What is Victrelis (boceprevir)?
Victrelis blocks 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.
Common side effects of Victrelis include:
- hair loss,
- dry skin,
- loss of appetite,
- altered taste senses,
- anemia, and
- low white blood cell count.
Serious side effects of Victrelis include serious skin reactions, including:
- Stevens-Johnson syndrome (SJS),
- drug reaction with eosinophilia and systemic symptoms (DRESS), and
- exfoliative dermatitis.
Drug interactions of Victrelis include:
- sildenafil, and tadalafil because it can increase their blood levels, leading to increased side effects from these drugs.
Victrelis should be used with caution with antifungal medications, certain antibiotics, and immunosuppressant medications because it can increase their levels in the body, leading to increased side effects and toxicity.
Victrelis should be used with caution with warfarin because it can increase or decrease the effect of warfarin.
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.
What are the important side effects of Victrelis (boceprevir)?
Side effects of boceprevir include:
- hair loss,
- dry skin,
- loss of appetite,
- altered sense of taste,
- 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.
Adverse reactions that led to dose modifications of any drug (primarily PegIntron and Rebetol) occurred in 39% of subjects receiving the combination of Victrelis with PegIntron/Rebetol compared to 24% of subjects receiving PegIntron/Rebetol alone. The most common reason for dose reduction was anemia, which occurred more frequently in subjects receiving the combination of Victrelis with PegIntron/Rebetol than in subjects receiving PegIntron/Rebetol alone.
Serious adverse events were reported in 11% of subjects receiving the combination of Victrelis with PegIntron/Rebetol and in 8% of subjects receiving PegIntron/Rebetol.
Adverse events (regardless of investigator's causality assessment) reported in greater than or equal to 10% of subjects receiving the combination of Victrelis with PegIntron/Rebetol and reported at a rate of greater than or equal to 5% than PegIntron/Rebetol alone in SPRINT-1, SPRINT-2, and RESPOND2 are presented in Table 3.
|Adverse Events||Previously Untreated|
(SPRINT-1 and SPRINT-2)
|Previous Treatment Failures|
|Percentage of Subjects Reporting Adverse Events||Percentage of Subjects Reporting Adverse Events|
|Body System Organ Class||Victrelis + PegIntron +Rebetol|
|PegIntron + Rebetol|
|Victrelis + PegIntron +Rebetol|
|PegIntron + Rebetol|
|Median Exposure (days)||197||216||253||104|
|Blood and Lymphatic System Disorders|
|General Disorders and Administration Site Conditions|
|Metabolism and Nutrition Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|Nervous System Disorders|
|Respiratory, Thoracic, and Mediastinal Disorders|
|Skin and Subcutaneous Tissue Disorders|
Other Important Adverse Reactions Reported In Clinical Trials
Among subjects (previously untreated subjects or those who failed previous therapy) who received Victrelis in combination with peginterferon alfa and ribavirin, the following adverse drug reactions were reported. These events are notable because of their seriousness, severity, or increased frequency in subjects who received Victrelis in combination with peginterferon alfa and ribavirin compared with subjects who received only peginterferon alfa and ribavirin.
Dysgeusia (alteration of taste) was an adverse event reported at an increased frequency in subjects receiving Victrelis in combination with peginterferon alfa and ribavirin compared with subjects receiving peginterferon alfa and ribavirin alone (Table 3). Adverse events such as dry mouth, nausea, vomiting and diarrhea were also reported at an increased frequency in subjects receiving Victrelis in combination with peginterferon alfa and ribavirin.
Changes in selected hematological parameters during treatment of adult subjects with the combination of Victrelis with PegIntron and Rebetol are described in Table 4.
Decreases in hemoglobin may require a decrease in dosage or discontinuation of ribavirin. If ribavirin is permanently discontinued, then peginterferon alfa and Victrelis must also be discontinued.
Neutrophils and Platelets
The proportion of subjects with decreased neutrophil and platelet counts was higher in subjects treated with Victrelis in combination with PegIntron/Rebetol compared to subjects receiving PegIntron/Rebetol alone. Three percent of subjects receiving the combination of Victrelis with PegIntron/Rebetol had platelet counts of less than 50 x 109 per L compared to 1% of subjects receiving PegIntron/Rebetol alone. Decreases in neutrophils or platelets may require a decrease in dosage or interruption of peginterferon alfa, or discontinuation of therapy. If peginterferon alfa is permanently discontinued, then ribavirin and Victrelis must also be discontinued.
Blood and Lymphatic System Disorders: agranulocytosis, pancytopenia, thrombocytopenia
Gastrointestinal Disorders: mouth ulceration, stomatitis
Skin and Subcutaneous Tissue Disorders: angioedema, urticaria; drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic skin eruption, toxicoderma
What drugs interact with Victrelis (boceprevir)?
