Towards a blood test for early-stage liver disease
Researchers uncover a set of proteins that are enriched in pre-symptomatic non-alcoholic fatty liver disease
Heidelberg, 1 March 2019 – One in four people in Western and Asian societies develop a build-up of fat in the liver as a result of an unhealthy diet. This disease – referred to as non-alcoholic fatty liver disease (NAFLD) – causes no symptoms initially but can develop into end-stage liver cirrhosis with limited treatment options. A discovery, published today in Molecular Systems Biology, paves the way for a simple blood test to detect early stages of NAFLD, opening up the possibility of preventing the development of liver cirrhosis through lifestyle changes or pharmaceutical intervention.
The liver is an important organ, filtering toxic substances from the body and producing proteins required for digestion, blood clotting, and other important physiological functions.
“The liver is very resilient and capable of regenerating itself, which may be the reason why liver damages due to excessive fat deposition can go undetected for a long time,” says EMBO Member Matthias Mann of the University of Copenhagen, Denmark, and the Max Planck Institute of Biochemistry in Martinsried, Germany, who led the study. However, when damage accumulates liver function eventually starts to fail.
To date, the standard procedure for diagnosing NAFLD is liver biopsy – a cumbersome and costly procedure that can lead to complications. Non-invasive methods that reliably detect early stage NAFLD are therefore urgently required.
Mann and his colleagues investigated the plasma proteome – the entire set of proteins present in the blood plasma – of NAFLD patients. Using sophisticated mass spectrometry technologies, they uncovered a set of proteins that accumulate in the plasma of patients with non-symptomatic NAFLD.
In a first set of experiments, they determined that the blood proteome of patients in a late stage of the disease differed considerably from that of healthy controls. Many proteins that were altered in the patients’ blood proved to be associated with known aspects of the disease, such as thrombosis, vitamin A and D deficiency, or defects in glucose metabolism. These observations show the validity of the procedure to find new disease-related proteins.
In the next step, comparing the proteome of patients in early stage NAFLD with that of healthy individuals, the researchers found only minor differences. They did, however, succeed in identifying six proteins that were significantly associated with early stage NAFLD.
“One of the proteins we uncovered, termed PIGR, is of special interest,” says Mann. “Individuals with NAFLD who do not show any symptoms have increased levels of PIGR in their blood. And the concentration of the protein increases the further the disease progresses, making PIGR an interesting biomarker candidate for the inclusion in liver damage tests.”
While current blood tests only detect liver damage at a late stage in disease development, the present study is an important step towards developing new diagnostic tools to identify patients with NAFLD in a much earlier, pre-symptomatic phase.
Plasma proteome profiling discovers novel proteins associated with non-alcoholic fatty liver disease
Molecular Systems Biology
Lili Niu, Philipp E. Geyer, Nicolai J. Wewer Albrechtsen, Lise L. Gluud, Alberto Santos, Sophia Doll, Peter V. Treit, Jens J. Holst, Filip K. Knop, Tina Vilsbøll, Anders Junker, Stephan Sachs, Kerstin Stemmer, Timo D. Müller, Matthias H. Tschöp, Susanna M. Hofmann, Matthias Mann
DOI: 10.15252/msb.20188793
Read the paper: http://msb.embopress.org/cgi/doi/10.15252/msb.20188793
Showing posts with label Fatty Liver. Show all posts
Showing posts with label Fatty Liver. Show all posts
Saturday, March 2, 2019
Thursday, February 21, 2019
Is high intake of whole grains associated with lower risk of developing liver cancer?
Media
Whole grains might help ward off liver cancer
Linda Carroll
Association of Intake of Whole Grains and Dietary Fiber With Risk of Hepatocellular Carcinoma in US Adults
Wanshui Yang, PhD1,2; Yanan Ma, PhD2,3; Yue Liu, MD2,4; et al Stephanie A. Smith-Warner, PhD5,6; Tracey G. Simon, MD7,8,9; Dawn Q. Chong, MD10; Qibin Qi, PhD11; Jeffrey A. Meyerhardt, MD, MPH12; Edward L. Giovannucci, MD, ScD2,5,6; Andrew T. Chan, MD, MPH2,8,9; Xuehong Zhang, MD, ScD2 Author Affiliations JAMA Oncol.
Published online February 21, 2019.
doi:10.1001/jamaoncol.2018.7159
Key Points
Question Is high intake of whole grains and dietary fiber associated with lower risk of developing hepatocellular carcinoma (HCC)?
Findings In this cohort study of 125 455 participants in the United States, including 141 patients with HCC, with an average follow-up of 24.2 years, increased intake of whole grains was associated with a reduced risk of HCC. A nonsignificant inverse HCC association was observed for total bran but not for germ; increased intake of cereal fiber but not fruit or vegetable fiber was associated with a nonsignificant lower risk of HCC.
Meaning Increased intake of whole grains and possibly cereal fiber and bran could be associated with reduced risk of HCC among US adults.
Abstract
Importance Increased intake of whole grain and dietary fiber has been associated with lower risk of insulin resistance, hyperinsulinemia, and inflammation, which are known predisposing factors for hepatocellular carcinoma (HCC). Therefore, we hypothesized that long-term intake of whole grains and dietary fiber may be associated with lower risk of HCC.
Objective To assess the associations of whole grain and dietary fiber intake with the risk of HCC.
Design, Setting, and Participants Cohort study of the intake of whole grains, their subcomponents (bran and germ), and dietary fiber (cereal, fruit, and vegetable) in 125 455 participants from 2 cohorts from the Nurses’ Health Study and the Health Professionals Follow-up Study.
Exposures Intake of whole grains, their subcomponents (bran and germ), and dietary fiber (cereal, fruit, and vegetable) were collected and updated almost every 4 years using validated food frequency questionnaires.
Main Outcomes and Measures Multivariable hazard ratios (HRs) and 95% CIs were estimated using Cox proportional hazards regression model after adjusting for most known HCC risk factors.
Results After an average follow-up of 24.2 years, we identified 141 patients with HCC among 125 455 participants (77 241 women and 48 214 men (mean [SD] age, 63.4 [10.7] years). Increased whole grain intake was significantly associated with lower risk of HCC (the highest vs lowest tertile intake: HR, 0.63; 95% CI, 0.41-0.96; P = .04 for trend). A nonsignificant inverse HCC association was observed for total bran (HR, 0.70; 95% CI, 0.46-1.07; P = .11 for trend), but not for germ. Increased intake of cereal fiber (HR, 0.68; 95% CI, 0.45-1.03; P = .07 for trend), but not fruit or vegetable fiber, was associated with a nonsignificant reduced risk of HCC.
Conclusions and Relevance Increased intake of whole grains and possibly cereal fiber and bran could be associated with reduced risk of HCC among adults in the United States. Future studies that carefully consider hepatitis B and C virus infections are needed to replicate our findings, to examine these associations in other racial/ethnic or high-risk populations, and to elucidate the underlying mechanisms.
https://jamanetwork.com/journals/jamanetworkopen
Whole grains might help ward off liver cancer
Linda Carroll
(Reuters Health) - Yet another benefit of eating a diet containing high amounts of whole grains may be a reduced risk of liver cancer, a new U.S. study suggests.
“Consumption of whole grains and dietary fiber, especially cereal fiber, have been associated with lower risk of obesity, type 2 diabetes, and nonalcoholic fatty liver disease, which are known predisposing factors for (liver cancer),” Zhang said. “Besides improving insulin sensitivity, metabolic regulation, and decreasing systemic inflammation, intake of whole grains and dietary fiber may improve gut integrity, and alter gut microbiota composition, thereby leading to increased production of microbiota-related metabolites including short-chain fatty acids, particularly butyrate.”
Original Investigation
JAMA Network OpenFebruary 21, 2019Association of Intake of Whole Grains and Dietary Fiber With Risk of Hepatocellular Carcinoma in US Adults
Wanshui Yang, PhD1,2; Yanan Ma, PhD2,3; Yue Liu, MD2,4; et al Stephanie A. Smith-Warner, PhD5,6; Tracey G. Simon, MD7,8,9; Dawn Q. Chong, MD10; Qibin Qi, PhD11; Jeffrey A. Meyerhardt, MD, MPH12; Edward L. Giovannucci, MD, ScD2,5,6; Andrew T. Chan, MD, MPH2,8,9; Xuehong Zhang, MD, ScD2 Author Affiliations JAMA Oncol.
Published online February 21, 2019.
doi:10.1001/jamaoncol.2018.7159
Key Points
Question Is high intake of whole grains and dietary fiber associated with lower risk of developing hepatocellular carcinoma (HCC)?
Findings In this cohort study of 125 455 participants in the United States, including 141 patients with HCC, with an average follow-up of 24.2 years, increased intake of whole grains was associated with a reduced risk of HCC. A nonsignificant inverse HCC association was observed for total bran but not for germ; increased intake of cereal fiber but not fruit or vegetable fiber was associated with a nonsignificant lower risk of HCC.
Meaning Increased intake of whole grains and possibly cereal fiber and bran could be associated with reduced risk of HCC among US adults.
Abstract
Importance Increased intake of whole grain and dietary fiber has been associated with lower risk of insulin resistance, hyperinsulinemia, and inflammation, which are known predisposing factors for hepatocellular carcinoma (HCC). Therefore, we hypothesized that long-term intake of whole grains and dietary fiber may be associated with lower risk of HCC.
Objective To assess the associations of whole grain and dietary fiber intake with the risk of HCC.
Design, Setting, and Participants Cohort study of the intake of whole grains, their subcomponents (bran and germ), and dietary fiber (cereal, fruit, and vegetable) in 125 455 participants from 2 cohorts from the Nurses’ Health Study and the Health Professionals Follow-up Study.
Exposures Intake of whole grains, their subcomponents (bran and germ), and dietary fiber (cereal, fruit, and vegetable) were collected and updated almost every 4 years using validated food frequency questionnaires.
Main Outcomes and Measures Multivariable hazard ratios (HRs) and 95% CIs were estimated using Cox proportional hazards regression model after adjusting for most known HCC risk factors.
Results After an average follow-up of 24.2 years, we identified 141 patients with HCC among 125 455 participants (77 241 women and 48 214 men (mean [SD] age, 63.4 [10.7] years). Increased whole grain intake was significantly associated with lower risk of HCC (the highest vs lowest tertile intake: HR, 0.63; 95% CI, 0.41-0.96; P = .04 for trend). A nonsignificant inverse HCC association was observed for total bran (HR, 0.70; 95% CI, 0.46-1.07; P = .11 for trend), but not for germ. Increased intake of cereal fiber (HR, 0.68; 95% CI, 0.45-1.03; P = .07 for trend), but not fruit or vegetable fiber, was associated with a nonsignificant reduced risk of HCC.
Conclusions and Relevance Increased intake of whole grains and possibly cereal fiber and bran could be associated with reduced risk of HCC among adults in the United States. Future studies that carefully consider hepatitis B and C virus infections are needed to replicate our findings, to examine these associations in other racial/ethnic or high-risk populations, and to elucidate the underlying mechanisms.
https://jamanetwork.com/journals/jamanetworkopen
Wednesday, February 20, 2019
Intercept - Phase 3 REGENERATE Study of Obeticholic Acid in Patients with Liver Fibrosis Due to NASH
Recommended Reading
Healio
February 19, 2019
The beginning of 2019 has already seen several significant advancements for the field of nonalcoholic steatohepatitis, from the inaugural NASH-TAG meeting to the recently announced positive results from the phase 3 study of Ocaliva.
Healio Gastroenterology and Liver Disease presents the following reports including trial results for Ocaliva (obeticholic acid, Intercept Pharma), a take-home report from NASH-TAG, and an update for this year’s International NASH Day.
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
February 5, 2019
Nonalcoholic steatohepatitis may soon supplant chronic hepatitis C as the leading cause of hepatocellular carcinoma among patients awaiting liver transplantation, according to the findings of a national longitudinal registry study
Press Release
Intercept Announces Positive Topline Results from Pivotal Phase 3 REGENERATE Study of Obeticholic Acid in Patients with Liver Fibrosis Due to NASH
First and largest successful pivotal Phase 3 study in patients with liver fibrosis due to NASH
OCA achieves primary endpoint demonstrating statistically significant improvement in liver fibrosis without worsening of NASH at 18 months (p=0.0002)
Intercept intends to file for regulatory approval in the U.S. and Europe in the second half of 2019
Results to be presented at European Association for the Study of the Liver 2019 International Liver Congress
The International Liver CongressTM
Every year in April, scientific and medical experts from a broad range of fields including hepatology, gastroenterology, internal medicine, cell biology, transplant surgery, infectious diseases, microbiology and virology, pharmacology, pathology and radiology and imaging come together from around the world to learn about the latest in liver research. Specialists share recent data, present studies and findings, and discuss the hottest topics on liver disease. The annual Congress attracts around 10,000 delegates and 250 media representatives from all over the world making this a truly international networking opportunity!
The International Liver CongressTM 2019 #ILC2019 will take place 10-14 April 2019 at the Reed Messe Wien Exhibition & Congress Center, Vienna, Austria.
Intercept Press Release
NEW YORK, Feb. 19, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced positive results from its pivotal Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). In the primary efficacy analysis, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis (p=0.0002 vs. placebo). In the primary efficacy analysis, a numerically greater proportion of patients in both OCA treatment arms compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis, but this did not reach statistical significance. As agreed with the U.S. Food and Drug Administration (FDA), in order for the primary objective to be met, the study was required to achieve one of the two primary endpoints.
The International Liver CongressTM
Every year in April, scientific and medical experts from a broad range of fields including hepatology, gastroenterology, internal medicine, cell biology, transplant surgery, infectious diseases, microbiology and virology, pharmacology, pathology and radiology and imaging come together from around the world to learn about the latest in liver research. Specialists share recent data, present studies and findings, and discuss the hottest topics on liver disease. The annual Congress attracts around 10,000 delegates and 250 media representatives from all over the world making this a truly international networking opportunity!
The International Liver CongressTM 2019 #ILC2019 will take place 10-14 April 2019 at the Reed Messe Wien Exhibition & Congress Center, Vienna, Austria.
Intercept Press Release
NEW YORK, Feb. 19, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced positive results from its pivotal Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). In the primary efficacy analysis, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis (p=0.0002 vs. placebo). In the primary efficacy analysis, a numerically greater proportion of patients in both OCA treatment arms compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis, but this did not reach statistical significance. As agreed with the U.S. Food and Drug Administration (FDA), in order for the primary objective to be met, the study was required to achieve one of the two primary endpoints.
“We are thrilled to report the first positive registrational Phase 3 study results in patients with NASH, a devastating disease that is on track to become a leading cause of liver transplant in coming years,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “The topline REGENERATE data we are reporting today support our belief that OCA will become the first approved medicine for those living with liver fibrosis due to NASH. We are deeply grateful to the patients, investigators and study staff whose ongoing participation in REGENERATE has brought us one step closer to delivering a much-needed therapeutic option to address the enormous unmet medical need in this population.”
Based on these results, Intercept intends to file for approval in the U.S. and Europe in the second half of 2019. OCA remains the only investigational drug to have received Breakthrough Therapy designation from the FDA for NASH with fibrosis. REGENERATE results will be presented at the European Association for the Study of the Liver (EASL): The International Liver CongressTM 2019.
“Patients with significant fibrosis due to NASH are at the greatest risk of progression to severe liver-related complications, such as liver failure and death, and fibrosis is considered the strongest predictor of liver-related mortality in this population,” said Zobair M. Younossi, M.D., Professor and Chairman of the Department of Medicine at Inova Fairfax Medical Campus, Professor of Medicine at Virginia Commonwealth University, Inova Campus and the Chair of the REGENERATE Steering Committee. “I am very encouraged by these results that demonstrate OCA’s ability to significantly improve fibrosis in patients with advanced disease. As the first successful pivotal trial in NASH, REGENERATE is an important advancement for the liver community.”
Efficacy Results
The primary efficacy analysis (Intent-to-Treat or ITT) assessed efficacy at 18 months in 931 patients with stage 2 or 3 liver fibrosis due to NASH. Overall study discontinuations in the primary efficacy analysis population were balanced across treatment arms: 16% in placebo, 17% in OCA 10 mg and 15% in OCA 25 mg.
