Tuesday, June 30, 2015

Holkira Pak : With Provincial Approval Ottawa Doctor Is Expecting To Cure Thousands Of His Patients

Related: AbbVie's HOLKIRA™ PAK Now Reimbursed in Ontario

Ontario approves second costly drug for hepatitis C
More from Elizabeth Payne, Ottawa Citizen

With provincial approval of a second costly drug that can cure hepatitis C, Ottawa liver specialist Dr. Curtis Cooper is now expecting to see thousands of his patients cured of the disease that, without treatment, had the potential to destroy their lives.

The Ontario government agreed this week to pay for the drug Holkira Pak which, pharmaceutical company AbbVie says had a 97 per cent cure rate in genotype 1 hepatitis C patients during clinical trials. It is the second hepatitis C drug the province has approved this year under the Ontario Drug Benefit exceptional access program. Earlier,the province agreed to pay for the drug Harvoni, which has a similar high cure rate for hepatitis C.

Both drugs cost in the $50,000 to $60,000 range, or more, which, until the province approved them, meant they were out of reach to most patients. Unlike previous treatments for hepatitis C, the drugs are easy to take in daily pill form, are well tolerated by patients and cure the disease in the vast majority of cases.

Their development and now approval has been called a landmark event in the lives of tens of thousands of Ontario residents suffering from hepatitis C.

June Updates
Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas..
An index of articles pointing the reader to the current controversy over the high price
of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States

Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States
Soumitri Barua; Robert Greenwald, JD; Jason Grebely, PhD; Gregory J. Dore, MBBS, PhD; Tracy Swan; and Lynn E. Taylor, MD

Discussion Only
Abstract | Methods | Results | Discussion | References
Full Text Available Online:
Ann Intern Med. Published online 30 June 2015 doi:10.7326/M15-0406

Considerable heterogeneity is present in Medicaid reimbursement criteria for sofosbuvir across the United States. Restrictions based on liver disease severity are common, with three quarters of states restricting sofosbuvir to persons with advanced fibrosis (F3) or cirrhosis (F4). One quarter of states require that persons living with HIV be receiving ART or have suppressed HIV RNA levels, whereas two thirds restrict sofosbuvir on the basis of prescriber type. Drug or alcohol use is included in the eligibility criteria of 88% of state Medicaid committees, with half requiring a period of abstinence and two thirds requiring urine drug screening. The restrictions are not consistent with the FDA-approved labeling for sofosbuvir or evidence-based recommendations and should be reconsidered (23).

Most states restrict sofosbuvir reimbursement to persons with advanced fibrosis (F3) or cirrhosis (F4), which is inconsistent with recent AASLD/IDSA recommendations (20). These recommendations state that HCV treatment is indicated for all patients with chronic HCV (regardless of disease stage) because HCV therapy is curative; improves quality of life; slows liver disease progression; and reduces the risk for cirrhosis, end-stage liver disease, HCC, and all-cause mortality (21). The recommendations state that patients at highest priority for immediate treatment include those with advanced fibrosis (F3) or compensated cirrhosis (F4) because of the higher risk for severe complications (for example, hepatic decompensation or HCC). Patients with fibrosis (F2) are listed in the next priority group for treatment because of their high risk for complications (21). However, most states do not include persons with fibrosis (F2) in their Medicaid reimbursement criteria. Note that persons with advanced fibrosis remain at risk for HCC even after achieving sustained virologic response (SVR) and must have long-term surveillance (24). In contrast, once HCV is cured in persons with mild to moderate liver disease, liver disease progression is rare. Requiring liver biopsy may pose the highest risk for death in HCV care with all-oral regimens.

The requirement that HIV-infected persons be receiving ART or have suppressed HIV RNA levels is also inconsistent with AASLD/IDSA recommendations indicating that persons co-infected with HIV and HCV are also at high priority for treatment because of their high risk for complications (21). HIV accelerates the HCV disease course, with faster progression to cirrhosis, liver failure, and increased HCV-related mortality (2527). The safety and efficacy of sofosbuvir-based, interferon-free combination therapy for co-infected persons is similar to results among those with HCV monoinfection (21, 2829). Reasons are varied about why co-infected persons may not be receiving ART (for example, normal CD4+ T-cell counts and low HIV RNA levels) or have suppressed HIV RNA levels (for example, drug-resistant HIV). Physicians who treat such co-infected persons may prefer to commence and complete HCV treatment first, before ART initiation, because HCV therapy is brief; further, DAA therapy often limits what antiretrovirals can be used concomitantly because of drug–drug interactions.

Two thirds of states have restrictions based on physician type, which is inconsistent with current practice whereby internists, other primary care physicians, HIV physicians not trained as infectious diseases specialists, nurse practitioners, and physician assistants treat HCV with pegylated interferon and ribavirin. The availability of sofosbuvir-based, interferon-free regimens simplifies therapy and reduces treatment-associated toxicities, which offers an opportunity for an expanded provider base for HCV treatment in patients without advanced cirrhosis (30).

The overwhelming majority of states restrict access to sofosbuvir for persons who inject drugs (PWID), those receiving treatment for drug dependency (for example, opioid substitution therapy), and those drinking alcohol. Most new and existing cases of HCV in the United States exist among current or former PWID (31). Since 2002, the National Institutes of Health HCV guidelines support HCV treatment regardless of injection drug use (32), and the AASLD/IDSA, European Association for the Study of the Liver, International Network on Hepatitis in Substance Users, and World Health Organization all advocate for inclusion of persons who use drugs in HCV treatment (21, 3335). A growing body of evidence shows that there is no justification for systematically withholding HCV treatment from PWID (21, 33, 36). The SVR rates are similar in PWID with or without opiate replacement therapy (21, 33, 3639). Drug use in the 6 months preceding HCV therapy initiation is not necessarily associated with poorer response to HCV therapy (4042). Reported rates of reinfection after SVR among PWID are low—generally a 1% to 5% risk per year, although concerns about reinfection rates in other subpopulations, such as surgeons, do not garner similar attention (33, 43). Rather than recommending the exclusion of PWID, AASLD/IDSA guidelines include PWID with earlier liver disease stages among a second-order priority group because of the prevention benefit of potential treatment; HCV treatment among PWID may decrease HCV transmission (21). In addition, evidence shows that HCV treatment of current and former PWID is cost-effective, particularly when the prevention benefits are considered (44). Further, Medicaid does not similarly deny medications for other diseases to persons who use or have used drugs or alcohol.