Potential For Victrelis To Affect Other Drugs
Boceprevir is a strong inhibitor of CYP3A4/5. Drugs metabolized primarily by CYP3A4/5 may have increased exposure when administered with Victrelis, which could increase or prolong their therapeutic and adverse effects. Boceprevir does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 in vitro. In addition, boceprevir does not induce CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP3A4/5 in vitro.
Boceprevir is a potential inhibitor of p-glycoprotein (P-gp) based on in vitro studies. In a drug interaction trial conducted with digoxin, Victrelis had limited p-glycoprotein inhibitory potential at clinically relevant concentrations.
Potential For Other Drugs To Affect Victrelis
Boceprevir is primarily metabolized by aldo-ketoreductase (AKR). In drug interaction trials conducted with AKR inhibitors diflunisal and ibuprofen, boceprevir exposure did not increase to a clinically significant extent. Victrelis may be coadministered with AKR inhibitors.
Boceprevir is partly metabolized by CYP3A4/5. It is also a substrate for p-glycoprotein. Coadministration of Victrelis with drugs that induce or inhibit CYP3A4/5 could decrease or increase exposure to boceprevir.
Established And Other Potential Significant Drug Interactions
Table 5 provides recommendations based on established or potentially clinically significant drug interactions. Victrelis is contraindicated with drugs that are potent inducers of CYP3A4/5 and drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
|digoxin*||↑ digoxin||Digoxin concentrations increased when administered with Victrelis. Measure serum digoxin concentrations before initiating Victrelis. Continue monitoring digoxin concentrations; consult the digoxin prescribing information for information on titrating the digoxin dose.|
|Anticoagulant: warfarin||↑ or
|Concentrations of warfarin may be altered when coadministered with Victrelis. Monitor INR closely.|
|Antidepressants: trazodone, desipramine||↑ trazodone
|Plasma concentrations of trazodone and desipramine may increase when administered with Victrelis, resulting in adverse events such as dizziness, hypotension and syncope. Use with caution and consider a lower dose of trazodone or desipramine.|
|escitalopram*||↓escitalopram||Exposure of escitalopram was slightly decreased when coadministered with Victrelis. Selective serotonin reuptake inhibitors such as escitalopram have a wide therapeutic index, but doses may need to be adjusted when combined with Victrelis.|
|Antifungals: ketoconazole*, itraconazole, posaconazole, voriconazole||↑ boceprevir
|Plasma concentrations of ketoconazole, itraconazole, voriconazole or posaconazole may be increased with Victrelis. When coadministration is required, doses of ketoconazole and itraconazole should not exceed 200 mg/day.|
|Anti-gout: colchicine||↑ colchicine||
Significant increases in colchicine levels are expected; fatal colchicine toxicity has been reported with other strong CYP3A4 inhibitors.
Treatment of gout flares (during treatment with Victrelis): 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (half tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
Prophylaxis of gout flares (during treatment with Victrelis): If the original regimen was 0.6 mg twice a day, reduce dose to 0.3 mg once a day. If the original regimen was 0.6 mg once a day, reduce the dose to 0.3 mg once every other day.
Treatment of familial Mediterranean fever (FMF) (during treatment with Victrelis): Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day).
|Antimycobacterial: rifabutin||↓ boceprevir
|Increases in rifabutin exposure are anticipated, while exposure of boceprevir may be decreased. Doses have not been established for the 2 drugs when used in combination. Concomitant use is not recommended.|
|Calcium Channel Blockers such as: amlodipine, diltiazem, felodipine, nifedipine, nicardipine, nisoldipine, verapamil||↑ calcium channel blockers||Plasma concentrations of calcium channel blockers may increase when administered with Victrelis. Caution is warranted and clinical monitoring is recommended.|
|Corticosteroid, systemic: dexamethasone||↓ boceprevir||Coadministration of Victrelis with CYP3A4/5 inducers may decrease plasma concentrations of boceprevir, which may result in loss of therapeutic effect. Therefore, this combination should be avoided if possible and used with caution if necessary.|
|prednisone*||↑ prednisone||Concentrations of prednisone and its active metabolite, prednisolone, increased when administered with Victrelis. No dose adjustment of prednisone is necessary when coadministered with Victrelis. Patients receiving prednisone and Victrelis should be monitored appropriately.|
|Corticosteroid, inhaled: budesonide, fluticasone||↑ budesonide
|Concomitant use of inhaled budesonide or fluticasone with Victrelis may result in increased plasma concentrations of budesonide or fluticasone, resulting in significantly reduced serum cortisol concentrations. Avoid coadministration if possible, particularly for extended durations.|
|Endothelin Receptor Antagonist: bosentan||↑ bosentan||Concentrations of bosentan may be increased when coadministered with Victrelis. Use with caution and monitor closely.|
|HMG-CoA Reductase Inhibitors:||For contraindicated HMG-CoA reductase inhibitors.|
|atorvastatin*||↑ atorvastatin||Exposure to atorvastatin was increased when administered with Victrelis. Use the lowest effective dose of atorvastatin, but do not exceed a daily dose of 40 mg when coadministered with Victrelis.|
