Common Treatment Side Effects

Common Treatment Side Effects 

Epclusa (sofosbuvir/velpatasvir) fixed dose, by Gilead Sciences for All genotypes 1-6

*Common Treatment Side Effects

The most common treatment side effects of Epclusa include headache and fatigue. If ribavirin is used, side effects of ribavirin can include possible anemia, fatigue, nausea, headache, insomnia and diarrhea were reported in clinical trials.

Warning and Precautions

FDA reports Epclusa carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone (heart medication) is used with sofobuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Epclusa is not recommended. Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood which could lead to reduced efficacy of treatment.

Coadminstration of Epclusa is not recommended with topotecan or proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir.

See full label instructions at drugs@fda and at www.gilead.com

 

Vosevi (sofosbuvir, velpatasvir, voxilaprevir) fixed dose, by Gilead Sciences for all Genotypes 1-6

*Most Common Side Effects: headache, fatigue, diarrhea, nausea.

*Caution: Vosevi may cause serious side effects, including:

*Hepatitis B virus (HBV) reactivation.  Before starting treatment, your physician will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with Vosevi.
Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your physician will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking Vosevi.

*Slow heart rate (bradycardia). Vosevi treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone, Nexterone, Pacerone), a medicine used to treat certain heart problems. In some cases bradycardia has led to death or the need for a heart pacemaker when amiodarone is taken with medicines similar to Vosevi that contain sofosbuvir. Get medical help right away if you take amiodarone with Vosevi and have any of the following symptoms: fainting or near fainting, dizziness or light headedness, not feeling well, weakness, extreme fatigue, shortness of breath, chest pains, confusion or memory problems.

*Do not take Vosevi if you also take any medicines that contain rifampin (Rifater, Rifamate, Rimactane, Rifadin).

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Mavyret (gelcaprevir/pibrentasvir) fixed dose by AbbVie for All genotypes.

Prior to Treatment:

All patients should be tested for evidence of current or prior Hepatitis B (HBV) core antibody (anti-HBc) before treatment with Mavyret.

Dosage and Duration:

Mavyret is a fixed-dose combination tablet containing glecaprevir 100 mg and pibrentasvir 40 mg. No ribavirin required. The recommended oral dosage of Mavyret is three tablets taken once daily with food.

For all genotypes: 1, 2, 3, 4, 5, 6 patients without any treatment experience and no cirrhosis, treatment is for 8 weeks. Patients without any treatment experience with compensated cirrhosis, treatment is for 12 weeks.

For genotype 1 patients who have been previously treated with an NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor, and no cirrhosis, recommended treatment is for 16 weeks.

For genotype 1 patients who have been previously treated with an NS3/4A PI 2 and with an NS5A inhibitor, with no cirrhosis and patients with compensated cirrhosis, treatment is for 12 weeks.

For all genotypes 1, 2, 4, 5, or 6 patients who have been previously treated with an PRS 3 with no cirrhosis, treatment is for 8 weeks and for patients with compensated cirrhosis, treatment is for 12 weeks. For patients with genotype 3 with no cirrhosis, treatment is for 16 weeks and patients with compensated cirrhosis, treatment is for 16 weeks.

For all genotype patients with chronic kidney disease recommended treatment is for 12 weeks.

Side Effects:

The most common side effects reported in clinical trials were headache, fatigue, nausea and some with diarrhea.

Cure Rate:

Clinical trials report cure rates from 92% to 100% with the average cure of 98%.

Drug Interactions:

It is very important to tell your physician and pharmacist any medical conditions you have and all medications, vitamins and supplements or herbs you take prior to taking Mavyret.

Mavyret should not be taken with atazanavir, or rifampin. Mavyret also interferes with other drugs, especially carbamazepine, efavirenz, and St. John’s wort.

It is important to note that additional drug to drug interactions may occur. To get a complete listing of drug interactions, see prescribing information list provided by Mavyret.

Warning:  

Mavyret is not recommended for children and is not recommended for patients with decompensated cirrhosis (severe hepatic impairment Child-Pugh C).

It has been reported that patients who are co-infected with Hepatitis B and C or patients who have had Hepatitis B in the past, could be at risk for hepatitis B reactivation. Hep B has been reported in HCV/HBV coinfected patients who were taking or had taken treatment with the Hep C direct acting antiviral and not receiving treatment for Hep B.

