October 23, 2013

IDSE: Hepatitis C Virus Year in Review

Infectious Disease Special Edition

ISSUE: OCTOBER 2013 | VOLUME: 1

The past 12 months have seen continued changes in the approach to screening for HCV, as well as new FDA approvals for genotype and viral load tests and treatment options. This review highlights advances in HCV care during that time frame, including research presented at recent gastroenterology and hepatology meetings.

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Hepatitis C Virus

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Living With the Hepatitis C Virus

If you have the hepatitis C virus, you'll want to prepare yourself for hepatitis C treatment, including lifestyle changes to help bring about the best possible outcome.

By Wyatt Myers | Follow @EverydayHealth

Medically reviewed by Pat F. Bass III, MD, MPH

42-46191053

Though the hepatitis C virus begins as an acute infection lasting just a few weeks, for 75 to 85 percent of people infected, the hepatitis C prognosis is for a chronic condition. The virus will stay in the body and continue to attack the liver.

“Chronic hepatitis C virus is known as the ‘silent killer’ because it is often asymptomatic until the liver starts to fail,” says Camilla Graham, MD, an assistant professor of medicine at Harvard Medical School in Cambridge, Mass. “Chronic infection can progress to serious liver disease, including scarring of the liver (fibrosis) and advanced scarring (cirrhosis).”

Over time, between 5 and 20 percent of people with the hepatitis C virus will develop cirrhosis, and between 1 and 5 percent will ultimately die from conditions related to the hepatitis C virus.

The hepatitis C virus can lead to additional complications for the liver. “In some cases, those with cirrhosis will go on to develop liver cancer or other complications of cirrhosis,” including life-threatening bleeding of the esophagus or stomach, or build-up of fluid in the abdomen, says Dr. Graham. “In the United States, hepatitis C virus is the leading cause of liver cancer.”

According to the Centers for Disease Control and Prevention, CDC, for those with hepatitis C, a gradual degradation of the liver that ultimately results in cirrhosis usually takes between 20 and 30 years to develop. “Once cirrhosis develops, the annual incidence of liver cancer is about 3 to 5 percent per year,” says John M. Vierling, MD, the director of Advanced Liver Therapies for St. Luke’s Episcopal Hospital in Houston.

Hepatitis C Treatment

Thanks to drug advances, about half of all people with the hepatitis C virus can be cured with targeted hepatitis C treatment. According to Graham, the most commonly used hepatitis C treatment is a two-part therapy that involves weekly injections of the drug pegylated interferon and a regimen of an antiviral drug called ribavirin, taken in pill form.

The course of this hepatitis C treatment is long, lasting 24 to 48 weeks, depending on your response to the drugs. About 50 percent of those with the hepatitis C virus can be cured with this treatment, though if you have the genotype 1 virus — which infects more than 70 percent of people with hepatitis C in the United States, the cure rate is only 40 to 46 percent and the treatment takes the full 48 weeks.

Some patients also take a direct-acting antiviral medication, either boceprevir (Victrelis) or telaprevir (Incivek). New hepatitis C drugs are on the horizon, to improve treatment.

There are side effects of this lengthy treatment, including skin rashes and other skin problems, weight loss, fatigue, cough, flu-like symptoms, general pain, and anemia. You’ll want to work closely with your doctor to gain the most benefit and have realistic expectations for the treatment.

Living With the Hepatitis C Virus

Even if hepatitis C treatment doesn’t rid your body of the disease, you can still live a healthy and productive life. Making positive lifestyle changes are particularly important for those living with hepatitis C to protect their liver as well as manage the emotional strain of the disease. Graham suggests these steps:

  • Abstain from alcohol and drug use.
  • Find a support group, so that you can share your thoughts, feelings, concerns, and emotions about the disease.
  • Attend regular check-ups with your doctor to get the best care possible.
  • Eat a healthful, balanced diet with plenty of fruits and vegetables and avoid too much salt, sugar, and fat.
  • Do gentle exercises like walking and swimming as frequently as you are able.
  • Avoid harmful fumes and toxins like paint thinner or cigarette smoke that can further damage the liver.
  • Rest whenever you feel tired to avoid overtaxing your body and immune system.

Planning for the Future

You may want to make long-range financial plans for better peace of mind. This may include working closely with a trusted financial advisor to obtain the appropriate life insurance policy or investments to protect your family if your condition worsens. If you are under long-term care for your hepatitis C treatment, you may be eligible for financial assistance through the government or specific hepatitis drug manufacturers.

Last Updated: 10/23/2013

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The Race Is On for the Next Big Hepatitis C Therapy

Peovided by The Motley Fool

By Amy Ho | More Articles
October 23, 2013

The Food and Drug Administration's Antiviral Drugs Advisory Committee's positive review of Johnson & Johnson (NYSE: JNJ ) and Medivir's hepatitis C therapy simeprevir foreshadows the drug's likely FDA approval tomorrow.. Fast on its heels will be Gilead Sciences (NASDAQ: GILD ) with its own hepatitis C drug sofosbuvir on Friday. Both drugs have benefited from priority review status.

Hepatitis C is a viral infection of the liver and has multiple genotypes, with genotype 1 the most prevalent. Complications include liver cancer and cirrhosis. Standard of care currently is interferon, which is delivered as a cumbersome injections 2-3 times a week, with only an efficacy of around 50%, and uncomfortable flu-like side effects.

While both Gilead and Johnson & Johnson's compounds are oral pills, they are currently only studied in combination with an interferon (peginterferon-alpha), manufactured by both Merck (NYSE: MRK ) as Pegintron and Roche (NASDAQOTH: RHHBY ) as Pegasys, and ribavirin, another anti-viral agent. Johnson & Johnson's simeprevir is seeking approval for treatment of genotype 1, while Gilead's sofosbuvir will target genotype 1, 2, 3, 4, 5 and 6.

While the FDA's internal review is a positive step for Johnson & Johnson to gain approval tomorrow, simeprevir is a niche enough drug that competitors won't be squeezed out of the market. Forty-eight percent of hepatitis C patients with genotype 1 had a variant that did not respond to simeprevir versus the control group.

Two other hepatitis C drugs already exist as first generation protease inhibitors: Victrelis (boceprevir) by Merck and Incivek (telaprevir) by Vertex Pharmaceuticals (NASDAQ: VRTX ) . Both were approved in 2011 and are also used in conjunction with peginterfereon-alpha and ribavirin. The approval of simeprevir could replace these earlier generation protease inhibitors.

Meanwhile, Gilead's sofosbuvir is perhaps seen as the more likely blockbuster, due to efficacy against all genotypes of hepatitis C and against even the most difficult to treat cases of hepatitis C. Even without interferon, sofosbuvir showed 70% cure rates and may be the closest to a truly interferon-free therapy yet.

The hepatitis C market is currently estimated at around $20 billion with potential to expand to $100 billion this decade . The more broad-reaching sofosbuvir expects peak sales at $3.8 billion  and simprevir is estimated annual sales of $400 million.

