- Side Effects
- Drug Interactions
- Pregnancy & Breastfeeding
- What Else to Know
Generic Name: boceprevir (discontinued)
Other Names: Victrelis (discontinued)
Drug Class: HCV Protease Inhibitors
What is boceprevir, and what is it used for?
These drugs are called direct-acting antiviral agents because they act directly on hepatitis C virus. They block the replication of hepatitis C virus in human cells by binding to and inhibiting protease enzymes that HCV use for reproducing. Inhibiting viral replication reduces HCV viral load in the body to undetectable levels in some patients.
The FDA approved boceprevir in March 2011. It was discontinued in 2015.
What are the side effects of boceprevir?
Side effects of boceprevir include
- hair loss,
- dry skin,
- loss of appetite,
- altered taste senses,
- anemia, and
- low white blood cell count.
Boceprevir can cause serious skin reactions, including
- Stevens Johnson syndrome (SJS),
- drug reaction with eosinophilia and systemic symptoms (DRESS), and
- exfoliative dermatitis.
Boceprevir should be discontinued if serious skin reactions occur.
What is the dosage for boceprevir?
Dosage Forms and Strengths
- 200 mg
Dosage Considerations – Should be Given as Follows:
Chronic Hepatitis C
- Discontinued; sale and distribution of boceprevir will be discontinued in the United States by December 2015
- Indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin
- The indication is specifically for adults with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy
- Initiate therapy with peginterferon alfa and ribavirin for 4 weeks, THEN
- Add boceprevir 800 mg orally every 8 hours (i.e., every 7-9 hours) with food
Duration of treatment depends on HCV-RNA levels at treatment weeks 8, 12, and 24
HCV-RNA levels at 8 weeks
- Previously untreated and HCV-RNA levels undetectable: Complete 3-medication regimen at week 28
- Previously untreated and HCV-RNA levels detectable: Continue 3 medication regimen through week 36, then continue peginterferon alfa and ribavirin through week 48
- Partial responders or relapsed and HCV-RNA levels undetectable: Complete 3-medication regimen at week 36
- Partial responders or relapsed and HCV-RNA levels detectable: Continue 3 medication regimen through week 36, then continue peginterferon alfa and ribavirin through week 48
HCV-RNA levels at 12 weeks
- Response-guided therapy was not studied in individuals who had less than a 2-log10 HCV-RNA decline by treatment week 12 during prior therapy with peginterferon alfa and ribavirin
- If considered for treatment, these patients should receive peginterferon alfa and ribavirin for 4 weeks followed by boceprevir for 44 weeks in combination with peginterferon alfa and ribavirin
- In addition, consideration should be given to treating previously untreated patients who are poorly interferon responsive (as determined at TW 4) with 4 weeks peginterferon alfa and ribavirin followed by boceprevir for 44 weeks in combination with peginterferon alfa and ribavirin to maximize rates of a sustained virologic response
HCV-RNA levels at 24 weeks
- If HCV-RNA levels are undetectable at treatment week 24, continue with the treatment regimen identified at week 8
- Discontinuation of therapy is recommended in all patients with any of the following circumstances:
- If HCV-RNA levels 1000 IU/mL or greater at week 8, discontinue the 3-medication regimen, OR
- If HCV-RNA levels 100 IU/mL or greater at week 12, discontinue the 3-medication regimen, OR
- If confirmed, detectable HCV-RNA levels at week 24, discontinue 3-medication regimen
- Peginterferon alfa and ribavirin for 4 weeks followed by boceprevir for 44 weeks in combination with peginterferon alfa and ribavirin
Renal or Hepatic Impairment
- No dose adjustment for boceprevir is required
- See peginterferon alfa and ribavirin monographs for recommended dose adjustments
- Must be administered in combination with peginterferon alfa and ribavirin
- Administer with a meal or light snack
Which drugs or supplements interact with boceprevir?
