H C V F A C T S H E E T F O R P A T I E N T S P R A C T I C E S U P P O R T T O O L K I T TRIPLE THERAPY FOR CHRONIC HEPATITIS C In May 2011, two new drugs to treat chronic hepatitis C (HCV) were approved by the FDA. Telaprevir (Incivek) and boceprevir (Victrelis) are protease inhibitors that interfere with the ability of the HCV virus to multiply. These new drugs are ONLY for patients with HCV genotype 1 infection. Pegylated interferon alfa [PegIFN] and ribavirin will still be the recommended treatment for patients with HCV genotype 2, 3 and others.
For patients with HCV genotype 1, the protease inhibitor (either telaprevir or boceprevir) is taken with PegIFN and ribavirin. That is why it is called“triple therapy” – all 3 drugs are required.
TELAPREVIR TRIPLE THERAPY BOCEPREVIR TRIPLE THERAPY
1. Telaprevir is an oral medication (750 mg, 3 times a day with food)
1. Boceprevir is an oral medication (800 mg, 3 times a day with food)
–OR–
3. Ribavirin is an oral medication (800-1400 mg daily,
3. Ribavirin is an oral medication (800-1400 mg daily,
In clinical trials with the new drugs, taking the three drugs together resulted in a better outcome (viral cure) for more people than those who onlytook two drugs (PegIFN and ribavirin). Also, many patients who took the three drugs (either telaprevir or boceprevir and PegIFN and ribavirin) did nothave to be treated for as long as those patients who took two drugs (PegIFN and ribavirin).
It is very important that these new drugs are used correctly. Problems can happen when medication is not taken according to the directions. Telaprevir and boceprevir must NOT be used alone; they should always be used with PegIFN and ribavirin. The dose of telaprevir or boceprevir shouldnot be lowered, and it needs to be taken every 7-9 hours. Patients should have written instructions from their health care provider about what to do ifa dose of medication is missed. Patients should completely understand how to use HCV medication and should ask if they have questions.
Patients should know about potential side effects associated with triple therapy, and tell their health care provider about any side effects of concern. Women who can become pregnant or women with a male partner who is being treated with triple therapy must use 2 forms of birth control duringand for at least 6 months after treatment to protect against the risk of birth defects associated with protease inhibitors in combination with PegIFNand ribavirin. POTENTIAL SIDE EFFECTS ASSOCIATED WITH TRIPLE THERAPY (MOST COMMON) Ribavirin Boceprevir Telaprevir continued w w w . H c V c m e . o r g H C V F A C T S H E E T F O R P A T I E N T S P R A C T I C E S U P P O R T T O O L K I T
Boceprevir and telaprevir can affect other medications (prescription and over the counter medications) and other medications can have an effect onboceprevir or telaprevir. This kind of drug-drug interaction can result in too much or too little of a given medication in the body and cause side effectsor treatment failure. Patients should always tell their health care provider about all vitamins, herbal supplements, prescription and non-prescriptionmedicines they take, and should not start to take any medication while on triple therapy without first talking about it with their health care provideror pharmacist.
MEDICATION GUIDES FOR PROTEASE INHIBITORS Medication guides provide useful information specifically for patients who are taking (or considering taking) a protease inhibitor for the treatment of chronic HCV genotype 1. Telaprevir (Incivek): http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf Boceprevir (Victrelis): http://www.fda.gov/downloads/Drugs/DrugSafety/UCM255471.pdf WEBSITES WITH HCV INFORMATION FOR PATIENTS The following Websites are reliable sources of information for patients about the diagnosis and treatment of HCV. Centers for Disease Control and Prevention: http://www.cdc.gov/hepatitis/C/index.htm National Institute of Diabetes and Digestive and Kidney Diseases: http://digestive.niddk.nih.gov/ddiseases/pubs/hepc_ez/ US Department of Veterans Affairs: http://www.hepatitis.va.gov/index.asp PubMed Health: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001329/ Mayo Clinic: http://www.mayoclinic.com/health/hepatitis-c/DS00097 HCV SUPPORT GROUP NETWORKS Patients with HCV can benefit from participation in a peer support group. Support groups can provide information, advice, coping skills, and connections to others with shared experiences. HCV Advocate National Support Group Listing: http://www.hcvadvocate.org/community/Groups.asp Hepatitis Central: http://www.hepatitis-central.com/hcv/support/main.html Web MD online HCV Support Group: http://exchanges.webmd.com/hepatitis-exchange References FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf. Accessed July 2011. FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf. Accessed July 2011. National Digestive Diseases Information Clearinghouse. Chronic hepatitis C: current disease management. 2010. US Department of Veterans Affairs http://www.hepatitis.va.gov/index.asp. Accessed July 2011. w w w . H c V c m e . o r g
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