The race for an oral, non-interferon agent could revolutionize patient care in terms of both reducing patient burden and increasing clinical outcomes. Both Johnson & Johnson with Medivir and Gilead are expected to gain approval this week; neither have experienced significant setbacks or raised concerns that would red-flag their approvals this week. However,  both simeprevir and sofosbuvir are such tiny agents in the vast arsenal of products by each company that FDA approval may or may not be reflected directly in stock price.

Nonetheless, more than 20 other agents are in development to take a piece of the pie for novel hepatitis C agents. AbbVie and Bristol-Myers Squibb are expecting to file New Drug Applications next year. Studies combining the different companies' agents have also yielded impressive cure rates -- over 90% for the combination of J&J's simprevir and Gilead's sofosbuvir, and 100% cure for the combination of Gilead's sofosbuvir and Bristol-Myers Squibb's daclatasvir.

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Want data on drugs? Look for clinical study reports

By Andrew M. Seaman

NEW YORK | Thu Oct 24, 2013 2:22am IST

NEW YORK (Reuters Health) - For information on how drugs work and affect people, a new study says regulatory reports that are rarely published are better sources than the typical documents that are publicly available.

German researchers found that so-called clinical study reports produced by pharmaceutical companies had complete information on 86 percent of study outcomes that are relevant to patients. In contrast, only about 39 percent of those outcomes were found in other sources, such as studies published in academic journals.

"For the first time, we know how much information we can gain from the types of documents we investigated," lead author Beate Wieseler said.

Wieseler is the head of drug assessment at the Institute for Quality and Efficiency in Health Care (IQWiG). IQWiG is a German agency that examines the risks and benefits of medical interventions.

Extra information is needed for various reasons, including the creation of medical guidelines and treatment decisions between doctors and patients, she said.

But clinical study reports, which can be hundreds or thousands of pages long, are not usually available to the public.

"I don't know when it was decided or how it was decided, but the (U.S. Food and Drug Administration) considers this information proprietary and doesn't give it to anyone else," Dr. Joseph Ross said.

Ross, who was not involved in the new study, has researched the availability of study results at the Yale School of Medicine in New Haven, Connecticut.

For the new analysis, published in PLOS Medicine, Wieseler and her colleagues analyzed trials on 16 drugs that IQWiG examined between 2006 and 2011.

They compared the information in the private clinical study results to publicly available sources, such as academic journals, the U.S. government-run website clinicaltrials.gov and a registry managed by the World Health Organization, to see which included more information on patient-relevant outcomes.

Those outcomes include events such as the number of study participants who died or experienced serious side effects, how patients responded to the drug and effects it had on their quality of life.

"The thing that's interesting about this report is that clinical study results are not systematically available so people have not been able to study it," Ross said.

Overall, the researchers identified 1,080 patient-relevant outcomes for the drugs. Of those, the clinical study reports had complete information on almost nine out of 10. The publicly available sources, however, only had complete information on about four of 10.

"It's not that surprising that unpublished clinical study reports have more data and results than published study results," Ross said.

Wieseler said that the U.S. Food and Drug Administration (FDA) and its European counterpart the European Medicines Agency could start publishing clinical study reports on their websites to give people access to the data.

A FDA spokesperson, however, told Reuters Health in an email that federal law prohibits the agency from "making a fair amount of clinical data publicly available."

"The issue of clinical trial data sharing - for a lack of better word - is a hot topic at the moment," Jeff Francer, vice president and senior counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), said.

PhRMA represents biopharmaceutical researchers and biotechnology companies.

"In many cases, companies and researchers have been sharing data for quite some time really under the radar," he said. "And I think companies are comfortable sharing clinical data with qualified researchers" as long as they protect patient privacy and use the data in an appropriate way.

In July, PhRMA and the European Federation of Pharmaceutical Industries and Associations adopted Principles for Responsible Clinical Trial Data Sharing (onphr.ma/1ie4SYy).

Under those principles, which take effect January 1, companies will make synopses of the clinical study reports that are submitted to government approval organizations available to the public.

"Each company is going to be going about it a different way," Francer said. "The key is that all of our members will have information on their websites about where (the public) can find this information."

As part of the adopted principles, researchers and scientists can also request clinical trial data from companies for medicines and indications approved in the U.S. and the European Union.

Preparing to share patient-level data takes the most work, according to Francer.

For example, companies need to address privacy commitments that are made to trial participants, create data request applications and put together boards to review those requests.

Implementing the principles will be an evolutionary process, Francer said.

"We also hope the academic community and government researchers will be just as open as industry researchers are going to be starting now," he added.

Ross said making clinical trial data available will help patients better understand the risks and benefits of drugs and medications.

"It needs to be in a place where people can access it and understand it to make informed decisions on what to use," he said.

SOURCE: bit.ly/1bfq8L3 PLOS Medicine, online October 8, 2013.

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Sofosbuvir Briefing Documents/Hearing Oct 25 --- Excerpts

Provided by NATAP

Download the PDF here
Download the PDF here

Please read the entire 2 documents for assured full context and the most reliable data.

FDA:

VI. GENERAL SUMMARY

The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C. In the HCV GT 2 and 3 populations, the sofosbuvir and ribavirin combination regimen provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen. In addition, SOF+RBV provides a therapeutic option for patients who are ineligible, intolerant or unwilling to take interferon-based regimens, thus addressing an unmet need in this patient population.

In the HCV GT 1 and 4 populations, sofosbuvir in combination with pegylated interferon and ribavirin provides increased efficacy and shorter treatment duration compared with currently approved regimens. The shorter 12 week duration translates into a better tolerated side effect profile with observed treatment discontinuations due to AEs of less than 2%. The available data are believed to be insufficient to make definite dosing recommendations for patients with GT 5 or 6.

No major safety issues associated with sofosbuvir use have been identified to date. The observed safety profile between the two durations (SOF+RBV 12 weeks versus SOF+RBV 16 weeks) evaluated in FUSION is similar.

Gilead Briefing Document Attached:

EXECUTIVE OVERVIEW

On 08 April 2013, Gilead Sciences (Gilead) submitted a New Drug Application (NDA) to the United States (US) Food and Drug Administration (FDA) for sofosbuvir (SOF). SOF is a uridine nucleotide analog with potent anti-viral activity against hepatitis C virus (HCV) genotypes 1 through 6. SOF has a favorable safety profile. When administered in combination with ribavirin (RBV) for genotypes 2 and 3 HCV infection, it is the first all-oral therapy for this patient population, many of whom previously failed treatment or could not be treated. For patients with genotypes 1, 4, 5, and 6 HCV infection, SOF in combination with RBV and pegylated interferon (Peg-IFN) provides a shorter, simpler, and more effective interferon-limiting regimen.

The proposed indication for SOF is for the treatment of chronic HCV infection, in combination with other agents in adult patients with genotype 1 to 6 and/or adult patients awaiting liver transplantation. The recommended dose of SOF is one 400-mg tablet once daily administered orally with or without food. Table 1 summarizes the proposed SOF regimens and treatment durations.

Conclusions

The availability of SOF in combination with other anti-HCV drugs will provide physicians with a new, safe, and effective treatment option for patients with chronic HCV infection. Benefits of treatment with SOF include high response rates with shorter treatment durations than the previous standard-of-care treatments, little risk of the development of resistance, and an improved or similar safety profile to the currently available therapies. For patients with genotype 2 or 3 HCV infection, including those who failed prior treatment or who are ineligible or intolerant to current therapies, it will be the first time that a treatment option is available. Overall, the results of the SOF development program support the positive benefit/risk profile for the proposed indication for SOF to be administered in combination with other agents for the treatment of chronic HCV infection in adults (Section 1, Table 1).

FUSION: Treatment-Experienced Patients with Chronic Genotype 2 or 3 HCV Infection see p 78 Gilead document

FDA ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING
OCTOBER 25, 2013
BACKGROUND PACKAGE
FOR
NDA 204671
SOFOSBUVIR (GS-7977)

FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION RESEARCH
OFFICE OF ANTIMICROBIAL PRODUCTS
DIVISION OF ANTIVIRAL PRODUCTS

During the Advisory Committee meeting, analyses will be presented addressing use of SOF+PEG+RBV in this population, including limitations of this approach such as the NEUTRINO single arm trial design and potential subpopulations in which this 12 week regimen may not be optimal (e.g., prior null responders). Acknowledging the lack of data directly obtained in this patient population, we believe that the SOF+PEG+RBV shorter treatment duration and improved tolerability profile warrants consideration by the Committee for use in HCV GT1 patients who have failed a prior PEG+RBV regimen.

As more DAA-based therapies emerge, the patient population who failed a prior PEG+RBV regimen is anticipated to diminish over time, and the traditional PEG+RBV-based treatment-naïve and treatment-experienced definitions may not be optimal. In addition, we recognize the baseline predictors identified from the long experience with PEG+RBV treatment may be different from those identified with DAA-based regimens.

C. Drug Interactions

Sofosbuvir is a substrate of drug transporters P-gp and BCRP, while GS-331007 is not. Drugs that are potent P-gp inducers in the intestine (e.g., rifampin or St. John's wort) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of sofosbuvir and thus should not be used with sofosbuvir. Coadministration of sofosbuvir with drugs that inhibit P-gp and/or BCRP would likely increase sofosbuvir plasma concentration (e.g., cyclosporine). The effects of coadministered drugs on the exposure of SOF and GS-331007 have been studied for cyclosporine, darunavir/ritonavir, emtricitabine, efavirenz, raltegravir, rilpivirine, tacrolimus, and tenofovir disoproxil fumarate. No clinically significant effect of sofosbuvir on these drug exposures has been observed. No significant changes in the exposures of sofosbuvir and GS-331007 caused by these coadministered drugs have been observed, with the exception of cyclosporine (CsA).

Coadministration of sofosbuvir with the P-gp and BCRP inhibitor CsA (administered as a single high dose of 600 mg), resulted in an increase (approximately 4.5-fold) in sofosbuvir exposure, but the exposure of GS-331007 was unchanged in the presence of CsA. The safety margins for sofosbuvir and metabolites after coadministration with CsA are adequate (AUC safety margins range from 2.9 to 10.3), when compared with exposures obtained in rat and dog in 3 to 9-month toxicology studies. Furthermore, limited safety data from ongoing post-transplant study (GS-US-334-0126) indicated that the safety of SOF+RBV is similar between subjects not taking CsA (N=30) and subjects taking CsA (N=10). Therefore, no dose modification of sofosbuvir is recommended when coadministered with CsA.

FROM GILEAD Briefing Document:

HCV1

(Click image to enlarge)

VI. GENERAL SUMMARY

\The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C. In the HCV GT 2 and 3 populations, the sofosbuvir and ribavirin combination regimen provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen. In addition, SOF+RBV provides a therapeutic option for patients who are ineligible, intolerant or unwilling to take interferon-based regimens, thus addressing an unmet need in this patient population.

In the HCV GT 1 and 4 populations, sofosbuvir in combination with pegylated interferon and ribavirin provides increased efficacy and shorter treatment duration compared with currently approved regimens. The shorter 12 week duration translates into a better tolerated side effect profile with observed treatment discontinuations due to AEs of less than 2%. The available data are believed to be insufficient to make definite dosing recommendations for patients with GT 5 or 6.

No major safety issues associated with sofosbuvir use have been identified to date. The observed safety profile between the two durations (SOF+RBV 12 weeks versus SOF+RBV 16 weeks) evaluated in FUSION is similar.

VII. PRELIMINARY TOPICS FOR THE ADVISORY COMMITTEE

The Division is convening this meeting to solicit the Committee's comments on the following topics. Please note, however, that these are preliminary topics and are still subject to change.

1. Considering potential risks and benefits do the available data support approval of sofosbuvir in combination with pegylated interferon and ribavirin for treatment of chronic hepatitis C in treatment-naïve adult patients with genotype 1 and 4 infection?
Background Information for Consideration (Issue 1): As the question states, we are asking the Committee to weigh all the risks and benefits in the vote for approval. Please note that a vote for approval, in general terms, doesn't mean that one must agree with all of the proposed dosing recommendations or that one must define all labeling recommendations. Questions 3 through 7 that follow the general approval question/vote will give the Committee a chance to provide opinions on more granular issues and labeling recommendations, if there is consensus that the overall risk-benefit is positive and supportive of approval for use in treatment of hepatitis C. If not, please consider what additional studies should be recommended.

2. Considering potential risks and benefits do the available data support approval of sofosbuvir in combination with ribavirin for treatment of chronic hepatitis C in adult patients with genotype 2 and 3 infection?
Background Information
for Consideration (Issue 2): As the question states, we are asking the committee to weigh all the risks and benefits in the vote for approval. The general background information included in Question 1 applies to this question as well.

3. Please comment on the strength of evidence for use of sofosbuvir in combination with pegylated interferon and ribavirin for treatment of chronic hepatitis C in patients with genotype 1 infection who are nonresponders to a prior course of pegylated interferon and ribavirin. Please comment if additional data are needed in this population.

4. Please comment on the strength of evidence (bridging analyses) for use of sofosbuvir and ribavirin for 16 weeks duration in treatment-naïve genotype 3 patients.

5. Please comment on the strength of evidence for use of sofosbuvir and ribavirin for 16 weeks duration in subgroups of genotype 2 patients who may benefit from an extended duration of therapy.

6. Please comment on the strength of evidence for use of sofosbuvir in combination with ribavirin in HCC patients meeting Milan criteria awaiting liver

-------------------------------------

B. HCV Genotype 1, 4, 5 and 6 Population

1. Efficacy in HCV Genotype 1, 4, 5 and 6 treatment-naïve population (NEUTRINO)

This Phase 3, multicenter, open-label trial enrolled treatment-naive subjects with chronic genotype 1, 4, 5, or 6 HCV infection. Subjects received SOF (400 mg once daily) + PEG (180 μg/week) + RBV (1000 or 1200 mg/day) for 12 weeks. A total of 327 subjects received study drugs, including 17% with compensated cirrhosis.