Prior to taking Mavyret, make sure your physician tests you for Hepatitis B antibodies and report any prior history of Hepatitis B or treatment for Hep B. Some cases have resulted in serious hepatitis reactivation, liver failure, and death.

Be sure to report pregnancy or breast feeding to your physician prior to taking Mavyret.

For full product information see Mavyret.com. For co-pay assistance or patient assistance program for Mavyret call: 1-877-628-9738 to learn more.

 

Harvoni (ledipasvir/sofosbuvir)fixed dose, by Gilead Sciences for genotypes 1a, 1b, 4, 5, 6

*Common Side Effects reported in >10% were fatigue and headache for those treated for 8, 12 or 24 weeks.

*Other side effects listed by the FDA reports less than 10% of patients experienced nausea, diarrhea and insomnia.

*Laboratory Abnormalities of elevations of Bilirubin and Lipase and Creatine Kinase in a small percentage of patients were observed.

*Caution Drug Interaction: Risk of Reduced Therapeutic Effects of Harvoni due to P-gp Inducers; Rifampin and St. John’s Wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.

*In addition to Rifampin and St. John’s Wort, there are other drug interactions with certain Antacids and other acid-reducing meds, Dignoxin, Anti-Seizure medications, Simprevir (Olysio), Rosuvastatin and HIV and TB medications.  See a complete list of drug reactions to Harvoni listed on Gilead’s/Harvoni website.  Be sure to talk to your physician and pharmacist about all medications and supplements you are taking prior to taking Harvoni.

US, FDA approved Harvoni, October 10th the first once-daily single tablet regimen for Hepatitis C genotype 1.  Harvoni by Gilead Sciences combines Ledipasvir, an NS5A inhibitor with the nucleotide analog polymerase inhibitor Sofosbuvir (Sovaldi) which was approved December 2013.

See Harvoni.com for more information and full product guide.

 

Harvoni By Gilead Sciences for all Genotypes 1, 4, 5, and 6, approved for Children (see specific guidelines) Sovaldi and Ribavirin also approved for Children with genotype 2 or 3 without cirrhosis or with compensated (mild) cirrhosis. (See for specific guidelines with Sovaldi/Ribavrin for children).

See New Hep C Treatment for Children with Harvoni and also Sovaldi/Ribavirin for more information.

Common Side Effects: most common side effects are: headache and fatigue; Less common are diarrhea, nausea and insomnia.

*Caution Drug Interaction: Risk of Reduced Therapeutic Effects of Harvoni due to P-gp Inducers; Rifampin and St. John’s Wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.

*In addition to Rifampin and St. John’s Wort, there are other drug interactions with certain Antacids and other acid-reducing meds, Dignoxin, Anti-Seizure medications, Simprevir (Olysio), Rosuvastatin and HIV and TB medications.  See a complete list of drug reactions to Harvoni listed on Gilead’s/Harvoni website.  Be sure to talk to your physician and pharmacist about all medications and supplements you are taking prior to taking Harvoni.

 

Olysio/Sovaldi Combo (simeprevir/sofosbuvir) with or without Ribavirin by Janssen Pharmaceuticals for genotypes 1a, 1b

* Patients with HCV genotype 1a infection should be tested for NS3 Q80K polymorphism. It is strongly recommended and alternative therapy should be considered if HCV genotype 1a with Q80K is detected before using Olysio.

*Common Side Effects: the most common side effects for Olysio/Sovaldi are fatigue, headache and nausea.  Sun or light sensitivity and rash have also been reported. OLYSIO® combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO®.

*Common Side Effects if Ribavirin are used: Read full Medication Guides at Olysio.com.  See separate common side effects listed below for Ribavirin.

*Caution Drug Interaction: OLYSIO® and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO® or other medicines in your body, which may affect the way OLYSIO® or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist.