- Boceprevir should not be combined with alfuzosin (Uroxatral), doxazosin (Cardura), sildosin (Rapaflo), tamsulosin (Flomax), sildenafil (Viagra), and tadalafil (Cialis) because it can increase their blood levels, leading to increased side effects from these drugs.
- Boceprevir should not be combined with carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), rifampin, and St. John's wort because they can increase the breakdown of boceprevir and decrease its effectiveness.
- Boceprevir should not be combined with lovastatin (Mevacor) and simvastatin (Zocor) due to increased risk of muscle aches, including rhabdomyolysis.
- Boceprevir should be combined with midazolam (Versed) and triazolam (Halcion) because of increased risk of sedation and respiratory depression.
- Boceprevir should be used with caution with HIV medications like atazanavir (Reyataz), ritonavir, (Norvir), darunavir (Prezista), and lopinavir/ritonavir (Kaletra) because it leads to fluctuating levels of boceprevir and the HIV medications, leading to decreased effectiveness.
- Boceprevir should be used with caution with arrhythmia medications because the combination can increase the risk of irregular heart rate and rhythm.
- Boceprevir should be used with caution with antifungal medications like ketoconazole (Nizoral), itraconazole (Sporanox), and voriconazole (Vfend); antibiotics like clarithromycin (Biaxin) and erythromycin (Erythrocin); immunosuppressant medications like cyclosporine (Gengraf, Neoral, Sandimmune), tacrolimus (Prograf), and sirolimus (Rapamune). Boceprevir can slow the breakdown of these medications and increase their levels in the body, leading to increased side effects and toxicity.
- Boceprevir should be used with caution with warfarin because it can increase or decrease warfarin breakdown, increasing or decreasing the effect of warfarin.
Is boceprevir safe to take if I'm pregnant or breastfeeding?
- Boceprevir is combined with ribavirin and peginterferon alfa, which cause fetal harm and birth defects if used in pregnant women or in male partners of women who are pregnant.
- Female patients of childbearing potential and their male partners as well as male patients and their female partners must use two effective birth control methods during treatment and for 6 months after treatment.
- Female patients should have monthly pregnancy tests during treatment and for 6 months after stopping treatment.
- It is not known whether boceprevir enters breast milk; therefore, it is best to be cautious before using it in nursing mothers. To avoid any potential risk to the newborn, a decision must be made to discontinue nursing or to discontinue the drug.
What else should I know about boceprevir?
Do I need a prescription for boceprevir?
What preparations of boceprevir are available?
- Capsule, 200 mg
How should I keep boceprevir stored?
- Boceprevir should be refrigerated at 2 C to 8 C (36 F 46 F) until dispensed. Refrigerated boceprevir can remain stable until the expiration date. Boceprevir can also be stored at room temperature up to 25 C (77 F) for 3 months.
- Boceprevir should be stored in tightly closed containers, avoiding exposure to excessive heat.
Boceprevir is an antiviral medication prescribed for the treatment of hepatitis C. Side effects of boceprevir include hair loss, dry skin, diarrhea, loss of appetite, nausea, altered taste senses, sleeplessness, irritability, fatigue, shivering, anemia, and low white blood cell count. Boceprevir is combined with ribavirin and peginterferon alfa, which cause fetal harm and birth defects if used in pregnant women or in male partners of women who are pregnant.
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Related Disease Conditions
Liver disease can be cause by a variety of things including infection (hepatitis), diseases, for example, gallstones, high cholesterol or triglycerides, blood flow obstruction to the liver, and toxins (medications and chemicals). Symptoms of liver disease depends upon the cause and may include nausea, vomiting, upper right abdominal pain, and jaundice. Treatment depends upon the cause of the liver disease.