Alcohol misuse and HCV infection frequently coexist (4548). Hepatitis C virus and alcohol act synergistically in causing more severe liver injury than seen with either disease alone (4, 4849). Persons with coexisting alcohol disorders are at a higher risk for HCV-related complications (4, 4849). Curing HCV is easier than curing alcohol disorders because pharmacotherapy for alcohol misuse is limited, and behavioral interventions are not always successful. The SVR rates are similar in drinkers and nondrinkers (4950).Further, the AASLD/IDSA recommendations have no HCV treatment restrictions regarding alcohol use.

This study examined criteria in Medicaid fee-for-service programs only—not in Medicaid managed care organizations. Results therefore reflect a subset of overall state Medicaid reimbursement criteria for sofosbuvir rather than a comprehensive catalog of all restrictions in state Medicaid programs. Future research on reimbursement criteria in Medicaid managed care organizations will be important to develop a more thorough understanding of Medicaid enrollees' access to sofosbuvir.

Current restrictions may violate federal Medicaid law, which requires states to cover drugs consistent with their FDA labels. Under the federal Medicaid statute, virtually all drugs from pharmaceutical manufacturers that have rebate agreements with the Secretary of Health and Human Services (which includes the manufacturer of sofosbuvir) must be available under state Medicaid programs, with only limited methods of restricting coverage (19). None of the restrictions on sofosbuvir coverage detailed here seem to meet the criteria for permissible restrictions. Although the price of new therapies creates financial challenges for federal and state Medicaid budgets, decisions for prioritizing patients for more immediate therapy should be based on clinical criteria and medical evidence. It is recommended that the restrictions be removed; apart from potentially being a human rights violation, they do not make (economic) sense in terms of clinical, public, and long-term health. In setting restrictions as a concession to economic constraints, the significant longer-term public health and economic benefits of curing HCV should be considered and weighed against the upfront treatment costs.

Concerns include that full coverage for HCV treatment could, in the short term, mean less coverage for other conditions. It is unrealistic, however, to expect that all potential candidates will immediately seek HCV treatment. One example of this is Massachusetts. Despite relatively unrestricted sofosbuvir access in its Medicaid fee-for-service program, recent data indicate that only 14% of Massachusetts Medicaid enrollees known to be diagnosed with HCV are engaged in treatment (22, 51).

Transparent, easily accessible, consistent, and evidence-based Medicaid criteria will permit greater and more equitable access to DAAs. As the HCV standard of care changes over time, it will be inefficient and costly to have differing treatment access protocols in the 51 fee-for-service programs and many more Medicaid managed care plans, with all of them being revised over time. More consistency is needed across the system so that where a Medicaid patient lives does not dictate what treatment she or he receives. Although this study examined sofosbuvir in particular, the first FDA-approved DAA as part of an interferon-free regimen, Medicaid may be setting a precedent as new DAAs are approved. Medicaid policies should be responsive to changes in standards of care and new treatment developments. State Medicaid pharmacy and therapeutics committees (or their equivalent) are generally responsible for implementing these policy changes and should be expected to act as expeditiously as possible to ensure that significant clinical changes are addressed in state Medicaid programs. These data suggest that state Medicaid policies for access to new DAAs should be reviewed and revised in line with national clinical recommendations.

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi
Posted 29 June 2015
By Alexander Gaffney, RAC

A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir).

Bioequivalence recommendations are a critical part of the submission of an Abbreviated New Drug Application (ANDA)—the application generic drug companies submit for each new generic drug.

Generic drugs, unlike new drugs, may be approved by FDA by showing that they are (among other things) bioequivalent to the drug they intend to reference. Bioequivalence can be shown in relatively small trials involving human subjects, which permits a company to avoid much larger—and much more expensive—full clinical trials required of new drug substances.

While generic drug companies can conduct their own bioequivalence testing, FDA often releases "bioequivalence recommendations" establishing recommended testing protocols for specific generic drug formulations. Each document contains a list of recommended studies (typically at least two), the characteristics of each study, the standard for bioequivalence that must be met by each generic product and potential waivers a generic company may apply for.

The documents are, in effect, a roadmap for regulatory approval for generic drug companies. The publication of a bioequivalence document does not, however, indicate that FDA will approve a generic drug product immediately. Patent and marketing exclusivity protections may still be in effect, which can preclude FDA approval or market access.
New Guidance

On 29 June 2015, FDA released a new batch of bioequivalence recommendations covering more than three dozen drug products, including several notable branded drug products not yet subject to generic competition.

Perhaps the most notable addition to the list is sofosbuvir, a blockbuster hepatitis C drug better known by its brand name Sovaldi. It is also a primary ingredient in the hepatitis C combination drug, Harvoni. The drug is one of the top-selling drug products in the world by total revenue.

Continue reading... http://www.raps.org/Regulatory-Focus/News/2015/06/29/22796/FDA-Releases-Dozens-of-New-Bioequivalence-Recommendations-Including-for-Sovaldi/#sthash.WxCrxVZX.dpuf

Monday, June 29, 2015

State restrictions for hepatitis C drug may go too far

State restrictions for hepatitis C drug may go too far

(Reuters Health) - State-run insurance programs for the poor may be putting up illegal barriers that prevent people with hepatitis C from getting a new treatment, a new study suggests.

"We had this idea that there were restrictions in place, but we didn't anticipate the breadth of these restrictions," said study author Robert Greenwald of the Center for Health Law and Policy at Harvard Law School in Jamaica Plain, Massachusetts.

About 3.2 million people in the U.S. are infected with hepatitis C, but many do not feel ill or know they have the disease, according the Centers for Disease Control and Prevention (CDC). There are about 17,000 new infections each year.

Without treatment, the hepatitis C virus can lead to liver failure, liver cancer or even death.

In 2013, the U.S. approved a new drug known as sofosbuvir, which is marketed here as Sovaldi by Gilead. Given in combination with other drugs, sofosbuvir achieves very high cure rates in patients with the difficult to treat infection.

But sofosbuvir costs about $1,000 per day, which adds up to about $84,000 for a 12-week course, the researchers write in Annals of Internal Medicine.

For the new study, Greenwald and his colleagues searched the Medicaid websites of each state and the District of Columbia in 2014. Medicaid, the state-run health insurance for the poor, is partly funded by the U.S. government.

Overall, 42 state Medicaid programs put restrictions on payments for sofosbuvir. About three quarters only allow the drug to be used when hepatitis C has already caused liver damage known as fibrosis or an even later stage of damage known as cirrhosis.

The vast majority of states include drug- and alcohol-based restrictions on payments for the drug, including abstinence and drug screening.

About two thirds of states restrict who may prescribe the medication, the researchers write. In a third of states, for example, it can only be prescribed by a specialist. In the other third, nonspecialists can prescribe it but they have to consult a specialist first.

About a quarter of states have restrictions based on the person's HIV status.

"I think the restrictions have significant personal and public health implications," Greenwald told Reuters Health.

