Dataset Information

Association of Renal Function and Direct-Acting Antiviral Agents for HCV: A Network Meta-Analysis.

ABSTRACT: The effectiveness and safety of direct-acting antiviral agents (DAAs) in hepatitis C virus (HCV) patients with renal insufficiency remain controversial. Therefore, this network meta-analysis aims to assess effectiveness and safety of DAAs in populations with different renal function. The pooled data were obtained from Cochrane Library, EMBASE, PubMed, and Web of Science. Thirteen studies recruited 6884 patients with hepatitis C infection and reported their outcomes in relation to different levels of renal function after treatment with DAAs. The results showed no difference in the virologic responses among patients with different renal function. Regarding safety, whereas in patients without chronic kidney disease (CKD) or with early CKD DAAs were associated with a risk ratio (RR) of 0.14 (95% confidence interval (CI), 0.04 to 0.43) for renal disorder, increased risk of renal function deterioration was found in advanced-CKD patients, though this effect may be related to the natural course of advanced CKD. Similarly, patients without CKD or with early CKD showed a lower risk of anemia (RR, 0.34; 95% CI, 0.20 to 0.57) and discontinuation (RR, 0.41; 95% CI, 0.39 to 0.56) than patients with advanced CKD. The efficacy of DAAs for HCV treatment was comparable in patients with advanced CKD and in those with early CKD or without CKD. However, the safety of DAAs should be verified in future studies.

SUBMITTER: Kao CC

PROVIDER: S-EPMC6210726 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Association of Renal Function and Direct-Acting Antiviral Agents for HCV: A Network Meta-Analysis.

Kao Chih-Chin CC Lin Yu-Shiuan YS Chu Heng-Cheng HC Fang Te-Chao TC Wu Mai-Szu MS Kang Yi-No YN

Journal of clinical medicine 20180929 10

The effectiveness and safety of direct-acting antiviral agents (DAAs) in hepatitis C virus (HCV) patients with renal insufficiency remain controversial. Therefore, this network meta-analysis aims to assess effectiveness and safety of DAAs in populations with different renal function. The pooled data were obtained from Cochrane Library, EMBASE, PubMed, and Web of Science. Thirteen studies recruited 6884 patients with hepatitis C infection and reported their outcomes in relation to different level ...[more]

PMID: 30274298

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Project description:BACKGROUND & AIMS:It is unclear whether direct-acting antiviral (DAA) treatment-induced sustained virologic response (SVR) reduces the risk of hepatocellular carcinoma (HCC) in patients with HCV infection. Therefore, in the current study, our aim was to determine the impact of DAA-induced SVR on HCC risk. METHODS:We identified 62,354 patients who initiated antiviral treatment in the Veterans Affairs (VA) national healthcare system from 1 January 1999 to 31 December 2015, including 35,871 (58%) interferon (IFN)-only regimens, 4,535 (7.2%) DAA?+?IFN regimens, and 21,948 (35%) DAA-only regimens. We retrospectively followed patients until 15 June 2017 to identify incident cases of HCC. We used Cox proportional hazards regression to determine the association between SVR and HCC risk or between type of antiviral regimen (DAA-only vs. DAA?+?IFN vs. IFN-only) and HCC risk. RESULTS:We identified 3,271 incident cases of HCC diagnosed at least 180 days after initiation of antiviral treatment during a mean follow-up of 6.1 years. The incidence of HCC was highest in patients with cirrhosis and treatment failure (3.25 per 100 patient-years), followed by cirrhosis and SVR (1.97), no cirrhosis and treatment failure (0.87), and no cirrhosis and SVR (0.24). SVR was associated with a significantly decreased risk of HCC in multivariable models irrespective of whether the antiviral treatment was DAA-only (adjusted hazard ratio [AHR] 0.29; 95% CI 0.23-0.37), DAA?+?IFN (AHR 0.48; 95% CI 0.32-0.73) or IFN-only (AHR 0.32; 95% CI 0.28-0.37). Receipt of a DAA-only or DAA?+?IFN regimen was not associated with increased HCC risk compared with receipt of an IFN-only regimen. CONCLUSIONS:DAA-induced SVR is associated with a 71% reduction in HCC risk. Treatment with DAAs is not associated with increased HCC risk compared with treatment with IFN. LAY SUMMARY:It was unclear whether direct-acting antiviral treatment-induced sustained virologic response reduces the risk of liver cancer in patients with HCV infection. We demonstrated that eradication of HCV infection with direct-acting antiviral agents reduces the risk of liver cancer by 71%.

