Real‐world use, effectiveness and safety of anti‐viral treatment in chronic hepatitis C genotype 3 infection

Cornberg, Markus; Petersen, Jörg; Schober, Andreas; Mauss, Stefan; Böker, K. H. W.; Link, R.; Günther, Rainer; Serfert, Yvonne; Pfeiffer-Vornkahl, H.; Manns, Michael P.; Sarrazin, Christoph; Hüppe, D; Berg, Thomas; Niederau, Claus

doi:10.1111/apt.13925

Cited by 40 publications

(35 citation statements)

References 32 publications

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“…The demographics of the patient cohort are shown in Table . Genotype (GT) 1 was most prevalent in our cohort, and SVR at 12 weeks after end of DAA therapy was achieved in 4797 from 4946 patients (97.0%) across all GTs, in line with prior reports on the real‐world efficacy of DAA therapy …”

Section: Resultssupporting

confidence: 89%

Baseline risk factors determine lack of biochemical response after SVR in chronic hepatitis C patients treated with DAAs

Tacke

Boeker²,

Klinker

et al. 2019

Liver International

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Background and Aims Liver function tests (alanine aminotransferase, ALT; gamma‐glutamyltransferase, GGT) not always normalize after elimination of hepatitis C virus (HCV) by direct acting antivirals (DAAs), possibly indicating concomitant non‐viral liver diseases. We analysed factors determining the biochemical response (normalized ALT/GGT) of DAA therapy in a large real‐world cohort. Method The German Hepatitis C‐Registry is a national multicenter registry study. Normal ALT was defined ≤35 U/L (female) and ≤50 U/L (male) or, according to AASLD, ≤19 U/L (female) and ≤30 U/L (male), normal GGT ≤40 U/L (female) and ≤60 U/L (male). Results At baseline, ALT was elevated in 3705/4946 (74.9%), ALT (AASLD) in 4669/4946 (94.4%) and GGT in 3018/4906 (61.5%). In this study, 97% of patients achieved SVR12. At week 12 after end of therapy, ALT was elevated in 451/4946 (9.1%), ALT according to AASLD in 1906/4946 (38.5%) and GGT in 863/4879 (17.7%). Persistently elevated ALT after DAA therapy was independently associated with high body mass index (BMI), age <70 years, liver cirrhosis, diabetes, alcohol consumption and not achieving SVR12. Using the stricter AASLD criteria, opioid substitution and male sex were additional predictors. Higher GGT at week 12 was associated with high BMI, age >70 years, liver cirrhosis, diabetes, alcohol consumption, opioid substitution and non‐SVR. Importantly, persistently elevated liver tests after treatment, particularly GGT, were associated with hepatic decompensation and mortality during 4‐years follow‐up. Conclusion Risk factors at baseline (obesity, diabetes, liver cirrhosis, alcohol consumption) are independently associated with persistently elevated liver function tests after SVR, indicating that these patients warrant further hepatological follow‐up. Clinical trial registration: German Clinical Trials Register (DRKS; ID DRKS00009717).

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Section: Resultssupporting

confidence: 89%

Baseline risk factors determine lack of biochemical response after SVR in chronic hepatitis C patients treated with DAAs

Tacke

Boeker²,

Klinker

et al. 2019

Liver International

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“…In cases of interferon intolerance the doses of the drug may be reduced or treatment with the other two drugs may be continued for a total of 24 weeks. Patients with contraindications to interferon may be treated with SOF + RBV alone for 24 weeks [42, 43]. …”

Section: Specific Recommendationsmentioning

confidence: 99%

Recommendations for the treatment of hepatitis C in 2017

Halota¹,

Flisiak²,

Juszczyk³

et al. 2017

ceh

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The goals of treatment is to eliminate HCV infection, stop or reverse histological changes, reduce the risk of hepatocellular carcinoma development and transmission of the infection to other individuals. According to the recommendation of the Polish Group of Experts for HCV in 2017 all patients with chronic HCV infection should receive treatment, but it is not recommended in patients at high risk of short overall survival. If access to therapy is restricted, priority should be given to patients whose HCV infection can lead to an unfavourable outcome of the disease within a short time frame, particular to individuals with liver cirrhosis, rapidly progressing liver fibrosis, extrahepatic manifestations of HCV infection, chronic kidney diseases, patients before and after organ transplantation. Current recommendations of Polish Group of Experts for HCV provide guidelines to select optimal medication, assessment of liver fibrosis, treatment efficacy, dealing with resistance to direct acting antivirals, monitoring for hepatocellular carcinoma, management of HBV/HCV coinfection and drug interactions. It constains also advice on treatment of special patients populations such as renal failure, liver transplant and hepatic decompensation, as well as retreatment of patients which failed interferon free therapy. Moreover specific recommendations of management patients infected with different genotypes with currently reimbursed regimens or those expected to become available shortly in Poland are also included.

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“…Hepatitis C virus (HCV) is a leading cause of advanced liver disease and thus a public health problem worldwide . Second‐generation direct‐acting antivirals (DAAs) have been shown to dramatically improve HCV eradication, a result that has been confirmed by real‐life studies …”

Section: Introductionmentioning

confidence: 96%

A different perspective on sofosbuvir‐ledipasvir treatment of patients with HCV genotype 1b cirrhosis: The ital‐c network study

Barone

Iannone

Shahini

et al. 2017

Journal of Viral Hepatitis

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Summary The effectiveness of a 12‐week course of sofosbuvir‐ledipasvir in treatment‐experienced HCV genotype 1b‐infected patients with cirrhosis is still under debate. Our primary endpoint was to compare the sustained virological response at post‐treatment week 12 (SVR12) of sofosbuvir‐ledipasvir in combination with ribavirin for 12 weeks, and sofosbuvir‐ledipasvir alone for 24 weeks. This was a prospective observational study that enrolled 424 (195 naive, 229 experienced; 164 treated for 12 weeks with Ribavirin and 260 with sofosbuvir‐ledipasvir alone for 24 weeks) consecutive HCV genotype 1b‐infected patients with cirrhosis. The SVR12 rates were 93.9% and 99.2% in patients treated for 12 and 24 weeks, respectively (P = .002). The baseline characteristics of patients treated for 12 weeks were significantly different from those treated for 24 weeks as regards their younger age (P = .002), prevalence of Child‐Pugh class A (P = .002), lower MELD scores (P = .001) and smaller number of nonresponders (P = .04). The shorter treatment was significantly associated with a lower SVR12 in univariate and multivariate analyses (P = .007 and P = .008, respectively). The SVR rate was unaffected by age, gender, BMI, Child‐Pugh class, MELD score or previous antiviral treatment. Patients receiving ribavirin experienced more episodes of ascites and headache but less recurrence of hepatocellular carcinoma (HCC), and were prescribed more diuretics and cardiopulmonary drugs. No patient discontinued treatment. The therapeutic regimen of sofosbuvir‐ledipasvir plus ribavirin administered for 12 weeks was less effective than sofosbuvir‐ledipasvir alone given for 24 weeks. At odds with European guidelines, the recommended 12‐week treatment with sofosbuvir‐ledipasvir alone might be suboptimal for this setting of patients.

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Real‐world use, effectiveness and safety of anti‐viral treatment in chronic hepatitis C genotype 3 infection

Cited by 40 publications

References 32 publications

Baseline risk factors determine lack of biochemical response after SVR in chronic hepatitis C patients treated with DAAs

Baseline risk factors determine lack of biochemical response after SVR in chronic hepatitis C patients treated with DAAs

Recommendations for the treatment of hepatitis C in 2017

A different perspective on sofosbuvir‐ledipasvir treatment of patients with HCV genotype 1b cirrhosis: The ital‐c network study

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