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

Abstract

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 ...

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

“…We observed an overall SVR rate of 50% for all genotypes in group A, which is comparable to SVR rates found in randomized clinical trials of peg-INF and ribavirin in HCV/HIV co-infected patients (27% to 40%) [11,12,28]. However, the SVR rates in mono-infected patients (52%) are slightly lower than those reported by a real-life cohort study of mono-infected patients treated by gastroenterologists at the same institution in the same time span (60,9%) [7]. The reasons for these differences are not clear, but we have to keep in mind that the ID clinic is attending for international patients, who might have different IL-28 haplotypes [7].…”

“…However, the SVR rates in mono-infected patients (52%) are slightly lower than those reported by a real-life cohort study of mono-infected patients treated by gastroenterologists at the same institution in the same time span (60,9%) [7]. The reasons for these differences are not clear, but we have to keep in mind that the ID clinic is attending for international patients, who might have different IL-28 haplotypes [7]. Also, it has to be noted that 9/84 of the mono-infected patients were lost to follow-up.…”

“…In general, HCV genotype, liver fibrosis, IL-28 haplotypes and quantitative HCV RNA are important baseline predictors of SVR [5]. Demographic factors, histological parameters and treatment related factors can also effect the response to treatment, but in general more than 50% of naïve mono-infected patients will achieve sustained virologic response (SVR) with the current standard therapy (pegylated interferon plus ribavirin) [6,7]. Two large registration trials have shown lower sustained virologic response rates (SVR) for dual therapy in HIV/HCV co-infected patients (~33%) compared to mono-infected patients (47-54%) [8-12].…”

Responses to peginterferon alfa-2a vs alfa-2b plus ribavirin in a Mexican population with chronic hepatitis C

“…The IDEAL study by McHutchison et al reported similar SVR rates of 40.9% (95% confidence interval [CI], 37.9-43.9) with peginterferon alfa-2a and 39.8% (95% CI, 36.8-42.8) with peginterferon alfa-2b (p = 0.57) [8]. In 2011, Zurwiesch et al studied a German cohort of 486 patients and reported no significant difference in the SVR rates with peginterferon alfa-2a (53.4%) and alfa-2b (53.7%) [11]. However, some authors have reported better responses with peginterferon alfa-2a.…”

“…However, clinical trials provide a high level of medical and supportive care, which tends to maximize patient compliance, and the inclusion and exclusion criteria may not reflect the clinical picture in a real-life setting [11]. Thus, the main objective of this study was to conduct a "reallife" comparison of peginterferon alfa-2a versus alfa2b plus ribavirin in a Mexican population with HCV genotype 1.…”