NICE issues appraisal consultation documents for three new hepatitis C therapies

Access to new hep C treatments put under the spotlight
NICE plans to restrict use of BMS’ Daklinza follow funding delay for Gilead's Sovaldi

As World Hepatitis Day draws to a close, Bristol-Myers Squibb has hit back at NICE's decision to restrict use of its new hepatitis C treatment Daklinza (daclatasvir) to a sub-population of patients.

In draft guidance released today, NICE has said that the NS5A replication complex inhibitor, in combination with other treatments, is recommended for HCV genotypes 1 and 4 who have significant fibrosis (liver scarring) without cirrhosis, if that patient has been previously treated with the injectable treatment interferon, or is ineligible or intolerant to interferon..


NICE issues appraisal consultation documents for three new hepatitis C therapies

The National Institute for Clinical Excellence (NICE) has today issued appraisal consultation documents for three new hepatitis C therapies; ledipasvir-sofosbuvir (Harvoni), daclatasvir (Daklinza, and ombitasvir/paritaprevir/ritonavir (with or without dasabuvir).

A summary of the recommendations, which at this stage are preliminary, are below:

Ledipasvir-sofosbuvir

Genotype 1
Recommended for use on treatment-naïve patients without cirrhosis for 8 weeks.
Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.
Recommended for use on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients with compensated cirrhosis for 12 weeks if a number of criteria (related to platelet count and previous history) are met.

Genotype 4
Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.
Recommended for use on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients with compensated cirrhosis for 12 weeks if a number of criteria (related to platelet count and previous history) are met.

The full document can be read here.

Daclatasvir
Recommended for use on genotype 1 and 4 treatment-experienced patients and patients who are interferon-ineligible or intolerant if the patient has significant fibrosis (METAVIR fibrosis stage F3-F4).

The full document can be read here.

Ombitasvir/paritaprevir/ritonavir (with or without dasabuvir)

Genotype 1b
Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-experienced patients with compensated cirrhosis for 12 weeks.

Genotype 1a
Recommended for use (with ribavirin) on treatment-naïve patients without compensated cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-experienced patients without compensated cirrhosis for 12 weeks.

The full document can be read here.

A consultation process will now occur whereby interested parties, including The Hepatitis C Trust, will provide comments on these recommendations. All comments must be submitted by 19th August, with further Appraisal Committee meetings being held on 3rd September. Final Appraisal Determination documents (which represent the final NICE recommendations) will then be published within 6 weeks of this meeting.

We would like to assure all patients that The Hepatitis C Trust will continue to argue for access to new treatments to be as wide as possible, and this will be reflected in our response to these preliminary recommendations.


FDA Acceptance of NDA for Merck's Grazoprevir/Elbasvir Treatment of Hepatitis C Genotypes 1, 4 and 6 Infection

Merck Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection


Company Granted FDA Priority Review with Target Action Date of January 28, 2016

Tuesday, July 28, 2015 6:30 am EDT

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients infected with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4 or 6.1 The FDA granted Priority Review for grazoprevir/elbasvir (100mg/50mg), with a Prescription Drug User Fee Act (PDUFA) action date of January 28, 2016.

“The U.S. FDA’s Priority Review designation for grazoprevir/elbasvir underscores how innovative treatment approaches for chronic hepatitis C are still needed for many patient populations,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “Our clinical data for grazoprevir/elbasvir in broad and diverse patient populations with chronic hepatitis C are very encouraging, and we look forward to continuing our dialogue with the FDA to bring this novel combination medicine to the appropriate patients with chronic hepatitis C.”

The New Drug Application for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials program, as well as the C-SURFER and C-SALVAGE trials. Data from these trials were previously presented at The International Liver Conference 2015™. Collectively, these trials evaluated treatment regimens of grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in multiple genotypes (GT1, 4 and 6) including patient populations who were previously treated, and those with cirrhosis or certain co-morbidities (e.g., HIV/HCV co-infection, chronic kidney disease stages 4 and 5).

