Thursday, August 31, 2017

Nonalcoholic fatty liver disease epidemic increasing greatly

Reuters Health Information: Nonalcoholic fatty liver disease epidemic increasing greatly

Nonalcoholic fatty liver disease epidemic increasing greatly
Last Updated: 2017-08-30
By Will Boggs MD

NEW YORK (Reuters Health) - The burden of nonalcoholic fatty liver disease (NAFLD) is increasing greatly, and the need for liver transplants is likely to outstrip the supply of donors, researchers report.

NAFLD includes nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH), which is an increasingly common cause of end-stage liver disease and is the second most common cause of hepatocellular carcinoma (HCC) requiring liver transplantation.

Chris Estes from the Center for Disease Analysis, Lafayette, Colorado, and colleagues developed a dynamic Markov model of NAFLD to assess the population health burden of the disease so that its healthcare impact can be forecast.

Their model predicts that the total NAFLD population will increase from an estimated 83.1 million cases (30.0% prevalence among people age 15 or older, 25.8% prevalence among all ages) in 2015 to 100.9 million cases (33.5% and 28.4%, respectively) by 2030.

During this interval, males with NAFLD are expected to outnumber females with NAFLD by 20%, according to the August 12 Hepatology online report.

The number of NASH cases is projected to increase by 63%, from about 16.5 million cases in 2015 to 27 million cases in 2030. Those with advanced liver disease will increase by an estimated 160%, from about 3.3 million cases in 2015 to 7.9 million cases in 2030, with compensated cirrhosis cases climbing to 3.1 million by 2030.

By 2030, the prevalence of decompensated cirrhosis will have increased by 180% (to 376,100 cases), resulting in an estimated increase of 59% in liver transplant cases (reaching 7,610 by 2030).

The model predicts a cumulative HCC incidence between 2015 and 2030 of 135,000 cases.

Total deaths among the NAFLD population are projected to increase by 44%, to 1.83 million annually, by 2030. About 12.5% of these will be excess cardiovascular deaths and about 3% excess liver-related mortality. Fewer than 1% of liver deaths are projected to occur among the liver transplant population.

The researchers note that the increase in the number of people eligible for liver transplant may outpace the supply of organs and influence their availability for other liver diseases. Even without the need for liver transplantation, the management of cirrhosis is a resource-intense drain on hospital resources.

"I hope other physicians will understand the magnitude of the liver disease we will see as fatty liver disease becomes the most common indication for liver transplantation in the U.S.," Dr. Neehar D. Parikh from University of Michigan, Ann Arbor, told Reuters Health by email.

Dr. Parikh and colleagues, in a related report, used data from the Organ Procurement and Transplantation Network, the Continuous National Health and Nutrition Examination Survey, and the U.S. Census Bureau to develop a linear regression model that examined the association between obesity and NASH additions to liver transplantation waitlists.

Between 2000 and 2014, the population of obese people increased by 44.9%, and NASH-related additions to the waitlist increased more than fourfold. Additions to the waitlist were best predicted by the prevalence of obesity 9 years earlier.

With the anticipated increase in the obese population (to more than 92 million adults by 2025), the number of NASH-related waitlist additions is also expected to increase by 55.4% (to 2,104 by 2030).

"In the hepatology community, there is a sense that fatty liver will be an enormous problem in the United States, and so our article gives objective data to back up that sense and a clear estimate of what we will be facing in the future if obesity trends in the U.S. continue to be on the trajectory they have been," Dr. Parikh said by email.

"There needs to be continued public health effort to reduce obesity rates," he said. "Our sensitivity analysis shows that if obesity in the U.S. increases as it has over the past 15 years, we will see the fatty liver-related liver transplant waiting list additions increase from a 55.4% increase to a 71.9% increase, which is quite dramatic. The fatty liver epidemic will only get worse without efforts to reduce obesity."

Dr. Zobair M. Younossi from Inova Health System and Beatty Center for Integrated Research, Falls Church, Virginia, told Reuters Health by email, "It is important to recognize that this is an important cause of liver disease and will be causing a higher burden in the future. Therefore, clinicians who see patients with fatty liver by imaging techniques or see patients with very mild liver enzyme elevations cannot discount these patients. They need to understand that there are ways to risk-stratify these patients with NAFLD and refer patients with potentially progressive form of NAFLD to be co-managed by specialized centers."

He offers several suggestions to address this ongoing challenge: raising awareness about NAFLD among medical professionals, policy makers, and the public; better noninvasive tests to accurately predict who will and who will not progress to advanced liver disease; and better treatment modalities, including more-effective strategies for lifestyle modification.

Estes did not respond to a request for comment.


Hepatology 2017.

Article Source

Health and economic effects of screening for hepatitis C in Canada

Recommended Reading
April 24, 2017
New hepatitis C screening guidelines will lead to avoidable deaths and soaring costs to health care system
The Canadian Task Force on Preventive Health Care recommends against screening for chronic hepatitis C virus (HCV) in adults at low risk in a guideline published in CMAJ (Canadian Medical
Association Journal).

In case you missed it.

Model-based projection of health and economic effects of screening for hepatitis C in Canada
William W.L. Wong, PhD, Aysegul Erman, MSc, Jordan J. Feld, MD, Murray Krahn, MD, MSc

Full Text Journal Article
Download PDF

2017 Aug 11. doi: 10.3851/IMP3186. [Epub ahead of print]

Because most hepatitis C virus (HCV) infections are asymptomatic and often unrecognized, screening for hepatitis C has been proposed as a plausible public health strategy. We examined the health and economic consequences of a selective one-time hepatitis C screening program for specific populations in the context of current treatment patterns.

We used a state-transition model to evaluate 2 general strategies: no screening, and screen and treat with direct-acting antiviral agents. We examined these strategies for 4 different target populations (scenarios): 1) asymptomatic people not at high risk for HCV infection, 2) immigrant populations with high prevalence, 3) a birth cohort of people aged 25-64 years and 4) a birth cohort of people aged 45-64 years of age. We obtained model data from the published literature and expert opinions. We used a payer perspective, a lifetime time horizon and a 5% discount rate.

Screening would prevent 49.7%, 57.4%, 64.1% and 49.6% of HCV-related deaths over the lifetime of the cohort for scenarios 1, 2, 3 and 4, respectively. Screening would produce incremental-cost-effectiveness ratios between $31 468/quality-adjusted life-year and $50 490/quality-adjusted life-year. Probabilistic sensitivity analyses indicated that the chance that screening would be cost-effective at $50 000 willingness-to-pay threshold was 39.5%, 63.2%, 58.4% and 58.1% for scenarios 1, 2, 3 and 4, respectively.

