Friday, February 17, 2017

News Recap

HCV & Heart Disease
More and more I am hearing that people who have just finished treatment for HCV have had a stroke!  Our community really needs to know that hepatitis C is an independent risk factor for various kinds of heart disease: cerebrovascular events (strokes), and ischemic heart disease caused by atherosclerosis (plaque build-up in the arteries – particularly the coronary and carotid arteries, which can cause heart attack (coronary) and impeded blood flow to the brain (carotid). As well the systemic inflammatory response to HCV is also a cause of atrial fibrillation, which is in itself a major stroke risk.

I know about afib (atrial fibrillation): I have it, and it acted up on me on a clinical trial I was on (Merck), so much that I was pulled off the trial. I had afib before but didn’t find out about it until they started testing me for the clinical trials. It is often a silent condition. They put me on meds which mostly work. However, when I went on Harvoni, my BP almost hit the roof (for me) and my heart was in afib. I was monitored closely, and things calmed down after about 2 weeks. I finished the Harvoni and am now cured. But I still have afib.

Updated: As I began to further investigate the relationship between heart disease and HCV, I became aware of a report from the Japan Pharmaceuticals and Medical Devices Agency, Harvoni, Sovaldi under Review for Risks of Hypertension, Cerebrovascular Disorder, (you can also view the pdf “Summary of Investigation Results” here: https://www.pmda.go.jp/files/000212953.pdf).  Previously, I had erroneously said that the risk of cerebrovascular events (stroke) and hypertension (high blood pressure) were listed in the Black Box Warnings in Japan, which they were not. However, in Japan the post-marketing incidence of stroke and high blood pressure were listed as adverse events, but it was concluded that in the absence of more robust data the post-marketing cases alone were insufficient to demonstrate a causal effect between sofosbuvir and cerebrovascular events or hypertension. In other words, there was insufficient evidence to list these as Black Box Warnings. Importantly, in Japan, the HCV epidemic had a 10-year head start and so the age-related cohort became an important factor.  More people in Japan with HCV are older, and thus more likely to have a higher incidence of hypertension and cerebrovascular disorders; however, surprisingly, the researchers found that when adjusted for age, there were actually fewer incidences of these events in the corresponding HCV population.

As well there was this troubling study Hepatitis C eradication with sofosbuvir leads to significant metabolic changes, which showed that after treatment success with sofosbuvir containing regimens, LDL levels rose. The authors note that “Chronic infection with HCV has been implicated in the development of hypolipidemia,” (a lowering of cholesterol levels). What they found was that the bounce back after cure was cause for concern: “The implications of these alterations in cardiovascular and cerebrovascular disease are beyond the scope of this retrospective study but should be further investigated.” High LDL is associated with increased risk for heart attack and stroke.

Finally, findings, published in the January 2016 edition of Gastroenterology from a meta-analysis of 22 epidemiological studies conducted in Italy shows that people with hepatitis C are at higher risk of dying from cardiovascular disease, having a stroke, or developing other cardiovascular problems than people with similar risk factors for heart disease who do not have hepatitis C.

The authors note that even after allowing for the well-established risk factors for heart disease – diabetes, high blood pressure, and smoking – the risk of death, cardiovascular disease, and carotid artery disease was still elevated in people with hepatitis C. Indeed, they describe the effect of hepatitis C on cardiovascular risk as “especially pronounced” in populations where diabetes, high blood pressure, or smoking are common. Cardiovascular Disease Risk Is Higher for People with Hepatitis C

Take Away Message: If you have hepatitis C you are at increased risk of stroke and heart attack.

In Other News:
The Iowa Department of Public Health is calling for widespread testing for hepatitis C after a study showed cases in Iowa have almost tripled since 2000. Interestingly, many of the newly infected do not have any of the traditional risk factors, and this is why they are calling for global testing. U.S.: Doctors, health officials want broad testing for hepatitis C

Hepatitis C virus treatment is often restricted in Medicaid patients [in Canada this would be PharmaCare]. In the news as well was yet another study showing that treating all patients – in this case those who cannot afford private healthcare – resulted in superior SVRs, substantial reductions in downstream negative clinical outcomes, and considerable cost savings. Current restrictive state policies regarding HCV treatment in Medicaid populations must be reassessed in the light of these data. U.S.: Treating Medicaid Patients With Hepatitis C: Clinical and Economic Impact.  The need to act now is confirmed by yet another study which shows that in the past decade there has been a nearly 40 percent increase in the prevalence of cirrhosis among people with hepatitis C in the U.S. Cirrhosis Increasing Among Hepatitis C Patients, According to Large US Study

But we all know this already!  Unfortunately, no matter how many times we come up with more proof that we need to ACT NOW, the powers that be don’t listen. Drug prices keep going up and here in Canada “one in 12 Canadians 55 years and older have decided not to take drugs their doctor said they should take, based on the cost.” This is according to a recently released study from UBC. This situation is causing people’s manageable health conditions to get worse, according to professor Steve Morgan with UBC’s school of population and public health, who says this costs us all more money in the end. Cost causing Canadians to say no to prescribed drugs

Internationally the global community has issued five new patent challenges against Gilead in an attempt to find a way around access to treatment. Hepatitis C Patent Challenges In India, Argentina To Allow Generic Production

You Got to Love It
In Australia, the city of Murray Bridge will trial a whole-community approach to raise awareness about liver health and increase testing and treatment of hepatitis C. Local doctors, sporting clubs and services will collaborate to offer testing to the community and education around symptoms of the disease and how it is spread. As of March 16, general practitioners will also be able to prescribe “new ground-breaking treatments” to those carrying the disease. Remember: In Australia, treatment is free!  Australia: Murray Bridge trials hepatitis C treatment project


Coming Up Next Week!

HepCBC will have Info booths at the following: