The assessment of data mining for the prediction of therapeutic outcome in 3719 Egyptian patients with chronic hepatitis C

Awad, Abeer; El-Akel, Wafaa; Doss, Wahid; Awad, Tahany; Radwan, Amr; Mabrouk, Mahasen

doi:10.1016/j.clinre.2012.09.005

Cited by 22 publications

(12 citation statements)

References 41 publications

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“…Advanced fibrosis also seemed to be a predictor of poor response; however, it failed to maintain in the multiple logistic regression. Similar to our finding, an elevated alpha-fetoprotein has been recently reported to be a strong predictor of poor response with 40 kDa interferon (Khairy and others 2012;Zayed and others 2013). An early biochemical response has not previously been well-acknowledged as a clear predictor of response.…”

Section: Discussionsupporting

confidence: 81%

The Efficacy of aHansenula-Derived 20 kDa Pegylated Interferon Alpha-2a in the Treatment of Genotype 4 Chronic Hepatitis C

Shehab

Elbaz²,

Deraz³

et al. 2014

Journal of Interferon & Cytokine Research

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Pending the emergence and approval of an effective interferon-free regimen, pegylated interferon will remain an integral part of the treatment of genotype 4 hepatitis C virus (HCV). A new 20 kDa pegylated interferon has been developed in a cost-saving fungal-based system and is commercialized in Egypt at a quarter to a third of the price of conventional pegylated interferon. We hereby test the efficacy and safety of this novel cost-saving interferon. One hundred ninety-three consecutive treatment-naive patients with genotype 4 HCV were treated using the following regimen: subcutaneous 20 kDa pegylated interferon 160 mg once weekly plus oral ribavirin 1,000 or 1,200 mg daily (based on body weight < 75 kg or ‡ 75 kg, respectively) for 48 weeks. A sustained virological response (SVR) of 51% was achieved. Interim responses included rapid virological response (RVR): 54%, early virological response (EVR): 78% (complete EVR: 71%, partial EVR: 7%), and end of treatment response: 63%. The most common adverse events were flu-like symptoms, dyspepsia, anorexia, and pruritus. Treatment-related serious adverse events were encountered in only 2 patients (1%). Discontinuation of treatment due to adverse events occurred in only 13 patients (7%). Multiple logistic regression analyses revealed the following factors as predictors of SVR: RVR (P < 0.001), alpha-fetoprotein < upper limit of normal (ULN) (P = 0.007), and early biochemical response (alanine aminotransferase < ULN at week 12, P = 0.018). Hansenula-derived 20 kDa pegylated interferon alpha-2a is an effective and safe treatment for genotype 4 chronic HCV. These results highlight the presence of a less costly treatment for chronic HCV, pending the emergence of an effective inexpensive interferon-free regimen. A direct comparison with 40 kDa interferon remains essential to adequately compare the efficacy and safety.

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Section: Discussionsupporting

confidence: 81%

The Efficacy of aHansenula-Derived 20 kDa Pegylated Interferon Alpha-2a in the Treatment of Genotype 4 Chronic Hepatitis C

Shehab

Elbaz²,

Deraz³

et al. 2014

Journal of Interferon & Cytokine Research

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“…Six were redundant[49, 51, 57, 68, 89, 99] and four were not relevant[30, 43, 60, 94]. Two studies did not contain original data[52, 98]. Three studies did not evaluate treatment-naïve patients[31, 32, 97], one study did not have at least 25 HCV-4 patients[33], and three studies included patients co-infected with hepatitis B virus, HIV, or other liver diseases[44, 70, 82].…”

