New Treatment for Hep C

 Epclusa by Gilead Sciences for All Genotypes 1-6.

Epclusa (sofosbuvir/velpatasvir), made by Gilead Sciences was approved by the U.S. FDA June 28, 2016.

*Epclusa is the first Hep C treatment available to used for all genotypes (1-6).

*Epclusa can be used with or without Ribavirin.

Dosage:

*1 pill, once daily dose combination of Sofosbuvir and Velpatasvir. If Ribavirin is used with treatment, this is a separate pill.

Treatment Duration Time

Standard treatment time is 12 weeks.

SVR (sustained virologic response) Cure Rate:

An average 98% SVR (sustained virologic response) cure rate from Hep C was shown in clinical trial studies with Hep C patients who did not have cirrhosis or those who had compensated cirrhosis.

An 83% to 94% SVR, cure rate was reported for patients in clinical trials who had decompensated cirrhosis (Child-Pugh B).

Common 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

For more information regarding Epclusa see (www.MySupportPath.com)

 

Vosevi by Gilead Sciences for all Genotypes 1-6

Vosevi (sofobuvir, velpatasvir, voxilaprevir), made by Gilead Sciences was approved by the U.S. FDA July 18, 2017.

Vosevi treats adults without cirrhosis or with mild cirrhosis. Treatment for patients who have been previously treated with direct-acting antiviral drug sofobuvir, or other treatment for Hep C that inhibit the protein NS5A.

*1 pill taken once a day at a scheduled time each day and taken with food.

Important Note: If you need to take an antacid medicine that contains aluminum or magnesium, take it either 4 hours before or 4 hours after you take Vosevi.

Treatment Duration Time: 

Treatment duration time may vary depending on viral genotype and prior treatment history. Standard length of treatment is 12 weeks.

*SVR12 Cure Rates: 96-97%

*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 by AbbVie for ALL Genotypes

The U.S. FDA approved Hepatitis C treatment Mavyret, for all genotypes, for patients without cirrhosis and those with compensated cirrhosis as well as patients with genotype 1 who have been previously treated with an HCV NS5A inhibitor or NS3/4A protease inhibitor but not both and for patients with severe kidney disease, including those on dialysis.

Mavyret is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor. Mavyret is taken without ribavirin. Mavyret is made by AbbVie and U.S. FDA approved on August 3, 2017.

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 By Gilead Sciences for Genotypes 1a, 1b, 4, 5, 6 for Adults 

Harvoni (Ledipasvir and Sovaldi), made by Gilead Sciences was approved by the U.S. FDA October 2014.

FDA approved expanded treatment options for Havoni February 12, 2016.

FDA approved expanded treatment options for Harvoni and Sovaldi to treat children ages 12 to 17 or weighing at least 77 pounds (35kg), on April 7th, 2017. Treatment options for children without cirrhosis or with compensated (mild) cirrhosis.

*1 pill, once daily dose combination of Ledipasvir and Sovaldi.

*Interferon free treatment for Genotypes 1a, 1b, 4, 5, 6 to be used with or without Ribavirin, depending on liver condition.

Treatment Duration Time: 

Genotype 1

*Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)

*Harvoni 12 weeks

______________________________________________________________

Genotype 1

*Treatment experienced without cirrhosis

*Harvoni 12 weeks

______________________________________________________________

Genotype 1

*Treatment experienced with compensated cirrhosis (Child-Pugh A)

*Harvoni 24 weeks

______________________________________________________________

Genotype 1

*Treatment naïve and treatment experienced with decompensated cirrhosis (Child-Pugh B or C)

*Harvoni + Ribavirin 12 weeks

_________________________________________________________________

Genotype 1 or 4

*Treatment naïve and treatment experienced liver transplant patient

without cirrhosis, or with compensated cirrhosis (Child-Pugh A)

*Harvoni +Ribavirin 12 weeks

________________________________________________________________

Genotype 4, 5, or 6

*Treatment naïve and treatment experienced without cirrhosis or

with compensated cirrhosis (Child-Pugh A)

*Harvoni 12 weeks

_______________________________________________________________

*Treatment Duration is 8 weeks for certain treatment-naive patients without cirrhosis and a baseline viral load below 6 million.

*Treatment-experienced patients without cirrhosis, 12 weeks of treatment is recommended.

* Treatment-experienced patients who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin with cirrhosis  are recommended to take treatment for 24 weeks.