Overall, a statistically significant proportion of subjects achieved SVR12 (90%, p < 0.0001) compared with a historical SVR12 rate of 60% (Table 6). Relapse accounted for most treatment failures, with an overall rate of 9%. No subject had on-treatment virologic failure. Subjects with GT1 (N=292) had an SVR12 rate of 89%, with a GT1a and GT1b subtype difference noted (SVR12 92% and 82%, respectively). Subjects with GT4 (N=28) had an SVR12 rate of 96%. It should be noted that few subjects with GT5 (N=1) and GT6 (N=6) were included in the clinical trial and the available data are believed to be insufficient to make definitive dosing recommendations for patients with HCV GT5 or 6 infection.

HCV2

(Click image to enlarge)

HCV3

(Click image to enlarge)

3. HCV Genotype 1 Infection, Prior Pegylated Interferon Nonresponders: Exploratory Analyses

HCV GT1 patients who failed prior treatment with PEG+RBV were not specifically studied in the SOF development program. Clinical HCV trials have generally categorized patients as treatment-naïve or treatment-experienced based upon their prior virologic response to a PEG+RBV regimen. Previous FDA analyses have demonstrated that PEG+RBV nonresponders are represented within the treatment-naïve population (Liu et al. Hepatology 2013, Liu et al. CID 2012, Florian et al. Hepatology 2013). Other baseline factors or patient characteristics such as cirrhosis status and viral load have been shown to predict response to a PEG+RBV regimen. The observed high overall SVR rate in HCV GT1 treatment-naïve subjects from NEUTRINO led the Division to use a similar approach to explore if the data may support use of SOF+PEG+RBV for 12 weeks in patients who have failed a prior PEG+RBV regimen. During the Advisory Committee meeting, analyses will be presented addressing use of SOF+PEG+RBV in this population, including limitations of this approach such as the NEUTRINO single arm trial design and potential subpopulations in which this 12 week regimen may not be optimal (e.g., prior null responders). Acknowledging the lack of data directly obtained in this patient population, we believe that the SOF+PEG+RBV shorter treatment duration and improved tolerability profile warrants consideration by the Committee for use in HCV GT1 patients who have failed a prior PEG+RBV regimen.

As more DAA-based therapies emerge, the patient population who failed a prior PEG+RBV regimen is anticipated to diminish over time, and the traditional PEG+RBV-based treatment-naïve and treatment-experienced definitions may not be optimal. In addition, we recognize the baseline predictors identified from the long experience with PEG+RBV treatment may be different from those identified with DAA-based regimens.

Extending the treatment duration by 4 weeks increased SVR12 rates in HCV GT2 subjects from 82% to 89%, and in HCV GT3 subjects from 30% to 62%.

HCV4

(Click image to enlarge)

Across the Phase 3 trials, higher SVR12 rates occurred in HCV GT2 subjects compared with HCV GT3 subjects.
· FISSION (treatment-naïve): HCV GT2 subjects had a significantly higher SVR12 rate than HCV GT3 subjects in the SOF+RBV 12 Week group (95% and 56% of HCV GT2 and 3 subjects, respectively) (p-value <0.0001).
· POSITRON (IFN-intolerant, ineligible, unwilling): HCV GT2 subjects had significantly higher SVR12 rates than HCV GT3 subjects in the SOF+RBV 12 Week group (93% and 61%, respectively) (p-value < 0.0001).
· FUSION (treatment-experienced): the SVR12 rate difference between HCV GT2 and 3 subjects was significant within each treatment duration group.
->SOF+RBV for 12 weeks: SVR12 rates were 82% and 30% for HCV GT2 and 3 subjects, respectively (p-value < 0.0001).
->SOF+RBV for 16 weeks: SVR12 rates were 89% and 62% for HCV GT2 and 3 subjects, respectively (p-value = 0.0052).

The HCV GT3 relapse rate in the 16 Week arm was still as high as 38% even though much lower than 66% in the 12 Week arm. This observation suggests the efficacy could potentially be further improved with longer treatment duration or an additional antiviral agent (e.g., PEG or another direct acting antiviral).

b. Bridging Analyses to Explore Treatment Duration in Treatment-Naïve Genotype 3 Subjects

The collective evidence from the Phase 3 trials indicates 12 weeks of SOF+RBV is not the optimal regimen for HCV GT3 patients. Reduced response rates in HCV GT3 subjects were driven by relapse, indicating extending the duration of therapy may improve SVR. FUSION demonstrated HCV GT3 treatment-experienced subjects receiving SOF+RBV for 16 weeks had significantly increased SVR12 rates compared with the same regimen for 12 weeks, 62% versus 30%, respectively, as well as lower relapse rates (38% versus 66%, respectively). Additionally, response rates for HCV GT3 subjects were consistently lower than HCV GT2 subjects across all three trials. These observations suggest that a longer treatment duration may also be beneficial in the HCV GT3 treatment-naïve population; however, the available Phase 3 trials only evaluated SOF+RBV for 12 weeks. Due to the overall lower SVR12 rate observed in HCV GT3 patients, the FDA requested the Applicant to provide analyses justifying a treatment duration for HCV GT3 treatment-naïve patients based on the available Phase 3 data. These analyses, which are included in the Applicant's background package, show their bridging analysis to estimate the SVR12 rate for 16 weeks of SOF+RBV in HCV GT3 treatment-naïve patients using the GT3 data from FISSION and FUSION.

FDA analyses were also conducted to estimate the treatment response of 16 weeks of SOF+RBV treatment in HCV GT3 treatment-naïve subjects. Instead of applying the Applicant's model to estimate the SVR12 rate, the FDA analyses extrapolated the SVR12 rate from the observed SVR12 rates in FISSION and FUSION based on an assumption of equivalent odds ratios of SOF+RBV 16 Weeks over SOF+RBV 12 Weeks compared to SOF+RBV 12 Weeks in both treatment-naïve and treatment-experienced HCV GT3 subjects. This odds ratio analysis predicted an SVR12 rate of 83% for 16 weeks of SOF+RBV in HCV GT3 treatment-naive subjects (Table 4). Alternative calculations based on using either relative risk (RR) or proportion difference (PD) were also evaluated and resulted in estimated SVR12 rates of 76% and 88%, respectively. Thus, these exploratory post-hoc analyses determined the estimated SVR12 rate for 16 weeks in HCV GT3 treatment-naive subjects ranges from 76% to 88% depending on the extrapolation approach used, and suggest 16 weeks of SOF+RBV treatment in HCV GT3 treatment-naïve subjects would lead to a higher SVR12 rate than the 56% SVR12 rate observed for 12 weeks of SOF+RBV treatment in the FISSION trial.

HCV5

(Click image to enlarge)

Source

FDA Panel to Discuss 2 New HCV Drugs

Infectious Disease

Published: Oct 23, 2013

By Michael Smith, North American Correspondent, MedPage Today

An FDA advisory committee is set to debate the merits of two new agents that act directly against hepatitis C (HCV) -- the first such agents to come before the agency since 2011.

Simeprevir and sofosbuvir are also the first in an anticipated wave of second-generation, direct-acting agents for the disease, which chronically afflicts about 3.2 million Americans.

The agency's Antiviral Drugs Advisory Committee will vote on whether to recommend approval of simeprevir on Thursday and sofosbuvir on Friday.