"I think anybody with a communicable disease or other medical condition should be taking this extremely seriously, because this gets to how our country responds to a cure," he added.

What's more, the researchers found many of the restrictions vary by state and do not correspond with the recommendations of medical organizations like the Infectious Diseases Society of America and the American Association for the Study of Liver Disease.

Also, the researchers say, the restrictions may violate a federal regulation that says state Medicaid programs must provide coverage for drugs consistent with the labels from the U.S. Food and Drug Administration if the manufacturer has a rebate agreement with HHS.

"What we’re really seeing here is this huge push back and frankly the insurer ruling the day so that the focus has been really on cost," Greenwald said.

The researchers caution that they only examined traditional Medicaid fee-for-service programs, and not managed care organizations, which may impose additional restrictions not cataloged in their results.

SOURCE: bit.ly/SQRXAa Annals of Internal Medicine, online June 29, 2015.

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

Health groups sue FDA for Gilead hepatitis C drug trial data

The Food and Drug Administration was sued by two advocacy groups seeking to force the faster disclosure of clinical trial data that helped Gilead Sciences Inc win approval for two blockbuster hepatitis C drugs.

In their June 25 lawsuit, Yale University's Global Health Justice Partnership and the Treatment Action Group, an AIDS non-profit, said doctors and patients deserve more information about the "enormously costly" drugs Harvoni and Sovaldi to make informed decisions about whether to use them.

Public health advocates and groups such as the World Health Organization have called for the broad release of clinical trial data, even if it were to compromise patient confidentiality or proprietary research.

According to the complaint filed in a federal court in New Haven, Connecticut, Harvoni and Sovaldi cost a respective $94,500 and $84,000 for 12-week regimens, straining state budgets and prompting insurers to restrict patient access.

The plaintiffs said Gilead ignored its request for the trial data, while the FDA said it would need 1-1/2 to two years to decide merely whether disclosure was proper to begin with. That's too slow, the groups said.

"Unless defendants disclose the requested information, hundreds of thousands more patients will be treated with drugs whose safety, efficacy, and cost effectiveness cannot be fully studied or understood," the complaint said.

Harvoni and Sovaldi accounted for $4.55 billion, or 60 percent, of Gilead's revenue from January to March.

The FDA is part of the U.S. Department of Health and Human Services, which is also a defendant. Gilead is based in Foster, City, California, and was not sued.

Neither the FDA nor Gilead immediately responded to requests for comment on Monday. The Wall Street Journal reported the lawsuit earlier in the day.

Hepatitis C is a liver infection often caused by the sharing of needles or other means to inject drugs. It affects about 150 million people worldwide, and kills roughly half a million annually.

Gilead won FDA approval for Sovaldi in December 2013 and Harvoni in October 2014. Sovaldi's chemical name is sofosbuvir, while Harvoni contains sofosvubir and ledipasvir.

In May, the WHO added new hepatitis C treatments to its "essential medicines" list.

The case is Treatment Action Group et al v. FDA, U.S. District Court, District of Connecticut, No. 15-00976.

(Reporting by Jonathan Stempel in New York; Editing by Richard Chang)

Source - http://www.reuters.com/article/2015/06/29/us-gilead-sciences-fda-idUSKCN0P92IZ20150629

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data


File this under ‘Show me the data.’

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.01%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Here’s what happened...

AbbVie's HOLKIRA™ PAK Now Reimbursed in Ontario

AbbVie's HOLKIRA™ PAK Now Reimbursed in Ontario

Common Drug Review grants positive recommendation for HOLKIRA PAK

Ontario is the second province in Canada to reimburse HOLKIRA PAK

In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of genotype 1 hepatitis C virus patients; additionally, 98 percent of patients completed treatment

MONTREAL, June 29, 2015 /CNW/ - AbbVie, a global biopharmaceutical company, today announced that the Common Drug Review (CDR) has posted the Canadian Drug Expert Committee (CDEC)'s positive recommendation1of HOLKIRA PAK for listing with provincial drug formularies. HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets) is an all-oral, short-course (12 weeks for the majority of patients), interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.

During their review, the CDEC clearly recognized the clinical value that HOLKIRA PAK brings to people living with hepatitis C and recommended that the treatment be covered under minimal conditions: liver fibrosis stage of ≥2, and treatment should be initiated by physicians with experience in the management of hepatitis C.

Following the positive CDR recommendation announcement, Ontario is the second province to reimburse HOLKIRA PAK on its public formulary through its Exceptional Access Program (EAP) as of June 29, 20152. In Ontario, HOLKIRA PAK will be covered under the following EAP criteria: for treatment-naïve and treatment-experienced adult patients with GT1 chronic HCV infection, with compensated cirrhosis.

"We finally have the tools to address hepatitis C. Although this disease is sometimes overlooked, it is the infectious disease that causes the most years of life lost in Canada. With new, extremely well-tolerated treatments, cure rates are now above 95 per cent," said Dr. Jordan Feld, a hepatologist at the Francis Family Liver Clinic at Toronto Western Hospital, part of the University Health Network. "Now that we can access these life-saving therapies for those who need them most, we have the possibility to actually eliminate hepatitis C from Canada."

HOLKIRA PAK combines three direct-acting antivirals to attack the virus at three separate stages of its replication process. In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of GT1 HCV patients, and 98 percent of patients completed treatment.

"Most patients with hepatitis C have been living with the disease for years or even decades," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation. "And after such a long duration of infection they are rapidly running into problems with liver failure and liver cancer. Having therapies that are both highly effective and accessible is critical to curing these individuals and preventing these complications."

According to the Public Health Agency of Canada, an estimated 242,500 Canadians are living with hepatitis C.3 A significant number of the estimated cases in Canada remain undiagnosed, although the exact proportion is unclear.4There are six different genotypes of hepatitis C; two-thirds of Canadians living with hepatitis C have genotype 1 – either subtype 1a or 1b – which are the most difficult to cure.5

"AbbVie is committed to providing the best solution to Canadians living with hepatitis C. With this milestone, we are getting closer to fulfilling this ambition," said Stéphane Lassignardie, general manager, AbbVie Canada. "Furthermore, Canadians prescribed HOLKIRA PAK will have the opportunity to be enrolled in AbbVie Care, our signature care program designed to provide a wide range of services including reimbursement assistance, education and ongoing disease management support for health care professionals and people living with genotype 1 hepatitis C."

HOLKIRA PAK was approved by Health Canada on December 22, 2014. The approval of HOLKIRA PAK was supported by a robust clinical development program that was designed to study the safety and efficacy of the regimen in six pivotal Phase 3 studies, including one trial exclusively in subjects with compensated cirrhosis, with more than 2,300 patients across 25 countries.