The primary efficacy analysis (Intent-to-Treat or ITT) assessed efficacy at 18 months in 931 patients with stage 2 or 3 liver fibrosis due to NASH. Overall study discontinuations in the primary efficacy analysis population were balanced across treatment arms: 16% in placebo, 17% in OCA 10 mg and 15% in OCA 25 mg.
An additional pre-specified full efficacy analysis at 18 months added an exploratory cohort of 287 NASH patients with stage 1 liver fibrosis and additional risk factors who were at increased risk of progression to cirrhosis (N=1,218).
Patients with biopsy proven NASH with fibrosis were randomized 1:1:1 to receive placebo, OCA 10 mg or OCA 25 mg once daily. A repeat biopsy was conducted after 18 months for histologic endpoint assessment. Patients without a repeat biopsy due to study discontinuation or other reason were treated as non-responders in the primary and full efficacy analyses.
Click On Image To Enlarge
Fibrosis Improvement at Month 18
NASH Resolution at Month 18
Safety and Tolerability
The safety population in this planned 18-month analysis of REGENERATE included 1,968 randomized patients who received at least one dose of investigational product (OCA or placebo).
Adverse events were generally mild to moderate in severity and the most common were consistent with the known profile of OCA. The frequency of serious adverse events was similar across treatment arms (11% in placebo, 11% in OCA 10 mg and 14% in OCA 25 mg) and no serious adverse event occurred in >1% of patients in any treatment arm. There were 3 deaths in the study (2 in placebo: bone cancer and cardiac arrest, 1 in OCA 25 mg: glioblastoma) and none were considered related to treatment.
The most common adverse event reported was dose-related pruritus (19% in placebo, 28% in OCA 10 mg and 51% in OCA 25 mg). The large majority of pruritus events were mild to moderate, with severe pruritus occurring in a small number of patients (<1% in placebo, <1% in OCA 10 mg and 5% in OCA 25 mg). A higher incidence of pruritus associated treatment discontinuation was observed for OCA 25 mg (<1% in placebo, <1% in OCA 10 mg and 9% in OCA 25 mg). According to the clinical study protocol, investigator assessed severe pruritus mandated treatment discontinuation.
Consistent with observations from previous NASH studies, OCA treatment was associated with an increase in LDL cholesterol, with a peak increase of 22.6 mg/dL at 4 weeks and subsequently reversing and approaching baseline at month 18 (4.0 mg/dL increase from baseline). Triglycerides rapidly and continually decreased in the OCA treatment arms through month 18. There were few and varied serious cardiovascular events and incidence was balanced across the three treatment arms (2% in placebo, 1% in OCA 10 mg and 2% in OCA 25 mg).
With respect to hepatobiliary events, more patients (3%) on OCA 25 mg experienced gallstones or cholecystitis compared to <1% on placebo and 1% on OCA 10 mg. While numerically higher in the OCA 25 mg treatment arm, serious hepatic adverse events were uncommon with <1% incidence in each of the
Source - Download PDF
MarketWatch
There are no approved treatments for NASH, or nonalcoholic steatohepatitis, a serious liver disease caused by fat accumulation in the liver that can result in chronic inflammation and scarring, or fibrosis. Eventually, the disease can lead to liver failure, cancer and death.
Intercept’s treatment, obeticholic acid (OCA), is meant to treat patients with liver fibrosis due to NASH. The Phase 3 trial enrolled 931 patients with liver fibrosis who were randomly assigned to be treated with a placebo drug or one of two doses of OCA.
Tuesday, February 12, 2019
Eating lots of meat tied to higher risk of liver disease
Reuters• February 12, 2019
By Lisa Rapaport
(Reuters Health) - People who eat a lot of animal protein may be more likely to have excessive fat in their livers and a higher risk of liver disease than individuals whose main source of protein is vegetables, a Dutch study suggests.
Researchers focused on what's known as non-alcoholic fatty liver disease (NAFLD), which is usually associated with obesity and certain eating habits. While dietary changes are recommended to treat this type of liver disease, research to date hasn't clearly demonstrated whether these changes can work for prevention.
Read more:
https://news.yahoo.com/eating-lots-meat-tied-higher-risk-liver-disease-231806194.htmlStudy:
Association of dietary macronutrient composition and non-alcoholic fatty liver disease in an ageing population: the Rotterdam Study
Monday, February 11, 2019
Gilead Data On Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Media
A fatty liver drug from Gilead Sciences posts negative results in late-stage clinical trial
By Adam Feuerstein @adamfeuerstein
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
In the study of 877 enrolled patients who received study drug, 14.4 percent of patients treated with selonsertib 18 mg (p=0.56 vs. placebo) and 12.5 percent of patients treated with selonsertib 6 mg (p=1.00) achieved a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment, compared with 12.8 percent of patients who received placebo. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.
“While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments. Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases. Data from this large study of patients with compensated cirrhosis due to NASH, including the extensive set of biomarkers collected, will further advance our understanding of the disease and inform our broader NASH development programs,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “We are grateful to the patients and investigators who participated in the STELLAR-4 study, and we now await the upcoming results from the Phase 3 STELLAR-3 trial of selonsertib in patients with bridging fibrosis (F3) due to NASH and the Phase 2 ATLAS combination trial of selonsertib, cilofexor (GS-9674) and firsocostat (GS-0976) in patients with advanced fibrosis due to NASH later this year.”
Further in-depth analysis of the findings is ongoing and the data will be submitted to an upcoming scientific conference. Gilead will work with the Data Monitoring Committee and investigators to conclude the STELLAR-4 study in a manner consistent with the best interests of each patient.
Selonsertib, cilofexor and firsocostat, alone or in combination, are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established for these agents.
About Selonsertib and the STELLAR-4 Study
Selonsertib is an investigational small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress. Oxidative stress can be increased in many pathological conditions including liver diseases such as NASH.
The STELLAR-4 study is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib in patients with compensated cirrhosis (F4) due to NASH. Eligible adults ages 18 to 70 years were randomized and received selonsertib 18 mg (n=354), selonsertib 6 mg (n=351) or placebo (n=172) for up to 240 weeks. Either selonsertib or placebo is being administered orally once daily. The primary endpoints of the study are a composite of the proportion of patients who achieve a ≥ 1-stage improvement in fibrosis according to the NASH CRN classification without worsening of NASH at week 48 and event-free survival at week 240 as assessed by time to the first clinical event. Further information about the clinical study can be found at www.clinicaltrials.gov.
About Gilead’s Clinical Programs in NASH
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis, including bridging fibrosis (F3) or compensated cirrhosis (F4), are at a significantly higher risk of liver-related mortality and all-cause mortality.
Gilead is advancing multiple novel investigational compounds for the treatment of advanced fibrosis due to NASH, evaluating single-agent and combination therapy approaches against the core pathways associated with NASH – hepatocyte lipotoxicity, inflammation and fibrosis. Investigational compounds in development include the ASK1 inhibitor selonsertib, the selective, non-steroidal FXR agonist cilofexor (GS-9674) and the ACC inhibitor firsocostat (GS-0976). The STELLAR-3 Phase 3 trial evaluating selonsertib among NASH patients with bridging fibrosis (F3) is ongoing. Cilofexor and firsocostat are currently in Phase 2 studies in NASH, including the ATLAS Phase 2 trial evaluating combinations of selonsertib, cilofexor and firsocostat in advanced fibrosis (F3 and F4) due to NASH.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
A fatty liver drug from Gilead Sciences posts negative results in late-stage clinical trial
By Adam Feuerstein @adamfeuerstein
February 11, 2019
Gilead Sciences said Monday that its experimental drug, called selonsertib, failed to improve liver scarring compared to a placebo in a Phase 3 clinical trial. The study enrolled nearly 900 patients with compensated cirrhosis, an advanced form of NASH at higher risk for liver-related death.
Read it here...
In The Journals
What is Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis
In The Journals
What is Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis
Gastroenterology & Hepatology
February 2019 - Volume 15, Issue 2
Diagnostic and Treatment Implications of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis
February 2019 - Volume 15, Issue 2
Diagnostic and Treatment Implications of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis
Press release
Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
In the study of 877 enrolled patients who received study drug, 14.4 percent of patients treated with selonsertib 18 mg (p=0.56 vs. placebo) and 12.5 percent of patients treated with selonsertib 6 mg (p=1.00) achieved a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment, compared with 12.8 percent of patients who received placebo. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.
