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AIDS InfoNet www.aidsinfonet.org Fact Sheet Number 684 SIMEPREVIR (Olysio) WHAT IS SIMEPREVIR? medications. When this happens, the Other common side effects of simeprevir Simeprevir is a drug used as part of drug will stop working. This is called include itching, nausea, diarrhea (see antiviral therapy against hepatitis C virus “developing resistance” to the drug. fact sheet 554), and vomiting. (HCV). The trade name in North America is Olysio. During its development it was Resistance can develop quickly. It is Because simeprevir is always taken in called TMC435. It is manufactured by very important to take antiviral combination with ribavirin, which can Janssen Pharmaceuticals. medications according to cause serious birth defects, do not take instructions, on schedule, and not to simeprevir if you or your sexual partner Simeprevir is an HCV protease inhibitor. skip or reduce doses. are pregnant or wants to become These drugs prevent the protease pregnant. Do not become pregnant for 6 enzyme from working. This makes it If your HCV viral load is too high after 4 months after you or your partner stop harder for the virus to multiply. See Step weeks of treatment, your doctor might taking simeprevir combination treatment. 6 of the HCV life cycle shown in Fact decide that you should stop taking Sheet 670. simeprevir to avoid having your HCV See fact sheet 680 for more information develop resistance. on the side effects of interferon and Simeprevir directly interferes with the ribavirin. HCV life cycle. Earlier drugs used to treat HCV were interferon and ribavirin (see HOW IS IT TAKEN? Be sure to tell your health care provider fact sheet 680.) They are primarily Simeprevir is taken once daily by mouth about any side effects that you are general immune boosters. Simeprevir as a 150 mg (mg) capsule.. having. must be used in combination with pegylated interferon and ribavirin Simeprevir must be taken with (pegIFN/RBV). It should not be used by pegIFN/RBV. Interferon is injected under HOW DOES IT REACT WITH itself. the skin, and ribavirin is taken by mouth. OTHER DRUGS? Fact sheet 680 has more information on Simeprevir combination therapy can these medications. affect how other drugs are processed by WHO SHOULD TAKE IT? the liver. This can change the amount Simeprevir was approved in 2013 as an Simeprevir use is based on “response of each drug in your bloodstream and antiviral drug for people infected with guided therapy.” The length of treatment cause an under- or overdose. HCV genotype 1 whose liver is still depends on how well it controls HCV functioning. People with decompensated viral load early in treatment. Drugs to watch out for include (unstable) liver cirrhosis, should not take antiretrovirals used for HIV, drugs to treat simeprevir. Signs of decompensated In most cases, simeprevir is taken for 12 high cholesterol (statins), rifampin to treat cirrhosis may include bleeding due to weeks. Treatment continues with tuberculosis, drugs for erectile varices (swelling veins) in the throat and pegIFN/RBV. Patients who have a good dysfunction, antifungal “azole” drugs, stomach, ascites (accumulation of fluid in response to simeprevir continue drugs to treat high blood pressure, the abdomen) or encephalopathy (brain treatment for an additional 12 weeks. antibiotics, sedatives (benzodiazepines) damage that causes personality changes Other patients take pegIFN/RBV for 36 antidepressants, hormonal or problems thinking). weeks, for a total of 48 weeks of contraceptives and others. treatment. Treatment has failed if viral load Simeprevir has not been studied in is over 1000 units per milliliter at week 4. If The herb St. John's Wort (See Fact people less than 18 years old, or in liver this occurs, simeprevir should be stopped. Sheet 729) lowers the blood levels of transplant patients. There is limited some protease inhibitors. Do not take it Simeprevir must be taken with food. This information on people who are also while taking simeprevir. increases blood levels of the drug. infected with HIV or with hepatitis B. Simeprevir needs some fat for good New drug interactions are being absorption. Do not take it with a fat-free Taking simeprevir along with identified all the time. Make sure that or low fat meal. Simeprevir should be pegIFN/RBV gives you a much better your health care provider knows stored at room temperature. chance of clearing HCV genotype 1 about ALL drugs and supplements infection than just taking pegIFN/RBV. you are taking. WHAT ARE THE SIDE EFFECTS? Simeprevir can cause a reduction of red WHAT ABOUT DRUG blood cell counts (anemia, see fact sheet RESISTANCE? 552.) An important side effect is skin rash Some new copies of HCV carry which may occur in over half of all mutations, meaning they are slightly patients. Sun light exposure can trigger different from the original virus. Some or worsen rash. Sun protection with mutated virus can keep multiplying even sunscreen and clothing is recommended. when you are taking anti-HCV Reviewed December 9, 2014

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