Project description:BACKGROUND:The treatment of hepatitis C (HCV) infections has significantly changed in the past few years due to the introduction of direct-acting antiviral agents (DAAs). DAAs could improve the sustained virological response compared to pegylated interferon with ribavirin (PR). However, there has been no evidence from randomized controlled trials (RCTs) that directly compare the efficacy among the different regimens of DAAs. AIM:Therefore, we performed a systematic review and network meta-analysis aiming to compare the treatment efficacy between different DAA regimens for treatment naïve HCV genotype 1. METHODS:Medline and Scopus were searched up to 25th May 2015. RCTs investigating the efficacy of second generation DAA regimens for treatment naïve HCV genotype 1 were eligible for the review. Due to the lower efficacy and more side effects of first generation DAAs, this review included only second generation DAAs approved by the US or EU Food and Drug Administration, that comprised of simeprevir (SMV), sofosbuvir (SOF), daclatasvir (DCV), ledipasvir (LDV), and paritaprevir/ritonavir/ombitasvir plus dasabuvir (PrOD). Primary outcomes were sustained virological response at weeks 12 (SVR12) and 24 (SVR24) after the end of treatment and adverse drug events (i.e. serious adverse events, anemia, and fatigue). Efficacy of all treatment regimens were compared by applying a multivariate random effect meta-analysis. Incidence rates of SVR12 and SVR24, and adverse drug events of each treatment regimen were pooled using 'pmeta' command in STATA program. RESULTS:Overall, 869 studies were reviewed and 16 studies were eligible for this study. Compared with the PR regimen, SOF plus PR, SMV plus PR, and DVC plus PR regimens yielded significantly higher probability of having SVR24 with pooled risk ratios (RR) of 1.98 (95% CI 1.24, 3.14), 1.46 (95% CI: 1.22, 1.75), and 1.68 (95% CI: 1.14, 2.46), respectively. Pooled incidence rates of SVR12 and SVR24 in all treatment regimens without PR, i.e. SOF plus LDV with/without ribavirin, SOF plus SMV with/without ribavirin, SOF plus DCV with/without ribavirin, and PrOD with/without ribavirin, (pooled incidence of SVR12 ranging from 93% to 100%, and pooled incidence of SVR24 ranging from 89% to 96%) were much higher than the pooled incidence rates of SVR12 (51%) and SVR24 (48%) in PR alone. In comparing SOF plus LDV with ribavirin and SOF plus LDV without ribavirin, the chance of having SVR12 was not significantly different between these two regimens, with the pooled RR of 0.99 (95% CI: 0.97, 1.01). Regarding adverse drug events, risk of serious adverse drug events, anemia and fatigue were relatively higher in treatment regimens with PR than the treatment regimens without PR. The main limitation of our study is that a subgroup analysis according to dosages and duration of treatment could not be performed. Therefore, the dose and duration of recommended treatment have been suggested in range and not in definite value. CONCLUSIONS:Both DAA plus PR and dual DAA regimens should be included in the first line drug for treatment naïve HCV genotype 1 because of the significant clinical benefits over PR alone. However, due to high drug costs, an economic evaluation should be conducted in order to assess the value of the investment when making coverage decisions.

Dataset Information

Association of Renal Function and Direct-Acting Antiviral Agents for HCV: A Network Meta-Analysis.

Publications

Association of Renal Function and Direct-Acting Antiviral Agents for HCV: A Network Meta-Analysis.

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