About Grazoprevir/Elbasvir

Grazoprevir/elbasvir is Merck’s investigational, once-daily, single-tablet combination therapy consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of Merck’s broad clinical trials program, grazoprevir/elbasvir is being evaluated in multiple HCV genotypes including patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and those on opiate substitution therapy.

In April 2015, the FDA granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

About Merck

Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA

This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

1 Grazoprevir is an HCV NS3/4A protease inhibitor and elbasvir is an HCV NS5A replication complex inhibitor

Press Release 

House to Vote on Emergency Bill to Fund Veterans Affairs Department

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House to Vote on Emergency Bill to Fund Veterans Affairs Department

By MATTHEW DALY

A three-month highway spending bill scheduled for a vote Wednesday in the House includes nearly $3.4 billion to fill a budget hole that the Department of Veterans Affairs claims would force it to close hospitals and clinics nationwide. Lawmakers from both parties said the spending was needed even as they complained about the VA's failure to anticipate the problem.

An amendment sponsored by Rep. Jeff Miller, R-Fla., chairman of the House Veterans Affairs Committee, would allow VA to use $3.35 billion from the new Veterans Choice program to pay for private health care for veterans from May 1 to Oct. 1.

Under the amendment, the VA could use up to $500 million from the Choice program to cover costs of treating the deadly hepatitis C virus.

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Dr Marcus Dorner - where are we in the treatment of viral hepatitis?

Dr Marcus Dorner - where are we in the treatment of viral hepatitis?
by Marcus Dorner, Mr Al McCartney

28 July 2015

On World Hepatitis Day, Dr Marcus Dorner of the Department of Medicine, describes the current state of viral hepatitis research and treatment options.

Research in the field of viral hepatitis, especially on hepatitis C virus (HCV) infection has made incredible progress in recent years. This has lead to the development of an enormous number of novel therapies promising a cure for most of the over 130 million infected people worldwide (WHO 2015).

Up until recently treatment meant one year of injections with interferon, which lead to significant side effects and did by no means guarantee cure of the disease. With new therapies being approved constantly, people chronically infected with HCV can now look forward to over 90% treatment success rates, with therapies shortening in duration and virtually absent of side effects (1, 7). This has clearly changed the landscape for both the treatment of infected patients and research on HCV.

During the past few years, the focus of research and clinical virology has shifted from drug development to the identification of infected people and the optimisation of novel combination treatments. Even though the official number of people with HCV ranges from 130-170 million, there are likely many people who do not know they are infected. The slow progression of HCV together with the nature of its transmission has lead to a large number of people living with infection without knowledge of it.

For the longest time, the public has associated HCV infection with intravenous drug use and the sharing of needles; clearly contributing to the stigma associated with infection. This however is only one part of the equation. Prior to routine blood supply screening the majority of new infections could be attributed to blood transfusions, and in recent years the use of inadequately sterilized tattooing needles and dental equipment has lead to several instances of transmission of the virus. This, together with the fact that prolonged infection with HCV eventually leads to the development of liver cirrhosis and liver cancer, underlines the urgency of identifying all infected individuals and ultimately curing them.

But this is exactly the problem policy makers are facing at the moment. The efficacy and curative effects of new treatments over a relatively short period of time have in turn resulted in prices that make universal treatment prohibitively expensive. With costs as high as £120,000 for each treatment the total for treating the estimated 214,000 HCV-infected in the UK would exceed 25 billion pounds, or about a quarter of the total annual budget of the NHS (2-6). Even though pharmaceutical companies are already lowering the prices for treatments (such as the Gilead Global Access Programme) there is an urgent need for a protective vaccine, which still does not exist, as well as more economically viable treatment alternatives.

Despite the significant progress in fighting chronic liver disease associated with viral hepatitis, another member of this viral family has gone nearly unnoticed. Hepatitis B virus (HBV) shares a lot of its clinical symptoms with HCV and is also associated with the development of liver cancer. It has infected over 350 million people worldwide (WHO 2015) - over 180,000 of those in the UK (GOV.UK 2015).

