News

NORTH CHICAGO, Ill., Nov. 14, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data from its ongoing Phase 3b TOPAZ-II study evaluating VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), with or without ribavirin (RBV), in adult patients with genotype 1a (GT1a) or genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection.¹ Results show that 95 percent (n=586/615) of patients in the TOPAZ-II trial achieved a sustained virologic response at 12 weeks post-treatment (SVR₁₂) after 12 or 24 weeks of treatment, a secondary endpoint for the study.¹ These data will be presented at The Liver Meeting® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

The TOPAZ-II study, a multicenter trial in the U.S., evaluates the impact of SVR₁₂ on the progression of liver diseases over the course of five years in a diverse patient population, including genotype 1 (GT1) HCV patients with or without cirrhosis and those who were treatment-naïve or pegylated interferon (pegIFN)/RBV treatment-experienced. Patients were treated with VIEKIRA PAK, with or without RBV, according to the dosing recommendations found in the U.S. full prescribing information.¹

"The preliminary data from TOPAZ-II show that a diverse population of genotype 1 HCV patients, including those with compensated cirrhosis, have been effectively treated with VIEKIRA PAK," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "These data show both GT1a and GT1b patients achieved high sustained virologic response rates when treated with VIEKIRA PAK, with or without ribavirin, for 12 or 24 weeks, which reinforces efficacy data from previous studies."

VIEKIRA PAK, with or without RBV, is indicated for the treatment of patients with GT1 chronic HCV infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA PAK is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity.

"If left untreated over a period of 20 to 30 years, approximately five to 20 percent of chronic hepatitis C patients may develop cirrhosis of the liver," said Nancy Reau, M.D., chief, Section of Hepatology, and associate director, Solid Organ Transplantation, Rush University Medical Center. "These results add to the body of medical information about the treatment of patients with genotype 1 chronic hepatitis C infection, and future data from this study will inform the impact of treatment with VIEKIRA PAK on liver disease progression."

About the TOPAZ-II Study

TOPAZ-II is an ongoing, single arm, open-label, Phase 3b multicenter study in the U.S. evaluating the safety and efficacy of 12 or 24 weeks of treatment with VIEKIRA PAK, with or without ribavirin, in treatment-naïve or pegIFN/RBV treatment-experienced, adult patients with GT1 chronic HCV infection with or without compensated cirrhosis.¹ Patients in the TOPAZ-II study will be followed up for a period of five years post-treatment to evaluate the long-term impact of SVR₁₂ on progression of liver disease.

The trial includes 615 patients, 115 (19 percent) with compensated cirrhosis and 500 (81 percent) without cirrhosis.¹ On-treatment virologic failure was experienced by 0.8 percent (n=5/615) of study patients, while 1.9 percent (n=11/590) experienced relapse. One percent (n=6/615) of patients prematurely discontinued treatment due to adverse events.¹ Four percent (n=25/615) experienced serious adverse events. Ribavirin dosage was reduced due to anemia in 30/474 (6.3 percent) patients or due to hemoglobin decreases in 20/474 (4.2 percent) patients who received RBV. The most commonly-reported adverse events (in ≥10 percent of patients) were fatigue, nausea, headache, pruritus and insomnia.¹

Genotype 1 subjects who were either treatment-naïve or previously treated with IFN or pegIFN/RBV received VIEKIRA PAK. Subjects with GT1a and all GT1 subjects with compensated cirrhosis also received RBV. The treatment duration was 12 weeks for all subjects except GT1a subjects with compensated cirrhosis who received treatment for 24 weeks. Treatment for 12 weeks was considered for some of these patients based on prior treatment history.¹ The primary endpoint is the incidence of all-cause death, liver-related death, liver decompensation, liver transplantation, hepatocellular carcinoma, and the composite of any of the above outcomes observed during the post-treatment period. Key secondary endpoints included the percentage of subjects with SVR₁₂ (HCV undetectable in the blood 12 weeks following the final dose of the study drug), on-treatment virologic failure and post-treatment relapse.¹ 

About VIEKIRA PAK

USE

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 doctor before taking VIEKIRA.

IMPORTANT SAFETY INFORMATION

When taking VIEKIRA 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?

• VIEKIRA 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 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. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA, and for about 2 weeks after treatment with VIEKIRA 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 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: 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 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 • triazolam (Halcion®)
• have had a severe skin rash after taking ritonavir (Norvir®)

What should people tell a doctor before taking VIEKIRA?

• 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.
• If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA 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. 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.
  • A new medicine must not be started without telling a doctor. A doctor will provide instruction on whether it is safe to take VIEKIRA with other medicines.
  • When VIEKIRA 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 treatment.

What are the common side effects of VIEKIRA?

• For VIEKIRA used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.
• For VIEKIRA used without ribavirin, side effects include nausea, itching, and sleep problems.

These are not all of the possible side effects of VIEKIRA. 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. 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.

Click here for full Prescribing Information, including the Medication Guide.

If people cannot afford their medication, they should contact www.pparx.org for assistance.

Additional Information about VIEKIRA PAK®

VIEKIRA PAK® has been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naive to difficult to treat patients, such as those with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV). VIEKIRA PAK is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity. VIEKIRA PAK consists of the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal. VIEKIRA PAK is taken for 12 weeks, except in GT1a patients with cirrhosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients, and in all patients who have cirrhosis or who have received a liver transplant.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

About AbbVie

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.

Forward-Looking Statements

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.

¹ Reau, N., et al. Preliminary Safety and Efficacy Results from TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes in HCV Genotype 1-infected Patients Receiving Ombitasvir/Paritaprevir/r and Dasabuvir +/-Ribavirin. Poster #1065; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13-17, 2015.

SOURCE AbbVie