For many years, the standard therapy for hepatitis C was a combination of peginterferon-alfa and ribavirin, drugs that are regarded as both difficult and dangerous to take.

In 2011, the FDA approved the first agents that act directly against the virus itself -- the protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek).

Simeprevir, another protease inhibitor, would be the third drug in the class if it passes the advisory committee's scrutiny. The FDA usually follows the guidance of its advisory committees but is not bound to do so.

Sofosbuvir, on the other hand, is a member of another class -- the nucleotide analog NS5B polymerase inhibitors. It would be the first in its class to get the nod, if the FDA approves it.

The makers of simeprevir, Janssen Research and Development, are asking for an indication to use the drug, in combination with peginterferon and ribavirin, in HCV genotype-1 patients who are either treatment-naive or who have failed previous interferon-based therapy.

The application is based on efficacy results from three placebo-controlled phase III trials, two in treatment-naive patients and one in patients who've relapsed. The primary endpoint in all three studies was the proportion of patients with undetectable virus 12 weeks after the end of therapy -- the so-called SVR12.

In pooled data for treatment-naive patients, the SVR12 rate was 80% among those getting all three drugs and 50% among those in the control group, who got placebo along with interferon and ribavirin.

In the trial among relapsers, the SVR12 rates were 79% in the simeprevir group and 36% among placebo patients.

In patients with genotype-1a, however, the presence of a relatively common genetic variant -- the Q80K polymorphism in the viral protease -- reduced the efficacy of the drug to the point where it was no longer statistically better than placebo.

The FDA reviewers recommended that if the drug is approved, prospective patients with genotype-1a disease should be screened for the variant and treated with other drugs if they have it. The efficacy of both telaprevir and boceprevir is unimpaired by the Q80K polymorphism.

FDA reviewers were also concerned about reports of photosensitivity and rash among patients taking the drug.

Gilead Sciences, the developer of sofosbuvir, is seeking an indication to use the drug, in combination with either ribavirin or with peginterferon and ribavirin, in patients with genotypes 1 through 6 of the HCV, as well as in adult patients awaiting liver transplant.

FDA staff reviewers said available data support a favorable benefit-risk assessment for sofosbuvir as part of a combination regimen for HCV. Also, the reviewers noted that the drug could form the basis, for the first time, of all-oral regimens for HCV.

There were no major safety issues associated with sofosbuvir, they concluded.

Source

PRESS RELEASE  October 23, 2013, 1:15 p.m. ET

OraSure Technologies Commends New York State Hepatitis C Testing Law

New Law Requires Health Service Providers to Offer a One-Time Hepatitis C Test to Individuals Born Between 1945 and 1965

BETHLEHEM, Pa., Oct. 23, 2013 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) applauds New York State's new hepatitis C (HCV) testing law, which requires providers in all clinical settings in the state of New York (except emergency rooms) to offer a one-time HCV test to individuals born between 1945 and 1965. Governor Andrew Cuomo signed the bill into law today and it will take effect as of January 1, 2014.

According to the Centers for Disease Control and Prevention (CDC), HCV is the most common chronic blood-borne infection in the United States. Up to 75 percent of people with hepatitis C are unaware of their infection. It is estimated that Baby Boomers (adults born between 1945 and 1965) are five times more likely to have hepatitis C than other adults. The CDC recommends that all Baby Boomers, approximately 78.2 million individuals, be tested for hepatitis C at least once.

"We applaud New York State on its new hepatitis C testing law, and for its leadership in taking action to fight the hepatitis C epidemic," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "As a result of this new law, we believe more individuals at risk for HCV will get tested and learn their hepatitis C status. With the use of our OraQuick(R) Rapid HCV test, individuals presumed to be infected can be referred immediately for follow-up care."

The OraQuick(R) HCV Rapid Antibody Test is the first and only FDA-approved, CLIA-waived rapid, point-of-care test for the detection of antibodies to the hepatitis C virus. OraQuick(R) HCV results are available in 20 minutes, which can help increase the delivery of test results, allowing early diagnosis and linkage to care, treatment and prevention services, particularly for those at risk for hepatitis C.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In July 2012, the Company received approval from the U.S. Food and Drug Administration for the Company's OraQuick(R) In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market - making it the first and only rapid OTC HIV test approved in the U.S. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.

Source

Also See: Governor Cuomo Signs Bill to Require Hospitals to Offer Hepatitis C Testing

Preview - New wave of oral hepatitis C drugs near U.S. approval

By Deena Beasley
Wed Oct 23, 2013 10:08pm IST

(Reuters) - Patients infected with the liver-destroying hepatitis C virus should soon have better treatment options as new tablets from Gilead Sciences and others approach U.S. regulatory approval.

Gilead's experimental drug sofosbuvir is the first of a new wave of oral therapies to be considered by the Food and Drug Administration, which has convened an advisory panel for Friday.

The treatment is seen as the crown jewel of Gilead's $11 billion purchase of biotechnology company Pharmasset and aims to replace some of the pills and injections now on the market.

"Treatment will become simpler, shorter and safer ... a broader group of patients can be treated," said John McHutchison, head of liver disease therapeutics at Gilead.

In a pre-hearing report issued on Wednesday, FDA staff concluded that sofosbuvir is safe and effective as part of a combination regimen for hepatitis C.

The deadline for a regulatory decision on the drug is December 8. Wall Street analysts have forecast sales of $1.85 billion next year, assuming a price of $85,000 per patient, according to ISI Group. Hepatitis C affects around 3.2 million Americans, killing more than 15,000 each year, mostly from illnesses such as cirrhosis and liver cancer.

The standard treatment has long been a combination of interferon, given by injection, and ribavirin, a pill. But both drugs have side effects and neither works directly against the virus. In addition, the regimen is not that effective for many people living with hepatitis C, especially those with hard-to-treat genotype 1 infections.

Technological advances over the past decade have enabled the development of direct-acting antivirals (DAAs) that specifically target the hepatitis C virus. Two new antiviral drugs, Incivek from Vertex Pharmaceuticals Inc and Victrelis from Merck & Co, have cured more HCV patients in recent years, but both are protease inhibitors and are still used in combination with interferon and ribavirin.

Protease inhibitors are designed to block certain enzymes the virus needs to replicate.

Gilead's drug is part of a new class known as nucleotide analogue inhibitors, or "nukes," designed to block a different enzyme the virus needs to copy itself. The company says the therapy is more difficult for the body to overcome, and expects treatment times to be shorter and easier to endure. It has first sought FDA approval to use sofosbuvir along with ribavirin as an all-oral therapy for genotype 2 and 3 infections, or about 28 percent of the U.S. hepatitis C patient population.

It is also seeking approval to use the drug in combination with both ribavirin and interferon for more common genotype 1 infections, while planning for file next year for an all-oral treatment regimen for those patients.

"We have a very, very high barrier to resistance," McHutchison said.

He estimates that around 70 percent of U.S. HCV patients have genotype 1, up to 20 percent are infected with genotype 2, and 8 percent have genotype 3.

COMPETITIVE ADVANTAGE?

Gilead is the world's largest maker of branded drugs to treat HIV, the virus that causes AIDS, but has turned to hepatitis C treatments to diversify its pipeline.