HOLKIRA PAK consists of the fixed-dose combination of ombitasvir/paritaprevir/ritonavir, taken once daily, and dasabuvir taken twice daily. HOLKIRA PAK is administered with or without ribavirin, depending on the type of hepatitis C virus in cause, the treatment history of the patient and the presence/absence of cirrhosis. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response across different patient populations.

The complete HOLKIRA PAK Product Monograph is available at the following location on Health Canada's website (http://hc-sc.gc.ca/index-eng.php); the manufacturer's website www.abbvie.ca, or by calling 1-888-704-8271.

Additional information about AbbVie's chronic hepatitis C clinical program can be found on www.clinicaltrials.gov.

Important Safety Information6
To help avoid possible side effects and ensure proper use, talk to your health care professional before you take HOLKIRA PAK. Talk about any health conditions or problems you may have, including if you:
are using a medicine containing ethinyl estradiol for contraception or for other reasons. You must not use medicines that contain ethinyl estradiol while taking HOLKIRA PAK. Your doctor will ask you to stop or consider changing to a different type of contraceptive medicine during your treatment.
have liver problems other than hepatitis C infection.
have any other medical condition.
have had a liver transplant.
are breastfeeding or plan to breastfeed. It is not known if HOLKIRA PAK passes into your breast milk. You and your health care provider should decide if you will take HOLKIRA PAK or breastfeed. You should not do both.
You or your partner should not become pregnant while taking HOLKIRA PAK with ribavirin and for six months after treatment is over.

Other warnings you should know about:
Let your health care provider know if you develop nausea, vomiting, loss of appetite, yellowing of your skin or eyes, or darkening of your urine while on treatment with HOLKIRA PAK.

If HOLKIRA PAK is administered with ribavirin, the warnings and precautions for ribavirin also apply to this combination regimen. Refer to the ribavirin Patient Medication Information for a full list of the warnings and precautions for ribavirin.

It is not known if taking HOLKIRA PAK is safe and effective in children under 18 years of age.

Your doctor may do blood tests before you start your treatment and regularly during your treatment. These blood tests are done to help your doctor to check if the treatment is working for you.

Tell your health care professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

HOLKIRA PAK should not be administered with other ritonavir-containing medicines (NORVIR®, KALETRA®). When co-administered with HOLKIRA PAK, atazanavir or darunavir should be taken without ritonavir.

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.ca and www.abbvie.com. Follow @abbvie on Twitter or view careers on ourFacebook or LinkedIn page.

Accessed on June 26, 2015

2 Ontario Ministry of Health and Long-Term Care. http://www.health.gov.on.ca/en/pro/programs/drugs/edition_42.aspx
Accessed on June 26, 2015

3 Public Health Agency of Canada. Hepatitis C Quick Facts. http://www.phac-aspc.gc.ca/hepc/index-eng.php.
Accessed on June 26, 2015

4 An update on the management of chronic hepatitis C: Consensus guidelines from the Canadian Association for the Study of the Liver, Canadian Journal of Gastroenteroly, Vol 26 No 6, June 2012

5 Hepatitis C Online. http://www.hepatitisc.uw.edu/go/treatment-infection/treatment-genotype-1/core-concept/all
Accessed on June 26, 2015

HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film coated tablets) Product Monograph. Date of Revision: December 22, 2014
Accessed on June 26, 2015

SOURCE AbbVie For further information: Eileen Murphy, AbbVie Canada, 514-832-7788, eileen.murphy@abbvie.com

Researchers say method to detect drug resistant hepatitis C virus mutants has been developed

The new detection method for a key drug resistant hepatitis C virus mutation

A rapid, sensitive, and accurate method to detect drug resistant hepatitis C virus (HCV) mutants has been developed. Researchers at Hiroshima University established a system to rapidly and accurately measure the presence of HCV Y93H drug resistant mutant strains, and evaluate the proportion of patients harboring this mutation prior to treatment. Even in serum samples with low HCV titers, 

Y93H drug resistant mutation could be successfully detected in more than half of the samples. This new system for detecting mutant strains may provide important pre-treatment information valuable not only for treatment decisions but also for prediction of disease progression in HCV genotype 1b patients.

HCV is a major cause of chronic liver disease, liver cirrhosis, and hepatocellular carcinoma, affecting up to 180 million people worldwide. HCV often acquires resistance against direct acting antiviral agents. Presence of the Y93H mutation prior to treatment has been reported as an important predictor of virologic failure. Direct sequencing is a commonly used method to detect this mutation. However, it is only capable of detecting viral subpopulations with frequencies of at least 10% to 20%. Next generation sequencing has recently been applied as a more sensitive method to analyze viral mutations, but it is still complex to perform and expensive for widespread clinical use.

By combining nested PCR and the Invader assay with well-designed primers and probes, the Y93H drug resistant mutation can be detected with a high success rate of 98.9% among a total of 702 Japanese HCV genotype 1b patients.

"Our assay system also showed a much lower detection limit for Y93H than using direct sequencing, and Y93H frequencies obtained by this method correlated well with those of deep-sequencing analysis." Professor Kazuaki Chayama, the principle investigator of this study at Hiroshima University, explained.

The proportion of the patients with the Y93H mutant strain estimated by this system was 23.6%, and this rate is comparable with that assayed by real-time PCR and ranked between those of deep sequencing and direct sequencing reported in the Japanese population, presumably reflecting the lower detection limit of Y93H.

This new system attained a high assay success rate and was more sensitive in detecting Y93H than direct sequencing. The evaluation of Y93H strain may provide important information for prediction of disease progression in HCV genotype 1b patients.

Schematic flow diagram representing a method of nested-PCR followed by Invader: (A) The initial PCR was performed to amplify a fragment containing a part of the mutant region from HCV-RNA which was extracted from the serum of a patient. (B) An aliquot of the inital PCR product was used for the second PCR to amplify a fragment. (C) Invader oligonucleotide and allele-specific probes anneal with target to form one base overlap. (D) Three types of standard nucleotide (Std-YY, Std-YH, and Std-HH) were prepared, which includes binary target sequences, corresponding to wild (Y) or mutant (H) variants, and annealing sites with the internal primers at each end. (E) The Invader assay for each standard was also performed in triplicate.

More information: "Rapid, Sensitive, and Accurate Evaluation of Drug Resistant Mutant (NS5A-Y93H) Strain Frequency in Genotype 1b HCV by Invader Assay." 

Sunday, June 28, 2015

Weekend Reading - Natural history of hepatitis C: An Updated Look at the Rate of Progression to Cirrhosis and the Incidence of Decompensation

Weekend Reading: Natural history of hepatitis C

On most weekends this blog offers up a bit of easy "Weekend Reading" on the topic of HCV.