Our analyses suggest that a one-time hepatitis C screening and treatment program in Canada is likely to be cost-effective for scenarios 2, 3 and 4. The screening programs we have evaluated would identify asymptomatic people with chronic HCV infection and would enable medical treatment to be offered if needed before the development of advanced liver disease.

NEJM A Tale of Two Epidemics — HCV Treatment among Native Americans and Veterans

A Tale of Two Epidemics — HCV Treatment among Native Americans and Veterans
Brigg Reilley, M.P.H., and Jessica Leston, M.P.H.

N Engl J Med 2017; 377:801-803
August 31, 2017DOI: 10.1056/NEJMp1705991

Full Text Journal Article 

In light of ongoing debates about health care budgets and rising drug prices, a current public health crisis can provide useful insights. For patients who get their health care through two separate federal agencies, the hepatitis C virus (HCV) epidemic is unfolding in vastly different ways. In recent years, the Department of Veterans Affairs (VA) health care system has mounted a response to HCV that should be the envy of any health system, public or private. On the other hand, the Indian Health Service (IHS), an agency that serves American Indians and Alaska Natives, is struggling to meet the needs of its patients with HCV.

Wednesday, August 30, 2017

Carlos Romero-Marrero on Hepatits B Cures, HCV Targeting, and the Opioid Epidemic

AUGUST 30, 2017
Kevin Kunzmann

Carlos Romero-Marrero, MD, Section Head of Hepatology at the Cleveland Clinic, sat down with MD Magazine recently to discuss what he believes are some of the major issues in hepatitis B and C care now, how far treatment has come, and how much further it has to go in light of the opioid epidemic....

Follow " LINK " to read full article.

Editorial: Health-Related Quality of Life in Chronic Hepatitis C

View Original Journal Article - Health-Related Quality of Life in Portuguese Patients with Chronic Hepatitis C, editorial provided below.

GE Port J Gastroenterol 2017;24:55-57

Health-Related Quality of Life in Chronic Hepatitis C
Cardoso H. · Silva M.                       

Hepatitis C virus (HCV) infection is one of the main causes of liver disease and has a great impact on patient outcomes. The estimate of chronically infected persons is about 160 million worldwide, but most of them are unaware of the disease. The clinical impact of HCV infection is highly variable, from minimal changes to cirrhosis and hepatocellular carcinoma, with or without extrahepatic manifestations. Nevertheless, the outcome of HCV infection is not restricted to the clinical endpoints, as it can affect multiple health and psychosocial dimensions.

In recent years, HCV infection has become increasingly noticeable for different reasons. On the one hand, the development of highly effective antiviral therapy has enabled the actual treatment and cure of most diagnosed patients, but on the other hand, the burden from the most severe complications, such as hepatocellular carcinoma, keeps increasing [1,2].

A comprehensive assessment of overall outcomes would include, besides clinical hepatic and extrahepatic manifestations, patient-reported outcomes (PRO) and economic consequences. A PRO is any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. It reflects patient experience using surrogate markers such as health-related quality of life (HRQoL), functional status, perceived stigma, and work productivity [3,4]. In this context, the study by Rei et al. [5] addresses an important topic and contributes to improve the scarce available Portuguese data. The main self-administered instruments used were the SF-12 (generic) and CLDQ (disease-specific) HRQoL questionnaires.

The first studies on the effects of HCV infection on patients' quality of life, using the short form SF-36 Health Survey, revealed that patients were polysymptomatic and had diminished quality of life with significant reductions in all domains. The reduction in quality of life could not be attributed to the degree of liver inflammation or to the mode of acquisition of the infection. Hence, the authors conclude that chronic HCV infection gives rise to physical symptoms that reduce the quality of life of infected patients [6]. Also, studies with matched controls demonstrated that work productivity is significantly impaired [7]. Regarding cognitive performance, a meta-analysis of studies in HIV-infected patients demonstrated a higher level of cognitive impairment associated with HCV infection [8].

One of the most frequent extrahepatic manifestations is depression. A review of neuropsychiatric symptoms commonly associated with HCV infection showed that major depression was related to illness perception, functional disability, impaired quality of life, fatigue severity, and the presence of psychiatric comorbidity [9]. Likewise, in the study of Rei et al. [5], there was a high prevalence of mood disorders (namely depression) with a negative impact on HRQoL, and the authors therefore recommend screening and suitable psychosocial interventions in a multidisciplinary setting.

Regarding the impact of antiviral therapy on PRO, there were several concerns regarding interferon-based regimens, which negatively affected quality of life during treatment [4,10,11]. Recent studies with antiviral regimens without interferon or ribavirin demonstrated an improvement of quality of life during treatment coinciding with viral suppression within the first month of therapy [12]. Also, Rei et al. [5] reported that oral antiviral treatment could be correlated with HRQoL increases in some domains, which provides growing evidence for the multiple benefits of appropriate HCV treatment.

The achievement of a sustained virological response is associated with an improvement of clinical outcomes, namely a reduction of all-cause mortality [13]. The impact on PRO following successful HCV therapy is also significant; several studies with paired HRQoL assessments demonstrated an overall improvement of all domains of SF-36. Viral eradication leads to HRQoL improvement, regardless of fibrosis stage. HCV patients with early fibrosis experience similar improvement of PRO as those with advanced fibrosis [12,14,15]. Curiously, the HRQoL improvement was progressive over time after the end of treatment, with scores after 24 weeks greater than at 12 weeks [15]. It might be interesting to study what will be the time frame for an extensive recovery of HRQoL after sustained virological response, in relation to healthy controls. Another issue that would benefit from research is the extent of recovery of other PRO, such as perceived stigma and work productivity.

In this era of widespread HCV antiviral therapy, it is important to recognize the comprehensive burden of this disease as well as the value of achieving HCV cure, which translates into benefits at different levels for the patient and society.

Tuesday, August 29, 2017

Treatment Of HCV Infection with New Drugs: Real World Experience in Southern Brazil

2017 Sep-Oct;16(5):727-733. doi: 10.5604/01.3001.0010.2717.

Treatment of Chronic HCV Infection with the New Direct Acting Antivirals (DAA): First Report of a Real World Experience in Southern Brazil.
Cheinquer H1, Sette-Jr H2, Wolff FH1, de Araujo A1, Coelho-Borges S1, Soares SRP2, Barros MFA2.

Full Text 

There is almost no data regarding the efficacy of direct acting antivirals (DAAs) therapy in Brazil. The aim of this historical cohort study is to describe the sustained virologic response (SVR) rate among real-world compensated chronic hepatitis C patients in three hepatology centers from Southern Brazil.

