Wednesday, March 6, 2019

Trio Health and Express Scripts’ Accredo Specialty Pharmacy Form Collaboration

Trio Health and Express Scripts’ Accredo Specialty Pharmacy Form Collaboration to Provide Real World Evidence on Prescription Medicines across Specialty and Rare Diseases

“Our collaboration with Accredo enables us to expand on our experience analyzing real world evidence in evaluating treatments for hepatitis C, oncology, RA, hemophilia and HIV, and review medications covering a broad range of diseases and conditions that are prescribed to millions of patients and cost billions of dollars.”

Trio Health announced today that Accredo Specialty Pharmacy will collaborate with Trio Health on their proprietary technology and analytics platform to provide real world evidence of outcomes on a wide range of medicines. The collaboration is expected to bring unprecedented value-based transparency to a medication’s journey.

“Our healthcare system is comprised of patients, pharmaceutical companies, payers, physicians, pharmacy benefits managers and pharmacies, all with differing interests in terms of innovation, pricing and access to care. The ability to evaluate a complete data set encompassing patient experience and outcomes enables unparalleled insight into medication selection and value, insight that has been missing from our healthcare system,” said Brent Clough, CEO of Trio Health. “We believe once these factors become clearer, patients and biopharma innovators will benefit, as payers adopt a true performance-based model for drug reimbursement.”

Continued Mr. Clough, “Our collaboration with Accredo enables us to expand on our experience analyzing real world evidence in evaluating treatments for hepatitis C, oncology, RA, hemophilia and HIV, and review medications covering a broad range of diseases and conditions that are prescribed to millions of patients and cost billions of dollars.”

Trio Health has the ability to analyze pharmacy, physician, and clinical information within its proprietary database. The resultant patient de-identified data is harmonized to bring a new understanding of the delivery, use and outcomes of prescription medications while optimizing care of real world patients. 

Tuesday, March 5, 2019

Has a second person with HIV been cured?

Has a second person with HIV been cured?
Mar. 4, 2019 , 6:05 PM

Timothy Ray Brown, aka the “Berlin patient,” the only person to be cured of HIV, may finally have company. A decade after Brown became famous thanks to a stem cell transplant that eliminated his HIV infection, a similar transplant from a donor who has HIV-resistant cells appears to have cured another man, dubbed the “London patient.”

“This is a big deal,” says Sharon Lewin, who heads the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia. “It tells us that Timothy Brown wasn’t a one-off.” Although the interventions that the two patients received could only be used on a tiny fraction of the 37 million HIV-infected people worldwide, their stories point to cure strategies that could be more widely applicable.

Monday, March 4, 2019

Hepatitis B and C among diabetes mellitus type 2 individuals

Prevalence of hepatitis B and hepatitis C among diabetes mellitus type 2 individuals 
Livia Melo Villar , Bruno Geloneze , Ana Carolina Junqueira Vasques , Maria Lucia Elias Pires , Juliana Custódio Miguel , Elisangela Ferreira da Silva , Vanessa Alves Marques , Leticia de Paula Scalioni , Elisabeth Lampe

Published: February 28, 2019

Diabetes mellitus type 2 (DM2) patients have higher risk to be infected with parenterally transmitted viruses, like hepatitis B or C virus. This study aims to determine HBV and HCV infection prevalence in DM2 patients from Northeast and Southeast Brazil. A total of 537 DM2 patients were included, 194 (36.12%) males and 343 (63.87%) females, with mean age of 57.13±11.49 years. HBV and HCV markers were determined using serological and molecular analysis, and risk factors were evaluated in a subgroup from Southeast (n = 84). Two HBV acute (HBsAg+/anti-HBc -) and one HBV chronic case (HBsAg+/anti-HBc+) were found. Six individuals (1.1%) were isolated anti-HBc, 37 (6.9%) had HBV infection resolved (anti-HBc+/anti-HBs+), 40 (7.4%) were considered HBV vaccinated (anti-HBc-/anti-HBs+). Thirteen patients (2.42%) had anti-HCV and 7 of them were HCV RNA+. In the subgroup, anti-HBc positivity was associated to age and anti-HCV positivity was associated to age, time of diabetes diagnosis, total bilirubin, indirect bilirubin, alkaline phosphatase at bivariate analysis, but none of them was statistically significant at multivariate analysis.