"Before we acquired Pharmasset we did a lot of due diligence," McHutchison said. "I think we picked the right nuke."

Sanford Bernstein analyst Geoffrey Porges believes Gilead's advantage over competitors in the HCV field may be increasing as it becomes more clear that a nuke-based regimen has fewer limitations in terms of dosing convenience and breadth of genotype effectiveness.

"We are approaching an inflection point for hepatitis C for Gilead," he said.

It is a competitive field, and there have been setbacks for some. Vertex said in July that the FDA had placed a partial hold on a mid-stage study of its experimental hepatitis C nuke. Bristol-Myers Squibb last year discontinued development of one of its experimental drugs after a patient died of heart failure during a clinical trial and several others were hospitalized.

While Gilead is perceived to be in the driver's seat in the race to produce all-oral treatments, Bristol-Myers is expected to present Phase III data on an interferon-free treatment for genotype 1 patients at next month's meeting of the American Association for the Study of Liver Diseases in Washington D.C.

That regimen will consist of daclatasvir, which blocks a protein called NS5A that plays a key role in HCV replication, that Bristol-Myers sees as the backbone of its hepatitis program, along with its protease inhibitor asunaprevir.

Bristol plans to begin pivotal testing of a three-pill therapy early next year. Companies like AbbVie and Boehringer Ingelheim are also spending millions to develop new hepatitis C treatments.

McHutchison said data on another Gilead all-oral regimen - sofosbuvir combined with NS5A inhibitor ledipasvir - will be presented at a medical meeting next April. The company plans to file for FDA approval of that regimen, which includes genotype 1 patients, in the first half of next year.

He said sofosbuvir has so far been tested in more than 3,000 patients and there have been no issues with heart problems or other side effects beyond those associated with the drugs it has been combined with.

Earlier trials of the company's all-oral combination for genotype 1 resulted in more than 95 percent of patients being cured, McHutchison said.

The FDA advisory committee will also hear comment this week on Johnson & Johnson's application to sell simeprevir, an experimental protease inhibitor designed to target genotype 1 HCV.

(Additional reporting by Bill Berkrot; Editing by Krista Hughes)

Source

Contact Information:
Governor's Press Office
NYC Press Office: 212.681.4640
Albany Press Office: 518.474.8418
press.office@exec.ny.gov

govseal

Andrew M. CuomoGovernor

Albany, NY (October 23, 2013)

Governor Andrew M. Cuomo today signed a new law that will better protect baby boomer New Yorkers from Hepatitis C by requiring hospitals and health service providers to offer testing for the virus to all patients born between 1945 and 1965.

"Hepatitis C is a debilitating and potentially fatal disease that disproportionately affects the baby boomer generation in New York and nationwide," Governor Cuomo said. "This new law will help fight Hepatitis C and keep New Yorkers safe by providing testing to those most likely to have this virus whenever they visit a medical facility. I thank Senator Hannon and Assembly Member Zebrowski for their work on this important legislation."

According to the United States Centers for Disease Control and Prevention (CDC), approximately 75 % of Hepatitis C infection and about 73 % of Hepatitis C-associated mortality occurs in individuals born between 1945 and 1965 – baby boomers. New York State Department of Health statistics show that as many as 150,000 New Yorkers are unaware of their Hepatitis C status. The new law (A.1286-A/S.2750-A) will ensure that all individuals born between 1945 and 1965 are offered a hepatitis C screening test or diagnostic test whenever they are a patient at a hospital, clinic or a physician's office.

Senator Kemp Hannon said, "I applaud the Governor for acknowledging this public health crisis and signing this bill into law. Nationwide, approximately three million adults are infected with the hepatitis C virus, most are baby boomers and three out of four are unaware they are infected. By requiring health care providers to offer hepatitis C testing, as recommended by the CDC, we have an opportunity to protect individuals from the leading cause of liver disease, and to treat and cure those who have been infected before they become seriously ill.”

Assembly member Kenneth Zebrowski said, "Hepatitis C is known as the “silent killer” because it can attack your liver for over a decade before you exhibit any symptoms. Recent estimates suggest that 1 out of 30 baby boomers could be infected with as many as 75% unaware. My father passed away from Hepatitis C in 2007, and my family experienced first hand the lack of information and knowledge surrounding this epidemic. This one time test will bring the disease out of the darkness and get thousands of New Yorkers lifesaving treatment before it is too late."

The new law will take effect on January 1, 2014.

Source

Provided by Healio

October 23, 2013

SAN DIEGO — Kris Kowdley, MD, reports during the American College of Gastroenterology Annual Scientific Meeting that 12 weeks of sofosbuvir combination therapy was well tolerated and effective in patients with hepatitis C genotypes 1 through 6 infection.

Previously treated patients with HCV genotype 3 infection may benefit from extending therapy to 16 weeks, according to Kowdley, director of the Liver Center of Excellence at the Digestive Disease Institute of Virginia Mason Medical Center in Seattle.

Disclosure: Kowdley has received grant/research support from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead/Pharmasset, Intercept, Janssen, Merck, Mochida and Vertex; and has served on advisory boards for AbbVie, Gilead, Merck and Vertex, and as a scientific consultant at Novartis.

For more information:

Kowdley K. #38: Sofosbuvir + Ribavirin with or without Peginterferon Is Well-tolerated and Associated with High SVR Rates: Integrated Results from 4 Phase 3 Trials in HCV Genotype 1-6. Presented at: the 2013 American College of Gastroenterology Annual Scientific Meeting; Oct. 11-16, San Diego.

Source

Gilead’s Hepatitis C Pill Works Better Than Current Therapy

Bloomberg News

By Anna Edney October 23, 2013

Gilead Sciences Inc. (GILD:US)’s experimental hepatitis C drug that lessens side effects and reduces length of treatment time is safe and effective against the disease, U.S. regulators said.

The medicine, sofosbuvir, has “a favorable benefit-risk assessment,” Food and Drug Administration staff said today in a review ahead of an Oct. 25 meeting of advisers to discuss the therapy. The FDA also will host an advisory panel tomorrow for Johnson & Johnson (JNJ:US) and Medivir AB (MVIRB)’s hepatitis C drug simeprevir.

Gilead, J&J, Medivir, AbbVie Inc. (ABBV:US) and Bristol Myers Squibb Co. are among companies working on a new generation of hepatitis C drugs that alleviate the burden of current treatments that include interferon injections, which can cause flu-like symptoms. The total market for hepatitis C drugs may reach more than $100 billion over a decade, according to Bloomberg Industries.

STORY: The Tequila Curse

For some patients, sofosbuvir “provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen,” FDA staff wrote in the report.

Sofosbuvir is estimated to generate $2 billion in sales next year, according to the average of eight analysts’ estimates compiled by Bloomberg.

Gilead rose 1.1 percent to $68.83 at 9:48 a.m. New York time. The shares had gained 85 percent this year through yesterday.

STORY: The Secrets of Bezos: How Amazon Became the Everything Store

Decision Date

The FDA didn’t find any heart risks associated with sofosbuvir after Bristol-Myers and Idenix Pharmaceuticals Inc. discontinued development of drugs in the same class last year based on cardiovascular safety concerns.

