When taking Harvoni, you may be more tired than usual. Read More »
There’s a chance that you may get headaches when taking Harvoni. Read More »
You may have trouble sleeping when taking Harvoni. Read More »
If you have reduced liver function, you should still be able to take Harvoni. Read More »
When you take Harvoni along with certain drugs, it can cause a slow heart rate. In some cases, this can be life-threatening. Read More »
Harvoni may make you feel weaker than usual. Read More »
When taking Harvoni, you may have mild digestive upset, such as nausea or diarrhea. Read More »
If you have severe kidney disease, you may have increased side effects from Harvoni. Read More »
Because Harvoni is new, it’s not certain what effects it may have on a pregnancy. Read More »
You may feel irritable or depressed while taking Harvoni. Read More »
Bradycardia (Slow Heart Rate)
Nausea or Diarrhea
Changes in Mood
Central Nervous System
One of the main side effects of Harvoni is tiredness. This tends to increase the
longer you take the drug. Tiredness may be related to an interaction with other
drugs that can slow your heart rate. If you feel tired while taking Harvoni, talk
with your doctor about how you can increase your energy level.
Some people have
when they take Harvoni. This side effect generally gets worse the longer you
take the drug. If you have headaches during your Harvoni treatment, ask your
doctor about ways to increase your comfort.
For a small
number of people, Harvoni causes insomnia (trouble sleeping). This side effect also
may get worse the longer you take the drug. Your doctor can suggest ways to
improve your sleep if you have problems while taking Harvoni.
about mood changes like irritability or depression were added to the drug label.
These effects may be linked to sofosbuvir, one of the drugs in the Harvoni
tablet. Some patients have reported that taking sofosbuvir with other hepatitis
C treatments caused them to feel irritable, depressed, or suicidal. These
effects are more likely to occur if a patient has a history of depression or
other mental illness.
If you have
mood changes or become depressed while taking Harvoni, call your doctor right away.
drugs, Harvoni can cause some stomach problems. A small number of patients have
while taking the drug. Like some other side effects, these tend to get a little
worse the longer you take the drug. If you have these side effects, your doctor
may suggest some over-the-counter treatments that can help.
If you have
reduced liver function, you should still
be able to take the normal dosage of Harvoni. Before taking Harvoni, be sure to share all of your medical records
with your doctor, including information on your liver health.
Urinary System (Kidneys)
If you have mild kidney disease, you should be able to take
Harvoni without any problems. Your doctor will likely prescribe the normal
dosage for you. But if you have severe kidney disease, your body may not be
able to process the drug well. This could lead to increased amounts of the drug
in your body, and increased risk of side effects. Before taking Harvoni, talk
with your doctor about whether this drug a good choice for you. And be sure to
share all of your medical records with your doctor, including information on
your kidney health.
A more serious side effect of Harvoni is
bradycardia (slow heart rate). This side effect usually happens
when Harvoni is taken with another drug called amiodarone. Amiodarone is used
to treat heart rhythm problems.
Bradycardia typically occurs up to two
weeks after you start taking these drugs together. It can cause multiple
symptoms because a slow heart rate can prevent your body from getting the
oxygen it needs. These symptoms can include:
- feeling like you’re going to faint, or actually fainting
- shortness of breath
- chest pains
- confusion or memory problems
If you have symptoms of bradycardia
(even if you’re not taking amiodarone with Harvoni), call your doctor right
away. This side effect can be life-threatening.
Reproductive System (Pregnancy)
If you’re pregnant or planning to become pregnant, talk with your doctor before taking
Harvoni. Harvoni is a pregnancy Category B medication. This means there haven’t
been enough studies done in pregnant women to confirm whether this drug is safe
to use during pregnancy. Harvoni has been tested in pregnant lab animals (rats),
but the results of those studies can’t always be applied to humans.
take Harvoni only if the potential benefits outweigh the risks to your pregnancy.
Talk with your doctor about your health and how this drug could affect your
pregnancy. If you decide to have treatment while pregnant, you may be able to
enroll in a pregnancy registry. These registries track the results of Harvoni
treatment. This data can provide information that can help other women make
decisions in the future.
- American Association for the Study of Liver Diseases. (2015, January 1). HCV guidance: recommendations for testing, managing, and treating Hepatitis C.Retrieved from http://www.hcvguidelines.org/full-report-view
- Afdhal, N., Zeuzem, S., Kwo, P., Chojkier, M., Gitlin, N., Puoti, M., . . . ION-1 Investigators. (2014, May 15). Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. The New England Journal of Medicine. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/24725239
- Afdhal, N., Reddy, K. R., Nelson, D. R., Lawitz, E., Gordon, S. C., Schiff, E., . . . ION-2 Investigators. (2014, April 17). Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection.The New England Journal of Medicine.Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/24725238
- Harvoni- ledipasvir and sofosbuvir. (2015, March 1).Retrieved from http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4ec77e4-bae8-4db0-b3d5-bde09c5fa075
- Lam, B. P., Jeffers, T., Younoszai, Z., Fazel, Y., & Younossi, Z. M. (2015, September 1). The changing landscape of hepatitis C virus therapy: focus on interferon-free treatment.Therapeutic Advances in Gastroenterology,8(5), 298-312. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4530432/
- Charlton, M., Everson, G. T., Flamm, S. L., Kumar, P., Landis, C., Brown, R. S. Jr, . . . SOLAR-1 Investigators. (2015, September). Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease.Gastroenterology, 149(3), 649-59. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/25985734
- Kowdley, K. V., Gordon, S. C., Reddy, K. R., Rossaro, L., Bernstein, D. E., Lawitz, E., . . . ION-3 Investigators. (2014, May 15). The New England Journal of Medicine,370(20), 1879-1888. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/24720702
- Centers for Disease Control and Prevention. (n.d.). Viral hepatitis–hepatitis C information.Retrieved from http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#section4
- HCV Advocate. (n.d.). HCSP Fact Sheet. Retrieved from http://hcvadvocate.org/hepatitis/factsheets_pdf/GT1_Harvoni.pdf