Cirrhosis of the liver refers to a disease in which normal liver cells are replaced by scar tissue caused by alcohol and viral hepatitis B and C. This disease leads to abnormalities in the liver's ability to handle toxins and blood flow, causing internal bleeding, kidney failure, mental confusion, coma, body fluid accumulation, and frequent infections. Symptoms include yellowing of the skin (jaundice), itching, and fatigue. The prognosis is good for some people with cirrhosis of the liver, and the survival can be up to 12 years; however the life expectancy is about 6 months to 2 years for people with severe cirrhosis with major complications.
Liver (Anatomy and Function)
The liver is the largest gland and organ in the body. There are a variety of liver diseases caused by liver inflammation, scarring of the liver, infection of the liver, gallstones, cancer, toxins, genetic diseases, and blood flow problems. Symptoms of liver disease generally do not occur until the liver disease is advanced. Some symptoms of liver disease include jaundice, nausea and vomiting, easy bruising, bleeding excessively, fatigue, weakness, weight loss, shortness of breath, leg swelling, impotence, and confusion. Treatment of diseases of the liver depends on the cause.
Hepatitis (Viral Hepatitis A, B, C, D, E, G)
Hepatitis is most often viral, due to infection with one of the hepatitis viruses (A, B, C, D, E, F (not confirmed), and G) or another virus (such as those that cause infectious mononucleosis, cytomegalovirus disease). The main nonviral causes of hepatitis are alcohol and drugs. Many patients infected with hepatitis A, B, and C have few or no symptoms of illness. For those who do develop symptoms of viral hepatitis, the most common are flu-like symptoms including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, and aching in the abdomen. Treatment of viral hepatitis is dependent on the type of hepatitis.
Hepatitis C (HCV, Hep C)
Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
What’s Worse, Hepatitis A, B, or C?
Because there is no vaccination available against hepatitis C, hepatitis C is often considered worse than hepatitis A or B.
Is Hepatitis Contagious?
Hepatitis means "inflammation of the liver," and there are several different types of such as A, B, C, D, and E. Some types of hepatitis are contagious and some types are not. Hepatitis symptoms vary upon the type of disease; however, the following symptoms may develop in someone with hepatitis: fatigue, nausea and vomiting, abdominal pain and discomfort, jaundice (yellowing of the skin and whites of the eyes), and loss of appetite. Treatment for hepatitis depends upon the cause. Some types of hepatitis have a vaccine to prevent spread of disease such as hepatitis A and B.
Hepatitis A and B Vaccinations
Hepatitis A and hepatitis B are the two most commnon viruses that infect the liver. Hepatitis A and Hepatitis B can be prevented and treated with immunizations (vaccinations) such as Havrix, Vaqta, Twinrix, Comvax, Pediarix, and hepatitis b immune globulin (HBIG).
Is Hepatitis B Contagious?
Hepatitis B is a type of liver infection. Hepatitis B is spread through person-to-person contact or through personal items like razors, toothbrushes, etc. Symptoms of hepatitis B include fever, yellowish skin (jaundice), dark urine, fatigue, nausea, and vomiting. There is no drug to cure hepatitis B; however, there is a hepatitis B vaccine available.
Hepatitis B (HBV, Hep B)
The hepatitis B virus (HBV, hep B) is a unique, coated DNA virus belonging to the Hepadnaviridae family of viruses. The course of the virus is determined primarily by the age at which the infection is acquired and the interaction between the virus and the body's immune system. Successful treatment is associated with a reduction in liver injury and fibrosis (scarring), a decreased likelihood of developing cirrhosis and its complications, including liver cancer, and a prolonged survival.
Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by people sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Hepatitis C Cure (Symptoms, Transmission, Treatments, and Cost)
Hepatitis is inflammation of the liver. There are a variety of toxins, diseases, illicit drugs, medications, bacterial and viral infections, and heavy alcohol use can case inflammation of the liver. Hepatitis C viral infection (HCV) is one type of hepatitis. According to the CDC, in 2014 there were an estimated 30,500 cases of acute hepatitis C infections in the US. An estimated 2.7-3.9 million people in the US have chronic hepatitis C. The virus is spread from person-to-person via blood-to-blood contact. Symptoms of HCV infection include joint pain, jaundice, dark urine, nausea, fatigue, fever, loss of appetites, clay colored stool. Hepatitis C can be cured with medications in most people. There is no vaccine against the hepatitis C virus.