*SVR12 Cure rates range between 94 to 99%.

*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.

 

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 below for specific guidelines with Sovaldi/Ribavrin for children).

FDA approved expanded treatment options for Harvoni and Sovaldi to treat children ages 12 to 17 or weighing at least 77 pounds (35kg), on April 7th, 2017. Treatment options for children without cirrhosis or with compensated (mild) cirrhosis.

Treatment Medication: Harvoni 1 pill a day. If Sovaldi/Ribavirin is prescribed the daily dosage of Ribavirin is weight-based and is administered orally in 2 divided doses with food.

SVR12 Cure Rates: 97 to 100%

Treatment Duration Time: Harvoni standard treatment time is 12 weeks for genotypes 1, 4, 5 and 6. Sovaldi/Ribavirin standard treatment time for genotype 2 is 12 weeks, for genotype 3 with or without cirrhosis is 24 weeks.

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 by Janssen for Genotypes 1a, 1b

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 December 6th, 2013.

* Patients with HCV genotype 1a infection should be tested for NS3 Q80K polymorphism which is a subtype virus strain of genotype 1. Not all Genotype 1 have this subtype. Hep C patients with genotype 1 need to be tested for this subtype prior to considering treatment with Olysio.  Those with this subtype NS3Q8OK variant have a decreased response rate to treatment with Olysio and need to considered for another therapy.

*All oral treatment pills of Olysio (simprevir) and Sovaldi (sofosbuvir).

*All combinations of use with Olysio are: Olysio/Sovaldi, or Olysio/Sovaldi + Ribavirin. Note: Olysio, Sovaldi and Ribavirin are pills. Specific treatment combination will depend on genotype, liver condition, past Hep C treatment history.

Treatment Duration Time:

*12 to 24 weeks depending liver condition and past treatment history.

*Recommended treatment duration of OLYSIO with peg-interferon alfa and ribavirin: 12 weeks, followed by 12 or 36 additional weeks of peg-interferon alfa and ribavirin depending on prior response status.

  • For specific dosage instructions for the other antiviral drugs used in combination with OLYSIO, see their respective prescribing information.

*SVR 12Cure Rates range between 91% to 94%.

*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 Peg Interferon-alfa/Ribavirin are used: skin rash, itching and nausea. When taking OLYSIO® in combination with Peg-IFN-alfa and RBV, you should also read full Medication Guides at Olysio.com.

*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.

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

 

Viekira Pak by AbbVie for genotypes 1a or 1b with or without cirrhosis

FDA approved Viekira Pak, December 19, 2014. Viekira Pak made by AbbVie is designed to treat Hep C patients who have genotype 1 varieties, with and without cirrhosis.

*A double pill regimen contains three drugs, ombitasvir, paritaprevir and dasabuvir. The double dose regimen contains one pill with ritonavir combined with paritaprevir and ombitasvir. The second pill contains dasavbuvir. Viekira Pak, an all oral treatment is Peg Interferon free. It can be used however with or without Ribavirin.

Dosing recommendations:

*Taken in the Morning: Two tablets of the combined ombitasvir, paritaprevir and ritonavir.

*Taken in the Morning and Evening: One tablet of dasabuvir.

*Viekira Pak is to be taken with a meal without regard to fat or calorie content.

*If Ribavirin is prescribed, dosing will be based on patient’s weight.

Treatment duration time:


Patient Population
Treatment* Duration
Genotype 1a,
without cirrhosis
VIEKIRA PAK + ribavirin 12 weeks
Genotype 1a,
with cirrhosis
VIEKIRA PAK + ribavirin 24 weeks**
Genotype 1b,
without cirrhosis
VIEKIRA PAK 12 weeks
Genotype 1b,
with cirrhosis
VIEKIRA PAK + ribavirin 12 weeks
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
**VIEKIRA PAK administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history.

For Use in Liver Transplant Recipients

In liver transplant recipients with normal hepatic function and mild fibrosis (Metavir fibrosis score of 2 or lower), the recommended duration of Viekira Pak with ribavirin is 24 weeks, for Hep C patients with genotype 1 subtype.  When Viekira Pak is administered with calcineurin inhibitors in liver transplant recipients, dosage adjustment of calcineurin inhibitors is needed.

 SVR12 Cure Rates between 91% to 100%.

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

 

Sovaldi (sofosbuvir) by Gilead Sciences for genotypes 1, 2, 3, 4.  Used in combination with other Hep C medications

Sovaldi (sofosbuvir) made by Gilead Sciences was approved  by the U.S. FDA on December 6, 2013.