After receiving a hepatitis C diagnosis, the first task at hand is understanding how the virus damages the liver. A good place to start is with the Natural History Of Hepatitis C. 

To date the natural history of hepatitis C remains controversial. Among HCV-infected individuals progression to advanced liver disease generally requires decades but is influenced by several host factors, the following offers an update on the natural history of hepatitis C using information found online at MedscapeNATAP, and the interactive website Hepatitis C Online.

The Natural History of Chronic Hepatitis C. An Updated Look at the Rate of Progression to Cirrhosis and the Incidence of Decompensation in a Large U.S. Health Maintenance Organization

We begin with a commentary  titled, "Hepatitis C: 25 Years Old, and Fading," written by William F. Balistreri, MD., recently published over at Medscape. The good doctor writes about a study presented last month at "Digestive Disease Week," which suggested the rate of developing cirrhosis and decompensation in people with HCV is higher than previously thought. An excerpt follows with a link to corresponding slides provided this week by Jules Levin @ NATAP.  In addition stroll over to "Hepatitis C Online" or download "Natural History of Hepatitis C Infection" for a quick review of related studies including; spontaneous clearance versus chronic infection and factors that may impact the rate of fibrosis,


Cirrhosis and the Incidence of Decompensation

The projected public health burden of HCV is based on old natural history studies. One presentation[6] suggested a need to reexamine the natural history of HCV because the current patient cohort is older and confounded by a higher prevalence of obesity, and other comorbid conditions that may affect the outcome of the disease. Therefore, investigators conducted a retrospective cohort study at Kaiser Permanente Southern California.

From 2002-2013, 60,338 adults had an HCV diagnosis code or a positive HCV RNA lab test. Of these, 33,124 HCV cases met inclusion criteria and were matched with 164,221 controls. Mean age of the HCV cases and non-HCV controls was 54 years. Among case-patients, 41% were white and 27% were Hispanic; among controls, the respective proportions were 46% and 28%.

Prevalent cirrhosis was found in 19% of the HCV-infected cohort and 1.4% of the non-HCV controls. The incident decompensation rate among previously compensated HCV patients with cirrhosis was 47%, which was almost twice the incident decompensation rate among non-HCV cirrhotic controls. Of note, 23% of HCV cases were diagnosed with cirrhosis after a median follow-up of 2 years, which indicates that the rates of development of HCV-related cirrhosis and decompensation are higher than previously reported. The authors attributed this to aging of the HCV cohort and associated comorbidities, such as obesity. Multivariable analyses to explore the relationship between baseline comorbid conditions and the incidence of cirrhosis and decompensation are ongoing.

  1. Nyberg LM, Li X, Chiang K, et al. The natural history of chronic hepatitis C. An updated look at the rate of progression to cirrhosis and the incidence of decompensation in a large U.S. health maintenance organization. Program and abstracts of Digestive Disease Week; May 16-19, 2015; Washington, DC. Abstract 809.

View All Slides@ NATAP

The Natural History of Chronic Hepatitis C. An Updated Look at the Rate of Progression to Cirrhosis and the Incidence of Decompensation in a Large U.S. Health Maintenance Organization

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About Hepatitis C Online
Hepatitis C Online is a free educational web site from the University of Washington.

The site is a comprehensive resource that addresses the diagnosis, monitoring, and management of hepatitis C virus infection. 

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Spontaneous Clearance versus Chronic Infection 
Variable Outcomes of Chronic Infection 
Factors Impacting Rate of Progression of Fibrosis 
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Friday, June 26, 2015

HCV TGIF Rewind - Peak body, Gilead welcome hepatitis report

HCV TGIF Rewind 

Welcome to TGIF rewind, a weekly digest of news, research and a look at today's headlines.

Wednesday AbbVie announced clinical trial results from TURQUOISE-III which showed 100% of genotype 1b patients with compensated liver cirrhosis reached a sustained virologic response at 12 weeks post-treatment after therapy with Viekirax and Exviera, here is the press release, a summary available online @ Healio.  

The June issue of "Clinical Liver Disease" is up folks, the journal is an official digital educational resource from the American Association for the Study of Liver Diseases. Visitors can read full text articles or sit back and watch either an author interview, or a presentation of each article, begin here.

In 2014 The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) with the International Antiviral Society developed a living document with ever evolving guidelines to treat HCV.
The "guidelines" have a complex algorithm for practitioners around the country to follow and see whats the right right treatment, for the right patients, for the right about of time. Yesterday the AASLD announced updates for the use of hepatitis C drugs with a summary published in the AASLD journal, Hepatology.

VA In The Headlines
VA to outsource care for 180000 vets with hepatitis C
"The VA had set aside nearly $700 million this year for HCV antiviral drugs. In documents and a written statement, department officials confirmed soaring patient loads and medication expenses have nearly wiped out that budget with several months to go in the federal fiscal year that ends Sept. 30. That's an estimated $400 million shortfall with more dramatic costs expected, beginning in October."

VA to outsource care for 180000 vets with hepatitis C
The Department of Veterans Affairs is moving to outsource care nationwide for up to 180,000 veterans who have hepatitis C, a serious blood and liver condition treated with expensive new drugs that are costing the government billions of dollars.

July 25
Wonder Drugs Blow a $1 Billion Hole in VA's Budget
Senior official at the Department of Veterans Affairs testified on Thursday that his agency is not rationing costly new drugs for veterans suffering from the potentially deadly Hepatitis C virus, as some have suspected, but acknowledged that the VA is reeling from the skyrocketing costs of providing the miracle drugs.

High Cost Of Specialty Drugs
June 26
Peak body, Gilead welcome hepatitis report
Australian Journal of Pharmacy
The report by the House of Representatives Standing Committee on Health, The Silent Disease – Inquiry into Hepatitis C in Australia has been welcomed by the peak body representing more than 230,000 Australians living with hepatitis C.

June 25
The rising cost of specialty drugs to treat complex, chronic or life-threatening conditions has the potential to break the pocket books of businesses, consumers, insurance companies and the state, according to Milam Ford of Blue Cross and Blue Shield of Louisiana.

Ford is the vice president of pharmacy services for Blue Cross and Blue Shield of Louisiana. He spoke with The News-Star Thursday about the rising cost of specialty drugs, which are used for cases of hepatitis C, cancer, rheumatoid arthritis, multiple sclerosis and more.

Related; June Updates
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

June 24
Community outreach program cures Pearland resident of Hepatitis-C
When Pearland resident John Rocks went into the hospital in 2012, the last thing he expected was to be diagnosed with Hepatitis-C(HEP-C) [an inflammation of the liver due to virus or bacteria], yet that's exactly what the doctor told him. “I had a ...

June 23
China rejects patent linked to Gilead hepatitis C drug
China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.