Gilead is seeking FDA approval of once-daily sofosbuvir combined for the majority of patients with pegylated interferon and another pill call ribavirin, both of which make up the backbone of current treatment for the virus as part of a regimen that can last as long as 48 weeks. Sofosbuvir can cut the treatment time to 12 weeks. J&J’s simeprevir gets therapy down to 24 weeks.

The FDA is scheduled to decide whether to approve sofosbuvir by Dec. 8, and simeprevir by Nov. 27.

Oral Combinations

For the majority of current patients interferon and ribavirin are combined with Merck & Co.’s Victrelis and Vertex Pharmaceuticals Inc. (VRTX:US)’s Incivek. Victrelis, Incivek and J&J’s simeprevir are protease inhibitors that battle genotype 1 hepatitis C, the most common form of the disease. Sofosbuvir is the first in a new class of drugs called nucleotide polymerase inhibitors and is effective across all six hepatitis C genotypes.

About 4 million Americans have the disease, which can cause liver cirrhosis, according to the National Institutes of Health. The disease can be passed through infected blood or body fluids, most commonly through needle-sharing by drug users. About 70 percent of U.S. hepatitis C patients carry the genotype 1 infection.

Gilead studied an all-oral combination of sofosbuvir and ribavirin for genotype 2 and genotype 3 patients and a combination with pegylated interferon and ribavirin for patients with the other genotypes, including 1, who haven’t been treated before.

Sofosbuvir combined with pegylated interferon and ribavirin for 12 weeks cured 90 percent of patients with genotypes 1,4,5 and 6 who hadn’t been treated before, Gilead said. FDA staff found data on patients with genotypes 5 and 6 to be insufficient to determine dosing because Gilead only studied 7 patients total with those types of hepatitis C.

New Data

“This is a two- or three-stage program,” John McHutchison, senior vice president of liver disease therapeutics at Gilead, said in an interview. “This is the first approval.”

Gilead is researching an all-oral combination of sofosbuvir and another Gilead drug ledipasvir the company hopes will hit the market about a year after sofosbuvir itself.

“Sofosbuvir seems to be the future of many of these highly effective all oral regimens,” McHutchison said.

FDA workers recommended yesterday potential simeprevir users be screened for a genetic mutation called Q80K polymorphism that renders the drug ineffective. No such suggestion was made regarding sofosbuvir.

Data from a mid-stage study on a combination of simeprevir and sofosbuvir with or without ribavirin are expected to be released in early November at the American Association for the Study of Liver Diseases’ annual conference in Washington, D.C.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Source

Also See: Briefing Information for the October 25, 2013 Meeting of the Antiviral Drugs Advisory Committee – Sofosbuvir

Provided by FierceBiotech

October 23, 2013 | By John Carroll

Friday's FDA panel review of Gilead's hep C drug sofosbuvir is shaping up as a marketing event. In an internal staff review released this morning, regulators said that the hep C drug combined with regimen would offer the first all-oral treatment for two key genotypes of hepatitis C patients, offering faster cures and an improved safety profile over anything currently on the market. And it presents a promising alternative for the large number of patients who can't tolerate the harsh impact of interferon injections.

Gilead's sofosbuvir appears headed for a quick if not early approval from the FDA, which would set it firmly on a path to a megablockbuster market, with a wide variety of analysts estimating peak annual sales at $5 billion-plus. And that would more than justify the $11 billion Gilead paid to get the treatment in the Pharmasset buyout.

The FDA concluded that "the currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C. In the HCV GT 2 and 3 populations, the sofosbuvir and ribavirin combination regimen provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen. In addition, SOF+RBV provides a therapeutic option for patients who are ineligible, intolerant or unwilling to take interferon-based regimens, thus addressing an unmet need in this patient population."

"In the HCV GT 1 and 4 populations, sofosbuvir in combination with pegylated interferon and ribavirin provides increased efficacy and shorter treatment duration compared with currently approved regimens. The shorter 12 week duration translates into a better tolerated side effect profile with observed treatment discontinuations due to AEs of less than 2%. The available data are believed to be insufficient to make definite dosing recommendations for patients with GT 5 or 6."

No major safety issues were founded related to the therapy, according to the FDA.

Sofosbuvir is widely expected to quickly topple the leaders in the hep C market, Vertex's Incivek and Victrelis from Merck. Both of those companies have been hurrying along substitute programs, but they're well behind the likes of Gilead, AbbVie and Bristol-Myers Squibb, which are all focused on developing cocktail therapies that will extend across the various genotype groups, where response times and cure rates can vary.

Gilead's own company review of the therapy—documents which typically provide only the most positive aspects of a drug profile—add that this is a drug that can be taken once a day without food, often without most other meds and generally without a dose adjustment. All those aspects help distinguish the therapy from what's on the market today.

- here's the FDA review
- here's the company review

Source

Also See: Briefing Information for the October 25, 2013 Meeting of the Antiviral Drugs Advisory Committee - Sofosbuvir

First-ever rally focused on liver disease to bring together advocates, patients, researchers and others to focus on treatments, cures for oft-overlooked organ.

Washington, DC (PRWEB) October 23, 2013

Liver disease affects millions of men, women and children worldwide and its incidence rates are growing. Deaths from liver disease increased substantially from 1990 to 2010. Yet few people are aware of the enormous health and economic burden of liver disease, or that much is treatable and preventable.

For many of these diseases, very little progress is being made on detection, prevention or cures. Liver transplantation is challenging; hepatitis C treatment is expensive and difficult; too few livers are available for patients awaiting transplant, and few are aware that one in 10 Americans has liver disease.

A diverse group of professionals, patients and advocates are intent on raising awareness and increasing public attention to the growing worldwide burden of liver disease.

Their members will hold the 1st International Rally for Liver Disease Awareness on Friday, November 1 at the Long View Gallery (1234 9th Street, NW) in Washington, DC at noon. Attendees are invited to arrive at 11 a.m. for networking and viewing rally partner displays. After the rally, guests can enjoy a reception and refreshments from 1:30 to 3:00 p.m.

The goals of the Rally are to increase public attention to the growing worldwide burden of liver disease, and to create a global community of stakeholders that will accelerate progress in liver disease prevention, early detection, treatment and research.

The Liver Rally is co-chaired by Dr. Melanie Thomas, President of CanLiv, by Donna Cryer, J.D., a health advocate, liver patient and transplant recipient and by Ivonne Fuller, CEO, Hepatitis Foundation International. Moderated by Cryer, the rally will feature representatives from the National Institutes of Health (NIH), the U.S. Department of Health and Human Services, Pediatric Liver Center at Johns Hopkins Medical Center, Partners Seeking a Cure, Hepatitis Foundation International, National Viral Hepatitis Roundtable and CanLiv - The Hepatobiliary Cancers Foundation.

The Rally will be available to view online at https://new.livestream.com/CanLiv/liverrally. Members of the public are invited to attend, and show their support for this cause. To view the agenda, visit: http://liverdiseaserally.org/join-the-rally.html. Sponsorships and donations are welcome at http://liverdiseaserally.org/donate-now.html.

