Optimizing treatment for <scp>HCV</scp> genotype 4: PEG‐IFN alfa 2a vs. PEG‐IFN alfa 2b; the debate continues

Esmat, Gamal; Kassas, Mohamed El; Hassany, Mohamed; Gamil, Mohamed; Raziky, Maissa El

doi:10.1111/liv.12397

Cited by 31 publications

(21 citation statements)

References 40 publications

(24 reference statements)

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“…Treatment of HCV is considered very important issue as it reduces the risk of decompensated liver cirrhosis and hepatocellular carcinoma hence reducing the morbidity and mortality [20]- [22]. In Egypt, PEG-IFN and RBV were introduced by ministry of health through a national treatment program for patients with chronic HCV infection since 2006, SVR rates ranged from 54% to 59% [23] [24]. The recent approval of DAAs for treatment of HCV-4 promises significant improvement in the outcome of therapy.…”

Section: Discussionmentioning

confidence: 99%

A Real Life Study on Treatment of Egyptian Patients with HCV Genotype IV with Simeprevir and Sofosbuvir

Hanno¹,

Elwazzan²,

Ibrahim³

et al. 2016

Health

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Background and Aims: Treatment with a combination of the nucleotide polymerase inhibitor sofosbuvir and NS3A (non-structural protein 3A) protease inhibitor simeprevir resulted in high rates of sustained virological response in chronic hepatitis C Genotype 4. Methods: We conducted a real life study on Egyptian patients coming to tropical medicine department clinic at El Mery main university hospital from February 2015 to February 2016 for treatment naïve and treatment experienced patients with chronic HCV genotype 4, including cirrhotics and non cirrhotics. Naïve (cirrhotics and non cirrhotics) and relapsers (non cirrhotics) received nucleotide polymerase inhibitor sofosbuvir and NS3A inhibitor simeprevir once daily for 12 weeks and 24 weeks for relapser cirrhotic patients. The primary end point was a sustained virologic response at 12 weeks after end of treatment. An informed consent was obtained from each patient at the beginning of the study (Real life study: a study on Egyptian patients when the drug was available in the market). Results: 30 naïve patients with HCV genotype 4 and 20 relapsers (10 non cirrhotic and 10 cirrhotic patients) were enrolled. Patient inclusion criteria: Naïve patients are those who tested positive for HCV RNA by PCR and had no experience to HCV treatment; Relapsers are those who tested positive for HCV RNA by PCR and had a previous treatment for HCV. Cirrhosis was diagnosed on ultrasound basis. Mean age was 53.57 ± 10.682 years old in naïve patients and 48.30 ± 5.100 years old in relapsers. Median baseline HCV RNA was 360,069 IU/mL for naïve patients and 1,245,000 IU/mL for relapsers; using Fib4 20% of naïve patients were F3-F4, while 40% of relapsers were F3-F4. Degree of fibrosis was confirmed by fibrotest in relapsers. Upon treatment of patients with sofosbuvir and semiprevir once daily for 12 weeks and 24 weeks only to cirrhotic relapsers, end of treatment PCR was negative in 100% in all groups including cirrhotics and non cirrhotics. Primary end point (SVR 12) was achieved in 100% of all patients. Second end point (SVR 24) was achieved in 96.6% of naïve patients; SVR 24 for non-cirrhotic relapsers was achieved in 100% of patients and in 90% of cirrhotic relapsers. One patient had transient total bilirubin elevations without in-A. Hanno et al. 781 creased ALT (alanine aminotransferase) or AST (aspartate aminotransferase). One patient developed cutaneous rash. Conclusion: Once daily sofosbuvir and simeprevir for 12 weeks provided high rate of sustained virological response among treatment naïve and treatment experienced patients with HCV genotype IV.

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Section: Discussionmentioning

confidence: 99%

A Real Life Study on Treatment of Egyptian Patients with HCV Genotype IV with Simeprevir and Sofosbuvir

Hanno¹,

Elwazzan²,

Ibrahim³

et al. 2016

Health

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“…Annually, 4000050000 patients have been treated, and 350000 patients had received therapy in this program by 2013 [150] . SVR rates for patients treated with the original PEGIFNα2a and alfa2b were 54%59% [151,152] and response rates to a locally produced biosimilar PEG IFN were reported at 52% [153] .…”

Section: Background In Hcv Treatmentmentioning

confidence: 99%

Hepatitis C genotype 4: The past, present, and future

Abdel-Ghaffar

Sira

Naghi

2015

WJH

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Hepatitis C virus (HCV) genotype (GT) 4 represents 12%-15% (15-18 million) of total global HCV infection. It is prevalent in Northern and Equatorial Africa and the Middle East, and is also present in some countries in Europe. GT-4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. In underdeveloped countries, risk factors associated with HCV infection may be due to unsafe medical practices or other factors such as familial transmission, mother's HCV status, or illiteracy. HCV prevention and control programs should include health education, increased community awareness towards the disease, controlling infection distribution in healthcare centers, proper sterilization of medical and dental instruments, and ensuring safe supply of blood and blood-products. Response rates to a 48-wk combined pegylated-interferon (PEG-IFN) and ribavirin (RBV) treatment range from 40%-69%, and HCV-GT-4 has been considered better than GT-1 but worse than GT-2 and GT-3 in treatment with PEG-IFN/RBV. However, with the introduction of the HCV-GT-1 effective protease inhibitors boceprevir and telaprevir in 2011, HCV-GT-4 became the "most difficult (GT) to treat". Recently, the direct-acting antivirals (DAAs) with pan-genotypic activities simeprevir, sofosbuvir, and daclatasvir have been recommended in triple regimens with PEG-IFN/RBV for the treatment of HCV-GT-4. An IFN-free regimen will be available for treatment of all genotypes of HCV in the near future. To date, several DAAs have been developed and are currently being evaluated in various combinations in clinical trials. As new regimens and new agents are being approved by the Food and Drug Administration, we can expect the guidelines for HCV treatment to be changed. The availability of shorter, simpler, and more tolerable treatment regimens can reduce the morbidity and mortality associated with HCV infection. With such a large number of therapeutic agents available, we can end up with a range of choices that we can select from to treat patients.

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“…The type of interferon either alpha 2a or alpha 2b as a predictor of response was a point of debate most of the time [12]. In this study, we found that there was no statistical significance between patients who had either type of Interferon and their treatment outcome.…”

Section: Discussionmentioning

confidence: 52%

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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Optimizing treatment for HCV genotype 4: PEG‐IFN alfa 2a vs. PEG‐IFN alfa 2b; the debate continues

Cited by 31 publications

References 40 publications

A Real Life Study on Treatment of Egyptian Patients with HCV Genotype IV with Simeprevir and Sofosbuvir

A Real Life Study on Treatment of Egyptian Patients with HCV Genotype IV with Simeprevir and Sofosbuvir

Hepatitis C genotype 4: The past, present, and future

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

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