As conclusion, low prevalence of HBV and high prevalence HCV was found in DM2 patients.

Full-text available online:

No need to discontinue hepatitis C therapy at the time of liver transplantation

No need to discontinue hepatitis C virus therapy at the time of liver transplantation
Catarina Skoglund, Martin Lagging, Maria Castedal

Published: February 22, 2019

Direct antiviral agents (DAA) has dramatically improved the therapy outcome of hepatitis C-virus (HCV) infection, both on the waiting-list and post liver transplantation (LT). DAA are generally well-tolerated in patients with mild to moderate liver and kidney failure, but some DAAs are contraindicated in patients with severe dysfunction of these organs. Today there are few studies of peri-LT DAA use and treatment is commonly discontinued at the time of LT. We report here our experience of DAA therapy given continuously in the perioperative LT period in a real-life setting in Sweden.

In total 10 patients with HCV-cirrhosis, with or without hepatocellular carcinoma, and a median age of 60.5 years (range, 52–65) wsere treated with DAAs on the waiting list for LT, and continued in the early postoperative period without any interruption, on the basis of not having reached a full treatment course at the time of LT. Sofosbuvir and a NS5A inhibitor with or without ribavirin, or sofosbuvir and ribavirin only, were given. The distribution of genotypes was genotype 1 and 3, in 4 and 6 patients, respectively. Six of the 10 patients had previously been treated with IFN-based therapy.

There were no adverse events leading to premature DAA discontinuation. All recipients achieved a sustained viral response 12 weeks after end-of-treatment (SVR12). At the time of LT the median MELD-score was 16.5 (range 7–21), CTP-score 9.0 (range 5–10), creatinine 82.5 μmol/L (range 56–135, reference 60–105), bilirubin 33 μmol/L (range 16–79, reference 5–25) and PK-INR 1.5 (range 1.1–1.8). The median duration of DAA therapy was 60 days (range 18–132) pre-LT, 54 days post-LT (range 8–111 days) and in total 15.5 weeks (range 12–30 weeks).

Interferon-free DAA therapy of HCV-infection given in the immediate pre- and post-operative LT period is safe, well-tolerated and yields high SVR rates.

Full-text available online:

Hepatitis C among intravenous drug users in upper middle-income countries.

Estimating the prevalence of hepatitis C among intravenous drug users in upper middle income countries: A systematic review and meta-analysis
Víctor Granados-García , Yvonne N. Flores, Lizbeth I. Díaz-Trejo, Lucia Méndez-Sánchez, Stephanie Liu, Guillermo Salinas-Escudero, Filiberto Toledano-Toledano, Jorge Salmerón

Published: February 26, 2019

This systematic review and meta-analysis characterizes the prevalence of hepatitis C virus (HCV) infection among intravenous drug users (IDUs) in upper middle-income countries.

Five databases were searched from 1990–2016 for studies that took place in countries with a GDP per capita of $7,000 to $13,000 USD. The data extraction was performed based on information regarding prevalence, sample size, age of participants, duration of intravenous drug use (IDU), recruitment location, dates of data collection, study design, sampling scheme, type of tests used in identifying antibody reactivity to HCV, and the use of confirmatory tests. The synthesis was performed with a random effects model. The Cochrane statistical Q-test was used to evaluate the statistical heterogeneity of the results.

The 33 studies included in the analysis correspond to a sample of seven countries and 23,342 observations. The point prevalence value estimates and confidence intervals of the random effects model were 0.729 and 0.644–0.800, respectively for all seven countries, and were greatest for China (0.633; 0.522–0.732) as compared to Brazil (0.396; 0.249–0.564). Prevalence for Montenegro (0.416; 0.237–0.621) and Malaysia (0.475; 0.177–0.792) appear to be intermediate. Mexico (0.960) and Mauritania (0.973) had only one study with the largest prevalence. A clear association was not observed between age or duration of IDU and prevalence of HCV, but the data from some groups may indicate a possible relationship. The measures of heterogeneity (Q and I2) suggest a high level of heterogeneity in studies conducted at the country level and by groups of countries.

In this systematic review and meta-analysis, we found that the pooled prevalence of HCV was high (0.729) among a group of seven upper middle income countries. However, there was significant variation in the prevalence of HCV observed in China (0.633) and Brazil (0.396). 

Full-text available online:

NIH study of brain energy patterns provides new insights into alcohol effects

NIH scientists present a new method for combining measures of brain activity (left) and glucose consumption (right) to study regional specialization and to better understand the effects of alcohol on the human brain.
Dr. Ehsan Shokri Kojori, NIAAA

NIH study of brain energy patterns provides new insights into alcohol effects
Assessing the patterns of energy use and neuronal activity simultaneously in the human brain improves our understanding of how alcohol affects the brain, according to new research by scientists at the National Institutes of Health. The new approach for characterizing brain energetic patterns could also be useful for studying other neuropsychiatric diseases. A report of the findings is now online in Nature Communications.

“The brain uses a lot of energy compared to other body organs, and the association between brain activity and energy utilization is an important marker of brain health,” said George F. Koob, Ph.D., director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of NIH, which funded the study. “This study introduces a new way of characterizing how brain activity is related to its consumption of glucose, which could be very useful in understanding how the brain uses energy in health and disease.”

The research was led by Dr. Ehsan Shokri-Kojori and Dr. Nora D. Volkow of the NIAAA Laboratory of Neuroimaging. Dr. Volkow is also the director of the National Institute on Drug Abuse at NIH. In previous studies they and their colleagues have shown that alcohol significantly affects brain glucose metabolism, a measure of energy use, as well as regional brain activity, which is assessed through changes in blood oxygenation.

“The findings from this study highlight the relevance of energetics for ensuring normal brain function and reveal how it is disrupted by excessive alcohol consumption,” says Dr. Volkow.

In their new study, the researchers combined human brain imaging techniques for measuring glucose metabolism and neuronal activity to derive new measures, which they termed power and cost.

“We measured power by observing to what extent brain regions are active and use energy,” explained Dr. Shokri-Kojori. “We measured cost of brain regions by observing to what extent their energy use exceeds their underlying activity.”

In a group of healthy volunteers, the researchers showed that different brain regions that serve distinct functions have notably different power and different cost. They then investigated the effects of alcohol on these new measures by assessing a group of people that included light drinkers and heavy drinkers and found that both acute and chronic exposure to alcohol affected power and cost of brain regions.

“In heavy drinkers, we saw less regional power for example in the thalamus, the sensory gateway, and frontal cortex of the brain, which is important for decision making,” said Dr. Shokri-Kojori. “These decreases in power were interpreted to reflect toxic effects of long-term exposure to alcohol on the brain cells.”

The researchers also found a decrease in power during acute alcohol exposure in the visual regions, which was related to disruption of visual processing. At the same time, visual regions had the most significant decreases in cost of activity during alcohol intoxication, which is consistent with the reliance of these regions on alternative energy sources such as acetate, a byproduct of alcohol metabolism.

They conclude that despite widespread decreases in glucose metabolism in heavy drinkers compared to light drinkers, heavy drinking shifts the brain toward less efficient energetic states. Future studies are needed to investigate the mechanisms contributing to this relative inefficiency.

“Studying energetic signatures of brain regions in different neuropsychiatric diseases is an important future direction, as the measures of power and cost may provide new multimodal biomarkers for such disorders,” says Dr. Shokri-Kojori.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health, is the primary U.S. agency for conducting and supporting research on the causes, consequences, prevention, and treatment of alcohol use disorder. NIAAA also disseminates research findings to general, professional, and academic audiences. Additional alcohol research information and publications are available at:

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit

Shokri-Kojori E, Tomasi D, Alipanahi B, Wiers CE, Wang GJ, Volkow ND (2019). Correspondence between cerebral glucose metabolism and BOLD reveals relative power and cost in human brain. Nat Commun. 10(1):690.

Sunday, March 3, 2019

HCV reinfection as a positive indication of high‐risk population treatment access

Recommended Reading
High response and re-infection rates among people who inject drugs treated for hepatitis C in a community needle and syringe programme
We show that it is feasible to recruit people who inject drugs(PWID) from a community-basedneedle and syringe programme (NSP) onto HCV treatment, and achieve over 80% SVR-12 andimpressive treatment adherence.

HCV reinfection as a positive indication of high‐risk population treatment access
Gregory J Dore

First published: 25 February 2019

Strategies to address HCV reinfection and limit its overall impact on HCV elimination are required, but the most important of these is ongoing engagement with high- risk individuals to enable detection of HCV reinfection and its retreatment without stigma and discrimination.

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Article shared via Twitter by Henry E. Chang‏.

First patient dosed in phase 2/3 trial of advanced HCC therapy

First patient dosed in phase 2/3 trial of advanced HCC therapy
March 3, 2019

Innovent Biologics announced first patient dosing in a phase 2/3 trial of Tyvyt with IBI305 for patients with advanced hepatocellular carcinoma taking place in China, according to a press release.

"HCC is the fourth most common cancer and the second leading cause of cancer related death in China,” Fan Jia, president of Zhongshan Hospital, said in the release. “The five-year survival rate is about 10%, and only 20-30% of patients have the opportunity for curative surgery. Current targeted therapies have only shown limited responses in HCC. Immune checkpoint inhibitors have brought new hope to patients with this life-threatening disease.”

Continue reading article...

Saturday, March 2, 2019

Discovery may lead to a blood test to detect early stages of NAFLD

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:

Current and future pharmacological therapies for managing cirrhosis and its complications

World J Gastroenterol. Feb 28, 2019; 25(8): 888-908
Published online Feb 28, 2019. doi: 10.3748/wjg.v25.i8.888

Current and future pharmacological therapies for managing cirrhosis and its complications
David Kockerling, Rooshi Nathwani, Roberta Forlano, Pinelopi Manousou, Benjamin H Mullish, Ameet Dhar 

Core tip: Pharmacological therapy is central to the management of cirrhosis and its complications. Whilst there has been recent debate about the safety of beta-blockade in patients with ascites, conversely there is growing interest in potential benefits relating to a reduction in gut bacterial translocation and hepatocellular carcinoma risk. In addition to its well-established role in treating hepatic encephalopathy, rifaximin may also have a key role in preventing secondary infections. In this review, we summarise these and other uncertainties, controversies and novel developments related to pharmacotherapy in the clinical management of chronic liver disease.

View full-text article online: 

Friday, March 1, 2019

Companies, states interested in Louisiana Netflix-style hepatitis C plan

Companies, states interested in Louisiana hepatitis C plan
By MELINDA DESLATTE Associated Press

Three drug companies are interested in Louisiana's plan to use a Netflix-style subscription model to buy access to hepatitis C drugs for Medicaid patients and prisoners, a treatment concept being watched by other states, the state health department announced Friday.

Health Secretary Rebekah Gee wants Louisiana to pay a fee to a drug manufacturer for unlimited access to its hepatitis C medication. The state will treat as many people as it can during the access period, rather than pay a per-patient treatment price
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