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
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/

Hepatitis C Virus Is Major Predictor of Liver Cancer in Hemophilia, U.S. Inpatient Data Reveals

Hepatitis C Virus Is Major Predictor of Liver Cancer in Hemophilia, U.S. Inpatient Data Reveals
by Ana Pena
Past infection with the hepatitis C virus (HCV) is the major risk factor for hepatocellular carcinoma (HCC), the most common type of liver cancer, a large study analyzing more than 18,000 U.S. inpatients with hemophilia reported.

HCV infection is also a major risk factor for the general population, but the study stresses that hemophiliacs can be particularly vulnerable, given their past exposure to clotting factor infusions that might have been infected.

Because of its large sample size, the report also provides baseline data to help establish the impact of new antiviral therapies for hepatitis C in the future, researchers say.


Iowa Medicaid Expands Care To Hepatitis C Patients, But Restrictions Remain

Iowa Medicaid Expands Care To Hepatitis C Patients, But Restrictions Remain
Starting this month more hepatitis C patients can qualify for care under Iowa Medicaid. But some doctors and advocates argue the remaining restrictions are immoral and illegal.

Previously, only Iowans with more advanced liver disease, a fibrosis score of F3 or above, would qualify for treatment. As of January 1, 2019, those with a score of F2 and above can request the treatment from their doctor through a process known as prior authorization, which requires they meet certain criteria beyond their need for the treatment.
Continue reading:
http://www.iowapublicradio.org/post/iowa-medicaid-expands-care-hepatitis-c-patients-restrictions-remain 

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications.

Hepatitis C: What happens when the doctor blames you for your own cancer?

The Washington Post
What happens when the doctor blames you for your own cancer?
By Monica Bhargava
As a trainee at an academic medical center, I observed weekly conferences where the care plans of new cancer patients were determined by a large team of expert physicians. The words “lung cancer” — followed by “nonsmoker” — often elicited murmurs of sympathy. I wondered whether this sympathy would lead to longer and more meaningful clinic visits with the patient in question, and whether the opposite would be true for the Vietnam veteran who had smoked for 40 years. The tight link between tobacco and lung cancer has hardened into stigma, and the potential for care disparities is real...
Those dealing with addiction and hepatitis C, a blood-borne virus often transmitted through sharing needles or other equipment to inject drugs, face a similar stigma. A high percentage of health-care professionals exhibit negative attitudes toward patients with substance use disorders, perceiving them as morally deficient or lacking self-control, and leading to reduced access to care...
Continue reading: 

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....

Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs

Washington Post: To Your Health - January 10, 2019 

Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs
Louisiana will use the 'Netflix' model, with the goal of treating 10,000 people with hepatitis C in its Medicaid and prison population by 2020.
By Carolyn Y. Johnson January 10 at 5:49 PM

Instead of paying for each prescription individually, Louisiana Gov. John Bel Edwards (D) said the state would essentially pay a subscription fee to a drug company, an alternative payment arrangement that has become known as the “Netflix model.” The state would then get unlimited access to the drug, similar to how consumers pay a monthly fee to stream unlimited television shows and movies.
Continue reading: 
https://www.washingtonpost.com/health/2019/01/10/louisiana-adopts-netflix-model-pay-hepatitis-c-drugs/?utm_term=.02763a658c7b 

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications.

Thursday, January 10, 2019

CDC - Rising rates of drug overdose deaths among women

Morbidity and Mortality Weekly Report (MMWR)
Drug Overdose Deaths Among Women Aged 30–64 Years — United States, 1999–2017
Weekly / January 11, 2019 / 68(1);1–5
Summary

What is already known about this topic?
The U.S. drug epidemic is evolving, including among women. Studies have highlighted rising rates of drug overdose deaths among women aged 45–64 years.

What is added by this report?
From 1999 to 2017, the death rate from drug overdose among women aged 30–64 years increased by 260%. Drug overdose deaths involving antidepressants, benzodiazepines, cocaine, heroin, prescription opioids, and synthetic opioids all increased. Among women aged 30–64 years, the average age at death for drug overdose deaths increased by nearly 3 years.