World Journal of Gastroenterology 2015 June 28
Hepatitis C virus (HCV) infection is a significant threat to the health of elderly patients, in whom liver disease progresses very rapidly and extrahepatic complications affect the quality of life. Till now, treatment attempts have been substantially limited by the side effects of interferon (IFN). Here we discuss how the availability of IFN-free regimens should prompt us to change our mind when assessing treatment indication and to consider a significantly larger number of possible candidates among elderly patients. Drug-drug interactions and assessment of liver disease-dependent vs comorbidities-dependent life expectancy, rather than anagraphic age, are likely to guide the choice of the aged HCV patients to be treated in the next future.

June 25
Clinical Care Options
Date Posted: 6/25/2015
In this downloadable slideset, Paul Y. Kwo, MD, reviews strategies for managing HCV infection in challenging patient populations, including an overview of data on the safety and efficacy of current regimens as well as potential future options.

June 23
MedPage Today
by Sarah Wickline Wallan
Various cannabinoid compounds did not improve nausea, vomiting, or appetite, and only slightly improved chronic pain and spasticity, in patients with various long-term health conditions, a review of randomized clinical trials found.

The greatest reductions in chronic pain were reported by patients who smoked tetrahydrocannabinol (THC) in eight of the trials, but the majority of the 79 trials in the meta-analysis demonstrated cannabinoids had little effect on HIV/AIDS patients with low-appetite and actually worsened chemotherapy-related nausea and vomiting, Penny F. Whiting, PhD, of University Hospitals Bristol NHS in England, and colleagues reported in the Journal of the American Medical Association.

Big Pharma
June 26
BMS is stopping early-stage discovery work in virology as part of a reshuffle in its R&D operations, pmlive.com reports.

The company stressed that the decision will not affect projects that have already reached the clinical development stage, which include beclabuvir for hepatitis C virus (HCV) in phase III and two HIV drugs in phase II, or indeed its marketed antiviral drugs including new HCV therapy Daklinza (daclatasvir).

The decision will mainly affect early programmes in hepatitis B and HIV, said the company, which said around 100 positions will be lost as a result. It will organisation will continue to focus on research in immuno-oncology as well as heart failure, fibrosis, genetically defined diseases and immunoscience.

Meanwhile, structural changes caused by the reshuffle include the opening of a facility in Cambridge, Massachusetts, due to open in 2018, as well as a the closure of its sites in Wallingford, Connecticut, and Waltham, Massachusetts, in 2018.

Around 200 workers from the two closing units and BMS’ New Jersey operations will relocate to the new unit, which will focus on discovery efforts in genetic diseases, molecular discovery technologies and discovery platform chemistry, said the company.
26 Jun 2015 | PharmaBusiness Daily

Blog Updates
June 26
The Top-Selling Drugs in America
NerdWallet (blog)-32 minutes ago
Sovaldi was first approved for most types of hepatitis C in 2013 and quickly skyrocketed to the top earnings spot in 2014. There are six genotypes of hepatitis C, ...

Greg Jefferys
My Hep C Travel Diary, Hepatitis C Advocate
Last Entry: Hepatitis C Musings (2015-06-25 15:03:51)
Tomorrow I should get my hepatitis C viral load results back.
click here to enter

Matt Starr
Hepatitis, Liver Disease Support Coach
Last Entry: Hepatitis C and Treatment - The Long Haul (2015-06-25 06:24:05)
Regardless of one's personal situation, what does it mean to hunker down for the long haul? Can we deal with liver disease and hepatitis, get serious and be open to a wide range of possible treatments, while still maintaining our love for life and what is all around us?
click here to enter

Karen Hoyt
Hepatitis C Advocate
Last Entry: Going Back to Bed after Liver Transplant Surgery(2015-06-24 06:40:27)
After the surgery, my transplant coordinators, friends, and family all conspired to make me rest. Then they got me all jacked up on steroids which made it totally impossible for me to sit still. It was quite a conundrum.
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Rick Nash
Hepatitis C Advocate
Last Entry: Road Tips (2015-06-23 14:11:01)
On my road trip to from San Diego to San Francisco, I took a critical look and what i did well, and where i could've improved and made a new road trip tip list for people living with the complications of Liver Disease.
click here to enter

Kim Bossley
Hepatitis C Advocate and Co-Founder, The Bonnie Morgan Foundation
Last Entry: Everyday Life (2015-06-22 12:21:29)
I am not what I used to be but I am happy, I am a fighter wanting to survive.
click here to enter

Lucinda K. Porter, RN
Author, Hepatitis C Advocate, Health Educator
Last Entry: When Hepatitis C Treatment is Hard and Scary (2015-06-22 06:07:58)
What if hepatitis C treatment isn't a cakewalk for you?

Enjoy the weekend!

Thursday, June 25, 2015

AASLD updates guidance for use of hepatitis C drugs

AASLD updates guidance for use of hepatitis C drugs

The American Association for the Study of Liver Diseases (AASLD), in partnership with the Infectious Diseases Society of America (IDSA) and in collaboration with the International Antiviral Society-USA (IAS-USA), created online Recommendations for Testing, Managing, and Treating Hepatitis C in 2014 to aid practitioners treating patients infected with hepatitis C virus (HCV). Now an update to the Guidance, with a summary of recommendations regarding treatment with direct-acting antiviral drugs, is published in the AASLD journal, Hepatology.

HCV is a blood-borne virus that infects the liver and may lead to cirrhosis or liver cancer (hepatocellular carcinoma). In the past 25 years HCV has gone from an undiagnosed disease to an epidemic level, with the World Health Organization (WHO) estimating that up to 150 million people worldwide live with chronic disease.

In the U.S., close to 30,000 new acute cases were reported in 2013 and 2.7 million Americans have chronic HCV according to the Centers for Disease Control and Prevention (CDC). "The good news is that HCV is now on the cusp of being a curable disease for the millions of Americans, many of whom are undiagnosed," says Dr. Gary Davis, President of MedLogician Consulting and co-chair of the AASLD/IDSA HCV Guidance writing panel. "The web-based Guidance document is an easy-to-use resource for practitioners treating HCV patients with novel antivirals."

A panel of 26 hepatologists and infectious diseases specialists and a patient advocate developed the original consensus recommendations that include:

HCV testing details and linkage to care
Recommendations for initial treatment of HCV infection in patients starting treatment
Retreatment information in persons in whom prior therapy has failed
Unique patient populations data

"The Guidance is a living document that will continually be updated with evidence-based advice about how to best use the next generation of direct-acting antivirals and other treatment options," comments Dr. Keith Lindor from the Arizona State University and President-elect of AASLD. "Our role as associations of researchers and clinicians is to provide key information in the appropriate format to patients and those who care for them."

