Sofosbuvir in Combination with Simeprevir +/- Ribavirin in Genotype 4 Hepatitis C Patients with Advanced Fibrosis or Cirrhosis: A Real-World Experience from Belgium

Degré, Delphine; Sersté, Thomas; Lasser, Luc; Delwaide, Jean; Stärkel, Peter; Laleman, Wim; Langlet, Philippe; Reynaert, Hendrik; Bourgeois, Stefan; Vanwolleghem, Thomas; Dastis, Sergio Negrin; Gustot, Thierry; Geerts, Anja; Steenkiste, Christophe Van; Galocsy, Chantal de; Lepida, Antonia; Orlent, Hans; Moreno, Christophe

doi:10.1371/journal.pone.0170933

Cited by 11 publications

(10 citation statements)

References 39 publications

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“…It is also worth mentioning that all our patient who discontinued treatment due to HCC were on SOF + DAC combination of two standalone drugs ± RBV, an observation that may be of significance in future as regards the debatable link between DAAs and HCC. Indeed, our findings are not different from the data of some previous studies, which also discussed the safety and tolerability of these drugs …”

Section: Discussioncontrasting

confidence: 69%

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Tolerability and effectiveness of generic direct‐acting antiviral drugs in eradication of hepatitis C genotype 4 among Egyptian patients

Lashen

Madkour

Aboufarrag

2019

Liver International

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Background We investigated tolerability and effectiveness of generic, less expensive direct antiviral drugs in the treatment of hepatitis C virus genotype 4 (HCV GT‐4) in an Egyptian cohort. Patients and Methods Retrospectively, we analysed data from 648 patients with HCV GT4 attending Alexandria Main University Hospital from January 2016 to May 2017 [488 treatment naïve/160 treatment‐experienced/288 with chronic hepatitis/360 with cirrhosis]. Patients received generic sofosbuvir/ledipasvir (n = 168, treatment naïve = 136, treatment‐experienced = 32) or sofosbuvir/daclatasvir (n = 480, treatment naïve = 352, treatment‐experienced = 128) ± ribavirin. We assessed sustained virologic response 12 weeks after treatment, non‐response, relapse, treatment discontinuation and drug adverse reactions. Results An overall sustained virologic response 12 weeks after treatment was achieved in 97.8%, non‐response in 0.6%, relapse in 0.3% and discontinuation of treatment in 1.3% of patients. Sofosbuvir/ledipasvir ± ribavirin regimen attained an overall sustained virologic response 12 weeks after treatment in 96.4% of patients (100% of treatment‐experienced vs 95.6% of treatment naïve, P = 0.28), vs 98.3% for sofosbuvir/daclatasvir ± ribavirin regimen (100% of treatment‐experienced vs 97.7% of treatment naïve, P = 0.08). No severe drug adverse events or deaths were reported except anaemia due to ribavirin. Conclusion Generic direct antiviral drugs used in treating Egyptian patients with HCV GT‐4 demonstrated equal potency, safety and tolerability compared to original brands, with low cost which would help to provide treatment to a larger scale of patients.

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Section: Discussioncontrasting

confidence: 69%

“…Indeed, our findings are not different from the data of some previous studies, which also discussed the safety and tolerability of these drugs. 5,6,20 Limitations of our study included the absence of data about HCV sub-genotype, RAVs, and IL28B genotypes in our cohort. We also could not provide liver biopsy data.…”

Section: Discussionmentioning

confidence: 99%

Tolerability and effectiveness of generic direct‐acting antiviral drugs in eradication of hepatitis C genotype 4 among Egyptian patients

Lashen

Madkour

Aboufarrag

2019

Liver International

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“…These results obtained from our study are broadly consistent with the major trends of proven efficacy of such combination therapy in managing HCV as shown in several previous publications [12][13][14][15][16][17][18][19][20]. Our findings were matching with the published results of a Phase III (PLUTO) clinical trial which investigated Simeprevir in combination with sofosbuvir in treatment of naïve and experienced patients with and without compensated cirrhosis in hepatitis C virus genotype 4 infection where this combination achieved SVR rate of 100% among study subjects [12].…”

Section: Discussionsupporting

confidence: 92%

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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“…It is possible that lepidopterans are less prone to forming robust ‘core’ microbiomes due to several factors: 1) very high pH in the midgut, 2) low retention time of food, 3) lack of microbe housing structures in the intestinal tract, and 4) continual replacement of the peritrophic matrix (Hammer et al 2017). Nevertheless, bacterial communities do continually associate with lepidopterans and influence a variety of important host processes (Broderick et al 2006; Anand et al 2010; Wang et al 2017).…”

Section: Introductionmentioning

confidence: 99%

Diversity of fall armyworm, Spodoptera frugiperda and their gut bacterial community in Kenya

Gichuhi

Subramanian

Khamis

et al. 2019

Preprint

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9The invasive fall armyworm (FAW), Spodoptera frugiperda (J.E. Smith) is a polyphagous pest that causes 10 widespread damage particularly to maize and sorghum in Africa. The microbiome associated with S. 11frugiperda could play a role in their success and adaptability. However, these bacterial communities remain 12 poorly studied, especially for S. frugiperda in Africa. We investigated the composition, abundance and 13 diversity of microbiomes associated with larval and adult specimens of S. frugiperda collected from four 14 maize growing regions in Kenya through high throughput sequencing of bacterial 16S rRNA gene. We 15 identified Proteobacteria and Firmicutes as the most dominant phyla and lesser proportions of 16 Bacteroidetes and Actinobacteria. We also observed differences in bacterial microbiome diversity between 17 larvae and adults that are a likely indication that some prominent larval bacterial groups are lost during 18 metamorphosis. Several bacterial groups were found in both adults and larvae suggesting that they are 19 transmitted across developmental stages. Reads corresponding to several known entomopathogenic 20 bacterial clades as well as the non-bacterial entomopathogen, Metarhizium rileyi (Farl.) Kepler, Rehner & 21 Humber (2014), were observed. Mitochondrial DNA haplotyping of the S. frugiperda population in Kenya 22 indicated the presence of both 'Rice' and 'Corn' strains, with a higher prevalence of the 'Rice' strain. Insights 23 into the microbiota may ultimately provide alternative avenues for controlling of this pest.24

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Sofosbuvir in Combination with Simeprevir +/- Ribavirin in Genotype 4 Hepatitis C Patients with Advanced Fibrosis or Cirrhosis: A Real-World Experience from Belgium

Cited by 11 publications

References 39 publications

Tolerability and effectiveness of generic direct‐acting antiviral drugs in eradication of hepatitis C genotype 4 among Egyptian patients

Tolerability and effectiveness of generic direct‐acting antiviral drugs in eradication of hepatitis C genotype 4 among Egyptian patients

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

Diversity of fall armyworm, Spodoptera frugiperda and their gut bacterial community in Kenya

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