Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry

Ruane, Peter; Ain, Dani; Stryker, Richard; Meshrekey, R.; Soliman, Mina; Wolfe, Peter; Riad, Joseph; Mikhail, Sameh; Kersey, Kathryn; Jiang, Deyuan; Massetto, Benedetta; Doehle, Brian P.; Kirby, Brian J.; Knox, Steven J.; McHutchison, John G.; Symonds, William T.

doi:10.1016/j.jhep.2014.10.044

Cited by 153 publications

(130 citation statements)

References 22 publications

(28 reference statements)

Supporting

Mentioning

115

Contrasting

Unclassified

Order By: Relevance

“…In the Egyptian ancestry trial, Ruane et al 38 enrolled 30 treatment-naive and 30 previously treated GT-4 patients who were treated for 12 weeks (n = 31) or 24 weeks (n = 29) with SOF and RBV. SVR12 was achieved in 68% of patients in the 12-week group and in 93% of patients in the 24-week group.…”

Section: Genotypes 4 5 Andmentioning

confidence: 99%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

View full text Add to dashboard Cite

India contributes significantly to the global burden of HCV. While the nucleoside NS5B inhibitor sofosbuvir became available in the Indian market in March 2015, the other directly acting agents (DAAs), Ledipasvir and Daclatasvir, have only recently become available in the India. The introduction of these DAA in India at a relatively affordable price has led to great optimism about prospects of cure for these patients as not only will they provide higher efficacy, but combination DAAs as all-oral regimen will result in lower side effects than were seen with pegylated interferon alfa and ribavirin therapy. Availability of these newer DAAs has necessitated revision of INASL guidelines for the treatment of HCV published in 2015. Current considerations for the treatment of HCV in India include the poorer response of genotype 3, nonavailability of many of the DAAs recommended by other guidelines and the cost of therapy. The availability of combination DAA therapy has simplified therapy of HCV with decreased reliance of evaluation for monitoring viral kinetics or drug related side effects. ( J CLIN EXP HEPATOL 2016;6:119-145) T here have been revolutionary changes in the management of chronic hepatitis C (CH-C) over the last few years. Pegylated interferon alfa (Peg-IFNa) plus ribavirin (RBV) therapy, which till the recent past was the standard of care, has been eclipsed by the arrival of newer directly acting antiviral agents (DAAs). Not only do the DAAs have better efficacy, they are also associated with lower side effects, have better tolerability, a shorter duration of therapy, and have simpler administration.In the recent guidelines issued by the American Association for the study of Liver Diseases (AASLD), in collaboration with the Infectious Diseases Society of America 1 and the European Association for Study of the Liver z (EASL), 2 the role of Peg-IFNa/RBV therapy in the management of HCV has been relegated to second-line, backup status. These newer guidelines, however, cannot be implemented in India as many of the recommended drugs are yet to be marketed in India. Other considerations for the treatment of HCV in India are a predominance of

show abstract

Section: Genotypes 4 5 Andmentioning

confidence: 99%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

View full text Add to dashboard Cite

show abstract

“…SOF plus RBV is an effective and well-tolerated treatment in patients of Egyptian ancestry and Egyptian patients chronically infected with genotype 4 HCV (Doss et al, 2015;Ruane et al, 2015). Yakoot et al (2015) reported that two generic SOF products (Grateziano or Gratisovir) are almost equally rapid and efficient in minimizing the HCV load in Egyptian patients.…”

Section: Discussionmentioning

confidence: 99%

Assessment of immunological, haematological and biochemical status after sofosbuvir-based combination therapy in HCV Egyptian patients from Menoufia Province

Ibrahim¹,

Soliman²,

El-Elaimy³

et al. 2016

J App Pharm Sci

View full text Add to dashboard Cite

Chronic hepatitis C virus (HCV) is a serious health problem in Egypt. Although the effectiveness of pegylated interferon (peg-IFN) and ribavirin (RBV) combined therapy, poor response rates and lamentable tolerability were recorded in the chronically HCV infected patients. Sofosbuvir ( SOF) target the highly conserved active site of the HCV-specific NS5B polymerase that affect directly the viral replication and has broad genotypic coverage. In the present study we investigated the efficacy of SOF-based combination therapy and its effects on the status of immune cells from chronically infected HCV Egyptian patients. HCV Patients were treated with a combination treatment of SOF, RBV and peg-IFN-α or SOF and RBV for either 12 or 24 weeks. Then biochemical, hematological parameters, immunological phenotyping, PBMCs proliferation and apoptosis were detected pre-and post-treatment. While SOF-based combination therapy improved the liver function, anemia, leucopenia and thrombocytopenia were detected especially after treatment with SOF, RBV and peg-IFN-α-2a.We observed significant reduction in the percentage of CD3 + CD4 + and CD3 + CD8 + cells post-treatment with either SOF and RBV or SOF, RBV and peg-IFN-α-2a as compared to the baseline. Moreover, SOF-based combination therapy altered the percentage of CD3 -CD8 + , CD14 + and CD20 + cells. The proliferative capacity of PBMCs was significantly decreased in both regimens, whilst the percentage of apoptotic cells was significantly augmented. SOF-based therapy regimens are efficacious in reducing HCV load in the current study with some adverse effects that include the reduction of the mononuclear cells from the blood periphery by apoptosis.

show abstract

“…When it was given for 12 wk without IFN as a dual therapy with RBV to HCVGT4 infected patients of Egyptian origin living in the United States, SVR rates of 79% and 59% were found in naïve and treatment experienced patients, respectively. Extending the treat ment for 24 wk yielded higher SVR rates: 100% and 93% [186] .…”

Section: Combination Therapy With Peg-ifn Rbv and Hcv Ns5b Polymerasmentioning

confidence: 95%

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

Abdel-Ghaffar

Sira

Naghi

2015

WJH

View full text Add to dashboard Cite

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.

show abstract

Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry

Abstract: The findings from the present study suggest that 24 weeks of sofosbuvir plus ribavirin is an efficacious and well tolerated treatment in patients with HCV genotype 4 infection.

Cited by 153 publications

References 22 publications

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Assessment of immunological, haematological and biochemical status after sofosbuvir-based combination therapy in HCV Egyptian patients from Menoufia Province

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

Contact Info

Product

Resources

About