Practitioners involved with treating patients with liver disease may access the Guidance, including new updates, at http://www.HCVGuidelines.org.

This guidance is published in Hepatology. Media wishing to receive a PDF of this article may contact sciencenewsroom@wiley.com.

Full citation: "Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus." Authors on behalf of the Hepatitis C Guidance Panel (see AASLD/IDSA HCV Guidance panel members and authors). Hepatology; Published Online: June 25, 2015, (DOI: 10.1002/hep.27950).

URL: http://doi.wiley.com/10.1002/hep.27950

About the Journal
Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published by Wiley on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://wileyonlinelibrary.com/journal/hep.

Researchers develop gel that could reduce jabs for Hepatitis C patients

The IBN behind the drug-delivering hydrogel. (from right) Dr Motoichi Kurisawa, Dr Ki Hyun Bae, Dr Keming Xu and Mr Fan Lee. Photo courtesy of the Institue of Bioengineering and Nanotechnology

Researchers develop gel that could reduce jabs for Hepatitis C patients
PUBLISHED: 6:09 PM, JUNE 25, 2015

SINGAPORE — Instead of weekly doses of discomfort, Hepatitis C patients could reduce the need for jabs by up to eight times if a drug-delivering hydrogel developed by researchers here reaches the market.

The gel works through a compound — called polyethylene glycol (PEG) — that serves as microscopic reservoirs for drugs typically used to treat chronic Hep C patients. The compound prevents premature leakage of the drugs, which also diffuse slowly as they flow in and out of the many “reservoirs” in the gel before being released out to the body.

It was previously impossible to use hydrogels to deliver drugs with long-term efficacy due to the difficulty in controlling the drug-release rate, said the Institute of Bioengineering and Nanotechnology (IBN), of the Agency for Science, Technology and Research, in a media release today (June 25).

The gel extends by up to 10 times the time taken for the amount of Hep C drugs in the body to be reduced by half, said Dr Motoichi Kurisawa, principal research scientist and IBN team leader. It reduces the need for frequent injections, he added.

Once the drugs are fully released, the gel degrades naturally and is passed out of the body.

The researchers’ findings were recently published in a journal called Biomaterials. But the new product could be several years from the market. The researchers are seeking a healthcare partner to conduct clinical trials, after studies conducted on animals.

Hep C, which affects about 0.2 per cent of the population here, is a liver disease that kills about half a million people worldwide yearly. Chronic Hep C patients typically undergo weekly injections of a protein drug called PEGylated interferon.

The gel is also being tested for the treatment of chronic diseases besides Hep C, said Dr Kurisawa.

The Future in Liver Medicine:Training the next generation of hepatologist: What will they need to know?

The Future in Liver Medicine, Liver and the Microbiome, & Liver Transplantation 

Hello folks, the June issue of Clinical Liver Disease is available online, here.

This journal is an official digital educational resource from the American Association for the Study of Liver Diseases. Along with full text access, each article includes a video presentation and author interview.

Clinical Liver Disease© The American Association for the Study of Liver Diseases
Volume 5, Issue 6 The Future in Liver Medicine, Liver and the Microbiome, & Liver Transplantation Pages 127 - 153, June 2015

The latest issue of Clinical Liver Disease is available on Wiley Online Library

The Future in Liver Medicine
Guest Edited by Meena Bansal, MD

The future of hepatology: Embrace change (pages 127–128)
Scott L. Friedman and Yael L. Friedman
Article first published online: 24 JUN 2015 | DOI: 10.1002/cld.473

Training the next generation of hepatologist: What will they need to know? (pages 129–131)
Dina L. Halegoua-De Marzio and Steven K. Herrine
Article first published online: 24 JUN 2015 | DOI: 10.1002/cld.461

Personalized management of hepatocellular carcinoma based on molecular information: Future prospects (pages 132–135)
Nicolas Goossens and Yujin Hoshida
Article first published online: 24 JUN 2015 | DOI: 10.1002/cld.483

Increasing impact of drug-induced liver injury (pages 136–138)
Paul H. Hayashi and Naga P. Chalasani
Article first published online: 24 JUN 2015 | DOI: 10.1002/cld.469

Future watch: Evolving trends in the management of nonalcoholic steatohepatitis (pages 139–141)
Arun J. Sanyal
Article first published online: 24 JUN 2015 | DOI: 10.1002/cld.477

Liver and the Microbiome
Guest Edited by Eamonn Quigley, MD

Host-microbiome interactions in health and disease (pages 142–144)
Liam O'Mahony
Article first published online: 24 JUN 2015 | DOI: 10.1002/cld.484

Liver Transplantation
Guest Edited by Paul Martin, MD
Hepatitis C treatment in liver transplant setting (pages 145–149)
Adam Peyton and Kalyan Ram Bhamidimarri
Article first published online: 24 JUN 2015 | DOI: 10.1002/cld.475

Renal dysfunction in cirrhosis (pages 150–153)
Chong Y. Parke, Paul Martin and Suphamai Bunnapradist
Article first published online: 24 JUN 2015 | DOI: 10.1002/cld.485

Wednesday, June 24, 2015

Viekira Pak - AbbVie hepatitis C cocktail succeeds in late-stage study

AbbVie hepatitis C cocktail succeeds in late-stage study

AbbVie Inc said on Wednesday that its hepatitis C cocktail Viekira Pak was effective whether or not it was used in combination with the compound ribavirin against the most common form of the disease, according to data from a late-stage study.

Viekira Pak, a combination of the drugs Viekirax and Exviera, was approved in December for use as both a standalone treatment and in tandem with ribavirin, a broad-spectrum antiviral approved in 1998.

All the patients in the study showed a sustained response to Viekira Pak as a standalone treatment after 12 weeks of treatment, AbbVie said.

The late-stage study on which the U.S. Food and Drug Administration based its decision to approve Viekira Pak in December showed it cured 91-100 percent of all patients with the infection.

Viekira Pak is one of three treatments for the liver-scarring disease fighting to corner the lion's share of the multi-billion dollar market and competes with Gilead Sciences Inc's Sovaldi and Harvoni, and Johnson & Johnson's Olysio.

(Reporting by Vidya L Nathan in Bengaluru, Editing by Simon Jennings)

AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis

- 100 percent SVR(12) rate achieved with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin(1)

NORTH CHICAGO, Ill., June 24, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.1 Patients received 12 weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV). These new results from AbbVie's Phase 3b study will be presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases in Berlin, Germany.

Approximately 160 million people worldwide are infected with HCV.2 Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide3 and in Europe, the most prevalent genotype is 1b (47 percent).4 Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in about 10-20 percent of people infected.2

"Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens," said Jordan J. Feld, M.D., MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada. "The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks."

