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- 저자 : W. Ray Kim (검색결과 32 건)
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MELD: From an Idea to a Practice
( W. Ray Kim ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
When the MELD score was initially developed in patients undergoing elective placement of transjugular intrahepatic portosystemic shunt, out of a host of variables considered, a number of variables were found to be significantly associated with mortality in the univariate stage. These included, in addition to the current components of MELD (namely, bilirubin, creatinine, and INR), the cause of cirrhosis, ascites, hepatic encephalopathy, and albumin, as well as the Child-Turcotte-Pugh score. Of these variables, only three variables were subsequently selected as the score to be implemented in organ allocation policy. Since MELD was adopted by OPTN, questions have been raised whether the score needs to be updated for patients waiting for transplantation, as opposed to the original patient sample of TIPS patients. It turned out that for all three variables, the existing coefficients underestimated the rapidity with which mortality increased. In addition, using different lower and upper bounds of the variables could attain some optimization of the score. Several investigators have observed that hyponatremia may reflect mortality risk not adequately captured by the MELD score. When analyzed in conjunction with other measures of renal function, hyponatremia carries prognostic information independent of serum creatinine. However, when directly measured renal function was also taken into account, serum sodium became redundant - suggesting that serum sodium may reflect renal physiology that is not captured by serum creatinine. Based on these data, several models to incorporate serum sodium into the MELD score have been proposed. Some features of interest in those models are (1) there are lower and upper bounds to serum sodium, beyond which mortality is not impact appreciably and (2) the impact of serum sodium is dependent of MELD in that hyponatremia is most important in patients with a low MELD score. The impact of hyponatremia in patients undergoing liver transplantation on their postoperative outcome has been debated. Earlier studies linked hyponatremia with poor outcome including shorter survival and higher incidence of complications. More recent data indicate that there is no difference in survival between patients with hyponatremia and those with normal sodium. In contrast, patients with hypernatremia had a significantly higher mortality and early post-transplant complications. In light of these data, incorporating serum sodium into the organ allocation scheme has been proposed. The Liver Simulation Allocation Model (LSAM) software has been utilized to predict implementation of such a system. When a number of models with MELD and sodium were compared with MELD score alone, the former models resulted consistently in lower waitlist mortality and fewer deaths after withdrawal, at the expense of marginal increase in post-transplant mortality. Taking into account serum sodium would result in lower overall mortality, including pre- and post-transplant deaths. Based on these data, MELD-Na* has been adopted for liver allocation in January 2016.
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( W. Ray Kim ),( Eric J. Lawitz ),( Peter Ruane ),( Catherine Stedman ),( Graham Foster ),( Robert H. Hyland ),( Sarah Coogan ),( Stephanie Moody ),( Hadas Dvory-sobo ),( Steven J. Knox ),( Diana M. B 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: Significant advances in the treatment of chronic hepatitis C have been made with direct acting antiviral (DAA) regimens. While SVR rates may now be achieved in the majority of patients, data describing long-term virologic and clinical outcomes with these regimens are needed. Methods: We report interim data from two 3-year registry studies capturing long-term outcomes in patients with chronic hepatitis C treated with DAAs. Subjects are enrolled into two registries according to SVR status; SVR (SVR registry) versus non-SVR (Sequence registry). We determined the durability of SVR, relapse and reinfection rates. The persistence of resistance associated variants (RAVs) in treatment failures is followed. Liver disease progression is assessed by periodic clinical & labroratory evaluations. Results: 5433 patients enrolled in the SVR registry with a median (range) follow-up of 71 (0-156) weeks. 536 patients enrolled in the Sequence registry with a median (range) of follow-up of 44 (0-159) weeks. Demographic and disease characteristics are described below. In the SVR registry, at the time of data analysis, 99.7% (5414/5433) of patients have maintained SVR with 0.3% (19/5433) having emergent virus (6 relapses, 8 new infections, 5 to be confirmed). Viral emergence occurred by Week 96 in all patients. In the Sequence registry of 89 patients who received an NS5A inhibitor and had baseline sequencing data, 91.0% (81/89) had NS5A RAVs at Week 96. HCC was reported in 0.3% (16/5433) and 0.9% (5/536) of patients in the SVR and Sequence registries through Week 96 respectively. There were no significant changes in laboratory evaluations or liver disease assessments. Conclusions: SVR achieved following treatment with DAA regimens is durable. In patients failing NS5A-containing regimens, treatment- emergent NS5A RAVs persist. Rates of clinical disease progression and HCC are low. Ongoing reporting from these registry studies will be required to confirm these findings.