What are the implications for public health practice?
Overdose deaths continue to be unacceptably high, and targeted efforts are needed to reduce the number of deaths in this evolving epidemic, including those among middle-aged women

Link:

Discussion Only:
From 1999 to 2017, the crude rate of drug overdose deaths among women aged 30–64 years in the United States increased by 260%. The rates of overdose deaths increased for all drug categories examined, with a notable increase in rates of deaths involving synthetic opioids (1,643%), heroin (915%), and benzodiazepines (830%). These findings are consistent with recent reports highlighting an overall increasing trend in deaths involving drugs, especially with shifts in the type of drugs involved (e.g., heroin) (4).

Other reports have highlighted the overall increase in overdose deaths and emergency department visits related to drug use, especially among women aged 45–64 years (1). In addition to demonstrating the varying drug overdose rate increases by age group, this study determined that the age distribution of decedents shifted from 1999 to 2017, and the average age of women aged 30–64 years dying from drug overdoses increased for every drug class analyzed except synthetic opioids. Prevention programs might need to shift response options as the overdose epidemic experiences demographic shifts. Further, as women progress through life, individual experiences can change in the type of substance used or misused and in the experiences of pain that might result in an opioid prescription (5–8).

The findings in this report are subject to at least three limitations. First, rate estimates of specific drugs involved with deaths might be affected by factors related to death investigation, such as the substances tested for or the circumstances under which tests are performed. For example, toxicology testing cannot distinguish between pharmaceutical fentanyl and illicitly manufactured fentanyl. Second, drug categories presented are not mutually exclusive, and deaths might have involved more than one substance. Increases in deaths involving certain drugs might be the result of increases in certain drug combinations. Finally, the percentage of deaths with specific drugs identified on the death certificate varies over time. Changes in testing and reporting of drugs might have led to observed increases in some drug entities involved in drug overdose deaths.

Substantial work has focused on informing women of childbearing age about the risk and benefit of the use of certain drugs, particularly for the risk posed by neonatal abstinence syndrome as a result of opioid use during pregnancy (9,10). The current analysis demonstrates the remaining need to consider middle-aged women who remain vulnerable to death by drug overdose. A multifaceted approach involving the full spectrum of care services is likely necessary. For example, health care providers who treat women for pain, depression, or anxiety can discuss treatment options that consider the unique biopsychosocial needs of women (2). Providers can consider implementing the CDC Guideline for Prescribing Opioids for Chronic Pain (3), and Medicaid programs can also examine whether prescribing of controlled substances to their clients meets established guidelines. Access to gender-responsive substance use disorder treatment services, especially for pregnant women and women with drug use disorders, can reduce harmful outcomes. Overdose deaths continue to be unacceptably high, and targeted efforts are needed to reduce the number of deaths in this evolving epidemic among middle-aged women.

Read Full Report: 

African-Americans may live longer after liver transplant if their donors are the same race

African-Americans may live longer after liver transplant if their donors are the same race
Journal of the American College of Surgeons study authors report that donor race-matching may aid in future organ allocation

American College of Surgeons
CHICAGO (January 10, 2019): Among African-American adults undergoing liver transplant to treat liver cancer, patients whose organ donor was also African-American lived significantly longer than those with a racially unmatched donor, report authors of a new study using national data. The study is published online as an "article in press" on the Journal of the American College of Surgeons website in advance of print publication.

These research findings suggest a possible way to improve long-term survival in a patient population that typically fares worse than other racial groups with liver cancer, which is the second deadliest cancer worldwide.1 Compared with other races, African-American patients with hepatocellular carcinoma (HCC)--the most common form of liver cancer--tend to have the poorest long-term survival and have worse outcomes after liver transplant.2 A liver transplant is the preferred and curative treatment option for some patients with early-stage HCC, according to the study authors.

Although past studies have linked unmatched donor-recipient race to worse overall survival in recipients of kidney, lung, and heart transplants, the role of donor race in liver transplantation has not been well defined, said principal investigator T. Clark Gamblin, MD, MS, MBA, FACS, professor and chief of surgical oncology at the Medical College of Wisconsin, Milwaukee.

For this study, Dr. Gamblin and his colleagues used the Organ Procurement and Transplantation Network's (OPTN's) national database. The researchers identified 15,141 adults with first-time HCC who received a transplant of a whole liver from a deceased donor between 1994 and 2015. Of those transplant recipients, 1,384 (9.1 percent) were African-American, and their records were further analyzed for the donor's race. A total of 325 patients (23.5 percent) received livers from African-American donors--labeled "matched"--and the other 1,059 patients (76.5 percent) were unmatched.