|pravastatin*||↑ pravastatin||Concomitant administration of pravastatin with Victrelis increased exposure to pravastatin. Treatment with pravastatin can be initiated at the recommended dose when coadministered with Victrelis. Close clinical monitoring is warranted.|
|Immunosuppressants: cyclosporine*||↑cyclosporine||Dose adjustments of cyclosporine should be anticipated when administered with Victrelis and should be guided by close monitoring of cyclosporine blood concentrations, and frequent assessments of renal function and cyclosporine-related side effects.|
|tacrolimus*||↑tacrolimus||Concomitant administration of Victrelis with tacrolimus requires significant dose reduction and prolongation of the dosing interval for tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.|
|sirolimus*||↑sirolimus||Concomitant administration of Victrelis with sirolimus requires significant dose reduction and prolongation of the dosing interval for sirolimus, with close monitoring of sirolimus blood concentrations and frequent assessments of renal function and sirolimus-related side effects.|
|Inhaled beta-agonist: salmeterol||↑ salmeterol||Concurrent use of inhaled salmeterol and Victrelis is not recommended due to the risk of cardiovascular events associated with salmeterol.|
|Narcotic Analgesic/Opioid Dependence: methadone*||↓ R-methadone||Plasma concentrations of R-methadone decreased when coadministered with Victrelis. The observed changes are not considered clinically relevant. No dose adjustment of methadone or Victrelis is recommended. Individual patients may require additional titration of their methadone dosage when Victrelis is started or stopped to ensure clinical effect of methadone.|
|buprenorphine/naloxone*||↑ buprenorphine/ naloxone||Plasma concentrations of buprenorphine and naloxone increased when
coadministered with Victrelis. The observed changes are
not considered clinically relevant. No dose adjustment of buprenorphine/naloxone or Victrelis is recommended.
|Oral hormonal contraceptives:||For contraindicated oral contraceptives.|
|drospirenone/ethinyl estradiol*||↑ drospirenone
↓ ethinyl estradiol
|Concentrations of drospirenone increased in the presence of boceprevir. Thus, the use of drospirenonecontaining products is contraindicated during treatment with Victrelis due to potential for hyperkalemia.|
|norethindrone/ethinyl estradiol*||↓ ethinyl estradiol
|Concentrations of ethinyl estradiol decreased in the presence of boceprevir. Norethindrone Cmax decreased 17% in the presence of boceprevir. Coadministration of Victrelis with a combined oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is not likely to alter the effectiveness of this combined oral contraceptive. Patients using estrogens as hormone replacement therapy should be clinically monitored for signs of estrogen deficiency.|
|PDE5 inhibitors:||For contraindicated PDE5 enzyme inhibitors.|
|sildenafil, tadalafil, vardenafil||↑ sildenafil
Increases in PDE5 inhibitor concentrations are expected, and may result in an increase in adverse events, including hypotension, syncope, visual disturbances, and priapism.
Use of REVATIO® (sildenafil) or ADCIRCA® (tadalafil) for the treatment of pulmonary arterial hypertension (PAH) is contraindicated with Victrelis.
Use of PDE5 inhibitors for erectile dysfunction:
Sildenafil: 25 mg every 48 hours
Tadalafil: 10 mg every 72 hours
Vardenafil: 2.5 mg every 24 hours
|Proton Pump Inhibitor: omeprazole*||↔ omeprazole||No dose adjustment of omeprazole or Victrelis is recommended.|
|Sedative/hypnotics:||For contraindicated sedatives/hypnotics.|
|alprazolam; IV midazolam||↑ midazolam
|Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during coadministration of Victrelis. A lower dose of IV midazolam or alprazolam should be considered.|
|* These combinations have been studied.|
Victrelis (boceprevir) is a man-made antiviral medication that targets hepatitis C virus (HCV). Victrelis is called a direct-acting antiviral agent because it acts directly on hepatitis C virus. Common side effects of Victrelis include hair loss, dry skin, diarrhea, loss of appetite, nausea, altered taste senses, sleeplessness, irritability, fatigue, shivering, anemia, and low white blood cell count. Victrelis 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. It is unknown if Victrelis enters breast milk.
Picture of Hepatitis B
Inflammation of the liver due to the hepatitis B virus (HBV), once thought to be passed only through blood products. See a...
Related Disease Conditions
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.
Hepatitis A (HAV, Hep A)
Hepatitis means inflammation of the liver. Hepatitis A (HAV, Hep A) is one type of liver disease caused by a virus. Since hepatitis A is a virus, it can pass from person to person from eating or drinking contaminated food or coming into contact with contaminated materials containing the virus. Symptoms of hepatitis A include stomach pain, diarrhea, dark yellow urine, jaundice, and more. There is a vaccine to prevent contracting hepatitis A.
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 persons sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
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.
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 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.
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.
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