Sofosbuvir

Sofosbuvir is an antiviral medication that is taken orally to prevent hepatitis C virus, also known as HCV, from spreading in the body.

Overview

Sofosbuvir is used alongside other antiviral medicines that work similarly such as peginterferon alfa or ribavirin for the treatment of a viral infection of the liver, which is known as chronic hepatitis C infection. It is only available via prescription from a qualified doctor and is available in the dosage form of a tablet under the brand name Sovaldi. It works by reducing the quantity of hepatitis C virus in your body and preventing the condition multiplying which may assist your liver in recovering. Chronic (long-term) hepatitis C infection can cause serious liver problems such as liver cancer or scarring (cirrhosis). It helps the body's immune system fight the infection. Sofosbuvir must be used alongside other treatments to have the best effect. Do not use sofosbuvir alone to treat hepatitis C.

Condition(s) treated?

  • Chronic Infection of Genotype 3 Hepatitis C Virus
  • Chronic Infection of Genotype 1 Hepatitis C Virus
  • Chronic Infection of Genotype 2 Hepatitis C Virus
  • Chronic Infection of Genotype 4 Hepatitis C Virus
  • Chronic Infection of Genotype 6 Hepatitis C Virus
  • Chronic Infection of Genotype 5 Hepatitis C Virus

Type of medicine?

  • Antiviral (oral tablet)

Side Effects

As with all medications, there can be a number of side effects associated with the taking of Sofosbuvir. We have listed these side effects below in terms of most common and serious side effects. If you experience some of the common side effects, it's important to note that these usually pass over time as your body adjusts to the medication; however, if they are causing havoc to your daily life, then contact your doctor or health care professional for advice on ways to minimize the intensity of the side effects. You can report all side effects to the FDA on FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Most common side effects

The most common side effects that occur with sofosbuvir when used in combination with ribavirin include:

  • Headache
  • Tiredness

The most common side effects that occur with sofosbuvir when used in combination with ribavirin and peginterferon alfa include:

  • Headache
  • Tiredness or weakness
  • Trouble sleeping
  • Nausea
  • Low red blood cell count
  • Chills
  • Fever
  • Side or lower back pain
  • Pale skin
  • Sores, ulcers, or white spots in the mouth
  • Itchy skin or rash
  • Diarrhea
  • Irritability

Serious side effects

If you experience any of the below serious side effects, then you need to seek urgent medical attention. These symptoms could be life-threatening, so it's important not to ignore them.

Blood effects. This drug, especially when used alongside peginterferon alfa, can lower your blood cell count. If your blood cell counts become dangerously low, you increase your risk of anemia, infections or bleeding problems.

  • Changes in behavior
  • Trouble concentrating
  • Discouragement
  • Feeling sad or empty
  • Loss of pleasure or interest
  • Thoughts of killing yourself

Severe slowing of your heart rate. The combination of sofosbuvir, amiodarone, and direct-acting antiviral (DAA) drugs can slow down your heart rate to a very low level. Warning signs of this include fainting or feeling like you may faint, chest pain, a general feeling of weakness, lightheadedness or tiredness. This could be fatal.

Dosage

The final dosage of any medication will depend on a number of factors, including your age, weight, height and previous medical history, as well as how severe your condition is. Below we give a general guide.

  • The dose that is recommended is one 400-mg tablet taken with or without food, orally by mouth once a day.
  • Don’t use sofosbuvir alone. Take it with other drugs that treat the hepatitis C virus (HCV) infection. You’ll take it with both ribavirin and peginterferon alfa or ribavirin alone.

The specific duration of treatment depends on the type of HCV you have:

  • People with genotype 4 or 1 HCV: sofosbuvir and peginterferon alfa and ribavirin for twelve weeks
  • People with genotype 2 HCV: ribavirin and sofosbuvir for twelve weeks
  • People with genotype 3 HCV: ribavirin and sofosbuvir for twenty-four weeks
  • People with liver cancer who are waiting for a liver transplant: ribavirin and sofosbuvir for up until the time of the liver transplant or for forty-eight weeks

Interactions

Drug interactions can affect how your medication works or increase your risk of serious side effects. Never start, stop, or change your dosage without the approval of your doctor first. Sofosbuvir can interact with other medications, vitamins and herbal products you may be taking, so it's important you inform them of absolutely everything you are taking. If you’re curious about how this drug might interact with something else you’re taking, talk to your pharmacist or doctor.

