AbbVie Receives CHMP Positive Opinion for VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Without Ribavirin for the Treatment of Chronic Hepatitis C in Genotype 1b Patients with Compensated Cirrhosis (Child-Pugh A) in
- EU label expansion supported by high cure rates shown in TURQUOISE-III study, a dedicated Phase 3b study of VIEKIRAX + EXVIERA without ribavirin for 12 weeks
- 100 percent SVR(12) (n=60/60) achieved in genotype 1b patients with compensated cirrhosis (Child-Pugh A); no patients discontinued treatment due to adverse events
Feb 26, 2016
NORTH CHICAGO, Ill., Feb. 26, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).
"This positive CHMP opinion brings us one step closer to delivering a ribavirin-free treatment option for GT1b patients with compensated cirrhosis that has demonstrated high cure rates with no treatment discontinuations in our clinical trial," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone reinforces our continued commitment to provide additional treatment options for the HCV community, and we look forward to the final decision by the European Commission."
Approximately 160 million people worldwide are infected with HCV.1 Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide.2 In Europe, the most prevalent genotype is 1b, accounting for 47 percent of the nine million people infected with chronic HCV.3,4
The CHMP opinion of the Type-II variation application for VIEKIRAX + EXVIERA is supported by data from the Phase 3b TURQUOISE-III study, which is part of AbbVie's larger clinical program investigating efficacy and safety in a broad range of GT1 patients. TURQUOISE-III is a dedicated Phase 3 study of VIEKIRAX + EXVIERA without RBV for 12 weeks in GT1b patients with compensated cirrhosis. Results from the TURQUOISE-III study showed 100 percent (n=60/60) of GT1b chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with VIEKIRAX + EXVIERA without RBV for 12 weeks.5 No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).5
On January 7, AbbVie announced that its supplemental New Drug Application (sNDA) for VIEKIRA PAK® was accepted and granted priority review by the U.S. Food and Drug Administration (FDA).
About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of CHC in adults.
Important EU Safety Information
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
VIEKIRAX and EXVIERA are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX with or without EXVIERA is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
Globally, prescribing information varies; refer to the individual country product label for complete information.
About VIEKIRA PAK
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated).
VIEKIRA is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a healthcare provider before taking VIEKIRA.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA PAK in combination with ribavirin, people should read the Medication Guide that comes with ribavirin, especially the important pregnancy information.
What is the most important information to know about VIEKIRA PAK?
⋅ VIEKIRA PAK may cause severe liver problems, especially in people with certain types of cirrhosis. These severe liver problems can lead to the need for a liver transplant, or can lead to death.
⋅ 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 doctor can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
⋅ A doctor should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.
⋅ A doctor may tell people to stop taking VIEKIRA PAK if signs or symptoms of liver problems develop. A doctor 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, color changes in stools, confusion, or swelling of the stomach area.
VIEKIRA PAK must not be taken if people:
⋅ have certain liver problems
⋅ take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) ⋅
carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) ⋅
colchicine (Colcrys®) ⋅
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 ⋅
⋅ have had a severe skin rash after taking ritonavir (Norvir®)
What should people tell a doctor before taking VIEKIRA PAK?
⋅ If they have: liver problems other than hep C 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 doctor 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 doctor should be consulted about the best way to feed a baby if taking VIEKIRA PAK. Pregnant females who have both hep C and HIV infection should talk with a doctor 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 doctor. A doctor will provide instruction on whether it is safe to take VIEKIRA PAK with other medicines.
- When VIEKIRA PAK is finished, a doctor should be consulted on what to do if one of the usual medicines taken was stopped or if the dose changed during VIEKIRA PAK treatment.
What are the common side effects of VIEKIRA PAK?
⋅ For VIEKIRA PAK used with ribavirin, side effects include tiredness, 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 sleep problems.
These are not all of the possible side effects of VIEKIRA PAK. A doctor should be notified if there is any side effect that is bothersome or that does not go away.
This is the most important information to know about VIEKIRA PAK. For more information, talk with a doctor.
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.
for full Prescribing Information, including the Medication Guide.
If people cannot afford their medication, they should contact www.pparx.org for assistance.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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2 Global Alert and Response (GAR): Hepatitis C. World Health Organization Web site. http://www.who.int/csr/disease/hepatitis/Hepc.pdf. Published 2003. Accessed February, 2016.
3 O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease:
Pathophysiology/Diagnosis/Management. 9th ed, Vol 1. Philadelphia, PA: Saunders Elsevier. 2010:1313-1335.
4 Hatzakis, A. et al. The state of hepatitis B and C in Europe: report from the hepatitis B and C summit conference. Journal of Viral Hepatitis, 2011; 18 (Suppl. 1):1-16.
5 Feld JJ, Moreno C, Trinh R, et al. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks. J Hepatol. 2016 Feb; 64(2):301-7.
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