In October 2015, the FDA issued this disturbing headline: “FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie.” The problem with that headline, is it needlessly scared patients who were taking Viekira Pak and Technivie, when in fact the warning pertained to patients who had advanced cirrhosis. In fact, doctors shouldn’t have been prescribing these drugs for their patients with that level of cirrhosis in the first place.
Treating cirrhotic hep C patients is tricky business. Cirrhosis is a serious medical condition, and although it can remain stable for a long time, it can also go south quickly. Patients with hep C-related cirrhosis clearly need to be treated, and treated soon. This article will discuss some of the risks and benefits of hepatitis C treatment in cirrhotic patients.
Some Words about Cirrhosis
Chronic hepatitis C virus (HCV) causes inflammation of the liver, eventually leading to tissue damage. Cirrhosis is the result of extensive scarring of the liver. The Centers for Disease Control and Prevention state that HCV typically causes cirrhosis in 5 to 20 percent of infected people over a period of 20 to 30 years. Overall, cirrhosis develops 20 to 30 percent of the time. Progression to cirrhosis may be accelerated in people who are older, obese, drink alcohol, or are immune-suppressed (such as people who are coinfected with HIV).
Cirrhosis has two levels: compensated and decompensated. Compensated cirrhosis means that the liver is still functioning relatively well. At this stage, the early symptoms may still be vague and some people may be unaware that they have cirrhosis.
Decompensated cirrhosis means that the liver is not functioning well. About one in five of those with HCV-induced cirrhosis will progress to a decompensated stage. Some serious complications that occur with decompensated cirrhosis are:
- Ascites, which is bloating from fluid build-up in the abdomen.
- Hepatic encephalopathy (HE) is a brain disorder that develops when the liver is unable to remove ammonia and other toxins in the body. HE may cause impaired concentration, sleep disturbances, confusion, or coma.
- Variceal hemorrhage is severe bleeding from enlarged veins in the esophagus and upper stomach).
HCV Treatment and Cirrhosis
Although cirrhosis is often irreversible, reversal was observed in nearly half of all cirrhotic patients whose hepatitis C was cured. Otherwise, liver transplantation is the only treatment for decompensated cirrhosis. The newest hepatitis C medicines offer the best possible chance of reversing liver damage, and avoiding liver transplantation.
The HCV Guidelines written by the American Association for the Study of Liver Diseases and Infectious Diseases Society of America offer clear treatment guidelines for people who have cirrhosis. Treatment recommendations for those with compensated cirrhosis are a bit different than the recommendations for noncirrhotic patients, depending on the medication and if this is a first treatment or retreatment.
Treatment for those with decompensated cirrhosis gets its own section in the HCV Guidelines. More importantly, the Guidelines recommend referring patients with decompensated cirrhosis to specialists, ideally in a liver transplant center. In other words, your local naturopath is not qualified to treat you if you have advanced liver disease. And if you think I am being overdramatic here, let me assure you that I am not. I failed in my effort to get a friend to let someone other than her naturopath treat her cirrhosis. When the naturopath eventually referred my friend to a liver transplant specialist, it was too late.
In general, the Guidelines advise proceeding cautiously. Generally, ribavirin is used with a combination of other drugs, such as daclatasvir and sofosbuvir or ledipasvir/sofosbuvir. The initial ribavirin dose is low and the amount is increased as tolerated. There are alternatives for those who aren’t able to tolerate ribavirin. For specific treatment recommendations based on genotype, visit the HCV Guidelines.
Risk and Benefits
Simply stated, if you have cirrhosis and you aren’t treated, you may live a long time with cirrhosis, get liver cancer, have kidney failure, need a liver transplant, or die. If you get treated, the treatment may or may not work or you may have complications during treatment. These complications are much like the ones people have from cirrhosis, and sometimes it isn’t the medication that caused the complication but the cirrhosis. However, patients and their families are quick to blame the treatment because it is human nature to connect the dots, even if there are other dots that can be connected.
However, if treatment works, you have a shot at a better life. A I mentioned before, studies indicate that cirrhosis may reverse in up to half of those who are cured, although it may take a year or two. And as wonderful as that is, there is something else that is wonderful—feedback from patients. In a large study conducted by Zobair M. Younossi and colleagues administered questionnaires to HCV patients with cirrhosis who underwent treatment that included sofosbuvir (Patient-Reported Outcomes in Chronic Hepatitis C Patients with Cirrhosis Treated with Sofosbuvir-Containing Regimens, Hepatology, November 2015). Researchers measured patient-reported outcomes (PROs), such as health-related quality of life, productivity, and fatigue.
HCV patients with cirrhosis showed significant impairment of PROs before initiation of treatment. No surprise there. PROs declined during treatment; again, no surprise, especially among patients whose treatment used peginterferon. But, the encouraging outcome, was patients who achieve a cure (SVR-12) had improved PROs, even if they had cirrhosis.
When HCV Treatment Fails
Sadly, HCV treatment doesn’t always work. And in some cases, it may fail not just once, but multiple times. Fortunately, new treatments are in the pipeline, and they just keep getting better. While you are waiting, devote your time to staying healthy. Avoid alcohol, eat a nutritionally-rich diet, and aim for a healthy weight. Don’t take vitamins or other dietary supplements unless prescribed by your doctor. Tell your doctor all the medications you take, and be sure you know how to take them. If you take acetaminophen (Tylenol), ask your doctor what a safe amount is, and check all products for added acetaminophen so you don’t take extra by mistake.
A cirrhosis diagnosis means more frequent regular medical tests and check-ups. Your doctor will monitor you for signs of liver cancer, kidney failure and worsening of your liver disease along with indications that you may need a liver transplant. In addition to office visits, expect more frequent lab and ultrasound tests. Keep your immunizations current.
Lastly, talk to your doctor about the benefits of drinking coffee, specifically the caffeinated kind. Many studies are show that caffeinated coffee use is associated with improvement in liver tissue. At last, something delicious that might be good for us!
HCV Advocate’s An Overview of HCV Disease Progression
HCV Advocate’s A Guide to Understanding Hepatitis C
Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. She blogs at www.LucindaPorterRN.com and HepMag.com This article originally appeared in the HCV Advocate March 2016 and is reprinted with permission.