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( W. Ray Kim ),( Anu Osinusi ),( Ajitha Mannalithara ),( Bo Hyun Kim ),( Raul Aguilar Schall ),( Diana Brainard ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Current direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection leads to sustained virological response (SVR) in the vast majority of patients, even in those with de compensated cirrhosis. SVR in patients with decompensated cirrhosis has been associated with improvement in liver func tion; however, the extent to which DAA impacts on mortality remains to be determined. We analyze mortality in patients who participated in clinical trials evaluating sofosbuvir-based regimens in patients with decompensated HCV cirrhosis (GS-US-334-0125, SOLAR and ASTRAL studies), in comparison with mortality predicted by a survival model derived in untreated HCV patients. Methods: Current direct-acting antiviral (DAA) therapy for hep atitis C virus (HCV) infection leads to sustained virological re sponse (SVR) in the vast majority of patients, even in those with decompensated cirrhosis. SVR in patients with decompensated cirrhosis has been associated with improvement in liver func tion; however, the extent to which DAA impacts on mortality remains to be determined. We analyze mortality in patients who participated in clinical trials evaluating sofosbuvir-based regimens in patients with decompensated HCV cirrhosis (GS-US-334-0125, SOLAR and ASTRAL studies), in comparison with mortality predicted by a survival model derived in untreated HCV patients. Results: There was a total of 492 patients, whose median age was 58 years, MELD 12, sodium 137mEq/l and albumin 2.9 g/ dl. Ascites and HE were common (79% and 63%, respectively). Altogether, 411/479 (86%) patients achieved SVR12. During the follow up, there were 25 deaths within one year of DAA therapy start, including 15 in the SOLAR and 10 in the ASTRAL data; no deaths occurred in GS-US-334-0125. The number of observed deaths in the clinical trials closely followed the expect ed/predicted numbers early in the treatment course (Figure). Starting at 100 days after initiation of DAA, however, the ob served number of deaths was statistically significantly smaller than expected (SMR=0.54, 95% confidence interval [CI]=0.30- 0.98). All subsequent deaths occurred at a lower frequency than expected. The last (25th) death during the study period occurred on day 339, when the SMR had decreased to 0.44 (95% CI=0.30-0.65), which remained unchanged at the end of the analysis (day 365). Conclusions: DAA therapy in patients with decompensated HCV cirrhosis leads to significantly decreased mortality, which may be apparent as early as 100 days after the initiation of therapy with the risk of mortality decreasing to 44% of the ex pected by the end of the first year.
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( W Ray Kim ),( Rohit Loomba ),( Selim Gurel ),( John Flaherty ),( Eduardo B Martins ),( Leland J Yee ),( Phillip Dinh ),( Maria Buti ),( Patrick Marcellin ) 대한간학회 2013 춘·추계 학술대회 (KASL) Vol.2013 No.1
Background: Patients with chronic hepatitis B Virus (HBV) infection are at increased risk for hepatocellular carcinoma (HCC). Population-based studies have suggested an increased risk of hepatocellular carcinoma (HCC) in patients with higher levels of HBV-DNA. Therefore, it is possible that anti-viral therapy that reduces HBV-DNA levels may reduce the occurrence of HCC. We examined the clinical and demographic characteristics of HCC cases in patients receiving tenofovir disoproxil fumarate (TDF). Methods: We studied the clinical and demographic characteristics of the 641 patients enrolled in pivotal studies GSUS- 174-0102 and GS-US-174-0103. Results: During the first 288 weeks of studies 102/103, there were 13 cases of HCC. Three cases occurred during the first 48 weeks. 9/13 cases were HBeAg-negative and 3 of these were cirrhotic. 4/13 cases were HBeAg-positive at baseline and 3 of these were cirrhotic. 11/13 cases were male. 2/13 patients had regression of histological cirrhosis on repeat liver biopsies. Among the 13 HCC cases, 5 were genotype (gt)-D, 4 gt-C, 1 gt- B, 1 gt-E, 1 gt-F and 1 unable to genotype. Conclusions: In 288 weeks of TDF therapy, there were only 13 cases of HCC. 3 of the HCC cases were reported within the first 48 weeks of therapy. Despite the small number of cases, HCC surveillance needs to be done in patients on long-time oral antivirals.
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