*FDA approved for Genotypes 1,2, 3, 4

*Oral treatment regimen for Genotypes 2 or 3

*Regimen for Hep C patients awaiting liver transplantation to prevent HCV recurrence.

Treatment and Duration Time:

*For Gentoype 1a, 1b: Treatments with either Harvoni (Sovaldi & Ledipasvir) or Sovaldi/Olysio are recommended with combination of Sovaldi.

*For Genotype 2: Sovaldi +ribavirin for 12 weeks.

*For Genotype 3: Sovaldi +ribavirin for 24 weeks.

Further treatment recommendations by American Association for Study of Liver Disease (AASLD) and Infectious Diseases Study of America (ISDA)

*For Genotype 4: Sovaldi +ribavirin for 24 weeks

*For Genotype 5: Sovaldi +ribavirin + peg-interferon alfa for 12 weeks.

*As an alternative treatment for Genotype 6: Sovaldi + ribavirin +peg-interferon alfa for 12 weeks.

Sovaldi in combination with ribavirin for 24 weeks can be considered for CHC (chronic hepatitis C) patients with genotype 1 infection who are interferon ineligible. Talk to your physician about which treatment option is best suited for your genotype, liver condition and any past treatment history.

SVR12Cure Rates 84% to 96%.

Common Side Effects For Sovaldi used in combination with ribavirin include; tiredness and headache and for Sovaldi used in combination with peg interferon alfa and ribavirin they include additional side effects of nausea, difficulty sleeping, and low red blood count. See separate side effect information for peg-interferon and ribavirin.

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

 

Daklinza (daclatasvir) by Bristol Myers Squibb (BMS) for Genotype 3 and Genotype 1

US, FDA Approved July 24, 2015. Daklinza (daclatasvir), a once daily pill for use in combination with sofosbuvir, which is used without Interferon and Ribavirin.  Used for Genotype 3, is the second most common genotype in the United States, with genotype 1 being the most prevalent.

*FDA Update for Daklinza Feb 5, 2016, Hep C treatment with Daklinza has been approved to include the following:

  • Approved for Genotype 3
  • Genotype 1 without cirrhosis
  • Genotype 1 and 3 post-transplant patients
  • Genotype 1 patients with compensated (Child-Pugh A) cirrhosis and decompensated (Child-Pugh B or C) cirrhosis
  • Genotype 3 patients with decompensated (Child-Pugh B or C) cirrhosis

Additionally, drug-drug interaction information regarding Daklinza coadministration with buprenorphanine/naloxone, darunavir/ritonavir, dolutegravir, or lopinavir/ritonavir were included in the label.

Precaution prior to treatment for Genotype 1a patients with cirrhosis: Consider screening for the presence of NS5A polymorphism at amino acids positions M28, Q30, L31, and Y93 in patients with cirrhosis who are infected with HCV genotype 1a prior to treatment with Daklinza and sofosbuvir with or without ribavirin.

*All oral treatment used once daily.

*Treatment duration time; 12 weeks.

SVR Cure rates showed in clinical trials to be:

*Genotype 3 patients 98% for treatment-naïve patients with no cirrhosis of the liver

*58% for treatment-naïve patients with cirrhosis.

*For treatment experienced patients, cure rates were 92% without cirrhosis and 69% for patients with cirrhosis.

*Cure of 97% was shown for Genotype 1 and Genotype 3 patients C0-infected HCV/HIV;

*Genotype 1 patients with Child-Pugh A, B, or C cirrhosis or with Genotype 1 who have had Hep C recurrance after Liver Transplant SVR rates from 97 to 90%.

*Genotype 1a patients with NS5A amino acid polymorphisms with cirrhosis (Child-Pugh A, B, or C), SVR rates showed, bewteen 33% for patients

* Genotype 1a patients with cirrhosis but without NS5A polymorphisam SVR rates are 88%

*Genotype 1 patients without cirrhosis but with NS5A polymorphism, SVR rates 100%.

*Gentoype 1 patients without cirrhosis but without NS5A polymorphism, SVR rate 99%

*Daklinza carries a limitation of use statement to inform prescribers that sustained virologic response rates are reduced in HCV genotype patients with cirrhosis.

*Warning: Daklinza 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 is co-administered with sofosbuvir in combination with another HCV direct acting antiviral, including Daklinza. Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommeneded.

