International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C

Zeuzem, Stefan; Pawlotsky, Jean‐Michel; Lukasiewicz, Esther; Wagner, Michael; Goulis, Ioannis; Lurie, Yoav; Gianfranco, Elia; Vrolijk, Jan-Maarten; Esteban, Juan Ignacio; Hézode, Christophe; Lagging, Martin; Negro, Francesco; Soulier, Alexandre; Verheij-Hart, Elke; Hansen, Bettina E.; Tal, Ronen; Ferrari, Carlo; Schalm, Solko W.; Neumann, Avidan U.

doi:10.1016/j.jhep.2005.05.016

Cited by 135 publications

(89 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In previous study for patients with chronic hepatitis C virus (HCV) infection, the reduction of the serum HCV RNA levels at 1 or 3 months treatment had a strong power to predict a sustained virologic response and the total duration of treatment. 12,13 However, in patients with a chronic HBV infection, an antiviral response as an indicator of future treatment outcomes has not yet been fully determined. Previous studies suggested that the HBV genotype, 14 the ALT level, 9,15 the degree of the decline of the HBV DNA level during therapy.…”

Section: Discussionmentioning

confidence: 99%

Virologic Response at 12 Months of Treatment Predicts Sustained Antiviral Efficacy in Patients with Adefovir-Treated Lamivudine-Resistant Chronic Hepatitis B

Jung¹,

Yeon²,

Han³

et al. 2010

Gut Liver

View full text Add to dashboard Cite

Background/Aims: The aim of our study was to define the potential role of virologic response at 12 months of treatment (VR12) in predicting subsequent virologic and clinical outcomes in adefovir (ADV)-treated lamivudine-resistant chronic hepatitis B. Methods: Two hundred and four patients with lamivudine-resistant chronic hepatitis B virus (HBV) treated with ADV monotherapy were included. Serum HBV DNA was quantified by real-time polymerase chain reactions. VR12 was defined as a HBV DNA level of less than 4 log10 copies/mL after 12 months of ADV treatment. Results: VR12 was observed in 110 of the 204 patients (54%). The mean HBV DNA reductions from baseline after 12 months of ADV treatment were 3.8 and 1.9 log10 copies/mL in patients with and without VR12, respectively (p＜0.001). The hepatitis B "e" antigen (HBeAg) seroconversion rates in patients with and without VR12 were 32% and 14% at 12 months treatment, respectively (p=0.018), and 40% and 27% at 24 months of treatment (p=0.032). The genotypic mutation rates to ADV in patients with and without VR12 were 0% and 6% at 12 months of treatment, respectively (p=0.033), and 21% and 42% at 24 months (p= 0.012). The rates of viral breakthrough in patients with and without VR12 were 0% and 7% at 12 months of treatment, respectively (p=0.072), and 9% and 25% at 24 months (p=0.006). Conclusions: Patients without VR12 may need to switch to or add on other potent antiviral drugs in their medical regimens. (Gut Liver 2010;4:212-218)

show abstract

Section: Discussionmentioning

confidence: 99%

Virologic Response at 12 Months of Treatment Predicts Sustained Antiviral Efficacy in Patients with Adefovir-Treated Lamivudine-Resistant Chronic Hepatitis B

Jung¹,

Yeon²,

Han³

et al. 2010

Gut Liver

View full text Add to dashboard Cite

show abstract

“…Therapy is monitored by assessing the kinetics of viral clearance based on HCV RNA quantitation (2,8,12,17). Available commercial kits are based on target amplification technology (reverse transcription-PCR) or on signal amplification (branched DNA).…”

mentioning

confidence: 99%

Impact of Hepatitis C Virus (HCV) Genotypes on Quantification of HCV RNA in Serum by COBAS AmpliPrep/COBAS TaqMan HCV Test, Abbott Antiretroviral Therapy HCV RealTime Assay, and VERSANT HCV RNA Assay

et al. 2007

View full text Add to dashboard Cite

The VERSANT HCV RNA 3.0 (bDNA), COBAS AmpliPrep/COBAS TaqMan HCV, and Abbott ART HCV RealTime assays were compared for hepatitis C virus RNA quantification in 158 clinical specimens (genotypes 1 to 5). RNA values differed significantly between methods (P < 0.0001), and mean titer differences ranged from 0.01 to 0.50 log 10 IU/ml depending on the genotypes.Hepatitis C virus (HCV) infection is a major cause of chronic liver disease. Therapy is monitored by assessing the kinetics of viral clearance based on HCV RNA quantitation (2,8,12,17). Available commercial kits are based on target amplification technology (reverse transcription-PCR) or on signal amplification (branched DNA). Irrespective of the method, the specificity of the hybridization between probe/primer and target is the determining factor of the method's performance. Polymorphisms within the primer/probe-targeted HCV regions may cause significant losses of performance and compromise the accuracy of viral load (VL) measurements. Based on their natural polymorphism, the HCV viruses have been classified into six major genotypes (GT) (14). Most known GT are found in Europe but with different distribution frequencies in various geographic regions (5).The aim of the present study was to evaluate the performance of the three commercially available HCV RNA quantitative assays, two real-time reverse transcriptase assays, and a signal amplification assay using a panel of serum samples from well-characterized HCV-infected patients with GT1 to GT5.Serum samples were collected during 2005 from 158 consecutive patients residing in Southern France, with HCV infection confirmed by use of a COBAS Amplicor HCV test, version 2.0 (detection limit of 50 IU/ml; Roche Diagnostics, Mannheim, Germany). Each serum sample was divided into three aliquots and stored at Ϫ80°C within 4 h of blood sampling. HCV genotype was determined by using a VERSANT HCV genotyping assay (line probe assay) (Bayer Diagnostics, Tarrytown, NY).All samples were processed in accordance with the manufacturer's instructions. The COBAS Ampliprep/COBAS TaqMan HCV test (CAP/CTM) (Roche Diagnostics, Mannheim, Germany) requires 1,050 l of serum with a sample input volume of 850 l and with a quantification range of 15 to 6.9 ϫ 10 7 IU/ml (1.18 to 7.84 log 10 ). The HCV RealTime assay (antiretroviral therapy [ART]; Abbott Laboratories, Abbott Park, IL) requires 1,000 l of serum, with a quantification range of 12 to 1 ϫ 10 7 IU/ml (1.08 to 7.0 log 10 ). The Abbott ART HCV kit was used in conjunction with the Abbott m1000 extraction and the m2000rt amplification systems. The VERSANT HCV RNA 3.0 (bDNA) assay (Bayer Diagnostics, Tarrytown, NY) requires 50 l of plasma or serum, with a quantification range of 615 to 7.7 ϫ 10 6 IU/ml (2.79 to 6.89 log 10 ) with the VERSANT 340 analyzer.Values outside the quantification ranges were exclude from comparison and correlation analyses. Mean values Ϯ standard deviations (SD) were determined for each method and compared using the Student paired t test for global results. Diffe...