Source

Unmet Need in Hepatitis C Gets Boost from Innovative Partnership

logo3

23. October 2013

Boehringer Ingelheim makes significant investment in groundbreaking hepatitis C program with two leading researchers from the Francis Family Liver Clinic, Toronto Western Hospital University Health Network

Burlington, ON, October 23rd, 2013 In a move to address a significant unmet need in hepatitis C in Canada, the University Health Network (UHN), together with Boehringer Ingelheim (Canada) Ltd. (BICL), announced today a multi-year partnership that aims to improve care, education and support for patients with hepatitis C. The program, known as Link-C, aims to improve access to hepatitis C care and treatment in remote areas of Ontario and other parts of Canada.

A large number of Canadians with hepatitis C remain undiagnosed. According to a single estimate, 21 per cent of Canadians infected with hepatitis C remain undiagnosed, however, some experts believe that this figure may be higher.1 In addition, many Canadians, particularly those living in remote areas, lack access to local care and treatment.2 While hepatitis C is an infection that can be cured, hepatitis C treatment and management is highly specialized and available from a limited group of health care providers with such expertise.3

The UHN/BICL partnership, which is supported through a $600,000 grant from BICL, is designed to support and motivate additional health care providers in rural areas to develop the expertise necessary to treat the disease. These funds will be focused on training physicians to actively engage and inform patients about the risk factors and optimal treatment options. Furthermore, the program will also inform recommendations for an optimal screening program.

“We recognize that an alarming number of Canadians lack timely access to hepatitis C care, which is why we’ve developed the Link-C program,” said Dr. Jordan Feld, Francis Family Liver Clinic, Toronto Western Hospital, a part of the University Health Network. “The diagnosis can be life-changing, yet there is a gap in awareness among patients and caregivers about the disease itself, its implications and treatment options. Link-C will bring education and support to more health care professionals so that we can improve care for the men and women with hepatitis C in Canada.”

Hepatitis C affects at least 240,000 Canadians with some estimates as high as 400,000.4 Left untreated, hepatitis C can lead to scarring of the liver, liver failure and potentially liver cancer.5 As there are a limited number of physicians who treat hepatitis C, patients can experience lengthy wait times.6 The goal of Link-C is to broaden the pool of health care professionals with expertise in hepatitis C, thereby increasing the number of health care professionals who can diagnose, treat and manage the disease.

“In addition to equipping additional health care providers with the expertise to identify and treat hepatitis C, Link-C will also engage and inform patients about the risk factors, symptoms and treatment options,” said Dr. Hemant Shah, Director of Education, Francis Family Liver Clinic, Toronto Western Hospital. “Ultimately, I think a program like Link-C will help build towards a national screening program. Hepatitis C is the only chronic viral infection that is curable, so the more we can provide access to information and education for patients and caregivers, the more effective we will be at ensuring that patients can deal with and manage this condition before it yields further and much more serious complications such as liver failure and cancer.”

According to data from 2009, approximately 10,000 to 12,000 new cases of hepatitis C are diagnosed in Canada each year.7 Increasing the number of health care providers who can treat and manage hepatitis C will help diagnose and cure the growing number of patients living with this disease.

Boehringer Ingelheim is working with hepatitis C experts to address the unmet medical need of many Canadians with this disease. “As a leader in advanced therapeutics for infectious diseases, including hepatitis C, Boehringer Ingelheim (Canada) Ltd. could not be more pleased to be partnering with the University Health Network on this program to address a significant area of unmet need facing hepatitis C patients,” said Dr. Ted Witek, president and CEO, Boehringer Ingelheim (Canada) Ltd . “We are delighted to be supporting the Link-C program, which will address some of the critical barriers to better care for both patients with hepatitis C and those who treat it.”

About Link-C
The Link-C program is composed of three pillars:

  • Increase the number of primary care providers treating hepatitis C outside of urban centres so that patients in remote areas can be treated locally.
  • Encourage patients to be screened and diagnosed, educate them about the symptoms and treatments available for hepatitis C, and involve them in the management of their care.
  • Inform recommendations for an effective screening protocol for hepatitis C through the review and analysis of diagnostic, cancer and patient outcome data.

About Hepatitis C
Hepatitis C is a blood-borne infectious disease and a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally.8 In Canada, an estimated 240,000 individuals, with some estimates as high as 400,000 are infected with the disease.9 The Canadian Liver Foundation estimates that since 2007 approximately 500 people die from hepatitis C-related illnesses in Canada each year.10 The number of hepatitis C-associated illnesses, including cirrhosis, liver failure, liver death and the need for liver transplants will likely double or triple in the next decade.11

About University Health Network
University Health Network includes Toronto General and Toronto Western Hospitals, Princess Margaret Cancer Centre, and Toronto Rehabilitation Institute. The scope of research and complexity of cases at University Health Network has made it a national and international source for discovery, education and patient care. It has the largest hospital-based research program in Canada, with major research in cardiology, transplantation, neurosciences, neurology, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. University Health Network is a research hospital affiliated with the University of Toronto. For more information, please go to www.uhn.ca.

About Boehringer Ingelheim (Canada) Ltd.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees.

Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2011, Boehringer Ingelheim posted net sales of 13.2 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 and is home to more than 750 employees across the country. For more information please visit www.boehringer-ingelheim.ca.

Jennifer Mota
Brand Communication Associate
Boehringer Ingelheim (Canada) Ltd.
(905) 631-4739 (B)
(905) 484-1452 (C)
Email: jennifer.mota@boehringer-ingelheim.com

Rererences  

1. Shah, H.A. et al. A Canadian screening program for hepatitis C: Is now the time? CMAJ. 2013.
2. Ontario Hepatitis C Task Force. A proposed strategy to address hepatitis C in Ontario 2009-2014. 2009.
3. Myers, R. et al. An update on the management of chronic hepatitis C: Consensus guidelines from the Canadian Association for the Study of the Liver. Can J Gastroenterol, Vol. 26, No 6, June 2012.
4. Sherman, M et al. Liver disease in Canada: A crisis in the making. Report by Canadian Liver Foundation. From web site. 2013.
5. Sherman, M et al. Liver disease in Canada: A crisis in the making. Report by Canadian Liver Foundation. From web site. 2013.
6. Myers, R. et al. An update on the management of chronic hepatitis C: Consensus guidelines from the Canadian Association for the Study of the Liver. Can J Gastroenterol, Vol. 26, No 6, June 2012.
7. Sherman, M et al. Liver disease in Canada: A crisis in the making. Report by Canadian Liver Foundation. From web site. 2013.
8. Hepatitis C. World Health Organization. From web, http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed October 11, 2013.
9. Sherman, M et al. Liver disease in Canada: A crisis in the making. Report by Canadian Liver Foundation. From web site. 2013.
10. Sherman, M et al. Liver disease in Canada: A crisis in the making. Report by Canadian Liver Foundation. From web site.
11. Zou, S. et al. Epidemiology and Health Care Planning: Estimating the Burden of Hepatitis C in Canada. Health Canada.

Source

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FDA

Disclaimer: Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552).

Gilead Sciences, Inc.

Disclaimer: The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Source – FDA