“While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments. Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases. Data from this large study of patients with compensated cirrhosis due to NASH, including the extensive set of biomarkers collected, will further advance our understanding of the disease and inform our broader NASH development programs,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “We are grateful to the patients and investigators who participated in the STELLAR-4 study, and we now await the upcoming results from the Phase 3 STELLAR-3 trial of selonsertib in patients with bridging fibrosis (F3) due to NASH and the Phase 2 ATLAS combination trial of selonsertib, cilofexor (GS-9674) and firsocostat (GS-0976) in patients with advanced fibrosis due to NASH later this year.”
Further in-depth analysis of the findings is ongoing and the data will be submitted to an upcoming scientific conference. Gilead will work with the Data Monitoring Committee and investigators to conclude the STELLAR-4 study in a manner consistent with the best interests of each patient.
Selonsertib, cilofexor and firsocostat, alone or in combination, are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established for these agents.
About Selonsertib and the STELLAR-4 Study
Selonsertib is an investigational small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress. Oxidative stress can be increased in many pathological conditions including liver diseases such as NASH.
The STELLAR-4 study is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib in patients with compensated cirrhosis (F4) due to NASH. Eligible adults ages 18 to 70 years were randomized and received selonsertib 18 mg (n=354), selonsertib 6 mg (n=351) or placebo (n=172) for up to 240 weeks. Either selonsertib or placebo is being administered orally once daily. The primary endpoints of the study are a composite of the proportion of patients who achieve a ≥ 1-stage improvement in fibrosis according to the NASH CRN classification without worsening of NASH at week 48 and event-free survival at week 240 as assessed by time to the first clinical event. Further information about the clinical study can be found at www.clinicaltrials.gov.
About Gilead’s Clinical Programs in NASH
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis, including bridging fibrosis (F3) or compensated cirrhosis (F4), are at a significantly higher risk of liver-related mortality and all-cause mortality.
Gilead is advancing multiple novel investigational compounds for the treatment of advanced fibrosis due to NASH, evaluating single-agent and combination therapy approaches against the core pathways associated with NASH – hepatocyte lipotoxicity, inflammation and fibrosis. Investigational compounds in development include the ASK1 inhibitor selonsertib, the selective, non-steroidal FXR agonist cilofexor (GS-9674) and the ACC inhibitor firsocostat (GS-0976). The STELLAR-3 Phase 3 trial evaluating selonsertib among NASH patients with bridging fibrosis (F3) is ongoing. Cilofexor and firsocostat are currently in Phase 2 studies in NASH, including the ATLAS Phase 2 trial evaluating combinations of selonsertib, cilofexor and firsocostat in advanced fibrosis (F3 and F4) due to NASH.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
Friday, January 11, 2019
At JPM, the NASH flood gates start to crack
J.P. Morgan Healthcare Conference in San Francisco
At JPM, the NASH flood gates start to crack
Jacob Bell
Articles available on this blog: Nonalcoholic Steatohepatitis (NASH)
Non-alcoholic Fatty Liver Disease (NAFLD)
Jan 11, 2019 - NASH update: 6 recent reports on treatment development
Jan 9, 2019 - Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis
After The Liver Meeting 2018 Summary: Viral Hepatitis & Fatty Liver Disease
At JPM, the NASH flood gates start to crack
Jacob Bell
Four companies are within striking distance of filing NASH drugs for approval, but the competitive landscape is more nuanced than simply crossing the finish line first...
While JPM didn't bring data updates for the later-stage NASH pipeline, drugmakers did give more color on their mindset heading into such a pivotal year....
John McHutchison, Gilead's head of R&D, told investors at JPM he anticipates "waves of approval," with the first being highly potent treatments for patients who have more advanced fibrosis, and then subsequent waves that work on less severe NASH and have better safety profiles.....
Read the article:
https://www.biopharmadive.com/news/nash-2019-jpm-readouts-deals-market-competition/545772/
Read the article:
https://www.biopharmadive.com/news/nash-2019-jpm-readouts-deals-market-competition/545772/
Articles available on this blog: Nonalcoholic Steatohepatitis (NASH)
Non-alcoholic Fatty Liver Disease (NAFLD)
Jan 11, 2019 - NASH update: 6 recent reports on treatment development
Jan 9, 2019 - Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis
After The Liver Meeting 2018 Summary: Viral Hepatitis & Fatty Liver Disease
NASH update: 6 recent reports on treatment development
NASH update: 6 recent reports on treatment development
Researchers continue efforts to study and develop safe and effective therapeutics to treat nonalcoholic fatty liver disease and its progressive form, nonalcoholic steatohepatitis, including several collaborative efforts between clinical development companies and societies.
Healio Gastroenterology and Liver Disease presents the following reports on recent NASH studies including data on a newly formed “NASH Roundtable,” positive results from recent clinical trials, and a new LiverMultiScan tool for identifying NASH....
Sunday, January 6, 2019
Gilead and Yuhan co-develop novel therapeutic candidates for Nonalcoholic Steatohepatitis (NASH)
Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis
Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis
FOSTER CITY, Calif. & SEOUL, Korea--(BUSINESS WIRE)--Jan. 6, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) and Yuhan Corporation (000100.KS; Yuhan) today announced that the companies have entered into a licensing and collaboration agreement to co-develop novel therapeutic candidates for the treatment of patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190106005116/en/
Under the agreement, Gilead will acquire global rights to develop and commercialize novel small molecules against two undisclosed targets in all countries, with the exception of the Republic of Korea where Yuhan will retain certain commercialization rights. Yuhan and Gilead will jointly conduct preclinical research, and Gilead will be responsible for global clinical development. Gilead will also be responsible for commercialization worldwide, outside of Yuhan’s rights in the Republic of Korea. In connection with this agreement, Yuhan will receive an upfront payment of $15 million and is eligible to receive up to an additional $770 million in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on future net sales. This agreement builds on the companies’ existing commercial collaboration to support the promotion of Gilead’s medicines in the Republic of Korea.
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis due to NASH, defined as bridging fibrosis (F3) or cirrhosis (F4), may face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation, and are at a significantly higher risk of liver-related mortality. Currently, patients living with NASH have limited treatment options.
“This collaboration builds on our long-term partnership with Yuhan, with a new focus on the investigation of novel approaches to treat patients with advanced fibrosis due to NASH that complement our ongoing research programs,” said John McHutchison, MD, AO, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “We look forward to working with the Yuhan team to advance our work in this area where there is a significant unmet need for patients.”
“I am very pleased by this collaboration, which significantly expands and deepens our longstanding, trusted partnership with Gilead. We are confident that Gilead’s expertise in liver disease will accelerate the development of our novel agents. As a company, we are committed to investigating new therapeutics to improve the lives of patients with NASH,” said Mr. Jung Hee Lee, President and CEO of Yuhan.
Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis
FOSTER CITY, Calif. & SEOUL, Korea--(BUSINESS WIRE)--Jan. 6, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) and Yuhan Corporation (000100.KS; Yuhan) today announced that the companies have entered into a licensing and collaboration agreement to co-develop novel therapeutic candidates for the treatment of patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190106005116/en/
Under the agreement, Gilead will acquire global rights to develop and commercialize novel small molecules against two undisclosed targets in all countries, with the exception of the Republic of Korea where Yuhan will retain certain commercialization rights. Yuhan and Gilead will jointly conduct preclinical research, and Gilead will be responsible for global clinical development. Gilead will also be responsible for commercialization worldwide, outside of Yuhan’s rights in the Republic of Korea. In connection with this agreement, Yuhan will receive an upfront payment of $15 million and is eligible to receive up to an additional $770 million in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on future net sales. This agreement builds on the companies’ existing commercial collaboration to support the promotion of Gilead’s medicines in the Republic of Korea.
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis due to NASH, defined as bridging fibrosis (F3) or cirrhosis (F4), may face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation, and are at a significantly higher risk of liver-related mortality. Currently, patients living with NASH have limited treatment options.
“This collaboration builds on our long-term partnership with Yuhan, with a new focus on the investigation of novel approaches to treat patients with advanced fibrosis due to NASH that complement our ongoing research programs,” said John McHutchison, MD, AO, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “We look forward to working with the Yuhan team to advance our work in this area where there is a significant unmet need for patients.”
