Extended peginterferon plus ribavirin treatment for 72 weeks versus standard peginterferon plus ribavirin treatment for 48 weeks in chronic hepatitis C genotype 1 infected slow-responder adult patients

Katz, Lior H.; Goldvaser, Hadar; Gafter‐Gvili, Anat; Tur–Kaspa, Ran

doi:10.1002/14651858.cd008516.pub2

Cited by 9 publications

(5 citation statements)

References 57 publications

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“…Some patients, however, achieve a rapid virological response (RVR), defined as undetectable HCV RNA after 4 weeks of PEG‐IFN/RBV treatment, with an 80–100% likelihood of achieving SVR; in contrast, patients who do not achieve an early virological response (EVR), defined as undetectable HCV RNA or ≥2‐log decrease from baseline at week 12 of therapy, have only an 8% chance of achieving SVR . Several studies have evaluated the effects of extending therapy in slow responders , with undetectable HCV RNA after 24 weeks suggested as a surrogate for SVR. To rigorously evaluate the antiviral effects of vitamin D supplementation in HCV genotype‐1 infected patients being treated with PEG‐IFN/RBV, we randomized patients who did not achieve RVR to receive or not receive vitamin D supplementation, beginning 8 weeks after the start of PEG‐IFN/RBV, and assessed the proportions of patients with undetectable serum HCV RNA after 24 weeks of treatment.…”

Section: Introductionmentioning

confidence: 99%

Effect of vitamin D supplementation on pegylated interferon/ribavirin therapy for chronic hepatitis C genotype 1b: a randomized controlled trial

Yokoyama

Takahashi

Kawakami

et al. 2013

Journal of Viral Hepatitis

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Chronic HCV-infected patients tend to have vitamin D deficiency, suggesting that vitamin D supplementation may enhance the efficacy of treatment with pegylated interferon (PEG-IFN) and ribavirin (RBV). We therefore assessed the effects of vitamin D supplementation on viral response to PEG-IFN/RBV. Eighty-four patients with HCV genotype 1b were randomized, 42 to oral vitamin D supplementation (1000 IU/day) and 42 to nonsupplementation (control), from week 8 to the end of PEG-IFN/RBV therapy. The primary end point was undetectable HCV RNA at week 24 (viral response [VR]). VR rate at week 24 was significantly higher in the vitamin D than in the control group (78.6% vs 54.8% P = 0.037). Adverse events were similar in both groups. When patients were subdivided by IL28B SNP rs8099917 genotype, those with the TT genotype group showed a significantly higher VR rate at week 24 with than without vitamin D supplementation (86.2% vs 63.3% vs P = 0.044). Although patients with the TG/GG genotype, who were relatively resistant to PEG-IFN treatment, had similar VR rates at week 24 with and without vitamin D supplementation, the decline in viral load from week 8 to week 24 was significantly greater with than without vitamin D supplementation. Multivariate analysis showed that rs8099917 genotype and vitamin D supplementation contributed significantly to VR at week 24. SVR rates were similar in the vitamin D and control groups [64.3% (27/42) vs 50% (21/42), P = 0.19]. Vitamin D supplementation may enhance the effects of PEG-IFN/RBV in HCV genotype 1b-infected patients.

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Section: Introductionmentioning

confidence: 99%

Effect of vitamin D supplementation on pegylated interferon/ribavirin therapy for chronic hepatitis C genotype 1b: a randomized controlled trial

Yokoyama

Takahashi

Kawakami

et al. 2013

Journal of Viral Hepatitis

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“…Slow responders are potential candidates for treatment intensification, and several previous trials have reported the virological benefits of prolonged 72-week combination therapy in such patients (9,11,(13)(14)(15)(16). In addition, a recent pooled analysis of slow responders found that 33% of the patients who received 72-week therapy achieved SVR, whereas only 27% of those who received 48 weeks of therapy did so (p=0.02), with relapse rates in the 72-and 48-week treatment groups of 32% and 51% (p=0.007), respectively (22). The present study showed a relapse rate of 60% with 72-week treatment.…”

Section: Discussionmentioning

confidence: 95%

Long-term Pegylated Interferon Monotherapy Following 72 Weeks of Pegylated Interferon and Ribavirin in Hepatitis C Virus Genotype-1-infected Slow Responders

et al. 2015

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Objective Slow responders to pegylated interferon (Peg-IFN) and ribavirin (RBV) among patients infected with hepatitis C virus (HCV) genotype 1 may benefit from an extended treatment course. The aim of this study was to determine the efficacy of persistent negative serum HCV RNA over 96 weeks during long-term Peg-IFN monotherapy following 72 weeks of combination therapy. Methods A total of 46 HCV genotype 1-infected slow responders were treated for 72 weeks with Peg-IFN and RBV combination therapy alone (n=25) or additional long-term biweekly treatment with 90 μg of Peg-IFN-α2a (n=21). The criterion for the completion of long-term Peg-IFN monotherapy was defined as the attainment of constantly negative HCV RNA in the serum over 96 weeks during IFN treatment. Results The patients with sustained negative serum HCV RNA during 96 weeks of IFN treatment had a higher rate of sustained virological response (SVR) than those without (81 vs. 40%, p=0.012). A multivariate analysis identified sustained negativity of serum HCV RNA over 96 weeks of IFN treatment to be a predictive factor for SVR. Conclusion In the present study, sustained negative serum HCV RNA over 96 weeks during long-term Peg-IFN monotherapy following 72 weeks of combination therapy of Peg-IFN and RBV resulted in beneficial virological outcomes among HCV genotype 1-infected slow responders.