Especially tell your healthcare provider if you take any of the following medicines (when taken by mouth or given by injection, where applicable): amiodarone (Cordarone®, Pacerone®) , amlodipine (Norvasc®), atazanavir (Reyataz®), atorvastatin (Lipitor®, Caduet®), carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), cisapride (Propulsid®, Propulsid Quicksolv®), clarithromycin (Biaxin®, Prevpac®), cobicistat-containing medicine (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), darunavir (Prezista®), delavirdine mesylate (Rescriptor®), dexamethasone, digoxin (Lanoxin®), diltiazem (Cardizem®, Dilacor XR®, Tiazac®), disopyramide (Norpace®), efavirenz (Sustiva®, Atripla®), erythromycin (E.E.S.®, Eryc®, Ery Tab®, Erythrocin®, Erythrocin Stearate®), etravirine (Intelence®), felodipine (Plendil®), flecainide (Tambocor®), fluconazole (Diflucan®), fosamprenavir (Lexiva®), indinavir (Crixivan®), itraconazole (Sporanox®, Onmel®), ketoconazole (Nizoral®), lopinavir (Kaletra®), lovastatin (Advicor®, Altoprev®, Mevacor®), mexiletine (Mexitil®), midazolam, milk thistle (Silybum marianum) or products containing milk thistle, nelfinavir (Viracept®), nevirapine (Viramune®, Viramune XR®), nicardipine (Cardene®), nifedipine (Adalat CC®, Afeditab CR®, Procardia®), nisoldipine (Sular®), oxcarbazepine (Oxtellar XR,Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Phenytek®), pitavastatin (Livalo®), posaconazole (Noxafil®), pravastatin (Pravachol®), propafenone (Rythmol SR®), quinidine (Nuedexta®, Duraquin®, Quinaglute®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), rifapentine (Priftin®), ritonavir (Norvir®), rosuvastatin (Crestor®), saquinavir mesylate (Invirase®), sildenafil (Revatio®, Viagra®), simvastatin (Zocor®, Vytorin®, Simcor®), sirolimus (Rapamune®), St. John’s wort (Hypericum perforatum) or products containing St. John’s wort, tadalafil (Adcirca®, Cialis®), telithromycin (Ketek®), tipranavir (Aptivus®), triazolam (Halcion®), verapamil (Calan®, Covera HS®, Isoptin®, Tarka®), voriconazole (Vfend®) .

This is not a complete list of medicines that could interact with OLYSIO®. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Olysio/Sovaldi Combo  approved by the FDA November 6th, 2014. Olysio/Sovaldi Combo which consists of Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with Sovaldi (sofosbuvir) as an all-oral, interferon and ribavirin-free treatment option for genotype 1 patients.

Both drugs had received prior independent approval from the FDA.  Olysio (simeprevir) made by Janssen was approved November 22, 2013. Sovaldi (sofosbuvir) made by Gilead Sciences was approved December6th2013. Olysio is not to be taken alone.

See Olysio.com for more information and full product guide.

 

Viekira Pak (ombitasvir/partiaprevir/ritonavir/dasabuvir) by AbbVie: for genotype 1a or 1b with or without cirrhosis

Common Side Effects for VIEKIRA PAK used with ribavirin, side effects include fatigue, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.

For VIEKIRA PAK used without ribavirin, side effects include nausea, itching, and insomnia.

These are not all of the possible side effects of VIEKIRA PAK. See Viekira.com for more information and full product guide.  A healthcare provider should be notified if there is any side effect that is bothersome or that does not go away.

Drugs Contraindicated with Viekira Pak: Certain drugs may decease loss of therapeutic activity of Viekira Pak or lead to harmful side effects.  Make sure to talk to your physician about all medications, and supplements you take prior to starting treatment with Viekira Pak.  *Important review FDA release of Contraindicated Drugs and List of Drug Interactions for Viekira Pak.

Note: A contraindication is a specific situation in which a drug, procedure, or surgery should not be used because it may be harmful to the patient. There are two types of contraindications: Relative contraindication means that caution should be used when two drugs or procedures are used together. Absolute contraindication means that event or substance could cause a life-threatening situation. A procedure or medication that falls under this category should be avoided.

Caution Drug Interaction: Potential for VIEKIRA PAK to Affect Other Drugs and Potential for Other Drugs to Affect One or More Components of VIEKIRA PAK

VIEKIRA PAK can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).

Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with VIEKIRA PAK. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA PAK, and for about 2 weeks after treatment with VIEKIRA PAK ends. A healthcare provider can provide instruction on when to begin taking ethinyl estradiol-containing medicines.

A healthcare provider should do blood tests to check liver function during the first 4 weeks of treatment and then as needed. A healthcare provider may tell people to stop taking VIEKIRA PAK if signs or symptoms of liver problems develop.

A healthcare provider must be notified right away if any of the following symptoms develop or if they worsen during treatment with VIEKIRA PAK: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, or color changes in stools.

VIEKIRA PAK must not be taken if people:

*have severe liver problems

*take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) – carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) – efavirenz (Sustiva®, Atripla®) – ergot containing medicines including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) – ethinyl estradiol-containing medicines – gemfibrozil (Lopid®) – lovastatin (Advicor®, Altoprev®, Mevacor®) – midazolam (when taken by mouth) – phenytoin (Dilantin®, Phenytek®) – phenobarbital (Luminal®) – pimozide (Orap®) – rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) – sildenafil citrate (Revatio®) when taken for pulmonary artery hypertension (PAH) – simvastatin (Zocor®, Vytorin®, Simcor®) – St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort – triazolam (Halcion®) or have had a severe skin rash after taking ritonavir (Norvir®).

What should people tell a healthcare provider before taking VIEKIRA PAK

If they have: liver problems other than HCV infection, HIV infection, or any other medical conditions.

If they have had a liver transplant. If they take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), a healthcare provider should check blood levels, and, if needed, may change the dose of these medicines or how often they are taken, both during and after treatment with VIEKIRA PAK.

If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA PAK will harm a person’s unborn baby or pass into breast milk. A healthcare provider should be consulted about the best way to feed a baby if taking VIEKIRA PAK. For pregnant females that have both HCV and HIV infection, they should talk with a healthcare provider about enrolling in the antiretroviral pregnancy registry.

About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA PAK.

A new medicine must not be started without telling a healthcare provider. A healthcare provider will provide instruction on whether it is safe to take VIEKIRA PAK with other medicines.

Sovaldi (sofosbuvir) by Gilead Sciences for genotypes 1, 2, 3, 4, 5, 6

 Most Common Side Effects of Sovaldi (sofosbuvir) listed from Gilead.  FDA approved Dec 2013.  Sovaldi can be used without peginterferon on certain genotypes and specific liver conditions. Used in combination with Ribavirin:

*tiredness *headache

The most common side effects of Sovaldi (sofosbuvir) when used in combination ribavirin include:

*tiredness  *headache   *nausea  *difficult sleeping  *low red blood count

*See Side Effects from Ribavirin below.  Talk to your doctor if you have ever dealt with depression or anxiety and the possible need to take an Anti-Depressant while on treatment.

 

Daklinza (daclatasvir + sofosbuvir) by Bristol-Myers Squibb for genotype 3 without Interferon or Ribavirn

Common Side Effects with Daklinza in combination with sofosbuvir and amiodarone may cause serious side effects, including:

  • Slow heart rate (bradycardia). Daklinza combination treatment with sofosbuvir may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone, a medicine used to treat certain heart problems. Get medical help right away if you take amiodarone with sofosbuvir and Daklinza and get any of the following symptoms: fainting or near-fainting, weakness, chest pain, dizziness or lightheadedness, tiredness, confusion, not feeling well, shortness of breath, memory problems.

The most common side effects of Daklinza when used in combination with sofosbuvir include headache and tiredness.

These are not all the possible side effects of Daklinza. Call your doctor for medical advice about side effects.

Please see US Full Prescribing Information and Patient Information.

 

Technivie (ombitasvir, paritaprevir and ritonavir) by AbbVie, used with Ribavirin for genotype 4

Common side effects: TECHNIVIE with ribavirin side effects include feeling weak, tiredness, nausea, and sleep problems.

These are not all of the possible side effects of TECHNIVIE. Tell your doctor if you have any side effect that bothers you or that does not go away.

USE

TECHNIVIE (ombitasvir, paritaprevir and ritonavir) tablets is a prescription medicine used with ribavirin to treat adults with genotype 4 chronic (lasting a long time) hepatitis C (hep C) virus infection without cirrhosis.

TECHNIVIE is not for people with certain types of liver problems.

This is the most important information to know about TECHNIVIE. For more information, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including the Medication Guide.

