Delayed versus immediate treatment for patients with acute hepatitis C: a randomised controlled non-inferiority trial

Deterding, Katja; Grüner, N.; Buggisch, Peter; Wiegand, Johannes; Galle, Peter R.; Spengler, Ulrich; Hinrichsen, Holger; Berg, Thomas; Potthoff, Andrej; Malek, Nisar P.; Großhennig, Anika; Koch, Armin; Diepolder, Helmut M.; Lüth, Stefan; Feyerabend, Sandra; Jung, M; Rogalska-Taranta, Magdalena; Schlaphoff, V.; Cornberg, Markus; Manns, Michael P.; Wedemeyer, Heiner

doi:10.1016/s1473-3099(13)70059-8

Cited by 83 publications

(56 citation statements)

References 29 publications

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“…162 A randomized controlled trial showed 13% higher SVR (67% versus 54%) in those who received Peg-IFN within 12 weeks of exposure. 163 However, recommendations are expected to change once results of highly effective therapy with a combination of DAAs are available. Presently data on the use of DAAs for treating AHCV infection are lacking.…”

Section: Antiviral Therapy For Ahcv Infectionmentioning

confidence: 99%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

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India contributes significantly to the global burden of HCV. While the nucleoside NS5B inhibitor sofosbuvir became available in the Indian market in March 2015, the other directly acting agents (DAAs), Ledipasvir and Daclatasvir, have only recently become available in the India. The introduction of these DAA in India at a relatively affordable price has led to great optimism about prospects of cure for these patients as not only will they provide higher efficacy, but combination DAAs as all-oral regimen will result in lower side effects than were seen with pegylated interferon alfa and ribavirin therapy. Availability of these newer DAAs has necessitated revision of INASL guidelines for the treatment of HCV published in 2015. Current considerations for the treatment of HCV in India include the poorer response of genotype 3, nonavailability of many of the DAAs recommended by other guidelines and the cost of therapy. The availability of combination DAA therapy has simplified therapy of HCV with decreased reliance of evaluation for monitoring viral kinetics or drug related side effects. ( J CLIN EXP HEPATOL 2016;6:119-145) T here have been revolutionary changes in the management of chronic hepatitis C (CH-C) over the last few years. Pegylated interferon alfa (Peg-IFNa) plus ribavirin (RBV) therapy, which till the recent past was the standard of care, has been eclipsed by the arrival of newer directly acting antiviral agents (DAAs). Not only do the DAAs have better efficacy, they are also associated with lower side effects, have better tolerability, a shorter duration of therapy, and have simpler administration.In the recent guidelines issued by the American Association for the study of Liver Diseases (AASLD), in collaboration with the Infectious Diseases Society of America 1 and the European Association for Study of the Liver z (EASL), 2 the role of Peg-IFNa/RBV therapy in the management of HCV has been relegated to second-line, backup status. These newer guidelines, however, cannot be implemented in India as many of the recommended drugs are yet to be marketed in India. Other considerations for the treatment of HCV in India are a predominance of

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Section: Antiviral Therapy For Ahcv Infectionmentioning

confidence: 99%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

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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%

“…14 Another randomized, open-label trial was conducted among Canadian adult drug users with chronic HCV to compare immediate treatment (treating 24 weeks for HCV genotype 1 and 48 weeks for genotypes 2 or 3) to delayed treatment (starting treatment after 24 weeks of observation for HCV genotype 1 and 48 weeks of observation for genotypes 2 or 3) with PEG-IFN alfa-2a plus RBV and followed for 96 months. 15 Similarly, patients who received the delayed treatment had a slightly lower SVR than the patients who received the immediate treatment (39% vs 65%, P=0.06).…”

Section: Rcts Dual Therapymentioning

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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“…SVR rate was reported as 90% in symptomatic patients who were treated immediately and 93% in those given delayed therapy. The authors emphasized that waiting for spontaneous clearance prevents unnecessary treatment, but it would be better to start treatment immediately in patients who cannot be closely followed (19). The study of Kamal et al (20) is important for comparing the different treatment durations with peg-IFN in acute HCV infection.…”

Section: Interferon-based Therapiesmentioning

confidence: 99%