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“…After a manual review, 118 duplicates and 650 studies irrelevant to our objectives were excluded, and 134 studies remained for further screening. Applying the inclusion and exclusion criteria, a total of 19 studies (four randomized control trials [RCTs], [14][15][16][17] ten meta-analysis studies, [18][19][20][21][22][23][24][25][26][27] three nonrandomized intervention studies, [28][29][30] one cross-sectional study, 31 and one cohort study 32 ) were included for the updated studies for this review (Table 1). Additionally, eight RCTs were also included in this review that were published during the study period of Chou et al 13 and met the inclusion/exclusion criteria, but were not reviewed by them.…”

Section: Methodsmentioning

confidence: 99%

“…20 Another meta-analysis compared the treatment duration of PEG-IFN plus RBV and found that extended PEG-IFN plus RBV for 72 weeks was more effective than standard PEG-IFN plus RBV for 48 weeks among patients with HCV genotype 1, while no difference in adverse events was observed for the two treatment strategies. 21 Finally, a pooled analysis based on five RCTs assessed the safety of standard-dose (180 µg/week) vs high-dose (360 µg/week) PEG-IFN alfa-2a plus RBV in HCV genotype 1 or 4 patients. 22 Although it did not find a statistically significant difference in frequencies of severe adverse events (3.2% vs 4.2%, P.0.05) or discontinuation rates (2.8% vs 2.9%, P.0.05), it showed that patients receiving high doses were more likely to experience weight loss compared to those receiving the standard dose (7.7% vs 3.3%, P,0.05).…”

Section: Studies Other Than Rcts Dual Therapymentioning

confidence: 99%

“…17,18,20 The duration of dual therapy continued to be a common research question, and another three articles reinforced the thought that the longer duration of dual therapy was associated with higher SVR in HCV genotypes 2 and 3. 19,21,35 In genotype 1, a clear advantage was still seen in triple therapy over dual therapy. However, five articles reported that this advantage did come at the cost of a higher rate of adverse effects, such as anemia with boceprevir and rash with telaprevir.…”

Section: December 15mentioning

confidence: 99%

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Current issues in comparative effectiveness research for hepatitis C

Yoo¹,

Yan²,

Rhien³

et al. 2014

CER

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Background: With increasing treatment options for hepatitis C, evidence of comparative effectiveness of these treatment options is required to improve treatment outcomes. The purpose of this study was to evaluate the most recent comparative effectiveness research and suggest future directions for hepatitis C research. Methods: We identified and evaluated the literature on comparative effectiveness research and conducted a literature search for additional studies since the most current review. A review of ongoing clinical trials in hepatitis C was performed to assess how forthcoming research is addressing the research gaps and limitations. Results: Since a comprehensive comparative effectiveness research review by Chou et al new studies have been published, which were mostly consistent with the consensus in the literature. A few of them added to comparative effectiveness research knowledge by addressing issues of the likelihood of sustained virologic response in an older cohort, the effect of genomics and individualizing treatment duration, or the effect of delayed treatment. Research gaps and limitations of the existing comparative effectiveness research and future study needs were well identified in the second study from Chou et al. Some of the gaps and limitations were filled by additional research over the past year, though many of them still remained unanswered. Conclusion: To have complete information on the effectiveness of alternative treatments for hepatitis C virus, further research is needed on results in the general population, the effectiveness of treatment methods such as noninvasive treatment and individualized treatment, and the long-term effects of triple therapies. Additionally, evidence from a real-world setting is lacking. Methodologically thorough and independently funded retrospective research will help to generalize the effectiveness of current therapies for hepatitis C virus.

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Extended peginterferon plus ribavirin treatment for 72 weeks versus standard peginterferon plus ribavirin treatment for 48 weeks in chronic hepatitis C genotype 1 infected slow-responder adult patients

Cited by 9 publications

References 57 publications

Effect of vitamin D supplementation on pegylated interferon/ribavirin therapy for chronic hepatitis C genotype 1b: a randomized controlled trial

Effect of vitamin D supplementation on pegylated interferon/ribavirin therapy for chronic hepatitis C genotype 1b: a randomized controlled trial

Long-term Pegylated Interferon Monotherapy Following 72 Weeks of Pegylated Interferon and Ribavirin in Hepatitis C Virus Genotype-1-infected Slow Responders

Current issues in comparative effectiveness research for hepatitis C

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