“I am very pleased by this collaboration, which significantly expands and deepens our longstanding, trusted partnership with Gilead. We are confident that Gilead’s expertise in liver disease will accelerate the development of our novel agents. As a company, we are committed to investigating new therapeutics to improve the lives of patients with NASH,” said Mr. Jung Hee Lee, President and CEO of Yuhan.
Monday, December 31, 2018
The $35 billion race to cure a silent killer that affects 30 million Americans
Sun, December 30, 2018 7:39 AM
The $35 billion race to cure a silent killer that affects 30 million Americans
Lori Ioannou
The race is on in the pharmaceutical industry to develop drugs to treat a form of fatty liver disease called nonalcoholic steatohepatitis, also known as NASH.
Industry experts estimate the global market for these new drugs is $35 billion.
The U.S. is spending $5 billion annually in health-care costs related to the disease, which include chemotherapy, transplants, tests and hospitalizations, reports the Center for Disease Analysis.
The National Institutes of Health estimates as many as 12 percent of U.S. adults have this disease, or 30 million people.
Saturday, December 1, 2018
After The Liver Meeting 2018 Summary: Viral Hepatitis & Fatty Liver Disease
The Liver Meeting® 2018
San Francisco, CA.
November 9-13, 2018
Page updated: December 13, 2018
After The Liver Meeting
Hi folks, today we have a nice summary of the Liver Meeting, highlighting significant research on both viral hepatitis and fatty liver disease. Follow each post-meeting link provided below and start reviewing expert analysis of key data presented at the meeting, listen to audio live from the meeting, or view slidesets, and capsule summaries.
HCV Advocate December Newsletter
December 1, 2018
In this month's HCV Advocate Newsletter coverage of the Liver Meeting continues; read easy to understand commentary on HCV-related topics that matter most to patients. In next month's issue notable research on liver cancer presented at the meeting will be featured.
The Liver Meeting® Content Now Available On Demand
Open Access: The Best of The Liver Meeting®. This product, bundled as downloadable slide sets, contains highlights from the meeting and investigates nine topics with key findings, data and analyses.
View the summary slide decks by topic.
Alcoholic Liver Disease
Basic and Translational Research
Cholestatic and Autoimmune Liver Diseases
Liver and Biliary Cancer
NAFLD/NASH
Pediatric Liver Diseases
Portal Hypertension/Cirrhosis
Liver Transplant
Viral Hepatitis
Webinar
Dec 4, 2018
“Liver Meeting 2018 Updates” presented by Tatyana Kushner, MD, MSCE from Mount Sinai Medical Center, available now over at HepCure.
Webcast
Dec 13, 2018
Chronic Liver Disease Foundation
Hep B Foundation
Nov 27, 2018
After the Liver Meeting, Dr. Tim Block, the @HepBFoundation's co-founder & President, answered some of the most asked questions about the path to a hepatitis B cure. This is a two-part series. Read the first Q & A here: http://ow.ly/UEAT50jOb61
Video
Quick Review: Each Day Of The Meeting
Practice Point is once again launching daily clinical clips reviewing hot topics in HCV, presented each day at the meeting. Although the activity is intended for physicians and health care professionals, anyone, especially patients can benefit from each 5-minute review as well:
Independent Conference Coverage from the 2018 Annual Meeting of the American Association for the Study of Liver Disease (AASLD)*
In this video series, Dr. Saab will present ‘what you need to know in 5‐minutes’ regarding today's presentations from AASLD 2018 in San Francisco, CA
Free "registration" is required, once accomplished:
ACCESS ACTIVITY
Answer 3 question pre-test, and click Access Activity.
San Francisco, CA.
November 9-13, 2018
Page updated: December 13, 2018
After The Liver Meeting
Hi folks, today we have a nice summary of the Liver Meeting, highlighting significant research on both viral hepatitis and fatty liver disease. Follow each post-meeting link provided below and start reviewing expert analysis of key data presented at the meeting, listen to audio live from the meeting, or view slidesets, and capsule summaries.
HCV Advocate December Newsletter
December 1, 2018
In this month's HCV Advocate Newsletter coverage of the Liver Meeting continues; read easy to understand commentary on HCV-related topics that matter most to patients. In next month's issue notable research on liver cancer presented at the meeting will be featured.
Start here:
http://hcvadvocate.org/news/NewsUpdates_pdf/Advocate_2018/advocate1218.pdfThe Liver Meeting® Content Now Available On Demand
Open Access: The Best of The Liver Meeting®. This product, bundled as downloadable slide sets, contains highlights from the meeting and investigates nine topics with key findings, data and analyses.
View the summary slide decks by topic.
Alcoholic Liver Disease
Basic and Translational Research
Cholestatic and Autoimmune Liver Diseases
Liver and Biliary Cancer
NAFLD/NASH
Pediatric Liver Diseases
Portal Hypertension/Cirrhosis
Liver Transplant
Viral Hepatitis
Webinar
Dec 4, 2018
“Liver Meeting 2018 Updates” presented by Tatyana Kushner, MD, MSCE from Mount Sinai Medical Center, available now over at HepCure.
Webcast
Dec 13, 2018
Chronic Liver Disease Foundation
Symposium live from the meeting featuring table discussions with leading physicians discussing viral hepatitis, launched in December by CLDF. The primary goal of this CME symposium is to better understand how to effectively identify, manage, and treat patients with viral hepatitis in order to achieve viral eradication by 2030.
Updates
Updates
December 4, 2018
This year at The Liver Meeting, data presented on liver transplantation focused on comorbid complications, such as alcohol misuse and obesity, and their correlated…
ID Practitioner
ID Practitioner
December 4, 2018
Hepatitis C debrief: Therapy has matured, access issues remain
The Liver Meeting 2018: Hepatitis B novel therapies debrief – key abstracts
Modern Medicine
December 4, 2018
HCV Expert Interview with Jordan Feld, MD, MPH
In this interview, Jordan Feld, MD, MPH, discusses key highlights from studies presented at The Liver Meeting 2018, held recently in San Francisco by the American Association for the Study of Liver Diseases (AASLD).
Hep
Website: Hep
December 3, 2018
Hepatitis C debrief: Therapy has matured, access issues remain
The Liver Meeting 2018: Hepatitis B novel therapies debrief – key abstracts
Modern Medicine
December 4, 2018
HCV Expert Interview with Jordan Feld, MD, MPH
In this interview, Jordan Feld, MD, MPH, discusses key highlights from studies presented at The Liver Meeting 2018, held recently in San Francisco by the American Association for the Study of Liver Diseases (AASLD).
Hep
Website: Hep
December 3, 2018
By Benjamin Ryan
A review of the major findings presented at the Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco
infohep
infohep
November 30, 2018
Website infohep Twitter - @infohep
This month’s infohep bulletin focuses on news from The Liver Meeting 2018, organised by the American Association for the Study of Liver Diseases (AASLD), which took place in San Francisco, USA, from 9 to 13 November 2018.
Website infohep Twitter - @infohep
This month’s infohep bulletin focuses on news from The Liver Meeting 2018, organised by the American Association for the Study of Liver Diseases (AASLD), which took place in San Francisco, USA, from 9 to 13 November 2018.
Link: Conference bulletin
Medscape
November 29, 2018
Website Medscape Twitter @Medscape
Viral Hepatitis: Five Highlights From the Liver Meeting
Dr William Balistreri reports on the most important viral hepatitis news from this year's Liver Meeting.
Clinical Care Options
Nov 27, 2018
Website Clinical Care Options - Twitter @CCO_Hepatitis
Hot Topics in NASH
Medscape
November 29, 2018
Website Medscape Twitter @Medscape
Viral Hepatitis: Five Highlights From the Liver Meeting
Dr William Balistreri reports on the most important viral hepatitis news from this year's Liver Meeting.
Clinical Care Options
Nov 27, 2018
Website Clinical Care Options - Twitter @CCO_Hepatitis
Hot Topics in NASH
Audio: NAFLD/NASH Studies Influencing My Practice Following San Francisco 2018
Viral Hepatitis
Audio: Key Viral Hepatitis Studies Influencing My Practice Following San Francisco 2018
Slides: Clinical Impact of New Viral Hepatitis Data From San Francisco 2018
CCO Coverage: https://www.clinicaloptions.com/hepatitis/conference-coverage/san-francisco-2018
Healio
Viral Hepatitis
Audio: Key Viral Hepatitis Studies Influencing My Practice Following San Francisco 2018
Slides: Clinical Impact of New Viral Hepatitis Data From San Francisco 2018
CCO Coverage: https://www.clinicaloptions.com/hepatitis/conference-coverage/san-francisco-2018
Healio
Healio presents highlights of Fatty Liver and NASH data presented this year at The Liver Meeting.