Zepatier (elbasvir/grazoprevir) by Merck for Genotypes 1 and 4

Common Treatment Side Effects when used without Ribavirin include:

*feeling tired *trouble sleeping *headache *diarrhea *nausea

 

Common Treatment Side Effects when used with Ribavirin include:

*low red blood cell counts (anemia) *feeling irritable *headache *stomach pain

*feeling tired *depression *shortness of breath *joint pain *rash or itching

NS5A Resistance Testing Recommended for Genotype 1a patients

Testing patients with Hep C genotype 1a for the presence of the virus with NS5A resistance-associated polymorphisms is recommended prior to treatment with Zepatier to determine dosage regimen and duration. In clinical trial patients receiving Zepatier for 12 weeks, their SVR rates were lower. For more detailed information see FDA and Merck’s press release.

Warning and Precautions:

Zepatier may cause increases in your liver-related blood tests (liver enzymes, etc..).  It is recommended your physician should monitor your liver panel with blood tests before and during your treatment with Zepatier.

Tell your healthcare provider right away if you get any of the following symptoms or if they get worse during treatment.

*loss of appetite *yellowing of your skin or eyes *nausea and vomiting *color changes in your stool *feeling tired or weak

Zepatier is not recommended in patients with moderate or severe hepatic impairment.  See more information from Merck’s press release.

Drugs that are NOT recommended to be used with Zepatier:

*Anticonvulsants: Phenytoin, Carbamazepine

*Antimycobacterials: Rifampin

*Herbal Products: St. Johns Wart (Hypericum perforatrum)

*HIV Medications: Efavirenz

*HIV Medications: Atazanavir, Darunavir, Lopinavir, Sasquinavir, Tipranavir

*Immunosuppressants: Cyclosporine

Eirum Chaudhri, a hepatologist and executive director of scientific affairs at Merck Research Labs, states, Zepatier offers a new ribavirin-free treatment option for some genotype 4 (GT4) patients. Zepatier can also be dosed safely for patients with advanced renal dysfunction, including patients on hemodialysis, because it is excreted primarily through the liver instead of through a renal excretion pathway like sofosbuvir-containing regimens (i.e. Harvoni and Sovaldi)

Zepatir, which won two FDA breakthrough designations, previously was approved in Canada.

For more detailed information see: Merck’s press release for Zepatier or FDA’s press releases for Zepatier, or Zepatier.com.

 

Common Side Effects of Ribavirin:

*possible vision problems   *fever, chils, body aches, flu symptoms

*pain in your upper stomach spreading to your back   *nausea    *vomiting,   *fast heart rate

*chest pain *wheezing   *shortness of breath   *depression

Talk to your doctor if you have ever dealt with depression or anxiety and the possible need to take an Anti-Depressant while on treatment.

 

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

It is important to be proactive and read full information on all medications.   Talk to your doctor and ask questions when deciding which one is right for you.  Epclusa, Harvoni, Sovaldi, Olysio, Daklinza, Techivie, Viekira Pak, Zepatier, and Ribavirin are oral medications.

Be sure to tell your doctor about ALL medications you take along with any other medical conditions you have before beginning Hep C Treatment.

 

Important to Note about all Side Effects

It is important to understand that side effects listed by the pharmaceutical companies does not mean you will experience any or all of these, but these have been reported.  The good news is you will be closely monitored by your doctor and if you do experience any side effects, there are medications to help alleviate  majority of these symptoms.  Make sure to contact your doctor if you experience any side effects so you can get the medications and help you need for relief.  Also, remember this is temporary and it will pass.  A good way to look at it is, You are in battle and your army, (the treatment) is fighting for you, killing the virus and restoring to you a healthy liver.   You can do this!

 

References

Gilead Sciences, makers of Epclusa (sofosbuvir/velpatasvir)

Gilead Sciences, makers of Harvoni (ledipasvir, sofosbuvir)

Gilead Sciences, makers of Sovaldi (Sofosbuvir).

Janssen, makers of Olysio (Simeprevir) and Olysio/Sovaldi Combo.

AbbVie, makers of Viekira Pak

Bristol-Myers Squibb, makers of Daklinza

AbbVie, makers of Technivie

Merck, makers of Zepatier

Ribavirin

American Liver Foundation

Center for Disease Control & Prevention 

Liver Specialist of Texas

Mayo Clinic  

 

See Resource/Support Listings for additional references.