Telaprevir-based triple therapy for hepatitis C null responders among living donor liver transplant recipients

Kaneko, Junichi; Sugawara, Yasuhiko; Yamaguchi, Takeshi; Harada, Nobuhiro; Akamatsu, Nobuhisa; Ishizawa, Takeaki; Aoki, Taku; Sakamoto, Yoshihiro; Hasegawa, Kiyoshi; Tamura, Sumihito; Tanaka, Tomohiro; Kokudo, Norihiro

doi:10.5582/bst.2014.01101

Cited by 6 publications

(7 citation statements)

References 22 publications

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“…[5] Over the past 3 decades, surgeons have endeavored to induce hypertrophy of a small FLR, particularly in patients with hepatocellular carcinoma (HCC) who were not eligible for liver resection. [6–8] Makuuchi et al [9] first described portal vein embolization (PVE) in 1990, which they used to induce hypertrophy of the left side of the liver to increase the safety of a major hepatectomy for treatment of hilar cholangiocarcinoma. Later, a 2-stage hepatectomy (TSH) was described by Adam et al [10] as a means to achieve an R0 resection in patients with bilobar liver tumors.…”

Section: Introductionmentioning

confidence: 99%

An updated systematic review of the evolution of ALPPS and evaluation of its advantages and disadvantages in accordance with current evidence

et al. 2016

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The main obstacle to achieving an R0 resection after a major hepatectomy is inability to preserve an adequate future liver remnant (FLR) to avoid postoperative liver failure (PLF). Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a novel technique for resecting tumors that were previously considered unresectable, and this technique results in a vast increase in the volume of the FLR in a short period of time. However, this technique continues to provoke heated debate because of its high mortality and morbidity.The evolution of ALPPS and its advantages and disadvantages have been systematically reviewed and evaluated in accordance with current evidence. Electronic databases (PubMed and Medline) were searched for potentially relevant articles from January 2007 to January 2016.ALPPS has evolved into various modified forms. Some of these modified techniques have reduced the difficulty of the procedure and enhanced its safety. Current evidence indicates that the advantages of ALPPS are rapid hypertrophy of the FLR, the feasibility of the procedure, and a higher rate of R0 resection in comparison to other techniques. However, ALPPS is associated with worse major complications, more deaths, and early tumor recurrence.Hepatobiliary surgeons should carefully consider whether to perform ALPPS. Some modified forms of ALPPS have reduced the mortality and morbidity of the procedure, but they cannot be recommended over the original procedure currently. Portal vein embolization (PVE) is still the procedure of choice for patients with a tumor-free FLR, and ALPPS could be used as a salvage procedure when PVE fails. More persuasive evidence needs to be assembled to determine whether ALPPS or two-stage hepatectomy (TSH) is better for patients with a tumor involving the FLR. Evidence with regard to long-term oncological outcomes is still limited. More meticulous comparative studies and studies of the 5-year survival rate of ALPPS could ultimately help to determine the usefulness of ALPPS. Indications and patient selection for the procedure need to be determined.

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Section: Introductionmentioning

confidence: 99%

An updated systematic review of the evolution of ALPPS and evaluation of its advantages and disadvantages in accordance with current evidence

et al. 2016

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“…Nine patients (47%) were treated with Tac‐based immunosuppression, and the remaining 10 were on CsA. Three patients had treatment failure of PEG‐IFN/RBV plus simeprevir therapy, and one patient was of treatment failure of PEG‐IFN/RBV plus telaprevir therapy …”

Section: Resultsmentioning

confidence: 99%

“…Three patients had treatment failure of PEG-IFN/RBV plus simeprevir therapy, 20 and one patient was of treatment failure of PEG-IFN/RBV plus telaprevir therapy. 21 Of the 19 patients treated with SOF/LDV, 18 patients (95%) completed the protocol of 12 weeks, while one patient stopped the treatment at 4 weeks due to worsening of interstitial pneumonia, which may not be associated with DAA therapy. All 18 patients who completed the 12-week treatment protocol achieved ETR.…”

Section: Patients Treated With Sof/ldvmentioning

confidence: 99%

Asunaprevir/daclatasvir and sofosbuvir/ledipasvir for recurrent hepatitis C following living donor liver transplantation

Omichi

Akamatsu

Mori

et al. 2016

Hepatology Research

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“…Hepatitis C virus (HCV) infection is a leading cause of chronic liver disease and liver transplantation . Compared with conventional interferon‐based therapies and boceprevir/telaprevir‐based triple therapies , newer direct‐acting antiviral agents have been shown to improve outcomes for liver transplant recipients with recurrent HCV infection . In one study of 34 postliver transplant recipients without cirrhosis, treatment with ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin for 24 weeks resulted in a sustained virologic response 12 weeks after the end of treatment (SVR12) rate of 97% ; an SVR12 rate of 95% was seen in another study ( n = 53) evaluating treatment with daclatasvir + sofosbuvir + ribavirin .…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study

et al. 2017

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This prospective, randomized, phase 2 study in subjects with recurrent hepatitis C virus (HCV) genotype 1 postorthotopic liver transplant evaluated once-daily simeprevir 150 mg + sofosbuvir 400 mg, with and without ribavirin 1000 mg. Primary endpoint was proportion of subjects with week 12 sustained virologic response (SVR12). Thirty-three subjects without cirrhosis were randomized 1:1:1 into three arms (stratified by genotype/subtype and Q80K): Arm 1, simeprevir + sofosbuvir + ribavirin, 12 weeks; Arm 2, simeprevir + sofosbuvir, 12 weeks; Arm 3, simeprevir + sofosbuvir, 24 weeks; 13 additional subjects (two with cirrhosis, 11 without cirrhosis) entered Arm 3. All 46 subjects received at least one dose of study drug; median age, 60 years; 73.9% male; 80.4% White; 71.7% genotype/subtype 1a [12 (36.4%) of these had Q80K]; median 4.5 years post-transplant. Among randomized subjects, SVR12 was achieved by 81.8% in Arm 1, 100% in Arm 2, and 93.9% in Arm 3; two subjects did not achieve SVR12: one viral relapse (follow-up week 4; Arm 1) and one missing follow-up week 12 data. In total, five subjects had a serious adverse event, considered unrelated to treatment per investigator. Simeprevir exposure was increased relative to the nontransplant setting, but not considered clinically relevant. Simeprevir + sofosbuvir treatment, with or without ribavirin, was efficacious and well tolerated (ClinicalTrials.gov Identifier: NCT02165189).

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Telaprevir-based triple therapy for hepatitis C null responders among living donor liver transplant recipients

Cited by 6 publications

References 22 publications

An updated systematic review of the evolution of ALPPS and evaluation of its advantages and disadvantages in accordance with current evidence

An updated systematic review of the evolution of ALPPS and evaluation of its advantages and disadvantages in accordance with current evidence

Asunaprevir/daclatasvir and sofosbuvir/ledipasvir for recurrent hepatitis C following living donor liver transplantation

Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study

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