Patients were included if they had at least 12 weeks follow-up after the end of therapy. Patients that were lost to follow-up or had treatment prematurely interrupted for any reason were considered treatment failure in this intention to treat analysis.

219 patients were analyzed. Mean age was 57.4 ± 10.9 years and 142/219 (64.8%) were male. Genotype 1 was present in 166 patients (75.8%; 1a 29.2%, 1b 46.6%); Genotypes 2, 3 and 4 in 8 (3.7%), 43 (19.6%) and 2 (0.9%), respectively. 96 (43.8%) were cirrhotic. 134 (59.5%) were treatment experienced. DAA therapies were: sofosbuvir (SOF) + ribavirin (RBV) in 10 patients; SOF + simeprevir (SMV) ± RBV in 73; SOF + pegylated interferon (PEG-IFN) + RBV in 6; SOF + daclatasvir (DCV) ± RBV in 51, SOF + ledipasvir (LDV) ± RBV in 61, and paritaprevir/ ritonavir + ombitasvir + dasabuvir (PTVr/OBV/DSV) ± RBV in 18 patients. SVR-12 was achieved in 208/219 (95%). Ten patients had virologic failure: 6 cirrhotic, 7 treatment experienced, and 6 either genotype 3 or 1a. No adverse event was attributed to the DAA therapy.

Real world experience with DAA therapy in Southern Brazil showed a high rate of SVR and excellent tolerability. Failure to achieve SVR was mainly observed among patients with at least one negative predictor of response: cirrhosis and/or genotypes 1a or 3.

Full text

Monday, August 28, 2017

When can we hear about the conquest of liver cancer? 

When can we hear about the conquest of liver cancer? 

“Early detection of liver cancer in Korea is only one fourth of those in Japan,” says Park Joong-won, chairman of the Liver Cancer Association, who has hopes in immune checkpoint inhibitors

Liver cancer, one of the four deadliest cancers in Korea, is called a "silent killer" because the diagnosis and the treatment are tricky.

Incidence rate of Hepatitis B, which has been cited as one of the major causes of liver cancer, has been significantly reduced due to the improved vaccination and treatment. But how come the incidence of liver cancer and the follow-up reduction in deaths have fallen short of expectations?

I visited the National Cancer Center (NCC)국립암센터 to interview Park Joong-Won박중원, a nationally renowned liver cancer expert, for an explanation to the question above and the best possible liver cancer treatment. Professor Park has been serving as chairman of the Liver Cancer Association since July.

Continue reading....

Fibrosis Faster Among Men With HCV, Study Finds
Hepatology in Focus

In Case You Missed It

Fibrosis Faster Among Men With HCV, Study Finds
Analysis aims to stratify progression among infected

Banff, Canada—In chronic hepatitis C infection, longer duration of infection and genotype 1 infection are independently associated with slower progression of disease, according to researchers in Canada.

Their meta-analysis—an update of the group’s 2008 study—also revealed that male sex and blood transfusion are associated with faster progression.

“We need better estimates of disease progression in hepatitis C–infected individuals,” said Aysegul Erman, MS, a doctoral candidate at the University of Toronto, who helped conduct the study. “Studies such as this could offer patients a better understanding of how fast they will progress in their disease.”
Continue reading....

ACG Redefines Normal Range of ALT
What exactly is a normal value for alanine aminostransferase? That question is at the heart of a new guideline on the evaluation of abnormal liver chemistries issued by the American College of...

Payors Denying DAAs to More HCV Patients
An increasing number of people infected with the hepatitis C virus are being denied a lifesaving treatment by their insurance provider, according to research presented at the 2017 Digestive

Review all news, here.

Syringe Exchange Program Aims To Slow Hepatitis C Infections In Alaska

August 29, 20172:53 PM ET
In Alaska, the virus is exploding among people ages 18 to 29. It's a trend that is mirrored nationwide. A recent study in Alaska found that the hepatitis C rate among young people doubled between 2011 and 2015. Rural parts of the state are being especially hard hit. In the remote islands of Southeast Alaska, where the capital Juneau is located, the rate nearly quintupled, rising by 490 percent.
"We talk mostly about opioid overdose deaths, but there's a lot more that happens related to opioid use than just deaths," explains Jay Butler, chief medical officer for Alaska's health department.


In Alaska, Hepatitis C Rate Rises Due To Injection Opioid Use
August 28, 20174:31 PM ET
Heard on All Things Considered 
In Alaska, the Hepatitis C infection rate is skyrocketing due to the high number of injection opioid users. The state is looking to needle exchanges to curb rising costs of drug addiction treatment. 

LINK - Listen or read transcript here.

FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers

FDA News Release
August 28, 2017

FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients

Vaccinia Virus Vaccine (Live) seized after being used inappropriately in vulnerable cancer patients

The U.S. Food and Drug Administration took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.

As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.

“Speaking as a cancer survivor, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.”

The seizure comes after recent FDA inspections at StemImmune Inc. and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction – stem cells derived from body fat), which was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues). The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.

Serious health problems, including those that are life-threatening, can also occur in unvaccinated people who are accidentally infected with the vaccinia virus by being in close contact with someone who has recently received the vaccine. In particular, unvaccinated people who are pregnant, or have problems with their heart or immune system, or have skin problems like eczema, dermatitis, psoriasis and have close contact with a vaccine recipient are at an increased risk for inflammation and swelling of the heart and surrounding tissues if they become infected with the vaccine virus, either by being vaccinated or by being in close contact with a person who was vaccinated.

“I’ve directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk,” Gottlieb added. “I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch.”

Health care professionals and consumers should report any adverse events related to treatments received at California Stem Cell Treatment Center to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

The U.S. Department of Justice filed the seizure complaint, on behalf of the FDA, in the U.S. District Court for the Central District of California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Sofosbuvir and daclatasvir in treatment of kidney transplantation recipients with HCV

Efficacy and safety of sofosbuvir and daclatasvir in treatment of kidney transplantation recipients with hepatitis C virus infection
Yan Xue, Li-Xin Zhang, Lei Wang, Tao Li, Yun-Dong Qu, Feng Liu  
World J Gastroenterol 23(32):5969-5976. Published online Aug 28, 2017. doi: 10.3748/wjg.v23.i32.5969

Download Article

Core tip: This is a prospective study to assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation (KT) patients with hepatitis C virus (HCV) infection. This study enrolled a prospective cohort of consecutive Chinese KT patients with HCV infection. The recipients were given sofosbuvir combined with daclatasvir with or without ribavirin. Sofosbuvir and daclatasvir treatments are highly efficient and safe. Patients tolerated the regimens and no serious adverse events were observed. Larger prospective cohort studies are needed to validate these results.

To assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation (KT) patients with hepatitis C virus (HCV) infection.

This study enrolled a prospective cohort of consecutive Chinese KT patients with HCV infection. They were given sofosbuvir combined with daclatasvir, with or without ribavirin. They were monitored regularly during and after the treatment.

Six patients were recruited in our prospective study cohort. All patients were male and naive to direct-acting antiviral treatment. The treatment duration was 12 wk. Most patients (4/6) were infected with HCV genotype 1b. HCV RNA was undetectable at week 4 after treatment and at the end of treatment in all patients. Sustained virological response rate at 12 wk was 100% (6/6). Two patients had to accept a half dose of sofosbuvir due to serum creatinine elevation during treatment. Kidney function in the remaining patients was stable. No serious adverse events (AEs) were observed. No patient discontinued antiviral therapy due to side effects.

Sofosbuvir and daclatasvir for treatment of KT recipients with HCV infection are highly efficient and safe. Patients tolerated the medications well, and no serious AEs were observed. Larger prospective cohort studies are needed to validate these results.

HCV Disease Progression - Alcohol Consumption

HCV Disease Progression
When newly diagnosed with HCV the first thing on a patients mind (it was on mine) is how much liver damage do I have, and how will this virus progress overtime. Only by research into the natural history of hepatitis C can this be estimated. However, because the time of acute HCV infection is often impossible to establish, disease progression is difficult to determine. There is a general consensus after acquiring the virus it takes 10 to 15 years before evidence of the disease appears on biopsy or noninvasive tests used to measure fibrosis, 20 or so years to develop cirrhosis, and around another decade to develop liver cancer, but is influenced by several host factors, especially alcohol consumption.

Alcohol consumption
Researchers often reference a unique cohort of HCV patients when describing the natural history of hepatitis C. Never has there been a more perfect natural history study, in that, the known dates of infection were precise. The famous and tragic cohort include 704 Irish women and 917 German women exposed to hepatitis C from contaminated Anti-D immunoglobulin in 1977 and 1979. In the following cohort study published in Journal of Hepatology 2017 Aug 23, researchers looked at host and treatment factors to estimate the effect of disease progression in 682 Irish women mentioned in the above cohort. The authors wrote;

In the mid 1990s, a group of women were diagnosed with chronic hepatitis C virus (HCV) infection following receipt of contaminated anti-D immunoglobulin between 1977 and 1979 in Ireland. Seventy-two (19%) developed cirrhosis and 18 had died from liver-related causes (5%) after 36 years of infection. Disease progression accelerated in the latest five years of follow-up, particularly in women with diabetes mellitus and high alcohol consumption. We recommend that patients with chronic HCV infection be advised of the additive harmful effect of high alcohol consumption.
View abstract, here.

2013 - German cohort of women after 35 years of infection
Going back to a study in 2013, in the German cohort of women after 35 years of infection, published in Hepatology, mild but significant disease progression at 35 years after infection is suggested, noting patients with self-limited HCV infection or who achieved SVR after antiviral treatment were protected from progressive liver disease and showed the best clinical long-term outcome.

2005 - German cohort of women after 25 years of infection
In 2005 a slow rate of disease progression in the German women after 25 years of infection is again suggested, given the high rate of spontaneous clearance (undetectable levels of the virus without initiating drug therapy.) as published in Journal of Hepatology. Comment on the study:

In sum, from the study of Wiese et al. [10] and a similar study in Ireland [11], one can conclude that a woman infected with HCV in her mid-20's has a near 50% chance of spontaneous recovery and in those with persistent infection, there is only a 5% probability of developing bridging fibrosis, cirrhosis or HCC during the first 25 years of infection. These relatively benign outcomes are quite encouraging, but this population represents a best-case scenario because of the young age and general good health at the onset of infection, and the rarity of co-morbid factors. Risk might increase slightly in males and would increase significantly in those infected at ages beyond 40, those with immunodeficiency states, those with excessive alcohol intake and perhaps those with high body mass index. Nonetheless, the 25-year outcome in the natural history of HCV infection is one of higher than expected spontaneous recovery and lower than predicted morbidity and mortality. Comment published in Journal of Hepatology.

Recommended Reading
Read more about alcohol use and disease progression.

Sunday, August 27, 2017

Easy Learning With Yogi - 2017 Drug-Induced Liver Injury Conference For Patients

2017 Drug-Induced Liver Injury Conference
June 6-7, 2017
Hi folks, recently a very nice person on Twitter asked if I will be attending the AASLD 2017 meeting, I smiled when I read the message, thinking they would never let me in. I'm just a woman who had HCV, always a patient first, with a passion to pass on information to my readers. However, for a moment I envisioned myself meeting the ever so handsome Ira M. Jacobson. The good doctor is my hero! But how might it all end? Badly. In my state of excitement, I'll attempt to say something clever, I am clever by the way, but under pressure, not so much.

Anyhoo, after coming down to earth, a tweet from @AASLD came through announcing content from the 2017 Drug-Induced Liver Injury Conference is ready to read over at the AASLD website. Off I went to see what I could see - for you and me.

What About The Conference?
In June, experts in clinical hepatology and toxicology gathered to share current information about drug-induced liver injury (DILI). For people outside the medical profession, navigating around this incredible information is time consuming, maybe even boring, unless you know where to look . So with that said, for those of you living with liver disease or viral hepatitis, I have highlighted a few points of interest to share with you.

Learning With Yogi

Well, on second thought, all the great information coming out of the conference isn't boring, some information is even pretty entertaining, for instance this presentation:
Diagnosing DILI in Patients with Active or Advanced Underlying  Liver Disease (with a little help from Yogi)

Download PDF

So What About HBV Reactivation Associated with HCV Therapy? 
Yep, the conference covered that too. After PDF download, scroll down to the following topics: Reactivation of Hepatitis B in Trials with Immune Suppressive Drug and Detecting, and Evaluating Drug-Induced Liver Injury DILI with Active or Advanced Liver Disease; here is a quick summary.

Opening First Session - Tuesday 6 June 2017

Download PDF
Reactivation of Hepatitis B in Trials with Immune Suppressive Drug
Rajender Reddy
Lastly, I want to talk briefly about what's been going on in the hepatitis C field where there's been hepatitis B reactivation reported in the context of DAA therapy.

Detecting, Evaluating Drug-Induced Liver Injury DILI with Active or Advanced Liver Disease
Jim Lewis
Just to finish up.  The non-DILI causes of jaundice and other events are more common than we think.  Remember, DILI is uncommon.  It's a rare event, but so many other things are more common. People get viral hepatitis, they have gallstone diseases, they have all of the other things that are listed here, all of which confuse someone who's looking at abnormal liver tests.

