Benefit&amp;ndash;risk assessment of new and emerging treatments for hepatitis C: focus on simeprevir and sofosbuvir

Gaetano, John N.

doi:10.2147/dhps.s43304

Cited by 38 publications

(25 citation statements)

References 27 publications

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“…SMV is active against genotypes 1, 2, 4, 5 and 6. It is administered as a oncedaily tablet orally and has demonstrated a favorable safety profile and limited drugdrug interactions [182] . RESTORE, a phase Ⅲ, multicenter, singlearm, openlabel study, conducted in France and Belgium, evaluated SMV (150 mg oncedaily for 12 wk in combination with PegIFN/RBV, followed by 1236 wk of PegIFN/RBV only) in 107 patients with HCV 4, either naïve or treatmentexperienced [183] .…”

Section: Combination Therapy With Peg-ifn Rbv and A Secondgenerationmentioning

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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Section: Combination Therapy With Peg-ifn Rbv and A Secondgenerationmentioning

confidence: 99%

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

Abdel-Ghaffar

Sira

Naghi

2015

WJH

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“…It has been documented that early diagnosis and treatment are essential to improve long-term health outcomes in this population [6]. The goal of HCV therapies is to minimize the high morbidity and mortality associated with the chronic infection with HCV [7].…”

Section: Introductionmentioning

confidence: 99%

“…This allowed for the discovery of new therapy targets that directly inhibit replication [7]. Some of These drugs improve the SVR up to 100% and have fewer side effects with shorter duration of therapy.…”

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of combination therapy (Simeprevir/Sofosbuvir) in the treatment of chronic HCV genotype IV patients

Wahsh¹,

Hussein²,

Gomaa³

et al. 2018

Med-Science

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Chronic infection with HCV is a worldwide health problem that may lead to cirrhosis, portal hypertension, hepatocellular failure and hepatocellular carcinoma in most of cases. A new era in HCV treatment has been started using direct acting antiviral activity. In this study we assess the safety and efficacy of a combination therapy Sofosbuvir/Simprevir in the treatment of chronic HCV patients genotype IV either cirrhotic or non-cirrhotic. In the outpatient clinic, one hundred and seventy five chronic HCV patients were recruited from Tropical Medicine Department at Fayoum public hospital. A combination of Sofosbuvir (400 mg) and Simeprevir (150 mg) was administered for those patients once daily over a period of 12 weeks. All patients have been followed up for clinical and laboratory parameters and HCV PCR to evaluate the efficacy and safety of this therapy. Sustained Virologic Response rate (SVR12) were 97.7% (169/173) (primary end point), and same results obtained at the second end point (SVR 24). In this study, cirrhotic patients showed lower SVR (92.7%) compared to non-cirrhotic patients (98.5%) (p-value 0.085). Majority of patients (57.14%) reported adverse events (AEs) during treatment and most common AEs were headache, fatigue, pruritus, dizziness and photosensitivity. On the basis of the evidence currently available, it seems fair to suggest that the combination therapy of (SMV/SOF) in the treatment of chronic HCV genotype IV naïve and experienced patient whether cirrhotic or non-cirrhotic is safe and effective. This was evidenced by monitoring patients' clinically and using hepatic parameters after drug administration. The adverse events affected patients were mild and tolerable among patients.

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“…Sofosbuvir is now used in combination with a number of DAAs that include the NS5A inhibitors ledipasvir, daclatasvir and the protease inhibitor simeprevir [13][14][15][16]. These combination regimens have produced cure rates between 95% and 99% with only 8-12 weeks of therapy.…”

Section: Introductionmentioning

confidence: 99%

Sofosbuvir: The Discovery of a Curative Therapy for the Treatment of Hepatitis C Virus

Sofia¹

2016

Successful Drug Discovery

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Benefit–risk assessment of new and emerging treatments for hepatitis C: focus on simeprevir and sofosbuvir

Cited by 38 publications

References 27 publications

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

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

Safety and efficacy of combination therapy (Simeprevir/Sofosbuvir) in the treatment of chronic HCV genotype IV patients

Sofosbuvir: The Discovery of a Curative Therapy for the Treatment of Hepatitis C Virus

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