Patients in TURQUOISE-III were either treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). No patients discontinued treatment due to adverse events.1 The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).1

"In the TURQUOISE-III study, GT1b patients with compensated liver cirrhosis achieved a 100 percent cure rate with VIEKIRAX + EXVIERA without ribavirin," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "TURQUOISE-III is part of our Phase 3b program, which aims to further enhance our understanding of AbbVie's regimen in HCV populations seen in clinical practice, and supports our commitment to continued investigation in this field."

TURQUOISE-III is a multi-center, open-label Phase 3b study to evaluate the safety and efficacy of 12 weeks of treatment with VIEKIRAX® + EXVIERA® without ribavirin (RBV) in adult patients (n=60) with genotype 1b chronic hepatitis C virus infection and compensated liver cirrhosis who were treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR12).1

No patients experienced virologic failure during treatment and no patients experienced virologic relapse following the end of treatment.1

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.

About AbbVie's HCV Clinical Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with or without ribavirin with the goal of achieving high sustained virologic response rates in as many patients as possible. AbbVie's global Phase 3b program plans to include more than 2,800 genotype 1 patients in over 200 study centers worldwide, including the U.S., Canada, Europe, Russia and Brazil.

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 chronic hepatitis C (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.

Pregnancy and concomitant use with ribavirin
When VIEKIRAX + EXVIERA are used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and 6 months after the treatment. Refer to the Summary of Product Characteristics for ribavirin for additional information.

ALT elevations
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.

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.

Adverse Reactions
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 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 Feld J, et al. TURQUOISE-III: Safety and Efficacy of 12-week Ribavirin-free Treatment for Patients with HCV Genotype 1b and Cirrhosis. Presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD) in Berlin, Germany, June 26-28, 2015
2 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15
3 Global Alert and Response (GAR): Hepatitis C. World Health Organisation Web site.http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html#HCV.
Published 2003. Accessed November, 2013
4 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

To view the original version on PR Newswire, visit:

SOURCE AbbVie Top of page

Tuesday, June 23, 2015

Burman's Specialty Pharmacy shows hepatitis C cure possible while cutting a third of the drug costs

Burman's Specialty Pharmacy study shows hepatitis C cure possible while cutting a third of the drug costs

MEDIA, Pa., June 23, 2015 /PRNewswire/ -- Burman's Specialty Pharmacy, a Diplomat company, announced a study showing that more than a quarter of hepatitis C patients may be treated with an eight-week therapy, four weeks shorter than the drug manufacturers originally expected. This represents potential for a huge cost savings in a health care ecosystem where hepatitis C treatments have posed a looming problem for payor organizations.

According to the study – reported in 'Specialty Pharmacy News' June edition – among 1,093 genotype 1a and 1b patients who have completed treatment over the last six months, 385, or 35%, had a clinical profile that qualified them for eight weeks, instead of 12 weeks, of Harvoni® therapy. "We worked with physicians on prescribing the shortened therapy for 284, or 74%, of those patients," said Paul Urick, president of Managed Markets and Industry Relations. The indicated population is treatment-naive and noncirrhotic, with an initial viral load of less than 6 million.

"An eight-week treatment cycle's wholesale acquisition costs average $63,000, a savings of $31,500 versus a 12-week treatment cycle," Urick added. "This is a great opportunity to make a difference to patients, and it's great for payors as well."

For Burman's qualifying patients:
A 12-week regimen of Harvoni® would have cost $26,923,050.
An eight-week regimen of Harvoni® totaled $17,948,700.
Savings amounted to $8,974,350 in Harvoni® costs alone.

"We know that not all physicians will be willing to prescribe eight weeks of treatment at all times," Urick said, "especially since each patient may have extenuating circumstances beyond prior treatment status and cirrhotic status, among other factors. It's at physicians' discretion as to how long they want to treat patients. Still, nearly 75% of patients who qualified did achieve a cure with 8-weeks of treatment for their Hepatitis C disease."

Burman's adds to this cost savings with enhanced therapy management. Burman's proprietary software platform HealthTrac is specifically designed to navigate the complexities of hepatitis C therapy and allow pharmacists and providers to collaborate on patient care.

"Our approach to hepatitis C therapy is based on collaboration between all parties in a patient's treatment continuum," said Steve Burman, president and CEO of Burman's. "Our goal is to maintain the high-touch treatment experience that drives a cure for our patients while driving down the costs that too often prevent care. Ultimately, we would like to affect real policy change that improves access to cures."

To learn more about Burman's Specialty Pharmacy, visit www.burmansmedical.com.

FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements give current expectations or forecasts of future events or our future financial or operating performance, and in this press release include the potential for an eight-week hepatitis C therapy with significant cost savings and Diplomat's distribution of the drug(s) set forth above (and any implied financial impact). The forward-looking statements contained in this press release are based on management's good-faith belief and reasonable judgment based on current information, and these statements are qualified by important risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from those forecasted or indicated by such forward-looking statements. These risks include sampling size and other risks related to conducting drug studies, the number of patients prescribed such drug(s) currently and in the future, patient's adherence to such drug(s), the number of distributors on panel and our relative distribution share, the timing of drug sales, the cost of such drug(s) and reimbursement rates by payors, drug competition, and the factors set forth in "Risk Factors" in Diplomat's Annual Report on Form 10-K for the year ended December 31, 2014 and in subsequent reports filed with or furnished to the Securities and Exchange Commission. Except as may be required by any applicable laws, Diplomat assumes no obligation to publicly update such forward-looking statements, which are made as of the date hereof or the earlier date specified herein, whether as a result of new information, future developments or otherwise.

About Burman's Specialty Pharmacy

Burman's is a leader in disease-specific treatment programs and has been in business for more than 50 years. Burman's comprehensive services and patient-first approach help patients and physicians navigate the complex waters of a variety of challenging health conditions, all while achieving improved results. Burman's offers individualized pharmaceutical care for a variety of challenging health conditions and complex drug therapies. To learn more, visit www.burmansmedical.com.

One year after VA scandal, veterans wait to be treated for everything from Hepatitis C to post-traumatic stress

One year after VA scandal, the number of veterans waiting for care is up 50 percent

By Emily Wax-Thibodeaux June 23 at 9:00 AM

One year after an explosive Veterans Affairs scandal sparked national outrage, the number of veterans on wait lists to be treated for everything from Hepatitis C to post-traumatic stress is 50 percent higher than at the same time last year, according to VA data.

VA’s leadership attributed the growing wait times to soaring demand from veterans for medical services, brought on by the opening of new centers and a combination of aging Vietnam veterans seeking care, the return of younger veterans from Iraq and Afghanistan and the exploding demand for new and costly treatments for Hepatitis C.