Of Interest
12 Detection and Management of DILI in NASH/NAFLD
Subjects – Naga Chalasani
As the NAFLD field has heated up, it has come up quite frequently that DILI is more common in patients with NAFLD. How do you monitor for it, given that there are baseline fluctuations in liver chemistries?
LINK - Begin here......

Easy Reading
Abstract I-6_2017: Detection and Evaluation of DILI in Patients with Chronic Liver Disease.
Download Abstract
The specific issue of detecting acute liver injury in patients with underlying chronic liver disease (CLD)  and assigning causality to diagnose DILI remains challenging. The 2009 FDA Guidance FDA detecting and managing hepatotoxicity in patients in clinical trials did not provide any specifics in terms of dealing with patients with CLD. Recent clinical trials evaluating various therapies in patients with chronic hepatitis B, hepatitis C, NAFLD, PBC, malignancy  (with hepatic metastases), among other disorders face the very real issue of assessing hepatic events in the setting of underlying liver disease, which brings with it a potentially different set of rules. As a result, clinicians and drug manufacturers have had to utilize what Dr Senior refers to as “medical reasoning” in order to determine if DILI has occurred, and how usual stopping rules should be modified using the currently available causality assessment methods. The topic at hand can be divided into the historical past, the present and the future.
LINK - Continue reading....

More Easy Reading
Session IV - Consortia for Best Practices to Reduce DILI
General Discussion of Issues [PDF]
4.1 The IQ Initiative
 # 8. And we're all familiar with those areas.  Patients with pre-existing liver diseases are very poorly covered by existing guidelines, and there are many questions regarding how to address drug-induced liver injury in these patients.  It includes Hepatitis C, B, and NASH, and so on. Specific populations such as pediatric populations, geriatric population, oncology patients are, again, not well covered by existing guidelines or guidance or position papers.  Non-hepatocellular DILI is a big topic.  We are almost entirely focused on hepatocellular DILI, but there are 15 other types of drug-induced liver injury that we are not addressing. Specific drug groups are a big issue, such as immunosuppressant drugs, the group of chemotherapy-related immunotherapy.  The question of drug re-challenge that is repeatedly being addressed, but there's no strong, clear guidelines for drug developers. And finally, the huge question of biomarkers is an ongoing question.

We All Know About This Website
4.4 LiverTox update and prospects
Okay, I was asked to give an update on LiverTox, which is an online website dedicated to drug-induced liver disease.  It's been a collaborative effort between NIDDK and the National Library of Medicine, and is meant to be a source of reliable information on the clinical features, courses, and outcomes, and perhaps management of drug-induced liver disease due to both prescription and non-prescription medications, to herbal and dietary supplements. And its aims are to advance knowledge and support research.

 # 8. So how did we come up with a list of drugs to be included in this?  There's no one place that I know that you can go to that lists all the drugs that are available in the United States.  We began with a list provided by the, ah, it's not a pointer, provided by the National Library of Medicine, a computerized list of 28,000 drugs, which was a little bit frightening at the time. But actually, most of them were multiples, like acetaminophen, there were over 1,000 drugs that include acetaminophen.  There were unfortunately 700 varieties of OxyContin that you can purchase in America.  So we took out all the duplicates, and we got down to a total of about 2,800 different compounds, chemical compounds.

And then going through those one at a time, we excluded those that were topical agents only.  We excluded those that were very special.  There were some like vaccines, plasma products, drugs that are not prescribed but are given in very rare situations.  And also we took out veterinary medications and took out drugs that were not approved in the United States. 

We came down with an initial master list of 900 different drugs, which was seen to be achievable.  But in the interim, we've added more, we've added some HDS products, and we've added new agents as they're approved by the FDA each year, # 9. We currently have on my master list about 1236 agents.  And as I said before, 1124 are on the website as of last week. 

So here it is again, 1124 agents, about 91% of those on my list, master list.  And if we take out the herbals and the nutritional supplements, the metals and so forth, we end up with around 1,000 different prescribed drugs.  And looking those, there are some that are really similar, and you can group them together. For instance, all the estrogens we group as estrogens.  All the anabolic steroids.  Some drugs are actually just isomers of each other, like esomeprazole and omeprazole.  We come down to what I think is about 941 different drugs.
LINK - Check Out LIVERTOX Website

4.7 Chinese DILIN experience
# 2. And as we all know, the incidence of DILI in the general population is not very high.  The data from the United States suggests it's less 20 in 100 individuals.  The data suggests the older the age, the higher the incidence.  But one of the most important reasons behind this is the more prescriptions in older people.

# 3. Also, it is not so frequent in the general population.  But in clinical practice, DILI is one of the most common reasons for no-cause liver injury or for a no-cause liver disease because the drug can cause all kinds of liver injury we have ever known. # 4. Some countries have reported their data.  For example, the data from the United States and the European countries,
the most frequent agent to cause DILI is antibiotics.  However, in the Asia region, like Korea or Singapore, the most frequent agent is herbals or the traditional Chinese medicines, TCMs.
LINK - Review above topics, download general discussion here....

Better yet, jump over the AASLD website and sift through vast amounts of information.

Enjoy the rest of your weekend! Bye Ira.

Saturday, August 26, 2017

How To Watch - First in Human: Real-life experiences of doctors, patients and researchers of NIH Clinical Center

How To Watch - First in Human

Welcome to this issue of "Weekend Reading," if you missed the new Discovery documentary "First in Human" about cutting-edge research taking place at the "National Institutes of Health’s Clinical Center," watch past and current episodes on either your TV (if you have on demand) or a favorite device by logging into your TV provider (cable or satellite company); list provided further down this page.

Documentary Background
Narrated by Jim Parsons, "First in Human" is a look at real-life stories of patients, researchers, and physicians who participate in clinical trials at the National Institutes of Health’s Clinical Center. NIH Clinical Center is the Nation's largest hospital devoted to clinical research, medical research that is saving and improving lives, and laying the groundwork for drugs used to cure devastating diseases.

Start by reading about America's first government-run hospital: "NIH Clinical Center," or review additional information about the "program," and just for fun, watch Jim Parsons on "Jimmy Kimmel" explain why he took part in the documentary.

Hepatitis C The NIH Connection 
In 1999, as a hepatitis C patient, I jumped into the pool of clinical trials, swimming around until I was completely cured. Rather you or a loved one have benefited from taking part in a clinical trial, or directly from medical research, we all have, know that you will be deeply moved by this awe inspiring documentary.