Alcohol Interaction

Don’t drink alcohol if you have the hepatitis C virus infection. It may cause further damage to your liver.

Heart medication

Taking amiodarone, with sofosbuvir, and other direct-acting antivirals can slow down your heart rate severely. This can be fatal so it's therefore not recommended.

Anti-seizure medications

  • Phenobarbital
  • Carbamazepine
  • Oxcarbazepine
  • Phenytoin

Don’t use any of the drugs listed above in combination with sofosbuvir. They can decrease the amount of sofosbuvir in your body which can reduce the effectiveness of sofosbuvir.

The use of antibiotics

  • Rifampin
  • Rifabutin
  • Rifapentine

Don’t use these above drugs in combination with sofosbuvir. They can decrease the amount of sofosbuvir in your body which means it may not work as well.

Herbal supplements

Don’t take St. John’s wort with sofosbuvir. It can decrease the amount of sofosbuvir in your body meaning it may not be as effective.

Human immunodeficiency virus (HIV) drugs

Don't use tipranavir in combination with ritonavir with sofosbuvir. They could decrease the amount of sofosbuvir in your body which means the drug will be less effective.

Warnings

People with hepatitis B virus

If you have ever suffered from hepatitis B virus infection, there is a possibility it could become active again during or after your treatment using sofosbuvir. This may cause liver failure, damage, or death. Before starting this drug, your doctor will check your blood for hepatitis B virus.

People suffering with depression

People with mental health issues including depression should be wary when using this drug. It can cause severe depression and lead to suicidal thoughts or a want to harm yourself. You should inform your doctor if you have a history of mental health issues before you commence using sofosbuvir.

People with severe kidney problems

Inform your doctor if you've got severe kidney problems or are on dialysis. Sofosbuvir is removed from your body by your kidneys so if you experience kidney problems, your body may be unable to filter this drug quick enough which could lead to toxic levels and severe side effects.

Pregnant women

Sofosbuvir is a category X pregnancy drug when used with both peginterferon alfa and ribavirin or ribavirin alone. Drugs with the category X should never be used during pregnancy under any circumstances. This use of this drug could cause the death of an unborn baby or birth defects.

Don’t take this drug combination if you’re pregnant. Men and women need to use two effective forms of birth control during and for six months after treatment when using this drug. Discuss birth control with your doctor or healthcare professional.

Call your doctor right away if you fall pregnant when taking this drug.

Women who are breastfeeding

It is not known if this drug passes through breast milk. However, if it does pass through, it could cause serious side effects in the child. You will need to discuss with your doctor to decide whether you should take the drug whilst breastfeeding or not.

Children

It is unknown if this drug is effective or safe for children younger than 18 years old. Keep out of reach of children.

Allergies

Sofosbuvir can cause a severe allergic reaction. Symptoms may include:

  • Trouble breathing
  • Hives
  • Swelling of your throat, eyes, face, tongue or lips

Do not take this drug again if you have previously had an allergic reaction to it as this could be fatal.

Storage

  • Keep sofosbuvir below 86°F (30°C). Do not freeze.
  • Ensure it is away from high temperatures
  • Keep it in its original container
  • Keep it away from places where they could get wet, such as bathrooms. Store this drug away from damp locations.

Summary

When used correctly, sofosbuvir is successful in treating those suffering from chronic hepatitis C. It's unknown if the use of this treatment can prevent you from passing the hepatitis C virus onto other people. Practice "safer sex" to lower the risk of passing the virus to others and don't share needles. There are many drug interactions with this medication, so it's important to inform your doctor of everything you are taking and your full medical history. Do not take under any circumstances if you are pregnant and hold off getting pregnant before, during and after taking this drug under the advisement of your doctor or healthcare professional.

Resources
Last Reviewed:
December 24, 2017
Last Updated:
December 22, 2017