Results of the IDEAL trial: “Mirror, mirror on the wall … Which's the fairest peg-interferon of them all?”

Wiesch, Julian Schulze zur; Lohse, Ansgar W.

doi:10.1002/hep.23376

Cited by 5 publications

(2 citation statements)

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“…The majority of patients received PEG interferon alpha 2a [29], three patients who were treated early in 2000 still received conventional non-pegylated interferon. New direct-acting antiviral agents for hepatitis C genotype 1 infection, such as boceprevir, telaprevir or simeprevir as well as sofosbuvir [17,18,30,31], were not approved yet during the analysed timeperiod.…”

Section: Discussionmentioning

confidence: 99%

German cohort of HCV mono-infected and HCV/HIV co-infected patients reveals relative under-treatment of co-infected patients

et al. 2014

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BackgroundCurrent German and European HIV guidelines recommend early evaluation of HCV treatment in all HIV/HCV co-infected patients. However, there are still considerable barriers to initiate HCV therapy in everyday clinical practice. This study evaluates baseline characteristics, “intention-to-treat” pattern and outcome of therapy of HCV/HIV co-infected patients in direct comparison to HCV mono-infected patients in a “real-life” setting.MethodsA large, single-center cohort of 172 unselected HCV patients seen at the Infectious Diseases Unit at the University Medical Center Hamburg-Eppendorf from 2000–2011, 88 of whom HCV/HIV co-infected, was retrospectively analyzed by chart review with special focus on demographic, clinical and virologic aspects as well as treatment outcome.ResultsAntiviral HCV combination therapy with PEG-interferon plus weight-adapted ribavirin was initiated in 88/172 (52%) patients of the entire cohort and in n = 36 (40%) of all HCV/HIV co-infected patients (group A) compared to n = 52 (61%) of the HCV mono-infected group (group B) (p = 0.006). There were no significant differences of the demographics or severity of the liver disease between the two groups with the exception of slightly higher baseline viral loads in group A. A sustained virologic response (SVR) was observed in 50% (n = 18) of all treated HIV/HCV co-infected patients versus 52% (n = 27) of all treated HCV mono-infected patients (p = 0.859). Genotype 1 was the most frequent genotype in both groups (group A: n = 37, group B: n = 49) and the SVR rates for these patients were only slightly lower in the group of co-infected patients (group A: n = 33%, group B: 40% p = 0.626). During the course of treatment HCV/HIV co-infected patients received less ribavirin than mono-infected patients.ConclusionOverall, treatment was only initiated in half of the patients of the entire cohort and in an even smaller proportion of HCV/HIV co-infected patients despite comparable outcome (SVR) and similar baseline characteristics. In the light of newer treatment options, greater efforts to remove the barriers to treatment that still exist for a great proportion of patients especially with HIV/HCV co-infection have to be undertaken.

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Section: Discussionmentioning

confidence: 99%

German cohort of HCV mono-infected and HCV/HIV co-infected patients reveals relative under-treatment of co-infected patients

et al. 2014

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“…The study was originally designed to fulfil a postapproval commitment to the FDA to determine the appropriate dose of PegIFN α2b in patients with HCV genotype 1, i.e., low‐dose (LD) therapy at 1.0 μg/kg/week vs the standard dose (SD) of 1.5 μg/kg/week, both plus Rbv; however, the most awaited result was the direct comparison with the 180 μg/week PegIFN α2a plus Rbv treatment. The final results created some turmoil in the Hepatology community [25–28]. The three regimens yielded similar SVR rates (PegIFN α2b LD and SD: 38% and 39.8%; PegIFN α2a: 40.9%); however, the PegIFN α2a arm had a higher end of treatment response rate (PegIFN α2b LD and SD: 49.2% and 53.2%; PegIFN α2a: 64.4%) that in turn was counterbalanced by a higher posttreatment relapse rate (PegIFN α2b LD and SD: 20% and 23.5%; PegIFN α2a: 31.5%).…”

Section: Treatment Efficacy In Hcv Patientsmentioning

confidence: 99%

Comparative trials of peginterferon α2a and peginterferon α2b for chronic hepatitis C

