Ledipasvir/sofosbuvir without ribavirin is effective in the treatment of recurrent hepatitis C virus infection post-liver transplant

Shoreibah, Mohamed; Orr, Jordan; Jones, DeAnn; Zhang, Jie; Venkata, Krishna; Massoud, Omar

doi:10.1007/s12072-016-9778-6

Cited by 6 publications

(4 citation statements)

References 19 publications

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“…Except one study that did not report patient ethnicity, the majority of patients were Caucasian, male, with a mean age of approximately 60‐year‐old, had GT1a HCV recurrence, and received tacrolimus as part of their immunosuppressive treatment. Five different DAA combination protocols were described: SOF/SMV with or without RBV (n = 8); SOF/LDV (n = 3); ASV/SMV (n = 2); DCV/SMV with or without RBV (n = 2); PrOD (n = 1) . Detailed baseline characteristics of the included studies are provided in Tables and .…”

Section: Resultsmentioning

confidence: 99%

Direct‐acting antiviral agents for liver transplant recipients with recurrent genotype 1 hepatitis C virus infection: Systematic review and meta‐analysis

Liu

Cao

et al. 2019

Transplant Infectious Dis

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Background Comprehensive evaluation of safety and efficacy of different combinations of direct‐acting antivirals (DAAs) in liver transplant recipients with genotype 1 (GT1) hepatitis C virus (HCV) recurrence remains limited. Therefore, we performed this systematic review and meta‐analysis in order to evaluate the clinical outcome of DAA treatment in liver transplant patients with HCV GT1 recurrence. Methods Studies were included if they contained information of 12 weeks sustained virologic response (SVR12) after DAA treatment completion as well as treatment related complications for liver transplant recipients with GT1 HCV recurrence. Results We identified 16 studies comprising 885 patients. The overall pooled estimate proportion of SVR12 was 93% (95% confidence interval (CI): 0.89, 0.96), with moderate heterogeneity observed (τ2 = 0.01, P < 0.01, I2=75%). High tolerability was observed in liver transplant recipients reflected by serious adverse events (sAEs) with pooled estimate proportion of 4% (95% CI: 0.01, 0.07; τ2 = 0.02, P < 0.01, I2 = 81%). For subgroup analysis, a total of five different DAA regimens were applied for treating these patients. Sofosbuvir/Ledipasvir (SOF/LDV) led the highest pooled estimate SVR12 proportion, followed by Paritaprevir/Ritonavir/Ombitasivir/Dasabuvir (PrOD), Daclatasvir (DCV)/Simeprevir (SMV) ± Ribavirin (RBV), and SOF/SMV ± RBV, Asunaprevir (ASV)/DCV. There was a tendency for favoring a higher pooled SVR12 proportion in patients with METAVIR Stage F0‐F2 of 97% (95% CI: 0.93, 0.99) compared to 85% (95% CI: 0.79, 0.90) for stage F3‐F4 (P < 0.01). There was no significant difference between LT recipients treated with or without RBV (P = 0.23). Conclusions Direct‐acting antiviral treatment is highly effective and well‐tolerated in liver transplant recipients with recurrent GT1 HCV infection.

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Section: Resultsmentioning

confidence: 99%

Direct‐acting antiviral agents for liver transplant recipients with recurrent genotype 1 hepatitis C virus infection: Systematic review and meta‐analysis

Liu

Cao

et al. 2019

Transplant Infectious Dis

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“…The American Association for the Study of Liver Diseases (AASLD) recommends the combination of ledipasvir/sofosbuvir (LDV/SOF) and RBV for 12 weeks for the treatment of HCV infection in LT recipients 19. We showed that the use of LDV/SOF without RBV is effective in achieving SVR 16. Since the data regarding the effect of this regimen on GFR in LT recipients is limited, we performed an ad hoc analysis to determine changes in the GFR with HCV treatment in LT recipients.…”

Section: Introductionmentioning

confidence: 95%

“…The newly introduced direct-acting antiviral agents (DAAs), administered with or without ribavirin (RBV), have revolutionized the treatment of recurrent HCV infection postLT, producing high sustained viral response (SVR) rates 14–16. This is important as HCV infection has been found to be a risk for developing renal insufficiency in the LT recipient.…”

