Friday, January 11, 2019

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.

The science is clear—with HIV, undetectable equals untransmittable


The science is clear—with HIV, undetectable equals untransmittable

NIH/National Institute of Allergy and Infectious Diseases

WHAT:
In recent years, an overwhelming body of clinical evidence has firmly established the HIV Undetectable = Untransmittable (U=U) concept as scientifically sound, say officials from the National Institutes of Health. U=U means that people living with HIV who achieve and maintain an undetectable viral load—the amount of HIV in the blood—by taking and adhering to antiretroviral therapy (ART) as prescribed cannot sexually transmit the virus to others. Writing in JAMA, officials from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) review the scientific evidence underlying U=U and discuss the implications of widespread acceptance of the message.

In the new commentary, NIAID Director Anthony S. Fauci, M.D., and colleagues summarize results from large clinical trials and cohort studies validating U=U. The landmark NIH-funded HPTN 052 clinical trial showed that no linked HIV transmissions occurred among HIV serodifferent heterosexual couples when the partner living with HIV had a durably suppressed viral load. Subsequently, the PARTNER and Opposites Attract studies confirmed these findings and extended them to male-male couples.

Validation of the HIV treatment as prevention strategy and acceptance of the U=U concept as scientifically sound have numerous behavioral, social and legal implications, the NIAID officials note. U=U can help control the HIV pandemic by preventing HIV transmission, and it can reduce the stigma that many people with HIV face.

The success of U=U as an HIV prevention method depends on achieving and maintaining an undetectable viral load by taking ART daily as prescribed. Numerous factors, including lack of access to quality health care, can make ART adherence difficult. To enhance the overall success of U=U, the authors emphasize the importance of implementing programs that help patients remain in care and address the barriers to daily therapy.

ARTICLE:
RW Eisinger, CW Dieffenbach, AS Fauci. HIV viral load and transmissibility of HIV infection: undetectable equals untransmittable. Journal of the American Medical Association DOI: 10.1001/jama.2018.21167 (2019).

WHO:
NIAID Director Anthony S. Fauci, M.D., is available for comment.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

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 www.nih.gov.

NIH…Turning Discovery Into Health®
https://www.nih.gov/news-events/news-releases/science-clear-hiv-undetectable-equals-untransmittable

Low hepatitis C prevalence in Belgium: implications for treatment reimbursement and scale up

Low hepatitis C prevalence in Belgium: implications for treatment reimbursement and scale up Amber Litzroth Email author View ORCID ID profile , Vanessa Suin, Chloé Wyndham-Thomas, Sophie Quoilin, Gaëtan Muyldermans, Thomas Vanwolleghem, Benoît Kabamba-Mukadi, Vera Verburgh, Marjorie Jacques, Steven Van Gucht and Veronik Hutse

BMC Public Health 201919:39
https://doi.org/10.1186/s12889-018-6347-z
© The Author(s). 2019
Received: 21 September 2018
Accepted: 19 December 2018
Published: 8 January 2019

Abstract
Background
Prevalence data of chronic hepatitis C virus (HCV) infection are needed to estimate the budgetary impact of reimbursement of direct-acting antivirals (DAAs). In Belgium, the restricted reimbursement criteria are mainly guided by regional seroprevalence estimates of 0.87% from 1993 to 1994. In this first Belgian nationwide HCV prevalence study, we set out to update the seroprevalence and prevalence of chronic HCV infection estimates in the Belgian general population in order to guide decisions on DAA reimbursement.

Methods
Residual sera were collected through clinical laboratories. We collected data on age, sex and district. HCV antibody status was determined with ELISA and confirmed with a line-immunoassay (LIA). In specimens with undetermined or positive LIA result, HCV viral load was measured. Specimens were classified seronegative, seropositive with resolved infection, indicative of chronic infection and with undetermined HCV status according to the test outcomes. Results were standardized for age, sex and population per district, and adjusted for clustered sampling.

Results
In total 3209 specimens, collected by 28 laboratories, were tested. HCV seropositivity in the Belgian general population was estimated to be 0.22% (95% CI: 0.09–0.54%), and prevalence of chronic HCV infection 0.12% (95% CI: 0.03–0.41). In individuals of 20 years and older, these estimates were 0.26% (95% CI: 0.10–0.64%) and 0.13% (95% CI: 0.04–0.43), respectively. Of the total estimated number of HCV seropositive individuals in Belgium, 66% were between 50 and 69 years old.

Conclusions
Prevalence of HCV seropositivity and chronic infection in the Belgian general population were low and comparable to many surrounding countries. These adjusted prevalences can help estimate the cost of reimbursement of DAAs and invite Belgian policy makers to accelerate the scaling up of reimbursement, giving all chronically infected HCV patients a more timely access to treatment.

Full-text available online: