TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) Receives FDA Approval as the First and Only All-Oral, Interferon-Free Treatment for Genotype 4 Chronic Hepatitis C in the U.S.

- TECHNIVIE provides an opportunity to treat adults in the U.S. who have genotype 4 (GT4) chronic hepatitis C virus (HCV) infection without cirrhosis, a population historically considered difficult-to-treat

- Approval is supported by a robust Phase II clinical trial of 135 chronic HCV GT4 patients, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who took TECHNIVIE with ribavirin (RBV)

News provided by

AbbVie

Jul 24, 2015, 02:00 ET

NORTH CHICAGO, Ill., July 24, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global, research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved TECHNIVIE (ombitasvir, paritaprevir, and ritonavir tablets) in combination with ribavirin (RBV) for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis. TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection. The approval of TECHNIVIE marks an important advancement in providing this historically difficult-to-treat population of HCV patients an opportunity for a cure. Virologic cure is defined as a sustained virologic response (SVR), which is when the virus is no longer detectable in the patient's blood 12 weeks after treatment (SVR₁₂).¹ TECHNIVIE is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B).

"Physicians have previously had limited options when it comes to treating people living with GT4 chronic hepatitis C," said Tarek Hassanein, M.D., professor of medicine, University of California San Diego School of Medicine. "The approval of TECHNIVIE in combination with ribavirin is important for these patients who now have an approved all-oral, interferon-free treatment option that provides a high probability of a cure."

The FDA granted priority review to AbbVie for TECHNIVIE, a designation granted to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness. This designation shortened the regulatory review period from the normal 10 months to six months. TECHNIVIE was also granted a Breakthrough Therapy designation by the FDA in 2014, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy.²

"As demonstrated by the PEARL-I study results, TECHNIVIE delivers on AbbVie's ongoing commitment to provide curative therapies for HCV patients who have historically been considered difficult-to-treat," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

About the PEARL-I Study

This approval of TECHNIVIE is based on data from the PEARL-I study, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR₁₂) in patients who received TECHNIVIE and RBV for 12 weeks. PEARL-I is an open-label Phase 2b study that evaluated the efficacy and safety of TECHNIVIE in GT4 chronic HCV patients without cirrhosis. The study included GT4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49). Additionally, 91 percent of patients who were new to therapy achieved SVR₁₂ (n=40/44) after taking TECHNIVIE without RBV. In the treatment-naive group without RBV, on-treatment virologic breakthrough was reported in one patient (two percent), and two patients (five percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms.

There were no discontinuations due to adverse events in these patients. The most commonly reported treatment-emergent adverse events (greater than 10 percent in any group) observed in patients receiving TECHNIVIE or TECHNIVIE with RBV, respectively, were asthenia (weakness) (25-29 percent), fatigue (7-15 percent), nausea (9-14 percent) and insomnia (5-13 percent). Four patients who received TECHNIVIE with RBV experienced decreased hemoglobin (anemia) which required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production. All patients treated with TECHNIVIE and RBV achieved SVR_12.

About AbbVie Patient Support Programs

For people living with chronic HCV infection who face financial difficulties, the AbbVie Patient Assistance Program provides AbbVie HCV medication at no cost to eligible patients. Additionally, AbbVie's patient support program, called proCeed™, provides a broad range of patient support options. The proCeed program can be accessed at www.technivie.com or by calling 1-844-2-PROCEED.

AbbVie also supports independent nonprofit organizations that assist eligible patients enrolled in federal and private insurance plans with their out-of-pocket medication costs.

About TECHNIVIE
TECHNIVIE is an all-oral antiviral treatment consisting of the fixed-dose combination of paritaprevir/ritonavir (150/100mg) co-formulated with ombitasvir (25mg) dosed once daily and taken with a meal, which is co-administered with weight-based RBV (1000mg or 1200mg in divided doses, twice daily), taken with food. The combination of two direct-acting antivirals, each with distinct mechanisms of action, targets and inhibits specific HCV proteins in the viral replication process.

Important Safety Information³

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.

IMPORTANT SAFETY INFORMATION
TECHNIVIE is taken 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 TECHNIVIE?

TECHNIVIE 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 TECHNIVIE. If these medicines are used as a method of birth control, another method must be used during treatment with TECHNIVIE, and for about 2 weeks after treatment with TECHNIVIE 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 TECHNIVIE 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 TECHNIVIE: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, or color changes in stools.

TECHNIVIE 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 • 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®)

Before taking TECHNIVIE, people should tell a doctor about all their medical conditions, including:

if they have liver problems other than hep C infection or have HIV infection.
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 TECHNIVIE.
if they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if TECHNIVIE 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 TECHNIVIE.
all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with TECHNIVIE.
- a new medicine must not be started without telling a doctor. A doctor will provide instruction on whether it is safe to take TECHNIVIE with other medicines.
- when TECHNIVIE 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 TECHNIVIE treatment.

What are the common side effects of TECHNIVIE?
TECHNIVIE with ribavirin side effects include feeling weak, tiredness, nausea, and sleep problems.

These are not all of the possible side effects of TECHNIVIE. 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 TECHNIVIE. 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, click here or visit rxabbvie.com/pdf/technivie_pi.pdf.

About Hepatitis C
Hepatitis C is inflammation of the liver caused by an infection with the hepatitis C virus. It is transmitted when an infected person's blood enters the bloodstream of another person. The Centers for Disease Control (CDC) estimates that 2.7 million people have chronic HCV infection in the U.S.⁴, which is more than two times as many people affected by the human immunodeficiency virus (HIV).⁵ There are six major HCV genotypes (GT1-6). While genotype 1 (GT1) is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases⁶, GT4 infection is estimated to account for approximately 1.1 percent of HCV infections⁷, and was historically considered difficult-to-treat. It is estimated that more than one million people currently living with HCV will develop cirrhosis (scarring of the liver) by the year 2020,⁸ and with HCV-related liver transplants on the rise, it has become a critical public health issue. As the population ages and HCV progresses, it is projected that total annual direct medical costs of HCV in the U.S. will reach $85 billion over the next 20 years.⁹

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 AASLD/IDSA/IAS–USA. When and in Whom to Initiate HCV Therapy. http://www.hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy. Accessed June 2015.

² U.S. Food and Drug Administration Online. Fact Sheet: Breakthrough Therapies. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm329491.htm. Accessed July 2015.

³ TECHNIVIE [package insert]. North Chicago, IL: AbbVie Inc.

⁴ Centers for Disease Control and Prevention. Hepatitis C FAQs for Health Professionals. Centers for Disease Control and Prevention website. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed July 2015.

⁵ Centers for Disease Control and Prevention (CDC). HIV in the United States: At A Glance. http://www.cdc.gov/hiv/statistics/basics/ataglance.html. Accessed June 2015.

⁶ 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

⁷ Manos MM, Shvachko VA, Murphy RC, et al. Distribution of hepatitis C virus genotypes in a diverse US integrated healthcare population. J Med Virol. 2012 Nov; 84(11):1744-50.

⁸ Davis, G., Alter M., El–Serag H., et al. Aging of Hepatitis C Virus-Infected Persons in the United States: A Multiple Cohort Model of HCV Prevalence and Disease Progression. Gastroenterology. 2010; Vol 138: 513-521.

⁹ Pyenson B., Fitch K., Iwasaki K., et al. (2009). Milliman Report. "Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease". http://us.milliman.com/uploadedFiles/insight/research/health-rr/consequences-hepatitis-c-virus-RR05-18-09.pdf. Accessed June 2015.

SOURCE AbbVie