Section: Introductionmentioning

confidence: 99%

Effect of Hepatitis C Treatment on Renal Function in Liver Transplant Patients

Shoreibah

Romano

Sims

et al. 2018

Journal of Clinical and Translational Hepatology

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Background and Aims: Hepatitis C Virus (HCV) is uniformly recurrent after liver transplant (LT) and recurrence is associated with an increased risk of mortality. Immunosuppressive medications increase the risk of chronic kidney disease, and the presence of chronic kidney disease presents a challenge for HCV treatment in LT recipients. The aim of this study was to assess changes in glomerular filtration rates (GFRs) of LT recipients receiving HCV treatment.Methods: This is a retrospective study of LT patients who received HCV treatment between 2015 and 2016 (n = 60). The outcomes of interest were differences in serum creatinine levels and in GFR, measured at treatment initiation and at 24 weeks after treatment. The average age of the patients was 59 years-old, and 17% were cirrhotic and 67% were treatment-experienced. All patients received sofosbuvir/ledipasvir without ribavirin.Results: All patients achieved sustained virologic response at 12 weeks after treatment (SVR12). At baseline, 55% of patients had GFR <60 mL/min per 1.73 m2. Among those patients, GFR did not change in 18%, 33% had improved GFR, and 48% had worsened GFR. Up to 45% of the patients had a GFR >60 mL/min per 1.73 m2. Among those patients, GFR did not change in 81%, and 19% had worsened GFR. In the entire cohort, 65% of patients had improved or stable GFR and 35% had worsened GFR. The average change in serum creatinine between baseline and 24 weeks was 0.10 (p = 0.18).Conclusions: This study showed improved or unchanged GFR in 65% and worsened GFR in 35% of LT recipients who achieved SVR12. Worsening of GFR was more frequently encountered in those with impaired renal function at baseline. Caution should be used when treating HCV in LT recipients, especially those with baseline status of renal impairment.

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“…Chronic hepatitis C virus (HCV) infection is the leading indication for liver transplantation (LT) in the United States . In 2013, the advent of all‐oral, interferon‐free direct‐acting antivirals (DAAs) transformed treatment options for HCV‐infected (HCV+) patients, and numerous studies have demonstrated the safety and efficacy of DAAs both pre‐ and post‐LT . With the approval of DAAs, providers were faced with the challenge of deciding whether to initiate treatment of HCV+ transplant candidates pre‐ or post‐LT.…”

Section: Introductionmentioning

confidence: 99%

Changes in practice and perception of hepatitis C and liver transplantation: Results of a national survey

Shaffer

Thomas

Bowring

et al. 2018

Transplant Infectious Dis

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With new practice guidelines, it is important to understand how liver transplant (LT) centers have incorporated direct-acting antivirals (DAAs) into the management of hepatitis C virus-infected (HCV+) candidates and recipients. To explore how DAAs have affected LT centers’ willingness to treat HCV+ candidates and recipients and to use HCV+ donors, we surveyed high volume US LT centers (11/2014–12/2015) regarding practices for HCV+ candidates, recipients, and donors, before vs. after DAAs. We used the Scientific Registry of Transplant Recipients to compare centers’ number of LTs, HCV+ recipients, and HCV+ donors in the years before (1/1/2012–12/31/2013) and after (1/1/2016–12/31/2017) survey administration. Of 80 centers contacted, 57 (71%) responded, representing 69% of the total volume of LTs in 2013. After DAAs, most centers increased treating candidates with low (≤15) model for end-stage liver disease (MELD) (85.2%), intermediate/high (>15) MELD (92.6%), and hepatocellular carcinoma (79.6%). There was consensus to treat low MELD candidates (90.7% “most of the time/always”), but less certainty for intermediate/high MELD candidates (27.8% “sometimes”). Universal post-LT HCV treatment increased (7.4% vs. 57.4%). After DAAs, 42.6% were more willing to use HCV+ donors for HCV+ candidates, and 38.9% were willing to consider using HCV+ donors for HCV- candidates. Overall, with DAAs, centers were more willing to treat HCV+ candidates and recipients and to use HCV+ donors; recent recommendations may help to guide treatment decisions for intermediate/high MELD candidates.

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Ledipasvir/sofosbuvir without ribavirin is effective in the treatment of recurrent hepatitis C virus infection post-liver transplant

Cited by 6 publications

References 19 publications

Direct‐acting antiviral agents for liver transplant recipients with recurrent genotype 1 hepatitis C virus infection: Systematic review and meta‐analysis

Direct‐acting antiviral agents for liver transplant recipients with recurrent genotype 1 hepatitis C virus infection: Systematic review and meta‐analysis

Effect of Hepatitis C Treatment on Renal Function in Liver Transplant Patients

Changes in practice and perception of hepatitis C and liver transplantation: Results of a national survey

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