Even though there is an effective vaccine available, millions of new HBV infections are reported each year. The good news for people infected is that funds allocated for viral hepatitis research will likely be re-allocated to focus on hepatitis B virus. It is however unlikely that the success story of HCV will repeat itself in the same time scale for HBV.

To date, many of the treatment options for HBV have been “borrowed” from HIV treatment, in that drugs affecting the HIV reverse transcriptase are also active in the hepatitis B virus. These treatments, although very effective in suppressing HBV replication do not constitute a cure for infection. Whenever treatment is interrupted hepatitis B virus starts replicating again. Even though in the last few years several new clinical trials were launched evaluating the efficacy of novel treatment options, a complete cure remains elusive.

It is important to keep in mind that, mainly due to the slow progression of viral hepatitis, the focus of the public is easily drawn to other infectious diseases with seemingly greater impact on public health. Globally however, the total number of people living with chronic liver disease associated with viral hepatitis is about 15 times the number of people living with HIV and the number of annual deaths are comparable to the number of people dying from seasonal influenza. These unimaginable numbers clearly mandate an even stronger effort to making effective and affordable vaccines and treatments available to everyone.

Both, hepatitis B and C virus only infect humans, making these pathogens perfect candidates for eradication; a goal that if accomplished would save countless lives in the future.

REFERENCES

1. Pawlotsky JM, Feld JJ, Zeuzem S, Hoofnagle JH. From non-A, non-B hepatitis to hepatitis C virus cure. Journal of hepatology 2015;62(1 Suppl):S87-99.

2. Leidner AJ, Chesson HW, Xu F, Ward JW, Spradling PR, Holmberg SD. Cost-effectiveness of hepatitis C treatment for patients in early stages of liver disease. Hepatology 2015;61(6):1860-1869.

3. Najafzadeh M, Andersson K, Shrank WH, Krumme AA, Matlin OS, Brennan T, Avorn J, Choudhry NK. Cost-effectiveness of novel regimens for the treatment of hepatitis C virus. Annals of internal medicine 2015;162(6):407-419.

4. Chhatwal J, Kanwal F, Roberts MS, Dunn MA. Cost-effectiveness and budget impact of hepatitis C virus treatment with sofosbuvir and ledipasvir in the United States. Annals of internal medicine 2015;162(6):397-406.

5. Westerhout K, Treur M, Mehnert A, Pascoe K, Ladha I, Belsey J. A cost utility analysis of simeprevir used with peginterferon + ribavirin in the management of genotype 1 hepatitis C virus infection, from the perspective of the UK National Health Service. Journal of medical economics 2015:1-19.

6. Akpo EI, Cerri K, Kleintjens J. Predicting the impact of adverse events and treatment duration on medical resource utilization-related costs in hepatitis C genotype 1 treatment-naive patients receiving antiviral therapy. PharmacoEconomics 2015;33(4):409-422.

7. Pawlotsky JM. New hepatitis C virus (HCV) drugs and the hope for a cure: concepts in anti-HCV drug development. Seminars in liver disease 2014;34(1):22-29.

Health Department issues advisory about Hepatitis C increase

TDH Issues Public Health Advisory on Hepatitis C Epidemic
Monday, July 27, 2015 | 11:55am

Disease that Can Destroy Livers on the Rise

NASHVILLE – The Tennessee Department of Health is issuing a public health advisory urging residents to increase their awareness about Hepatitis C, a life-threatening disease spread by direct contact with blood from an infected person. The rate of acute Hepatitis C cases in Tennessee has more than tripled in the last seven years, and the steadily increasing number of cases may only represent “the tip of the iceberg” of the state’s Hepatitis-C epidemic, according to TDH Commissioner John Dreyzehner, MD, MPH.

