Top News Stories of 2018 by Alan Franciscus
An HCV Advocate tradition is to take a poll among our staff and come up with a list of the most important news stories of the year. The most prominent news story that started the year off (on a bad note) was the possible connection between the treatment of hepatitis C (HCV) with direct-acting antivirals (DAAs) and hepatocellular carcinoma (HCC-liver cancer) and the high cost of HCV DAA medications. The most hopeful news stories that ended the year were just the reverse. The liver cancer and generic news stories are our top news stories of the year. The remainder of the stories are not in any particular order of importance. Nonetheless, they are all newsworthy stories of 2018.
Liver Cancer: DAA cure and liver cancer – as mentioned above, last year ended with the controversial issue of whether DAAs could potentially cause hepatocellular carcinoma (HCC- liver cancer). One result of this was that in 2017, guidelines were established for people who were cured after DAA treatment: People with no or minimal fibrosis before treatment required no further liver cancer follow-up; People with severe fibrosis (stage 3) or cirrhosis (stage 4) required regular monitoring for liver cancer. These guidelines remain. Good News: This year, the evidence shows that DAAs do not produce liver cancer.
Liver Cancer is on the increase mainly due to NAFLD/NASH (fatty liver disease), hepatitis B (HBV), alcoholic liver disease, and HCV.
For more information about liver cancer see Lucinda Porter’s article in this issue of the HCV Advocate newsletter.
Generic Drugs: Generic direct– acting antiviral (DAA) drugs have been launched around the world and have been found to be just as effective and cheaper as the brand name drugs produced by the well-known manufacturers (Gilead, Abbvie, etc.). In 2018, Gilead announced that it was launching its own generic subsidiary in the United States, and will be selling generic versions of Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir) in January 2019. The price for a typical course of therapy will be $24,000. The lower price of these drugs will mean that many people in the U.S. will now have access to treatment. This may also drive down the prices of the competitors’ drugs.
Hepatitis A (HAV): Vaccine – preventable HAV continues to infect, sicken and kill many people across the United States. The large outbreaks started in 2017 and continued through 2018. HAV outbreaks don’t seem to be ending anytime soon. Kentucky has had one of the worst outbreaks of HAV this year—there have been 3,021 cases of HAV cases identified. Half of the cases required hospitalization and 19 people have died as of December 01, 2018. Kentucky has also had one of the highest rates of acute HCV in recent years.
Read more about the HAV outbreak: http://outbreaknewstoday.com/kentucky-hepatitis-outbreak-tops-3000-cases-36871/
HEP is tracking the national outbreak of HAV. Read more: https://www.hepmag.com/iframe/hepatitis-a-outbreak-map
WHO HCV Elimination Guidelines: Nine countries have committed to eliminate HCV. Unfortunately, the United States is not listed in the report as on track towards HCV elimination. Some states have committed to eliminating HCV, but there have only been a handful. The reason is obvious—lack of commitment from our local, state and national government to identify and treat everyone with HCV. Unless we commit to treat everyone with HCV, we will never eliminate it.
New HCV Infections / Opioid Epidemic: A report released in 2018, the Centers for Disease Control and Prevention (CDC) estimated that in 2017 that there were 41,200 new HCV infections in the United States. The new infections were largely fueled by the opioid epidemic sweeping across the country. Many experts believe this figure is likely an underestimate.
Read the report: https://www.cdc.gov/hepatitis/statistics/2016surveillance/index.htm
Additionally, another report released in 2018 listed a staggering amount of deaths reported from drug overdoses killing about 72,000 Americans in 2017—this surpassed the deaths from the peak year of deaths from HIV, car crashes or gun deaths.
Treating People with HCV: Unfortunately, the treatment of people with HCV is still very low when you consider that less than half of the people with HCV have been diagnosed and a fraction of those diagnosed have been treated and cured. One study from 2018 found that less than 10% of people have been treated and cured based on a meta-analysis of studies between January 2003 and July 2013. There are many issues that contribute to the low treatment uptake such as the high cost of the medications, access to medical care, lack of screening, follow-up care, and lack of knowledge about the medications. Hopefully, this will improve in 2019.
There are other populations of HCV that have not been treated including people who use drugs and prisoners. There has been a more concerted effort to treat these populations but more needs to be done if we are ever going to eliminate HCV in our lifetime.
Read about treating people who use drugs: http://www.aidsmap.com/Meta-analysis-shows-hepatitis-C-treatment-is-highly-effective-for-drug-users/page/3346208/
HCV Screening: The general lack of screening is disappointing. Risk factor and baby boomer screening are not working. HCV is the most common blood-borne infection in the United States, it can be cured and can save millions of lives, but only if it is diagnosed. We have drugs that can cure the virus, require a short duration of treatment, are relatively easy to tolerate, and can cure more than 90% of people who are treated. These reasons strengthen the case for a one-time test for every American. The price of the drugs are also decreasing. What’s stopping us?
Alcohol: A study released in 2018 reported that there was no safe level of alcohol. The alcohol study was very controversial, but it shouldn’t be in the world of liver disease. Additionally, heavy alcohol use is one of the main causes of liver failure, the reason for liver transplantation and death.
DAAs & Liver Transplantation: Not only are DAAs reducing the risk of liver cancer they are also reducing in the number of liver transplants and improving liver transplantation outcomes. The reduction of liver transplants has been dramatic since 2016 and keep the need keeps declining.
Another benefit of DAA therapy is that HCV positive organs from deceased individuals are now being transplanted into people who are HCV negative. Soon after organ transplantation, the people are treated with DAA therapy and cured. This approach gives the people who received the HCV positive transplanted organ a second chance at life. Additionally, studies found that receiving an HCV positive organ did not affect survival of the patient. Pretty amazing!
Pregnancy: Due in large part to the opioid crisis and the new HCV epidemic there has been an increase in HCV positive pregnant women and children born with HCV. In July 2018, Kentucky passed the first law in the nation that all pregnant women should be screened for HCV during their prenatal visit. Hopefully, other states will take notice and pass similar laws.
Conclusion: 2018 was a year of highs and lows but 2019 has the potential to dramatically change HCV in the United States because of Gilead’s generic subsidiary with the lower price. This action alone could alter the landscape of HCV in more ways than one:
Optimistically: The lower drug costs → more efforts for HCV screenings → more people treated/cured → less need for liver transplants → lower rates of liver cancer → increased move towards HCV elimination goal = dramatically lower future deaths from HCV.
National Hepatitis Roundtable Year-in-Review: