Efficacy and safety of Paritaprevir/r/Ombitasvir/Dasabuvir ±Ribavirin in GT1 HCV infected patients treated in real life settings (AMBER study - interim analysis

Editor's Note:  Read our Fact Sheet HCV in Japan:   click here: 

AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval in Japan for the Treatment of Genotype 1 Chronic Hepatitis C

• New interferon and ribavirin-free treatment option for patients with most common type of hepatitis in Japan, genotype 1 chronic hepatitis C, including those with compensated cirrhosis[1]
• VIEKIRAX consists of a 12-week, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir, dosed once daily[1]
• Approximately 1.5 to 2 million people are living with hepatitis C in Japan, one of the highest rates of hepatitis C infection in the industrialized world[2],[3]

NORTH CHICAGO, Ill., Sept. 28, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved VIEKIRAX® (ombitasvir/paritaprevir/ritonavir), as a new interferon and ribavirin-free treatment option for adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis.1 VIEKIRAX consists of a 12-week, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir, dosed once daily.

"Today's approval represents an important step forward for the treatment of Japanese patients, a population with specific needs based on patient and viral characteristics," said Jean-Michel Pawlotsky, MD, PhD, professor of medicine at the University of Paris-Est, France. "VIEKIRAX is a valuable new addition to a number of treatments that are changing the face of hepatitis C, making it possible to achieve high virologic cure rates, even in patients whose disease has progressed to compensated liver cirrhosis."

Japan has one of the highest rates of hepatitis C infection in the industrialized world, with approximately 1.5 to 2 million people living with HCV.2, 3 Genotype 1 is the most common HCV genotype in Japan with 60 to 70 percent of patients infected and, of those, about 95 percent are infected with the genotype 1b (GT1b) sub-type.4

"We are pleased to provide VIEKIRAX as a new treatment that offers a high probability of virologic cure for GT1b HCV patients and are working to support access to our treatment in Japan," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We are also prioritizing disease education and awareness by collaborating with stakeholders to identify and address the diverse challenges across Japan, such as supporting screening and diagnosis initiatives, and providing accurate information to the medical community about treatment options."

The approval is supported by the Phase 3 GIFT-I study.1 An overall 95 percent (n=140/148) of treatment-naïve and 94 percent (n=102/109) of treatment-experienced GT1b HCV infected patients achieved SVR12 with VIEKIRAX.1

The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load. A secondary endpoint in GT1b HCV patients with compensated cirrhosis achieved 91 percent (n=38/42) SVR12.5

Across all treatment arms three patients (n=3/363) experienced on-treatment virologic failure, eight patients (n=8/354) experienced post-treatment relapse and three patients discontinued treatment due to adverse events. The most commonly reported adverse events (>5 percent in any arm) were nasopharyngitis, headache, peripheral edema, nausea, pyrexia and decreased platelet count.5 In April 2015, AbbVie was granted priority review by the MHLW for VIEKIRAX, on the basis of clinical usefulness of the treatment and recognizing the severity and unmet need of the disease in Japan.

About the GIFT-I Study5

GIFT-I comprises 363 patients in two sub-studies.

In sub-study 1, 321 genotype 1b (GT1b) patients without cirrhosis, both treatment-naïve and interferon (IFN) [with or without ribavirin (RBV)] treatment-experienced, were randomized to receive either ombitasvir/paritaprevir/ritonavir (Arm A) [OBV/PTV/r] or placebo (Arm B) [2:1 randomization ratio, stratified by treatment history, past response, viral load and IFN eligibility]. Patients initially randomized to placebo (Arm B) then received OBV/PTV/r for an additional 12 weeks of open-label treatment. Sustained virologic response was assessed 12 weeks post-treatment (SVR12) as a primary efficacy endpoint in a sub-group of previously untreated, non-cirrhotic GT1b patients who were eligible for therapy with IFN and had a high viral load, defined as an HCV RNA level ≥ 100,000 IU/mL and received at least one dose of the double-blind, active study drug.

In sub-study 2, 42 GT1b treatment-naïve and IFN (with or without RBV) treatment-experienced patients with compensated cirrhosis received open-label treatment for 12 weeks (Arm C) with SVR12 and assessed as a secondary efficacy endpoint.

One patient from each arm (n=3/363) experienced on-treatment virologic failure [Arm A, 0.5% (n=1/215); Arm B, 0.9% (n=1/106); Arm C, 2.4% (n=1/42)]. Across all arms, eight patients (n=8/354) experienced post-treatment relapse [Arm A, 2.4% (n=5/209); Arm B, 1.0% (n=1/105); Arm C, 5.0% (n=2/40)].

AbbVie studied its two direct-acting antiviral treatment regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b.

About VIEKIRAX in Japan

Indication in Japan

VIEKIRAX is indicated for the improvement of viremia in chronic hepatitis C or compensated hepatic cirrhosis C in patients of serogroup 1 (genotype 1).

Summary of Safety Information

Contraindications

VIEKIRAX is contraindicated in patients with a history of known hypersensitivity to an ingredient in VIEKIRAX, patients with severe hepatic impairment (Child-Pugh C) or patients being treated with the following drugs: azelnidipine, triazolam, iv midazolam, blonanserin, pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, sildenafil citrate [Revatio], tadalafil [Adcirca], rivaroxaban, vardenafil hydrochloride hydrate, riociguat, simvastatin, atorvastatin calcium hydrate, carbamazepine, phenytoin, phenobarbital, rifampin, efavirenz, foods containing St. John's Wort (Hypericum perforatum), ethinyl estradiol-containing medicinal products.

Precautions for Use

Positive result for HCV RNA should be confirmed before administering VIEKIRAX and decompensated cirrhosis should be excluded.

When VIEKIRAX is used for patients co-infected with HIV/HCV, administer VIEKIRAX only to patients whose virological suppression has been achieved by anti-HIV therapy as ritonavir may cause resistance against a HIV protease inhibitor.

During the administration of VIEKIRAX, perform liver function tests regularly because hepatic function disorder may occur.

Co-administration of VIEKIRAX with drugs that are substrates of CYP3A4, P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs, potentially requiring dose adjustment or clinical monitoring.

The safety of VIEKIRAX in pregnant women has not been established. VIEKIRAX should be used in pregnant women and women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment.

Do not administer VIEKIRAX to nursing mothers. If VIEKIRAX is administered to a nursing mother by necessity, breast feeding must be discontinued during treatment.

Safety and effectiveness have not been established in children.

Adverse Reactions

Major adverse reactions included peripheral edema in 15 subjects (4.1%), headache in 12 subjects (3.3%) and nausea in 10 subjects (2.8%)

About AbbVie's HCV Clinical Development Program in Japan

AbbVie's HCV clinical development program in Japan focuses on our two direct-acting antiviral treatment and is designed with the goal of achieving high SVR rates in chronic HCV infected patients, including additional genotypes and patients with compensated cirrhosis.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV 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 hepatitis C.

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 VIEKIRAX [package insert]. Tokyo, Japan: AbbVie Ltd; 2015.

2 Kohnodai Hospital. National Center for Global Health and Medicine [cited 20 February 2013]. Available from: http://www.ncgm.go.jp/center/forpatient_hcv.html

3 Gower, E.  Global epidemiology and genotype distribution of the hepatitis C virus infection. Journal of Hepatology 2014; 61: S45-S57, Table 2. 

4 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. Available from: http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html

5 Kumada H, et al. Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. Hepatology. 2015 Jul 3. doi: 10.1002/hep.27972.

SOURCE AbbVie

For further information: Media: Judy Low, +65 9880 2604, judy.low@abbvie.com; or Jane Woo, +1 (847) 937-4754, jane.woo@abbvie.com; or Investor Relations: Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

Australia: Hepatitis C drug buyers club aims to set up new source of support

 "The FixHepC Buyers Club has successfully helped patients with a doctor's prescription to arrange personal importation and testing of a course of the drugs for a fraction of the US cost - between $US930 ($A1292) and $US1980 ($A2795). The cure rates from these generic medications have reportedly been excellent with results posted on the fixhepc.com website."

A group of campaigning patients and doctors has launched a Dallas Buyers' Club-style operation to help Australia's estimated 233,000 hepatitis C sufferers get new life-saving drugs without paying astronomical bills.

The move comes after the Kirby Institute for infection and immunity in society published a report showing the number of Australians with hep-C related severe liver disease has more than doubled in 10 years.

The FixHepC Buyers Club has been set up to import new wonder drugs such as Harvoni  and Sovaldi from China, instead of waiting for Gilead Sciences, the American pharmaceutical giant which owns the patents, to negotiate a price with the Pharmaceutical Benefits Scheme.

Read more: http://www.smh.com.au/national/health/hepatitis-c-drug-buyers-club-aims-to-set-up-new-source-of-support-20150924-gjts1t.html#ixzz3mnntLHL7

One senator's push to fund hepatitis C treatment for veterans

Many veterans who fought to protect and defend our country are still fighting to get the support they need from the federal government. Fortunately, help may be on the way for veterans living with hepatitis C, one of the greatest threats facing former servicemen and women.

Recently, the Senate Appropriations Committee followed the lead of Sen. Mark Kirk (R-Ill.) and approved a budget for the Department of Veterans Affairs (VA) that included an additional $200 million to fund critical hepatitis C treatments for a total of more than $1.5 billion for hepatitis C over the next two years. The measure is now on its way to the full Senate for a final vote. This means that Kirk's pathway to securing these needed treatments for the veterans community may come in contact with federal budget cap debates and be blocked as the next federal fiscal year approaches. It will make a big difference if veterans of all generations contact their members of Congress to insist that veterans' healthcare priorities must be left untouched during spending debates. Veterans have sacrificed enough — especially those living with hepatitis C — than to have to stand by while Congress fights about the numbers.

While hepatitis C has reached epidemic levels nationwide, the veterans community has a hepatitis C infection rate that is nearly double the national average. For veterans, this deadly, blood-borne disease is a leading cause of liver failure, catastrophic liver damage and liver cancer. It impacts veterans disproportionately due to a variety of factors, including battlefield blood exposure, emergency transfusions and mandatory vaccinations in the era before hepatitis C testing became common.

Read more...

Gilead Drug Combo Could Be Indicated for All Forms of Hepatitis C

Study shows drug may eliminate need for HCV genotype testing altogether

A new Gilead Sciences drug combination that targets six genotypes of the hepatitis C virus (HCV) has achieved promising results in four international phase III clinical studies.

 Gilead has announced results from ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4. The studies evaluated a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) with velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of genotype 1 to 6 chronic HCV infection.

In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 patients with genotype 1 to 6 HCV infection received 12 weeks of SOF/VEL. Among these patients, 21%% had compensated cirrhosis and 28% had failed prior treatments. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. The primary endpoint for all studies was a sustained virological response at week 12 post-treatment (SVR12)

Read more.....

U.S. Food and Drug Administration Grants Fast Track Designation to Can-Fite's CF102 in the Treatment of Liver Cancer

PETACH TIKVA, Israel, Sept. 17, 2015 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA's Orphan Drug designation.

Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite's earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug's development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.

"We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients."

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.

About CF102 

CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced psoriasis clinical trial. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company's CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Read complete press release here

Researchers find HCV treatment uptake declined over time among HIV/HCV coinfection

Note:  You may be required to sign up to read this article: 

In the Swiss HIV Cohort Study, researchers found that hepatitis C virus infection treatment uptake over the last 13 years has been low and many patients co-infected with HIV and hepatitis C remained untreated since 2013.

“The Swiss HIV Cohort Study offers an ideal platform to study the natural course of HCV infection and long-term influence of HCV treatments in a nationwide representative population of HIV-infected patients,” the researchers wrote in the Journal of Hepatology. “We aimed to assess the changes in epidemiology, clinical course and therapy of HCV infection between 2001 and 2013 and to characterize the population who remains eligible for the new HCV treatment options by the end of 2013.”

Of 12,401 patients, 17% were positive for HCV RNA (n = 2,107) and 23.8% were seropositive for HCV. Thirty-percent of the HCV RNA-positive patients (n = 636) began therapy with an incidence of 5.8 per 100 person-years (95% CI, 5.3-6.2). Of the patients treated with pegylated interferon and ribavirin, 50% achieved sustained virologic response, which represented 15% of all participants with replicating HCV infection, according to the research. Also, of the 636 treated patients, 11% were treated twice and 2% were treated at least 3 times.

Read more....

Hepatitis C Workshop Set

ALAMOSA — Hepatitis C is an infectious (contagious) liver disease that spreads through blood-to-blood contact with an infected person.

Andres Guerrero with the Colorado Department of Public Health and Environment and Chris Grano with Hep C Connection in Denver will present the workshop ”Hep C- What you need to Know” on Thursday, October 8, in Alamosa.

The workshop will be held at SLV Heath Education Center at 1919 Main St. in Alamosa. Two times for the same program are available — 3:30–5 p.m. and 7– 8:30 p.m.

Hep C testing will be available at no charge for people who use injection drugs, were born between 1945 and 1965, had sex partners who are Hep C positive, had tattoos in prison or jail and/or had blood products or tissue before 1992. Testing is available for those who qualify with the above criteria through the Colorado Department of Public Health and Environment from 1– 2:30 p.m. October 8th at the SLV Heath Education Center at 1919 Main St. in Alamosa. No appointment is needed for testing and spaces are limited.

Call the SLV AHEC at 589-4977 for further information or to register by October 6.

Read more....