Fatty liver highlights from The Liver Meeting 2018Hep B Foundation
Nov 27, 2018
After the Liver Meeting, Dr. Tim Block, the @HepBFoundation's co-founder & President, answered some of the most asked questions about the path to a hepatitis B cure. This is a two-part series. Read the first Q & A here: http://ow.ly/UEAT50jOb61
Video
Quick Review: Each Day Of The Meeting
Practice Point is once again launching daily clinical clips reviewing hot topics in HCV, presented each day at the meeting. Although the activity is intended for physicians and health care professionals, anyone, especially patients can benefit from each 5-minute review as well:
Independent Conference Coverage from the 2018 Annual Meeting of the American Association for the Study of Liver Disease (AASLD)*
In this video series, Dr. Saab will present ‘what you need to know in 5‐minutes’ regarding today's presentations from AASLD 2018 in San Francisco, CA
Free "registration" is required, once accomplished:
ACCESS ACTIVITY
Answer 3 question pre-test, and click Access Activity.
Easy to navigate index; link to meeting coverage, updates during and after the meeting, with a focus on viral hepatitis, nonalcoholic steatohepatitis/NASH, liver cancer and liver transplantation.
Check back for updates
Enjoy the weekend!
Tina
Thursday, November 29, 2018
HighTide Receives Fast Track Designation for new drug to treat NASH
[Rockville, Maryland, Nov. 27, 2018] — HighTide Therapeutics Inc., a clinical-stage biopharmaceutical company, announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with nonalcoholic steatohepatitis (NASH).
Liping Liu, PhD, Chief Executive Officer of HighTide, commented, “NASH represents a rapidly developing field with potential therapeutic options in the pipeline, yet none have made it to the market. At the recent AASLD Liver Meeting, experts in the field generally agreed that modest clinical responses to date are likely to be improved by thoughtful combination approaches. HTD1801, a multifunctional oral therapeutic, was designed to address the complex nature of NASH, especially for patients with comorbid diabetes and/or dyslipidemia. We are pleased by the FDA’s decision and look forward to bringing this much needed solution to millions of patients suffering from this disease.”
“This represents another step forward in our development of HTD1801 for the treatment of liver diseases with no currently approved therapies. We are proceeding with parallel clinical development of HTD1801 for NASH as well as primary sclerosing cholangitis (PSC) for which HTD1801 already received Orphan Drug Designation and Fast Track Designation,” said Janice Soreth, M.D., Chief Strategy and Regulatory Officer of HighTide, former Associate Commissioner for Special Medical Programs at the FDA.
FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An investigational drug that receives Fast Track Designation is eligible for more frequent communications between the FDA and the company relating to the development plan and clinical trial design, and may be eligible for priority review if certain criteria are met.
HighTide completed a first in human study of HTD1801 in healthy volunteers. A multi-center Phase 2 trial in adult patients with NASH is scheduled to enroll soon in the United States. A multi-center Phase 2 trial in adult patients with PSC is currently ongoing in the United States.
About HighTide Therapeutics and HTD1801
HighTide Therapeutics Inc., founded in 2011, is dedicated to the discovery and development of innovative therapeutics for people suffering from chronic liver diseases, gastrointestinal diseases and metabolic disorders with large and unsatisfied market needs.
HTD1801 is a new molecular entity being developed for the treatment of PSC and NASH.
About Nonalcoholic Steatohepatitis
Nonalcoholic steatohepatitis (NASH), a form of nonalcoholic fatty liver disease (NAFLD), is a chronic, complex liver disease characterized by hepatitis – inflammation of the liver – and liver cell damage, which can lead to fibrosis of the liver. NASH can lead to cirrhosis and liver cancer. Prevalence of NASH is on the rise and it may soon surpass hepatitis C as a cause for liver transplant. Currently, there are no approved therapies for NASH.
Liping Liu, PhD, Chief Executive Officer of HighTide, commented, “NASH represents a rapidly developing field with potential therapeutic options in the pipeline, yet none have made it to the market. At the recent AASLD Liver Meeting, experts in the field generally agreed that modest clinical responses to date are likely to be improved by thoughtful combination approaches. HTD1801, a multifunctional oral therapeutic, was designed to address the complex nature of NASH, especially for patients with comorbid diabetes and/or dyslipidemia. We are pleased by the FDA’s decision and look forward to bringing this much needed solution to millions of patients suffering from this disease.”
“This represents another step forward in our development of HTD1801 for the treatment of liver diseases with no currently approved therapies. We are proceeding with parallel clinical development of HTD1801 for NASH as well as primary sclerosing cholangitis (PSC) for which HTD1801 already received Orphan Drug Designation and Fast Track Designation,” said Janice Soreth, M.D., Chief Strategy and Regulatory Officer of HighTide, former Associate Commissioner for Special Medical Programs at the FDA.
FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An investigational drug that receives Fast Track Designation is eligible for more frequent communications between the FDA and the company relating to the development plan and clinical trial design, and may be eligible for priority review if certain criteria are met.
HighTide completed a first in human study of HTD1801 in healthy volunteers. A multi-center Phase 2 trial in adult patients with NASH is scheduled to enroll soon in the United States. A multi-center Phase 2 trial in adult patients with PSC is currently ongoing in the United States.
About HighTide Therapeutics and HTD1801
HighTide Therapeutics Inc., founded in 2011, is dedicated to the discovery and development of innovative therapeutics for people suffering from chronic liver diseases, gastrointestinal diseases and metabolic disorders with large and unsatisfied market needs.
HTD1801 is a new molecular entity being developed for the treatment of PSC and NASH.
About Nonalcoholic Steatohepatitis
Nonalcoholic steatohepatitis (NASH), a form of nonalcoholic fatty liver disease (NAFLD), is a chronic, complex liver disease characterized by hepatitis – inflammation of the liver – and liver cell damage, which can lead to fibrosis of the liver. NASH can lead to cirrhosis and liver cancer. Prevalence of NASH is on the rise and it may soon surpass hepatitis C as a cause for liver transplant. Currently, there are no approved therapies for NASH.
Sunday, November 11, 2018
The Liver Meeting® - Nonalcoholic Fatty Liver Disease Patients Have Higher Rates of All Non-Liver-Related Cancers
Updated Nov 12, 2018
Meeting Coverage @ infohep
People with fatty liver disease are at greater risk for multiple cancers
Liz Highleyman / 12 November 2018
People with non-alcoholic fatty liver disease (NAFLD) were found to have higher rates of cancer, with the greatest increase observed for gastrointestinal cancers, according to findings presented yesterday at the 2018 AASLD Liver
Read More: http://www.infohep.org/People-with-fatty-liver-disease-are-at-greater-risk-for-multiple-cancers/page/3365838/
Conference Updates: infohep news
Twitter - @infohep
The Liver Meeting news bulletin
Sign up for our AASLD Liver Meeting news bulletin.
Meeting Coverage @ infohep
People with fatty liver disease are at greater risk for multiple cancers
Liz Highleyman / 12 November 2018
People with non-alcoholic fatty liver disease (NAFLD) were found to have higher rates of cancer, with the greatest increase observed for gastrointestinal cancers, according to findings presented yesterday at the 2018 AASLD Liver
Conference Updates: infohep news
Twitter - @infohep
The Liver Meeting news bulletin
Sign up for our AASLD Liver Meeting news bulletin.
Meeting Coverage @ Healio
Fatty liver imposes 91% higher risk for cancer
Nov 11, 2018
Nov 11, 2018
“The risk of malignancy was higher in NAFLD vs. controls ... 91% higher than the general population when we take all cancers into account,” Alina M. Allen, MD, of Mayo Clinic, Rochester, Minn., said during her presentation. “Obesity is associated with a higher risk of cancer only in those with NAFLD and not in those without.”
Meeting Updates
Nonalcoholic Fatty Liver Disease Patients Have Higher Rates of All Non-Liver-Related Cancers
November 9, 2018
Data from a new study presented this week at The Liver Meeting® found that rates of malignancy occurring outside of the liver were higher in adults with nonalcoholic fatty liver disease than among adults across most types of cancers.