Did You Know?
In the mid-20th century across the United States, patients were contracting Hepatitis following blood transfusions. Researchers in the Clinical Center Blood Bank, led by Harvey Altar, developed lifesaving tests that screened for Hepatitis B in the blood supply and led to the virtual elimination of cases in which patients contracted Hepatitis B through blood transfusions. The same researchers working in the Clinical Center along with others working outside of NIH also eventually identified Hepatitis C and a test for screening for Hepatitis C in blood banks.....
History of NIH Clinical Center 

First in Human: The Trials of Building 10
On July 6, 1953, the NIH Clinical Center welcomed its first patient, Charles Meredith, a Maryland farmer. Meredith arrived at the Clinical Center to participate in a study on hormone treatments for prostate cancer. His admission to the Clinical Center was the start of a unique research effort by the Federal government.....

Discovery Documentary First in Human
First in Human is a three-part documentary capturing the real-life experiences of doctors, researchers, staff, patients and their caregivers, at the NIH Clinical Center. 
The documentary airs on three sequential Thursday evenings on August 10, 17, and 24, at 9:00 p.m. ET/PT on Discovery.
For over a year, Discovery, in collaboration with John Hoffman (Weight of the Nation, Sleepless in America), was embedded in the NIH Clinical Center to capture the challenges faced in diagnosing and treating diseases.
Narrated by Jim Parsons (Big Bang Theory, Hidden Figures), the three-episode series showcases the innovative work that takes place within the NIH Clinical Center and provides an in-depth look at the reality of experimental medicine in clinical trials.
Continue reading...

Jim Parsons on Jimmy Kimmel
Published on Aug 10, 2017

Watch Live
Click on an episode (sign in key) and pick your provider.

Sign in with your TV provider to stream the program, here is a list of providers.

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Citizens Cablevision - Floyd, VA

The new paradigm in the treatment of chronic hepatitis C disease: Faster, Higher and Stronger

Citius Altius Fortius: The new paradigm in the treatment of chronic hepatitis C disease

Aug 26, 2017

Download Full Text Article
Provided By Henry E. Chang‏ via Twitter

Abraham GM, et al. – This study focuses on the treatment of chronic hepatitis C disease. Findings reveal that most of the direct–acting antiviral agents (DAAs) for chronic hepatitis C infection had a high barrier to resistance and are extremely well–tolerated by patients. DAAs, in addition, demonstrate 90% or higher efficacy rates.
  • The treatment paradigm for chronic hepatitis C infection has dramatically changed with the advent of the direct–acting antiviral agents (DAAs), especially the duration, tolerability and response to therapy.
  • The DAAs are classified in to several classes and are variously indicated in the treatment of one or more genotypes of infection.
  • All these agents are orally administered, and they, in majority, are eliminated renally (with exceptions), and don'’t require adjustment in mild to moderate renal insufficiency.
With the advent of the direct-acting antiviral agents (DAAs) for chronic hepatitis C infection, the treatment paradigm has dramatically changed, especially the duration, tolerability and response to therapy. The DAAs fall into several classes and are variously indicated in the treatment of one or more genotypes of infection. All these agents are orally administered, and they are largely renally eliminated (with exceptions), don’t require adjustment in mild to moderate renal insufficiency. Most of these agents demonstrate a high barrier to resistance and are extremely well-tolerated by patients. Overall efficacy rates are 90% or higher.
Download Article

Of Interest
Systematic review: cost-effectiveness of DAAs for treatment of HCV genotypes 2-6

New At Hepatitis C Online:
Vosevi and Mavyret
Information on Gilead's newly FDA approved Vosevi and AbbVie's Mavyret  is now available.

Full Text Articles
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C.

Friday, August 25, 2017

Women who inject drugs may be at greater risk of HCV than men

Science Spotlight
National Institutes of Health (NIH)

Women who inject drugs may be at greater risk of HCV than men
August 25, 2017
Lost in Japan - Stock image

There is a clear body of research assessing sex and gender differences in risk behaviors among people who inject drugs, however little or no research has investigated sex differences in hepatitis C (HCV) susceptibility. A newly published analysis examining data from more than 1800 people suggests that women who inject drugs have a 38% higher risk of contracting HCV than their male counterparts. Interestingly, while sharing of syringes and other injection equipment is a significant risk factor for HCV, differences in these behaviors did not account for the higher risk among women. The research was funded by the National Institute on Drug Abuse (NIDA), part of the National institutes of Health.

The analysis used data from the International Collaboration of Incident HIV and HCV in Injecting Cohorts, a project of pooled biological and behavioral data from ten prospective cohorts of people who inject drugs, including the United States, Australia, Canada and the Netherlands. This study includes data from seven of the 10 cohorts.

The results underscore the need for research to better understand the behavioral, social and biological factors that contribute to higher HCV susceptibility in women. For example, it is unclear why enrollment in medication assisted treatment programs for opioid addiction reduced the risk for contracting HCV to a greater extent in men than in women. In addition, studies are needed to determine if differences in hormonal activity or immune cell composition between the sexes contribute to these findings. Understanding the reasons behind the difference in risk can help with future, more tailored HCV prevention approaches by the public health community.

For a copy of the paper, go to "The effect of female sex on hepatitis C incidence among people who inject drugs: results from the international multi-cohort InC3 Collaborative External link, please review our disclaimer.," published in Clinical Infectious Diseases.

For more information about hepatitis and substance use, go to:

For more information about women and drugs, go to: 


Dr. Matt and Dr. Mike's Medical Podcast -The basic anatomy and functions of the liver.

Dr. Matt and Dr. Mike's Medical Podcast
August 25, 2017
Episode 8 - The Liver

After a joke, music intro, this patient friendly program will discuss the basic anatomy and functions of the liver.
Why is our poo brown? What is Jaundice and why do people with Jaundice turn yellow?
In this episode, Dr. Matt talks about the embryological origins of the liver and gross anatomy, while Dr. Mike talks about the function of the liver and its diverse role/s in metabolism, protein synthesis, hormone production, and storage.

Listen here...........

NASH - Boehringer Ingelheim Initiates Phase IIa Study In Debilitating Liver Disease

Boehringer Ingelheim Initiates Phase IIa Study Of Compound Acquired From Pharmaxis (PXS.AX) In Debilitating Liver Disease NASH
  • Boehringer Ingelheim commences Phase II program of investigational drug candidate BI 1467335 acquired from Pharmaxis with a 12 week Phase IIa proof of clinical principle study in non-alcoholic steatohepatitis (NASH) 
INGELHEIM, Germany and SYDNEY, Aug. 24, 2017 /PRNewswire/ -- Boehringer Ingelheim and pharmaceutical company Pharmaxis (ASX: PXS) announce that Boehringer Ingelheim has initiated a European and North American Phase IIa trial in NASH with BI 1467335 (formerly known as PXS-4728A), acquired from Pharmaxis in May 2015. The compound is an oral inhibitor of amine oxidase, copper containing 3 (AOC3)1, and works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.