Section: Resultsmentioning

confidence: 99%

Meta-analysis

Yee

Nguyen

Zhang

et al. 2014

European Journal of Gastroenterology &Amp; Hepatology

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Background The burden of hepatitis C virus genotype 4 (HCV-4) is high in Africa and East Mediterranean countries. Previous reports estimate sustained virologic response (SVR) rates in HCV-4 to be ~20–70%. However, many of these studies are limited by different study designs and small sample sizes. Aim Our aim was to evaluate treatment outcome and host/viral factors on SVR in HCV-4 patients treated with pegylated interferon and ribavirin (PEG IFN+RBV) in a systematic and quantitative fashion. Methods A comprehensive literature search in MEDLINE and EMBASE for ‘genotype 4’ was conducted in November 2013. Abstracts from AASLD, APASL, DDW, and EASL in 2012/2013 were reviewed. Inclusion criteria were original studies with ≥25 treatment-naïve HCV-4 patients treated with PEG IFN+RBV. Exclusion criteria were co-infection with HIV, HBV, or other genotypes. Effect sizes were calculated using random-effects models. Heterogeneity was determined by Cochrane Q-test (p-value <0.05) and I-squared statistic (>50%). Results We included 51 studies (11,102 HCV-4 patients) in the primary analysis. Pooled SVR was 53% (95% CI: 50–55%) (Q-statistic = 269.20, p<0.05; I2 = 81.43). On sub-group analyses, SVR was significantly associated with lower viral load, OR 3.05 (CI 1.80–5.17, p<0.001); mild fibrosis, OR 3.17 (CI 2.19–4.59, p<0.001); and favorable IL28B polymorphisms, rs12979860 CC versus CT/TT, OR 4.70 (CI 2.87–7.69, p<0.001), and rs8099917 TT versus GT/GG, OR 5.21 (CI 2.31–11.73, p<0.001). Conclusions HCV-4 patients treated with PEG IFN+RBV may expect SVR rate of ~50%. Lower viral load, mild fibrosis, and favorable IL28B (rs12979860 CC and rs8099917 TT) are positively associated with SVR.

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“…Pretreatment AFP showed lower levels in responders and higher levels in relapsers. Zayed et al in 2013 published a decision tree model based on the pretreatment AFP value as an initial split variable at a cutoff of 8.08 ng/ml [10,11].…”

Section: Discussionmentioning

confidence: 99%

Pathology Predictors of Response to Combined Therapy of Chronic HCV Patients; Is it Applicable in the DAA Era?

El-Sayed

Esmat

Doss

et al. 2016

GHOA

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Introduction & aim: Liver biopsy has been considered the ''gold standard'' of diagnosis, the most direct way of visualizing the necroinflammatory and architectural status of liver in HCV patients planned for therapy. We aimed to study the relation between pathological findings in liver biopsy and their impacts on sustained virological response (SVR) in HCV patients receiving pegylated interferon and ribavirin (Peg/Riba). Methods:A retrospective analysis on data collected from 1486 HCV patients receiving Peg/Riba between May 2012 and May 2013 at the National Hepatology and Tropical Medicine Research Institute (NHTMRI). Initial labs before treatment including percutaneous liver biopsy were analyzed in relation to virological response.Results: 982 (66.1%) of patients were males and 504 (33.9%) were females. The mean age was (43.72 ± 9.527y), with 1008 (67.8%) more than 40 years. Higher SVR achieved in patients with no or mild steatosis than moderate to severe degrees (96% vs 4%, p: 0.001). More than 60% of patients with no or mild fibrosis showed SVR (p: 0.04). Patients with mild activity showed much higher SVR than patients with severe or advanced activity (67.1% vs 32.9%, p: 0.001). Negative viral load at w12 was significantly higher in patients with no or mild fibrosis (96.7% vs 94.9%, p: 0.004), no or mild steatosis (95.7% vs 94%, p: 0.024), but was not related to activity (95.8% vs 95.7%, p: 0.869). Conclusion:Steatosis, fibrosis and activity affected treatment outcome and could directly affect treatment decision. The response rate of peginterferon alpha 2a was comparable to alpha 2b. These findings are important to decide antiviral course in patients with multiple DAA RAVs leading to failure.

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The assessment of data mining for the prediction of therapeutic outcome in 3719 Egyptian patients with chronic hepatitis C

Cited by 22 publications

References 41 publications

The Efficacy of aHansenula-Derived 20 kDa Pegylated Interferon Alpha-2a in the Treatment of Genotype 4 Chronic Hepatitis C

The Efficacy of aHansenula-Derived 20 kDa Pegylated Interferon Alpha-2a in the Treatment of Genotype 4 Chronic Hepatitis C

Meta-analysis

Pathology Predictors of Response to Combined Therapy of Chronic HCV Patients; Is it Applicable in the DAA Era?

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