Rumi

Aghemo

Prati

2012

Journal of Viral Hepatitis

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Standard of care for patients with chronic hepatitis C is pegylated interferon (pegIFN) combined with ribavirin (Rbv). It results in persistent viral eradication and prevents the progression of liver disease and the associated complications in about 50% of treated patients. Currently, two PegIFNs are available that differ significantly in terms of pharmacokinetic and pharmacodynamic profiles as a consequence of different pegylation chemistries. While the registration trials of the two therapeutic regimens demonstrated the superiority of each PegIFN vs the native IFN α2b, the superiority of one regimen over the other in terms of treatment efficacy remains unknown. Retrospective cohort studies and randomized prospective head-to-head trials have attempted to resolve the considerable controversy over this issue and support evidence-based treatment decisions.

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“Real-Life” comparison of pegylated-interferon 2a versus 2b combination therapy of chronic hepatitis C virus

et al. 2011

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We read with great interest the article by Stepanova et al. 1 In this report from the United States with 10,582 eligible individuals (1.52% of whom were positive for hepatitis C virus [HCV] antibody [anti-HCV]), the rate of insurance coverage was significantly lower in patients with HCV infection (61.2%), particularly in 66.7% patients who could be candidates for treatment (54.3%), than in subjects without HCV infection (81.2%). Only 36.3% of HCV-infected patients were potentially eligible for treatment and had health insurance. The authors considered that access to care for patients infected with HCV is critical, and their results can have important implications for health insurance coverage of HCV-infected patients and should be considered under the new health care reform legislation. With the current standard-of-care (SOC) regimen with a combination of pegylated interferon-alfa (PegIFN) and ribavirin, sustained virological response (SVR) rates in Western countries were around 50% and 83% for genotype 1 and 2/3 patients, respectively. 2,3 In addition to the well-known adverse effects of the PegIFN/ribavirin, which might terrify both physicians and patients and need careful monitoring as well as management, another important barrier that prevents patients from receiving SOC is the high cost of treatment of HCV, which the authors estimate is up to $48,000 per year in the United States. Insurance coverage to reduce the economic impact is critical in these patients, given the inability of most to afford the treatment. Recently, Yan et al. also reported that concern about cost is one of the most common causes (37%) for nontreatment before the government reimbursed all treatment for chronic hepatitis C (CHC) in Hong Kong. 4 Reduction of the economic burden for HCV therapy helps improve the treatment uptake of patients with CHC. In Taiwan, patients with CHC who are infected with genotype 1 and 2, and who are treated with PegIFN/ribavirin, achieve high SVR rates in our previous randomized trials (80% and 95%, respectively). 5,6 In addition, Asian patients had the highest frequency of the advantageous allele in the gene for interleukin-28B, with up to 88% of Taiwanese patients with CHC having the rs8099917 TT genotype in our reports, 7,8 which has been shown to be an important predictor of response. It seems reasonable to encourage Taiwanese patients with CHC to undertake the SOC regimen. In Taiwan, National Health Insurance (NHI) commenced in 1995, with a very high universal coverage rate of 99.5% by the end of 2008, resulting in a narrowed disparity in health care between the wealthy and the poor. 9 The reimbursement for anti-HCV therapy by the Taiwanese NHI started in 2003 if patients meet all the criteria: (1) positive for anti-HCV; (2) the alanine aminotransferase levels !2Â upper limit of normal on two occasions 3 months apart during the 6-month period; and (3) fibrosis stage !2 (revised to stage 1 or greater since 2004). The criteria were further revised in 2009: (1) patients with positive anti-HCV and serum HCV ...

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Results of the IDEAL trial: “Mirror, mirror on the wall … Which's the fairest peg-interferon of them all?”

Cited by 5 publications

References 19 publications

German cohort of HCV mono-infected and HCV/HIV co-infected patients reveals relative under-treatment of co-infected patients

German cohort of HCV mono-infected and HCV/HIV co-infected patients reveals relative under-treatment of co-infected patients

Comparative trials of peginterferon α2a and peginterferon α2b for chronic hepatitis C

“Real-Life” comparison of pegylated-interferon 2a versus 2b combination therapy of chronic hepatitis C virus

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