Can Alcoholic Hepatitis Be Cured?
Liver damage from mild alcoholic hepatitis can usually be cured by complete abstinence from alcohol and lifestyle changes. Learn about symptoms, treatment, and survival rates.
Is Hepatitis A Contagious?
Hepatitis means inflammation of the liver. Hepatitis A is one type of hepatitis. Hepatitis is transmitted through person to person contact, contaminated ice, vegetables, fruits, and untreated water. Hepatitis A can be prevented by the hepatitis A vaccine. Symptoms of hepatitis A may include nausea and/or vomiting, fever, loss of appetite, abdominal pain, dark urine, clay-colored stools, jaundice (yellowish color to skin and/or eyes, or joint pain.
Hepatitis E Viral Infection
Hepatitis E (hep E) is a type of hepatitis viral infection that includes hepatitis A, B, C, D, F, which is caused by the hepatitis E virus. Usually, you get (transmitted) hepatitis E from eating or drinking dirty or contaminated water. Hepatitis E can be very serious, especially if a woman is pregnant. Up to ¼ of women who are pregnant with the hep E virus can die from the infection. The signs and symptoms of hepatitis E infection are nausea and vomiting, brown or dark urine, stool changes jaundice (yellow eyes and skin), pain in the right side of the abdomen, dark or brown urine, and light-colored stool. Some people with hep E don’t have any symptoms so they don’t know that they are contagious. It takes about 6 weeks to recover from hep E. A person who has any type of hepatitis, including hepatitis E, should not drink any alcohol. Hep E complications are rare, but when they do occur they include severe (“fulminant”) hepatitis, liver failure, and death. Currently, no specific drugs or treatments are available for hepatitis E. Moreover, the only hepatitis E vaccine currently is available in China. Avoid alcohol, keep hydrated, and getting rest are home remedies for hepatitis E. Talk to your doctor before taking any over-the-counter (medications), especially those containing acetaminophen (Tylenol and others). Usually, the prognosis and life expectancy for hepatitis E after recovery is good. Most people do not have long term liver problems from the infection.
Can Alcoholic Hepatitis Be Reversed?
While mild alcoholic hepatitis may be reversed, once it reaches the stage of liver cirrhosis, it is irreversible. After diagnosis, abstaining from alcohol can improve your lifespan.
What Causes Hepatitis?
Hepatitis is inflammation of the liver. It can occur due to a variety of factors, but the most common cause is a virus infection. The types of hepatitis are hepatitis A, B, C, D, and E. Hepatitis can be acute (short-term) or chronic (long-term) and can have fatal complications. Early diagnosis, treatment and lifestyle modification can slow or inhibit the progression of the disease and reduce complications.
How Long Can You Live With Hepatitis A?
Acute illness of hepatitis A typically subsides within two months; however, it may last for up to six months in more severe cases.
What Is HCV Positive? Symptoms and Causes
HCV positive (reactive) is an interpretation of the results of the HCV antibody test that may mean the following.
Hepatitis Vaccines for Hepatitis B and C
Hepatitis is a family of viruses that infect the liver. There are vaccines for hepatitis A and B infections, but not for hepatitis C.
Is Hepatitis B HBV Curable?
While there is no permanent cure for hepatitis B, 90 percent of adults infected with the virus ultimately recover from their symptoms within a few months.
What Happens If You Have Hepatitis?
Hepatitis is a term used to describe inflammation or swelling of the liver. Chronic liver infection and inflammation could damage the liver parenchyma (tissue) and lead to complications.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.