Hepatitis C: efficacy and safety in real life

Flisiak, Robert; Pogorzelska, Joanna; Flisiak-Jackiewicz, Marta

doi:10.1111/liv.13293

Cited by 50 publications

(43 citation statements)

References 49 publications

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“…A recent review on efficacy and safety of oral DAA reported an overall SVR12 of 92% in cirrhosis patients treated with sofosbuvir/ledipasvir combination therapy . Other real‐life observational studies have reported an SVR12 between 94% and 98% in treatment‐naïve genotype 1 patients treated with combination of sofosbuvir and ledipasvir; including a study by Zeng et al, wherein naïve genotype 1 patients were treated with a combination of generic sofosbuvir and ledipasvir, SVR12 among cirrhotic and noncirrhotic patients was 96.8% and 96.9%, respectively.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

Gupta

Rout

Patel

et al. 2018

Journal of Viral Hepatitis

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Novel direct-acting antivirals (DAAs) are now the standard of care for the management of hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real-life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented. Four hundred and ninety patients (mean age: 38.9 ± 12.7 years) were treated with generic DAAs in the study time period. Their clinical presentations included chronic hepatitis (CHC) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n = 372, 75.9%) followed by genotype 1 (n = 97, 19.8%). Treatment naïve and treatment-experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%), respectively. Generic DAA treatment regimens included sofosbuvir in combination with ribavirin (n = 175), daclatasvir alone (n = 149), ribavirin and peginterferon (n = 80), ledipasvir alone (n = 43), daclatasvir and ribavirin (n = 37), and ledipasvir and ribavirin (n = 6). Overall SVR12 was 95.9% (470/490) for all treatment regimens. SVR12 for treatment naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58), respectively, P = .005. High SVR12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR12 with 12 or 24 weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAAs are associated with high SVR rates in patients with HCV infection in a real-life clinical scenario.

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Section: Discussionmentioning

confidence: 99%

Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

Gupta

Rout

Patel

et al. 2018

Journal of Viral Hepatitis

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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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“…The combinations of DAAs were designed to target HCV NS3/4A protease, NS5B polymerase and NS5A and have resulted in a revolution in the treatment of chronic hepatitis C. Interestingly, even in difficult to treat patients with HIV co‐infection, compensated and decompensated cirrhosis, liver transplantation and severe renal impairment, these combinations show high efficacy (90%‐100% rates of SVR) and excellent safety. Results of their efficacy and safety in real life studies are in accordance with those of clinical trials and show SVR rates of more than 90% in patients with genotypes 1 and 4 …”

Section: Hcvmentioning

confidence: 60%