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      The very-rapid and the ultra-rapid virologic response to two treatment options in patients with chronic hepatitis C: an interim report of a prospective randomized comparative effectiveness study

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          Abstract

          Background

          We aimed in this interim report to compare two registered generic sofosbuvir products for the degree and speed of virologic response to a dual antiviral treatment protocol within the first 2 weeks of treatment.

          Methods

          Data collected during the period of this interim report from the first 25 patients randomized to either one of two generic sofosbuvir products (Grateziano or Gratisovir) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose were analyzed for both the degree and speed of virus load reduction at the end of 1 and 2 weeks from starting treatment.

          Results

          The baseline Log10 transformed virus load (Log polymerase chain reaction) showed a fairly similar marked and significant reduction in both groups by more than 4 and 5 Logs at the end of week 1 and 2 of starting treatment, respectively. The differences between the two treatment groups at both analysis points were not statistically significant ( P>0.05) by repeated measures factorial analysis of variance test. The differences in proportions of patients with ultra-rapid virologic response at the end of week 1 and very-rapid virologic response at the end of week 2 in both groups were also not statistically significant ( P>0.05).

          Conclusion

          We can conclude from this interim report that the two generic products Gratisovir and Grateziano are almost equally fast and efficacious in reducing the hepatitis C virus load in our study setting.

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          Most cited references 8

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          A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt.

          The hepatitis C pandemic has been systematically studied and characterized in North America and Europe, but this important public health problem has not received equivalent attention in other regions. The objective of this systematic review was to characterize hepatitis C virus (HCV) epidemiology in selected countries of Asia, Australia and Egypt, i.e. in a geographical area inhabited by over 40% of the global population. Data references were identified through indexed journals and non-indexed sources. In this work, 7770 articles were reviewed and 690 were selected based on their relevance. We estimated that 49.3-64.0 million adults in Asia, Australia and Egypt are anti-HCV positive. China alone has more HCV infections than all of Europe or the Americas. While most countries had prevalence rates from 1 to 2% we documented several with relatively high prevalence rates, including Egypt (15%), Pakistan (4.7%) and Taiwan (4.4%). Nosocomial infection, blood transfusion (before screening) and injection drug use were identified as common risk factors in the region. Genotype 1 was common in Australia, China, Taiwan and other countries in North Asia, while genotype 6 was found in Vietnam and other Southeast Asian countries. In India and Pakistan genotype 3 was predominant, while genotype 4 was found in Middle Eastern countries such as Egypt, Saudi Arabia and Syria. We recommend implementation of surveillance systems to guide effective public health policy that may lead to the eventual curtailment of the spread of this pandemic infection. © 2011 John Wiley & Sons A/S.
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            Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C.

            Interferon-based regimens for the treatment of chronic hepatitis C have become increasingly effective and are able to eradicate virus in more than one half of cases. Early identification of patients who will not respond is desirable because treatment might be stopped, thereby avoiding the expense and inconvenience of unnecessary therapy. We examined the accuracy of different degrees of viral inhibition during the early weeks of treatment (early virologic response [EVR]) with pegylated interferon alfa-2b and ribavirin (PEG/R) in identifying patients who would not respond to therapy. The best definition of EVR was a reduction in hepatitis C virus (HCV) RNA by at least 2 logs after the first 12 weeks of treatment compared with baseline. Between 69% and 76% of patients achieved this threshold, depending on the treatment regimen, and sustained virologic response (SVR) occurred in 67% to 80% of these patients. Patients who did not reach EVR did not respond to further therapy. If treatment had been stopped in patients without EVR, drug costs would have been reduced by more than 20%. In conclusion, early confirmation of viral reduction following initiation of antiviral therapy for chronic hepatitis C is worthwhile. It provides a goal to motivate adherence during the first months of therapy and a milepost at which to reassess the need for continued treatment. Most patients who are able to complete the first 12 weeks of therapy achieve EVR and have a high probability of SVR. Patients who fail to achieve EVR will not clear virus even if an additional 9 months of therapy is received. Therapy can be confidently discontinued in those cases.
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              A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C.

              The recommended treatment for patients infected with hepatitis C virus genotype 2 (HCV2) is pegylated interferon (peginterferon) and ribavirin for 24 weeks. To assess whether a shorter 16-week treatment is as effective as a standard 24-week treatment. Patients with HCV2 infection were randomised in a 1:2 ratio to either 16 weeks (n = 50) or 24 weeks (n = 100) of treatment with peginterferon alpha-2a (180 mug/week) and weight-based ribavirin 1000-1200 mg/day, with a 24-week follow-up period. A rapid virological response (RVR) was defined as seronegative for HCV RNA at 4 weeks of treatment, and the primary end point, sustained virological response (SVR), as seronegative for HCV RNA at the 24-week follow-up. The rate of RVR and SVR was 86% (43/50, 95% confidence interval (CI) 76% to 96%) and 94% (47/50, CI 87% to 100%), respectively, in the 16-week group, which was comparable to 87% (87/100, CI 80% to 94%) and 95% (95/100, CI 91% to 99%) in the 24-week group. Patients with RVR had a significantly higher SVR rate than patients without RVR in both 16-week (100% vs 57%, p = 0.015) and 24-week groups (98% vs 77%, p = 0.002). Multivariate analysis showed that RVR and age were independent factors associated with SVR. Both treatment arms were equally well tolerated. The incidence of alopecia was significantly higher in the 24-week group (49%) than in the 16-week group (20%, p = 0.001). 16 weeks and 24 weeks of peginterferon treatment with weight-based ribavirin at a dose of 1000-1200 mg/day provided equal efficacy in patients with HCV2 who achieved RVR at 4 weeks.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2015
                11 November 2015
                : 9
                : 6027-6033
                Affiliations
                [1 ]Green Clinic and Research Center, Alexandria University, Alexandria, Egypt
                [2 ]Abbas Helmy Clinics, Alexandria University, Alexandria, Egypt
                [3 ]Tropical Medicine and Hepatology Department, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt
                [4 ]Microbiology Department, High Institute of Public Health, Alexandria University, Alexandria, Egypt
                [5 ]Mabarat El Asafra Labs, Alexandria, Egypt
                [6 ]Pharco Corporation, Alexandria, Egypt
                Author notes
                Correspondence: Mostafa Yakoot, Green CRC & Abbas Helmy Clinics, 27 Green Street 21121, Alexandria, Egypt, Tel +20 12 2392 7561, Email yakoot@ 123456yahoo.com
                Article
                dddt-9-6027
                10.2147/DDDT.S95499
                4651553
                © 2015 Yakoot et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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