of 40) with Peg-IFN/RBV. Per-protocol analysis showed higher SVR24 rates in patients who received ALV/RBV, IFN-free after RVR (92%; n 5 56 of 61) than with ALV alone after RVR (72%; n 5 13 of 18) or with Peg-IFN/RBV (70%; n 5 23 of 33). Both RVRs and SVRs to ALV IFN-free regimens were numerically higher in genotype 3-than in genotype 2-infected patients. Viral breakthrough was infrequent (3%; n 5 7 of 258). IFN-free ALV treatment showed markedly better safety/tolerability than IFN-containing regimens. Conclusions: ALV plus RBV represents an effective IFN-free option for a proportion of patients with HCV genotype 2 or 3 infections, with high SVR rates for patients with early viral clearance. Further investigations of ALV in IFN-free combination regimens with directacting antiviral drugs deserve exploration in future trials. (HEPATOLOGY 2015;62:1013-1023 A n estimated 184 million people, representing 3% of the global population, are infected with the hepatitis C virus (HCV), with at least 350,000 deaths occurring annually from associated liver disease. 1 HCV is classified into seven major genotypes; genotypes 2 and 3 account for 25%-50% of all infections in

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Extended duration therapy with pegylated interferon and ribavirin for patients with genotype 3 hepatitis C and advanced fibrosis: Final results from the STEPS trial

Cited by 15 publications

References 18 publications

Factors Associated with Failure to Achieve SVR in Hepatitis C Genotype 3 Patients Within an Integrated Care Delivery System

Factors Associated with Failure to Achieve SVR in Hepatitis C Genotype 3 Patients Within an Integrated Care Delivery System

Hepatitis C genotype 3 disease

Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection

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