SAN FRANCISCO – Preliminary data from a new study presented this week at The Liver Meeting® – held by the American Association for the Study of Liver Diseases – found that rates of malignancy occurring outside of the liver were higher in adults with nonalcoholic fatty liver disease than among adults across most types of cancers.
Nonalcoholic fatty liver disease (commonly called NAFLD or fatty liver disease) is used to describe liver complications that arise from the buildup of excess fat in the liver. NAFLD is estimated to affect more than 80 million Americans.
SAN FRANCISCO – Preliminary data from a new study presented this week at The Liver Meeting® – held by the American Association for the Study of Liver Diseases – found that rates of malignancy occurring outside of the liver were higher in adults with nonalcoholic fatty liver disease than among adults across most types of cancers.
Nonalcoholic fatty liver disease (commonly called NAFLD or fatty liver disease) is used to describe liver complications that arise from the buildup of excess fat in the liver. NAFLD is estimated to affect more than 80 million Americans.
Malignancy is among the most common causes of death in patients with NAFLD. To examine whether increased malignancy risk is similar across all types of cancers, researchers at the Mayo Clinic in Rochester, Minn. conducted a study to determine the rates of cancer diagnoses among NAFLD patients compared to other adults in the United States of similar age and sex.
“Population-based studies such as this one can offer important epidemiologic data regarding the important threats to the health of a community,” explains Alina M. Allen, MD, assistant professor of medicine, Mayo Clinic, and the study’s co-author. “While it is known that individuals with NAFLD are at higher risk to develop cancers, it was not clear which type of cancer and how much higher their risk is, in reference to the general population. Such data would enable appropriate counseling and could inform screening policies.”
The researchers identified 4,782 NAFLD patients and compared them to 14,441 age- and sex-matched controls living in Olmsted County, Minn., between 1997 and 2016 using the Rochester Epidemiology Project database. They calculated age- and sex-adjusted incidence ratios of common cancers per 100,000 person-years between these two patient groups. The median age of the NAFLD patients was 54, and 54 percent were women. Median follow-up time was eight years. Overall, 788 (16 percent) of NAFLD patients and 1,752 (12 percent) of controls were diagnosed with malignancies during the study’s timespan.
Rates of malignancy were higher for NAFLD compared to controls for most types of cancers. The increased malignancy rate for NAFLD patients was highest for liver cancer, followed by stomach cancer, pancreatic cancer, and uterine cancer. Overall, breast, prostate and colon cancers were the three most common malignancies among NAFLD patients.
“These data provide an important “hierarchical” overview of the top most important malignancy risks associated with NAFLD. Liver cancer had the highest increase in relative risk, and this was not a surprising finding,” says Dr. Allen. “However, the 2.5-fold higher risk of stomach and pancreatic cancer are novel data that the medical community should be aware of. Future studies should further examine this association to determine if screening methods should be implemented in this population.”
Editor’s note: This press release contains updated data that is not reflected in the published abstract but will be presented at The Liver Meeting®.
About AASLD
AASLD is the leading organization of clinicians and researchers committed to preventing and curing liver disease. The work of our members has laid the foundation for the development of drugs used to treat patients with viral hepatitis. Access to care and support of liver disease research are at the center of AASLD’s advocacy efforts.Read the press release and additional information about AASLD are available online at www.aasld.org.
Friday, November 9, 2018
Gilead Presents Data From Nonalcoholic Steatohepatitis (NASH) Development Program for Advanced Fibrosis at The Liver Meeting® 2018
Meeting Coverage @ Healio
Nov 27, 2018
SAN FRANCISCO — In this exclusive video perspective from The Liver Meeting 2018, Rob Myers, MD, senior director of the liver diseases therapeutic area at Gilead…
Gilead Press Release
November 09, 2018
Gilead Presents Data From Nonalcoholic Steatohepatitis (NASH) Development Program for Advanced Fibrosis at The Liver Meeting® 2018-- Phase 2 Data Presented on Investigational FXR Agonist GS-9674 in NASH --
-- Enrollment Complete in Phase 2 ATLAS Combination Trial of Three Investigational Therapies Targeting Distinct Mechanisms of the Disease --
SAN FRANCISCO--(BUSINESS WIRE)--Nov. 9, 2018-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the company’s clinical development program for advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Data presented support the ongoing development of the company’s investigational compounds, evaluate the utility of noninvasive tests for the identification of patients with advanced fibrosis, and demonstrate the significant burden of disease in affected patients. The data presented across 24 abstracts are being shared at The Liver Meeting® 2018 in San Francisco this week.
Data from a Phase 2 randomized, placebo-controlled trial of the investigational, selective, non-steroidal farnesoid X receptor (FXR) agonist GS-9674 will be presented. In this study, 140 NASH patients were treated with GS-9674 100 mg, GS-9674 30 mg or placebo orally once daily for 24 weeks. A decline of at least 30 percent in hepatic fat measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) was observed in 38.9 percent of patients treated with GS-9674 100 mg (p=0.011 vs placebo), 14 percent treated with GS-9674 30 mg (p=0.87), and 12.5 percent with placebo. Improvements in liver biochemistry tests (serum GGT) and markers of reduced bile acid synthesis (serum C4 and bile acids) were observed in the 30 mg and 100 mg arms of GS-9674-treated patients.
GS-9674 was generally well tolerated; moderate to severe pruritus, or itching, occurred in 14 percent of patients in the GS-9674 100 mg arm compared to four percent in the GS-9674 30 mg and placebo arms. Changes in lipid profile and glycemic parameters did not differ between GS-9674 and placebo-treated patients. The most common adverse events in patients treated with GS-9674 were pruritus, upper respiratory tract infection, headache and fatigue. Treatment was discontinued due to adverse events in one patient treated with GS-9674 100 mg (two percent), five patients treated with GS-9674 30 mg (nine percent), and two patients with placebo (seven percent).
A separate Phase 2 study (ATLAS) is investigating treatment with GS-9674, the investigational apoptosis signal-regulating kinase 1 (ASK-1) inhibitor selonsertib, and the investigational acetyl-CoA carboxylase (ACC) inhibitor GS-0976 alone or in combination, in patients with advanced fibrosis due to NASH. This randomized, double-blind 52-week study will assess improvement in fibrosis without worsening of NASH, adverse events and laboratory abnormalities in approximately 350 patients.
“We believe our development program is well positioned to address the unmet need for effective therapies for people living with advanced fibrosis due to NASH. We are pleased to share that the Phase 2 ATLAS combination trial of experimental GS-9674, selonsertib, and GS-0976 has completed enrollment ahead of schedule,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “We also continue to support the liver community in the study of noninvasive tests to help overcome the risks and limitations of liver biopsies in the diagnosis of advanced fibrosis due to NASH.”
Noninvasive Tests
In a late-breaker session, Gilead will present an analysis of baseline data from its Phase 3 STELLAR trials of selonsertib suggesting that the use of currently available noninvasive tests (NITs) can accurately identify patients with advanced fibrosis (F3-F4) due to NASH and potentially reduce the need for liver biopsy. The use of the Fibrosis-4 (FIB-4) index, Enhanced Liver Fibrosis (ELF) test and liver stiffness measurement by FibroScan® (FS) each demonstrated good sensitivity and specificity for the discrimination of advanced fibrosis due to NASH when compared to liver biopsy. When used sequentially, FIB-4 followed by FS or the ELF test accurately identified advanced fibrosis in 76-81 percent of patients while reducing the frequency of indeterminate results to as low as 13 percent.
“There is a major need for accurate and readily available tests to diagnose patients with advanced fibrosis due to NASH, a disease which affects many aspects of patients’ lives,” said Zobair Younossi, MD, MPH, FACP, FACG, AGAF, FAASLD, lead study author and Chairman and Professor, Department of Medicine, Inova Fairfax Hospital. “These findings from the STELLAR program indicate that currently available noninvasive tools, when used alone or sequentially, can identify these patients with advanced fibrosis due to NASH rather accurately, providing a potentially simple option for physicians to use in clinical practice.