Non-alcoholic fatty liver disease (NAFLD), the most common liver disorder in Western industrialized nations, and its more serious form NASH, is highly prevalent amongst patients with type 2 Diabetes. NASH is a major cause of liver fibrosis and cirrhosis and is an area of high unmet medical need with no treatments currently available. The high prevalence of type 2 diabetes and obesity is expected to make NASH one of the most common causes of advanced liver disorders in coming decades. 25% of the general adult population in the world has NAFLD and the prevalence of NASH has been found to range from 1.5% to 6.45% in current research, a number twice as high as 20 years ago.

In 2016 Boehringer Ingelheim obtained Fast Track Designation from the US Food and Drug Administration (FDA) for the development of BI 1467335 in NASH. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions which fill an unmet medical need. The designation provides opportunities for Boehringer Ingelheim to accelerate the development of this investigational drug candidate in NASH.

This Phase IIa trial is a multi-centre, double-blind design in 150 patients with clinical evidence of NASH. The primary objectives are to establish proof of clinical principle, investigate suitable dosing, and to evaluate the safety of BI 1467335. Patients will be randomized to either one of four dosages of BI 1467335 or to placebo for a 12-week treatment period.2 A subsequent Phase IIb study will seek to confirm and extend these findings.

Dr. Christopher Corsico, Chief Medical Officer Boehringer Ingelheim Boehringer Ingelheim commented, "Advancing BI 1467335 into Phase II clinical research is important news for patients with NASH. Boehringer Ingelheim is committed to developing novel therapeutics designed to address unmet medical need and improve public health. Boehringer Ingelheim looks forward to further studying this novel compound in NASH patients". 

10 million reasons that treatment of cancers caused by viruses may advance

10 million reasons that treatment of cancers caused by viruses may advance
The National Institute of General Medical Sciences has awarded LSU Health New Orleans a $10 million grant over five years to support new basic research studies advancing the development new diagnostic and therapeutic approaches for virus-induced cancers.

"Viruses are responsible for approximately 20% of all human cancers," notes Krzysztof Reiss, PhD, Professor and Director of Neurological Cancer Research at LSU Health New Orleans Stanley S. Scott Cancer Center, the grant's principal investigator. "This funding will support four promising junior investigators who will study the molecular details of virus-host interactions while using patient samples, clinical data and biological systems to facilitate clinical translation of their most promising findings."

Virus-related cancers including cervical, anorectal and head and neck cancers associated with Human Papilloma Virus (HPV), Kaposi sarcoma and primary effusion lymphoma associated with Kaposi sarcoma-associated herpes virus, liver cancers associated with Hepatitis B and Hepatitis C viruses, and others are rapidly increasing in our region and disproportionately affect the African-American population. This increase may be explained in part by the large number of HIV+ patients in the region.

"However, our data also show that co-infection with viruses promotes malignant transformation," says Dr. Reiss. "Therefore, understanding why and how particular viruses and viral co-infections promote the development of malignancies in our minority and vulnerable populations is essential to identifying and implementing new prevention, diagnostic and treatment strategies. Training a new cadre of investigators capable of conducting novel research in this field is therefore essential for our state."

The grant is a Centers of Biomedical Research Excellence, or COBRE, grant. The purpose of these grants is to strengthen an institution's biomedical research infrastructure through the establishment of a thematic multi-disciplinary center and to enhance the ability of investigators to compete independently for complementary NIH individual research grants or other external peer-reviewed support. The funding is intended to support investigators from several complementary disciplines. It will enable the institution to develop a critical mass of investigators and enhance their competitiveness in a specific research area and in some cases, will facilitate the development of new disease-specific research centers or augment the capability of existing centers.

"This $10 million competitive award represents a significant recognition of the quality of research here at LSU Health New Orleans," says Dr. Larry Hollier, Chancellor of LSU Health New Orleans. "This type of grant is even more valuable than the monetary award because grants like this provide comprehensive support to the research pipeline. They not only fund basic science research which underlies treatment advances, but they also help develop the next generation of competitively funded faculty research scientists."

The funding will support research projects led by LSU Health New Orleans promising junior investigators Zhiqiang Qin, MD, PhD, and Chris McGowin, PhD, both Assistant Professors of Microbiology, Immunology & Parasitology, and Donna Neumann, PhD, Assistant Professor of Pharmacology, as well as Tulane Assistant Professor of Pathology Zhen Lin, MD, PhD. It will also support two pilot projects - Myeloid-Derived Suppressor Cells (MDSCs) and HIV Malignancies, and John Cunningham Virus-induced MDSCs in Central Nervous System Tumors.

"In addition to the value of research programs like this in terms of lives saved and improved quality of life, the LSU Health New Orleans research enterprise is a robust economic engine, attracting millions of outside dollars to the city and state that also support jobs in a highly desirable industry," says Dr. Steve Nelson, Dean of LSU Health Sciences Center New Orleans' School of Medicine.

"This major award dovetails with the clinical programs in cancer prevention and immunotherapy of our Cancer Center, and will bring cutting-edge research in these important fields to our state,"says Dr. Augusto Ochoa, Director of the Stanley S. Scott Cancer Center at LSU Health New Orleans.

The grant complements funding donated by the Al Copeland Foundation for cancer research through the Copeland-LSUHSC Partnership in Viruses, Cancer, and Immunotherapy.


HCV - Current treatment status and barriers in mainland China: A national multicenter cross-sectional survey in 56 hospitals

doi: 10.1097/MD.0000000000007885
Research Article: Observational Study

Current treatment status and barriers for patients with chronic HCV infection in mainland China: A national multicenter cross-sectional survey in 56 hospitals
Bian, Dan-Dan MDa; Zhou, Hai-Yang MDb; Liu, Shuang MD, PhDa; Liu, Mei MD, PhDa; Duan, Carol MDb; Zhang, Jin-Yan MDa; Jiang, Ying-Ying MDa; Wang, Ting MD, PhDa; Chen, Yu MD PhDa; Wang, Zhao MDb; Zheng, Su-Jun MD, PhDa,*; Duan, Zhong-Ping MD, PhDa,

Chronic hepatitis C virus (HCV) infection is a serious public health problem worldwide. China, as the country with the largest number of HCV infections in the world, plays a significant role in eliminating hepatitis C. Due to different financial situations and education background, hepatitis C patients take different actions for their disease treatment and management. Therefore, antiviral treatment status should be attached great importance to learn the medical demand of patients. A nationwide, multicenter survey was conducted from July 2015 to June 2016. Of 1798 inpatients and outpatients with chronic HCV from 56 hospitals participated in the survey. Each patient completed the questionnaire with questions about his/her antiviral therapy status, perception of treatment barriers, and expectations for future treatment. In total 1622 patients, including 1241 with chronic hepatitis C, 344 with cirrhosis, and 37 patients with hepatocellular carcinoma, fulfilled data collection requirements and finally were included in analysis. Overall, up to 30.7% of the patients had not or currently does not intend to receive antiviral therapy. The main reason was expecting more potent and well-tolerance medication (31.5%), followed by the fear of interferon related side effects (27.5%). Multiple regression analysis showed that the patient's annual income, the severity of HCV, and comorbidity were independent predictors of not receiving antiviral therapy. The whole patients were expecting more potent and well tolerance medication available soon. In summary, Peg-IFN/RBV treatment regimen cannot meet the need of patients well, and safe and efficient direct-acting antivirals are urgently needed in mainland China.

Source - Full Text

Lurking epidemic of hepatitis C virus infection in Iran: A call to action

World J Hepatol. Aug 28, 2017; 9(24): 1040-1042
Published online Aug 28, 2017. doi: 10.4254/wjh.v9.i24.1040

Letters To The Editor
Lurking epidemic of hepatitis C virus infection in Iran: A call to action 
Reza Taherkhani, Fatemeh Farshadpour

Download PDF

Despite having a relatively low prevalence in the Iranian general population, the burden of hepatitis C virus (HCV) infection is on the rise, and hepatitis C is predicted to be the most important leading cause of viral hepatitis-related mortality in the near future in Iran. The recent population-based epidemiological studies have revealed the predominant role of injecting drug use in increasing prevalence of HCV infection. Undoubtedly, new management paradigm is required to drive down the rising wave of hepatitis C in Iran. Priority should be given to young injecting drug users as the cornerstone of the lurking epidemic of HCV infection in Iran.

Key Words: General population, Injecting drug user, Epidemiology, Hepatitis C virus, Iran

Core tip: Iran is known as a low-endemic country for hepatitis C virus (HCV) infection, while the recent population-based epidemiological studies have revealed the increasing burden of HCV infection in the Iranian population. The asymptomatic nature of HCV infection and the undiagnosed HCV-infected injecting drug users have fueled this increase. Obviously, the current management paradigm is inadequate if control of HCV infection is aimed to be achieved.
Citation: Taherkhani R, Farshadpour F. Lurking epidemic of hepatitis C virus infection in Iran: A call to action. World J Hepatol 2017; 9(24): 1040-1042

Less than 0.5% of the population, as many as 186500 patients are infected with hepatitis C virus (HCV) in Iran[1]. The majority of HCV-positive patients have been infected by injecting drug use, equivalent to 75% of the HCV-infected population[2]. The burden of HCV infection shows a rising trend, and HCV infection is projected to be the most important leading cause of viral hepatitis-related mortality in the near future in Iran[1,3]. Obviously, the current management paradigm is inadequate if control of HCV infection is aimed to be achieved.

Mandatory screening of all blood donors for hepatitis C resulted in a remarkable decrease in the prevalence of HCV infection[1,2,4,5]. In view of the success in the Iranian Blood Transfusion Organisation, the talk of HCV elimination has been intensified. However, all hopes came to knot due to rising wave of HCV infection among injecting drug users (IDUs), those whom the control of HCV transmission among is the most difficult. The shared use of drug paraphernalia and lack of awareness among young IDUs regarding the risk of acquiring HCV infection via needle-sharing are the root cause of the increasing prevalence of HCV infection among IDUs community[1]. At the same time, the asymptomatic nature of HCV infection and the undiagnosed HCV-infected IDUs would accelerate this increase[1].

The recent changes in the genotype distribution of HCV have also fueled this epidemic[6]. High rates of mutation in HCV genome have resulted in the emergence of seven major genotypes and at least 67 subtypes[7]. Each geographic region has a distinct genotypic pattern, which depends on the predominant mode of transmission, risk factors, life style, the source of infection, disease transmission patterns and age distribution in that particular region[8,9]. These genotypic patterns are not constant, change overtime and influence the epidemiology of HCV infection in that region[10,11]. The most prevalent subtype in Iran is 1a, followed by 3a and 1b. Over the last decade, however, a gradual decrease in the frequency of subtypes 1a and 1b and an increase in subtype 3a have been reported due to changes in the routes of transmission of HCV from blood transfusion to injecting drug use[6,9-12]. These changes should be taken in to consideration to establish better strategies for managing the silent epidemic of hepatitis C in Iran.

Another challenge is treatment of HCV-infected population. Despite having poor tolerability, prolonged treatment course and frequent side effects, interferon (IFN)-based therapy is still recommended as the first-line therapy in Iran due to affordability and local availability[3,9]. Annually, 2.4% of the Iranian HCV-infected population is treated by pegylated IFN plus ribavirin, with approximately 58%-78% of patients showing a sustained virological response (SVR) depending on the HCV genotype[2]. Introduction of IFN-free direct-acting antivirals (DAAs) has revolutionized the treatment course of HCV infection due to superior rates of SVR, favorable tolerability, fewer side effects and shorter treatment period[13-15]. However, in reality, the restricted accessibility and high price of DAAs outweigh these benefits. Recently, the production of a domestic DAA, the combination of daclatasvir and sofosbuvir, with health insurance coverage has been announced in Iran, paving the way for low-cost access to DAAs and subsequently widespread use of these drugs in the near future[1,3]. This domestically produced DAA, Sovodak, has shown favorable SVR rates in Iranian patients infected with genotypes 1 or 3 HCV, the most predominant genotypes in Iran, providing an opportunity to improve the treatment rate and subsequently eliminate HCV infection in the future[1].

These challenges in the management of hepatitis C epidemic cannot be neglected any longer. Resent changes in the epidemiology of HCV would demand changes in health policies, prevention and management strategies. In view of the success of the transfusion-safety measures implemented in the Iranian Blood Transfusion Organization[4,9], screening of high-risk populations for hepatitis C, new therapeutic strategies with an emphasis on timely diagnosis and treatment, expansion of harm-reduction interventions, public education regarding the risk of HCV infection, as well as comprehensive cooperation and mobilization of health care providers are required to drive down the rising wave of HCV infection in Iran once again. Priority should be given to young IDUs as the cornerstone of this silent epidemic. Furthermore, national health policies should be prioritized in a way to curb the lurking epidemic of HCV infection once and for all.