HCV: Focus on Side Effects

BY MICHAEL R. PAGE, PHARMD, RPH
PUBLISHED WEDNESDAY, JUNE 10, 2015
Hepatitis C is a disease that causes progressive liver damage without causing other symptoms.

Over time, this liver damage can cause advanced liver disease, cirrhosis and even liver cancer. Even more concerning, hepatitis C usually does not have any symptoms—sometimes for decades—and when symptoms finally do occur, it can be too late to reverse the damage. Getting tested and treated can help patients prevent liver disease and liver cancer. Because of this, the Centers for Disease Control and Prevention recommends that all patients in the baby boomer generation (anyone born between 1945 and 1965) get a one-time test for hepatitis C.1-5

One of the reasons why hepatitis C is an important priority now is that new treatments are available that do not require injections. Older treatments, such as peginterferon and ribavirin, were able to cure about 40 percent to 50 percent of patients with chronic hepatitis C infection, but treatment was poorly tolerated and usually lasted six months to one year. Some side effects of interferons include depression and flu-like symptoms.

The companion medication, ribavirin, can cause a severe form of anemia and birth defects, if pregnant women are exposed to the medicine. It is important to note that ribavirin is still sometimes used to help boost the effectiveness of the newer medications.1,2,6,7

Newer medications work directly on parts of the hepatitis C virus. Because of this, these treatments are called direct-acting antivirals and have several advantages over older treatments. For instance, direct-acting antivirals only need to be used for approximately 12 to 24 weeks, are more likely to result in cure and are better tolerated than the older treatments.1-3

As of February 2015, the Food and Drug Administration has approved three different all-oral treatments for hepatitis C. These include Harvoni tablets, Viekira Pak and the combination of Olysio and Sovaldi tablets. Although these medications are associated with side effects like fatigue, nausea, itchy skin and insomnia, it is important to remember that many of these effects may occur in patients who have HCV but who are not getting treatment.6-10

To get an accurate picture of how likely these side effects are to occur, it is important to look at the number of patients who develop these side effects even when they are not taking medication. From this, it is possible to calculate the number of patients who would need to take the medication to develop one additional case of the side effect over what would be expected to occur in patients not taking the medication at all.

This number is called the number needed to harm. For example, if the number needed to harm is 20, one additional side effect would be expected if 20 patients were to switch from a placebo to the active treatment. Common side effects with the newer treatments are listed in the table.6-9

Although the newer medications are generally better tolerated than older medications, no medication is without risk. The side effects listed in this article are only the common side effects. Please consult with your pharmacist or physician for more information about all of the potential side effects of treatments for hepatitis C. 

References
  1. Centers for Disease Control. Hepatitis C. http://www.cdc.gov/hepatitis/hcv/pdfs/hepcgeneralfactsheet.pdf. Accessed February 2015.
  2. Food and Drug Administration. Faster, Easier Cures for Hepatitis C. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm405642.htm. Accessed February 2015.
  3. Food and Drug Administration. Birnkrant D. Drug development guidelines for Hepatitis C virus. http://www.fda.gov/drugs/newsevents/ucm385395.htm. Accessed February 2015.
  4. Centers for Disease Control. Hepatitis C: Why Baby Boomers Should Get Tested. http://www.cdc.gov/knowmorehepatitis/Media/PDFs/FactSheet-boomers.pdf. Accessed February 2015.
  5. Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012;61(RR-4):1-32.
  6. COPEGUS (ribavirin) [package insert]. South San Francisco, CA: Genentech, Inc; 2013.
  7. PEGASYS (peginterferon alfa-2a) [package insert]. South San Francisco, CA: Genentech, Inc; 2014.
  8. HARVONI (ledipasvir and sofosbuvir) tablets [package insert]. Foster City, CA: Gilead Sciences; 2014.
  9. VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) [package insert]. North Chicago, IL: AbbVie Inc; 2015.
  10. AIDSMED website. FDA Approves Olysio-Sovaldi Hep C Combo. http://www.aidsmeds.com/articles/Olysio_Sovaldi_approval_1667_26373.shtml. Accessed February 2015.
 

Table 1: Common Side Effects with Medications for Hepatitis C

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