Five years after transplant, 64.2 percent of race-matched patients were still alive compared with 56.9 percent of unmatched patients, the researchers found. On average, race-matched patients lived 4.75 years longer after transplant than the unmatched patients, with a median overall survival of 135 months versus 78 months.

This effect of donor race continued even after the researchers statistically matched the two groups on multiple donor and recipient characteristics that are important to transplant success and patient survival. On these adjusted analyses, a race-matched transplant independently predicted improved overall survival, the investigators reported. Specifically, African-American transplant recipients had 34 percent greater odds of long-term survival when the donor's race was the same. African-Americans who received a liver from a white person--the most common race among donors--had a reported 53 percent increased risk of death.

The survival advantage with race-matching reportedly did not become apparent until after one year.

"Our data are intriguing," said Dr. Gamblin. "But our results require validation through further investigation of the role of race in optimizing outcomes of liver transplant for treatment of HCC."

"It is certainly premature to recommend a change in compatibility screening criteria based on our findings alone," continued Dr. Gamblin, who noted that race is not currently a consideration during compatibility screening of donors for liver transplant. "Likewise, recipients should not turn down a liver based on the race of the donor because they may not get another one," he added, referring to the nationwide organ shortage.

Less than one-fourth of the African-American liver transplant recipients in this study had race-matched donors, which corresponds to national statistics showing low organ donation rates by African-Americans. Although 29.8 percent of all U.S. candidates waiting for an organ transplant are African-American, only 13.5 percent of all organ donors in 2015 were African-American.3

Asked if their study might encourage more African-Americans to become organ donors, Dr. Gamblin replied, "It is my hope that everyone consider liver donation. There are not enough donors, and people on the waiting list are dying every day waiting for an organ."

More than 13,500 people are on the liver transplant waiting list based on OPTN data as of December 18, 2018.4

Nearly 33,000 Americans were diagnosed with liver cancer and liver bile duct cancer in 2015, the Centers for Disease Control and Prevention estimates.5 Risk factors for HCC include persistent infection with hepatitis B or C and cirrhosis of the liver. A liver transplant not only treats liver cancer but also allows the liver to function normally again.

Dr. Gamblin's coauthors are Jack P. Silva, MD, formerly a research fellow at the Medical College of Wisconsin and now a general surgery resident at the University of Southern California, Los Angeles, as well as Meghan N. Maurina; Susan Tsai, MD, MHS, FACS; Kathleen K. Christians, MD, FACS; Callisia N. Clarke, MD, FACS; Harveshp D. Mogal, MD, FACS; and Kia Saeian, MD, all from the Medical College of Wisconsin.

"FACS" designates that a surgeon is a Fellow of the American College of Surgeons.

This study was presented in August 2018 at the Sixth Annual Solid Organ Transplant Symposium in Milwaukee, Wis.

Citation: The Effect of Donor Race-Matching on Overall Survival for African American Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma. Journal of the American College of Surgeons. Available at: https://www.journalacs.org/article/S1072-7515(18)32235-X/fulltext.

1 Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136(5):E359-E386.
2 Artinyan A, Mailey B, Sanchez-Luege N, Khalili J, Sun CL, Bhatia S, et al. Race, ethnicity, and socioeconomic status influence the survival of patients with hepatocellular carcinoma in the United States. Cancer. 2010;116(5):1367-1377.
3 US Department of Health and Human Services Office of Minority Health. Organ donation and African Americans. 2016. Available at: https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=27. Accessed December 17, 2018.
4 Organ Procurement and Transplantation Network. Data. Available at: https://optn.transplant.hrsa.gov/data/. Accessed December 18, 2018.
5 Centers for Disease Control and Prevention. Liver and Intrahepatic Bile Duct Cancer, United States--2006-2015. United States Cancer Statistics (USCS) data brief, No. 5. Atlanta, GA: Centers for Disease Control and Prevention; 2018.

About the American College of Surgeons
The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 80,000 members and is the largest organization of surgeons in the world. For more information, visit http://www.facs.org.