show abstract

“…Preporuke za poboljšanje uspeha HCV terapije za G2/3 su bazirane na RVR i nivou bazalne viremije (Tabela 6). Kod bolesnika sa G2/3 koji imaju odmaklu fibrozu/cirozu ili kofaktore, koji negativno utiču na virusološki odgovor (rezistencija na insulin, metabolički sindrom, steatoza jetre koja nije virusnog porekla) ne preporučuje se skraćivanje terapije, čak ni kod niske bazalne viremije i postignutog RVR [3,29].…”

Section: Uvodunclassified

Savremena terapija hroničnog hepatitisa C: efikasnost i mogućnost predviđanja terapijskog odgovora

Bozic

Bojović

Đonić-Nenezić

et al. 2011

BII

View full text Add to dashboard Cite

1Klinika za infektivne i tropske bolesti Kliničkog centra Srbije, Beograd Uvod. Hepatitis C virus (HCV) je jedan od glavnih uzročnika hroničnog hepatitisa, ciroze jetre i hepatocelularnog karcinoma (HCC). Savremena terapija hroničnog hepatitisa C (HHC) podrazumeva primenu pegilovanog interferona alfa 2a ili 2b (PEG IFN-α2a ili PEG IFN-α2b) i ribavirina (RBV). Cilj rada je da se proceni efikasnost HCV terapije i faktora za predviđanje terapijskog odgovora. Rezultati. U grupi bolesnika sa HHC više je bilo muškaraca (59,3%), starijih od 40 godina (58,2%), sa visokim stepenom bazalne viremije (63%) i sa G1 (67%) HCV. Bridging fibroza i ciroza (F3, F4) su nađene kod 54 (27, 84%) bolesnika. Stabilan virusološki odgovor (SVR) je postignut kod 69,2%, relaps kod 11,9%, a bez odgovora na terapiju je bilo 19,8% bolesnika. Faktori koji su uticali na postizanje SVR bili su: non-1 genotip HCV (OR 5,9; 95% IP: 1,9-18,0), EVR (OR 0,92,; 95% IP: 2,73-35,97) i bolesnici mlađi od 40 godina (OR 3,66; 95% IP: 1,48-9,0). Neuspeh terapije u vidu relapsa zavisio je od visine bazalne viremije (OR 0,37; 95% IP: 0,12-0,97), godina života >40 godina (OR 4,8; 95% IP: 1,35-17,84) i prisustva ciroze (OR 2,1; 95% IP: 1,0-4,7). Kod bolesnika bez odgovora na terapiju faktori predviđanja neuspeha su bili: G1 (OR 3,9; 95% IP: 1,5-10,3), visoka bazalna viremija (OR 3,45; 95% IP: 1,19) i prekid u kontinuitetu primene terapije (OR 4,49; 95% IP: 1,76).Zaključak. Savremena, standardna terapija je bila efikasna kod 127/194 (69,2%) bolesnika sa HCC. Najznačajniji faktori za predviđanje uspeha terapije bili su: genotip HCV, EVR kod G1, životno doba bolesnika, stepen bazalne viremije, prisustvo ciroze i prekid u kontinuitetu terapije.Ključne reči: hronični hepatitis C, efikasnost antivirusne terapije, predviđanje virusološkog odgovora.

show abstract

International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C

Cited by 135 publications

References 19 publications

Virologic Response at 12 Months of Treatment Predicts Sustained Antiviral Efficacy in Patients with Adefovir-Treated Lamivudine-Resistant Chronic Hepatitis B

Virologic Response at 12 Months of Treatment Predicts Sustained Antiviral Efficacy in Patients with Adefovir-Treated Lamivudine-Resistant Chronic Hepatitis B

Impact of Hepatitis C Virus (HCV) Genotypes on Quantification of HCV RNA in Serum by COBAS AmpliPrep/COBAS TaqMan HCV Test, Abbott Antiretroviral Therapy HCV RealTime Assay, and VERSANT HCV RNA Assay

Savremena terapija hroničnog hepatitisa C: efikasnost i mogućnost predviđanja terapijskog odgovora

Contact Info

Product

Resources

About