Burden of Disease
Baseline data from patients enrolled in the STELLAR Phase 3 program presented in a poster session at The Liver Meeting® 2018 demonstrate the significant burden of disease among people with advanced fibrosis due to NASH. In 1,660 patients enrolled in the STELLAR trials, patient-reported outcome measures (PROs) were assessed prior to treatment initiation and compared with population norms. The data demonstrate that physical health-related PRO scores of NASH patients were significantly lower than population norms. In addition, patients with cirrhosis had lower PRO scores than those with bridging fibrosis in areas including bodily pain, social functioning, and all but one domain of the disease-specific Chronic Liver Disease Questionnaire (CLDQ) for nonalcoholic fatty liver disease (NAFLD) and NASH.
In another analysis of patients enrolled in the STELLAR Phase 3 study presented during a poster session, elevated values of the ELF test and NAFLD fibrosis score were associated with impairment in PROs, especially physical health-related scores and the scores captured by the disease-specific CLDQ-NAFLD/NASH. These data extend prior observations that noninvasive fibrosis markers may predict fibrosis stage and adverse clinical outcomes, and now, impairments in health-related quality of life, in patients with NASH.
GS-9674, selonsertib and GS-0976 are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Their safety and efficacy have not been established.
About Gilead’s Clinical Programs in NASH
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis, defined as bridging fibrosis (F3) or cirrhosis (F4), are at a significantly higher risk of liver-related mortality.
Gilead is advancing multiple novel investigational compounds for the treatment of advanced fibrosis due to NASH, evaluating single-agent and combination therapy approaches against the core pathways associated with NASH – hepatocyte lipotoxicity, inflammation and fibrosis. Investigational compounds in development include the ASK1 inhibitor selonsertib, the selective, non-steroidal FXR agonist GS-9674 and the ACC inhibitor GS-0976. The STELLAR Phase 3 trial program evaluating selonsertib among NASH patients with bridging fibrosis (F3) or cirrhosis (F4) is ongoing. GS-9674 and GS-0976 are currently in Phase 2 studies in NASH.
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2376502
The Liver Meeting: Gilead making gains in NASH, PSC programs
New data from two mid-stage studies of Gilead Sciences Inc.'s farnesoid X receptor agonist (FXR) reported during the American Association for the Study of Liver Diseases meeting showcased the company's ongoing efforts to establish new strengths beyond viral hepatitis C, where time and competition have eroded its dominance. Though still active on the next frontier of the hepatitis battle, HBV, most of the company's liver disease pipeline today is focused on nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and primary biliary cirrhosis (PBC).
Monday, November 5, 2018
Liver Meeting® 2018- Exalenz to Present Positive Clinical Data for Breath ID® in NASH cirrhosis patients
Exalenz to Present Positive Clinical Data for the Breath ID® 13C-Methacetin Breath Test System at the Liver Meeting® 2018
MODI’IN, Israel and MANASQUAN, N.J., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Exalenz Bioscience Ltd. (TASE: EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced that the Company will present positive data from a Phase 2 trial, conducted by Galectin Therapeutics in NASH cirrhosis patients (ie the NASH-CX trial), utilizing its BreathID® 13C-Methacetin Breath Test (MBT) System in patients with compensated non-alcoholic steatohepatitis (NASH).
The poster presentation is titled “The Noninvasive Point of Care MBT Accurately Predicts Decompensation Events Better Than MELD in Compensated (MELD <15) Nash Cirrhotics” (#1337) will be presented at the Liver Meeting® 2018 on November 10 at 2:00 PM PT / 5:00 PM ET. The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), is being held November 9 - 13, 2018 in San Francisco. The lead author is Naga Chalasani, MD, Associate Dean for Clinical Research and a Professor of Medicine at the Indiana University School of Medicine.
“Results of this study indicate that the MBT has the potential to predict liver decompensation in patients with compensated NASH cirrhosis, which may enable earlier intervention and improved management of these patients,” said Raffi Werner, Chief Executive Officer of Exalenz Bioscience. “We believe that these results add to the growing body of data supporting the MBT as an important alternative to more invasive detection methods and support our strategy to advance this innovative test to the market, potentially launching the product in 2020.”
About MBT
MBT is a simple, noninvasive Point of Care breath-based test in which a patient drinks a half glass of a tasteless solution that is metabolized exclusively in the liver. The patient’s exhaled breath is automatically collected and assayed with the BreathID® system to measure the amount of a specific breakdown product of the solution, which reflects the rate of liver metabolism.
In addition to evaluating MBT to monitor NASH patients, it is also being developed to detect CSPH in the advanced NASH patient population, as well as in monitoring patients with confirmed diagnoses of acute liver failure (ALF). The ability to monitor patients with a simple, noninvasive test has the potential to radically improve the management and outcomes of patients with an array of liver diseases.
About NASH
MODI’IN, Israel and MANASQUAN, N.J., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Exalenz Bioscience Ltd. (TASE: EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced that the Company will present positive data from a Phase 2 trial, conducted by Galectin Therapeutics in NASH cirrhosis patients (ie the NASH-CX trial), utilizing its BreathID® 13C-Methacetin Breath Test (MBT) System in patients with compensated non-alcoholic steatohepatitis (NASH).
The poster presentation is titled “The Noninvasive Point of Care MBT Accurately Predicts Decompensation Events Better Than MELD in Compensated (MELD <15) Nash Cirrhotics” (#1337) will be presented at the Liver Meeting® 2018 on November 10 at 2:00 PM PT / 5:00 PM ET. The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), is being held November 9 - 13, 2018 in San Francisco. The lead author is Naga Chalasani, MD, Associate Dean for Clinical Research and a Professor of Medicine at the Indiana University School of Medicine.
“Results of this study indicate that the MBT has the potential to predict liver decompensation in patients with compensated NASH cirrhosis, which may enable earlier intervention and improved management of these patients,” said Raffi Werner, Chief Executive Officer of Exalenz Bioscience. “We believe that these results add to the growing body of data supporting the MBT as an important alternative to more invasive detection methods and support our strategy to advance this innovative test to the market, potentially launching the product in 2020.”
About MBT
MBT is a simple, noninvasive Point of Care breath-based test in which a patient drinks a half glass of a tasteless solution that is metabolized exclusively in the liver. The patient’s exhaled breath is automatically collected and assayed with the BreathID® system to measure the amount of a specific breakdown product of the solution, which reflects the rate of liver metabolism.
In addition to evaluating MBT to monitor NASH patients, it is also being developed to detect CSPH in the advanced NASH patient population, as well as in monitoring patients with confirmed diagnoses of acute liver failure (ALF). The ability to monitor patients with a simple, noninvasive test has the potential to radically improve the management and outcomes of patients with an array of liver diseases.
About NASH
More than 8 million people in the United States and Europe are living with advanced non-alcoholic steatohepatitis (NASH), the most severe form of non-alcoholic fatty liver disease (NAFLD) and a major risk factor for liver transplant and the development of primary liver cancer. The incidence of NAFLD is expected to increase more than 21% by 2030, with a concomitant increase of more than 63% in the incidence of NASH in the same period.
Friday, November 2, 2018
Liver Meeting® 2018 - Fatty Liver Disease in the Spotlight
AASLD 2018
San Francisco, CA. November 9-13, 2018.
Medscape Medical News, November 2, 2018
Fatty Liver Disease in the Spotlight at The Liver Meeting
Recommended Reading
San Francisco, CA. November 9-13, 2018.
Medscape Medical News, November 2, 2018
Fatty Liver Disease in the Spotlight at The Liver Meeting
Current and future treatments for fatty liver disease, particularly nonalcoholic steatohepatitis, the most prevalent liver disease in the United States, will be explored at The Liver Meeting....
Results from phase 2 studies of drugs for nonalcoholic steatohepatitis — Mgl-3196 (Madrigal Pharmaceuticals), obeticholic acid (Ocaliva/Intercept Pharmaceuticals), GS-9674 (Gilead Sciences), NGM282 (NGM Bio), arachidyl amido cholanoic acid (Aramchol, Galmed Pharmaceuticals), and tropifexor (Novartis) — will be presented.Read More.....
Researchers are figuring out how to make better use of the treatments they have on hand, particularly for hepatitis C and hepatocellular carcinoma, said Kimberly Brown, MD, from the Henry Ford Health System in Detroit, who is cochair of the scientific programming committee for the meeting....
Recommended Reading
Medscape Gastroenterology, May 18, 2018
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