Common Side Effects for Daklinza are fatigue and headache.

See Daklinza for full information in product insert guide.

 

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

U.S. FDA approved Zepatier by Merck, January 28, 2016 for use with or without Ribavrin.

*All oral treatment. Fixed dose combination of Elbasvir and Grazoprevir.

Dosage:

The recommended dosage of Zepatier is one tablet taken orally once daily with or without food at the same time each day.

Treatment Duration Time:

Standard treatment time for most Hep C patients is 12 weeks on Zepatier but Zepatier offers treatment to patients in two small subpopulations as well. Hep C patients with genotype 1 (GT1) whose HCV has mutations with resistance to treatment and Hep C patients with genotype 4 (GT4) who have failed prior Hep C treatment with peg-interferon alfa and ribavirin, 16 weeks of treatment with Zepatier is recommended.

Cure Rate

In six clinical trial studies, Zepatier helped eliminate the Hepatitis C virus (HCV) in 94 to 97% of patients with the most common HCV genotype 1 (GT1), and 97 to 100% of patients with the least common genotype 4 (GT4).

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.

 

Technivie (ombitasvir, paritaprevir, and ritonavir) for use in combination with ribavirin for Genotype 4

US, FDA approved Technivie by AbbVie, July 24, 2015 for use in combination with ribavirin for genotype 4 patients without scarring and without poor liver function (cirrhosis).

*Technivie is used without Interferon.

*All oral treatment. Two tablets daily (in the morning)with meal without regard to fat or calorie content.

*Treatment duration; 12 weeks.

SVR Cure rates showed 100% using Technivie with ribavirin, and Technivie used without ribavirin SVR cure rate was 91%.

Warning: Technivie carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants. The elevations occurred more frequently in females taking contraceptives containing ethinyl estradiol. Contraceptives containing ethinyl estradiol must be discontinued prior to starting Technivie. Hepatic laboratory testing should be performed during the first four weeks of starting treatment, and as clinically indicated thereafter. Technivie not recommended for patients with known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome).

Common Side Effects with ribavirin: fatigue, weakness (asthenia), nausea, insomnia, itching (pruritus), and other skin reactions. The majority of adverse reactions were mild in severity.

See Technivie for full information and product insert guide.

 

Ribavirin:

Common Side Effects of Ribavirin

See for more information: Medline Plus/US National Libarary of Medicine/National Institute of Health 

Ribavirin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

*Cough  *upset stomach  *vomiting   *diarrhea   *constipation   *heartburn

*loss of appetite   *weight loss   *changes in ability to taste food   *dry mouth

*difficulty concentrating   *difficulty falling asleep or staying asleep

*memory loss   *rash   *dry, irritated, or itchy skin   *sweating

*painful or irregular menstruation (period)   *muscle or bone pain   *hair loss

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

*hives

*swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

*hoarseness   *difficulty swallowing or breathing

*pain in the stomach or lower back   *bloody diarrhea   *bright red blood in stools

*black, tarry stools   *stomach bloating   *confusion   *dark-colored urine

*yellowing of the skin or eyes   *unusual bleeding or bruising   *vision changes

*fever, chills, and other signs of infection   *depression

*thinking about hurting or killing yourself   *mood changes   *excessive worry

*irritability

*starting to use street drugs or alcohol again if you used these substances in the past

*intolerance to cold

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.

Deciding Which New Drug to Use

Each patient will need to look at the pro’s and con’s of the new medications.  Each has side effects to be considered.  Talk to your doctor about treatment side effects and which treatment is best suited for your genotype, viral load, liver condition,  any past treatment history and overall medical condition as well as all medications and supplements you take.

Also contact pharmaceutical companies.  Each company provides detail information on how the drug is used, side effects, drug interactions and more.  Each company also provides a 24 hour 7 day a week registered nurse support.

Talk to your doctor about drug interactions of all current medications that you are taking.

See my blog posts on Daily Life, and Hep C Patient Interviews / Hep C Patient’s Treatment Journey also see Videos .

References

epclusa.com or see My Support Path

harvoni.com

olysio.com

sovaldi.com

viekira.com

merck.com

daklinza.com

technivie.com 

Ribavirin information

Peg Interferon information 

Mayo Clinic for Hepatitis C 

Center for Disease Control and Prevention for Hepatitis C 

American Liver Foundation for Hepatitis C

Life Beyond Hepatitis C.com