“In addition to reported cases of acute Hepatitis C it is estimated that more than 100,000 Tennesseans may be living with chronic Hepatitis C and not know it,” Dreyzehner said. “Many people have Hepatitis C for years, not realizing it, while the viral infection slowly destroys their livers.”

To see the advisory, go to http://tn.gov/health/article/health-advisories.

There is no vaccine to prevent Hepatitis C, so efforts to avoid exposure to infected blood are most important in preventing the spread of the disease. Most of the increase in transmission of Hepatitis C in Tennessee is due to the sharing of contaminated needles and syringes among intravenous drug users who are abusing both legal and illegal pain medicines.

Once infected with Hepatitis C, some people may recover fully, but most, 70 to 85 percent, will develop long-term infection. Early symptoms of Hepatitis C infection can include fatigue, abdominal pain, itching and dark urine. Many people, however, are not aware they have the disease until the virus has already caused liver cancer or liver damage.

“We strongly encourage those who suspect they might be infected to seek testing as soon as possible,” Dreyzehner said. “Testing can be done by a private health care provider and in some county health departments. The Centers for Disease Control and Prevention recommends all individuals born from 1945 to 1965 be tested, as well as individuals of any age who have any specific risk factors, including a history of injection drug use or unsanitary tattooing or piercing. If chronic Hepatitis C infection is present, a doctor can recommend treatment options. The sooner an infection is identified and treatment started, the better a person’s chances are for recovery.”

The treatment for Hepatitis C is currently expensive and a person can later become re-infected. A recent CDC report shows Hepatitis C is the most common blood-borne infection in the United States, with approximately three million people living with the infection. That report, available online at www.cdc.gov/mmwR/pdf/wk/mm6417.pdf, includes information about a 364 percent increase in Hepatitis C in four Appalachian states, including Tennessee, between 2006 and 2012.

“The best way to prevent Hepatitis C infection is to avoid recreational use of pain medicines, to avoid injecting drugs, and to not let those you love become dependent on or inject pain medicines or other illicit drugs such as heroin and methamphetamines,” Dreyzehner said. “We must all work more aggressively to reduce Hepatitis C in our communities; left unchecked, it will destroy families and wreak havoc on communities.”

The mission of the Tennessee Department of Health is to protect, promote and improve the health and prosperity of people in Tennessee. TDH has facilities in all 95 counties and provides direct services for more than one in five Tennesseans annually as well as indirect services for everyone in the state, including emergency response to health threats, licensure of health professionals, regulation of health care facilities and inspection of food service establishments. Learn more about TDH services and programs at www.tn.gov/health.


Genotype in Hepatitis C Determines Treatment Course/Genotype 1 is Common with Increasingly Effective Treatment

  • Monday, July 27, 2015
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Many Factors Determine Treatments in Hepatitis C Patients 
Published on Jul 27, 2015
While genotype is one of the overriding factors in determining course of treatment for patients with hepatitis C there are other areas to consider as well. This can include other health conditions they are being treated for, potential drug use, and other medications they are taking as well.
Source - MD Magazine TV



Determining Genotype in Hepatitis C Determines Treatment Course
Published on Jul 27, 2015
Once a patient has tested positive for hepatitis C the question then becomes which of the six genotypes and sub-genotypes do they have. Answering that question will determine what the next steps in care will be.
Source - MD Magazine TV



Genotype 1 Hepatitis C is Common with Increasingly Effective Treatment
Published on Jul 27, 2015 In the United States the two most common forms of hepatitis C are genotypes 1 and 2. They are also becoming increasingly easy to treat though the medications can be expensive for some patients.
Source - MD Magazine TV




Gilead's Greed that Kills

Gilead's Greed that Kills

Jeffrey Sachs
Director, Earth Institute at Columbia University
Gilead Sciences is an American pharmaceutical company driven by unquenchable greed. The company is causing hundreds of thousands of Americans with Hepatitis C to suffer unnecessarily and many of them to die as the result of its monopolistic practices, while public health programs face bankruptcy. 
Gilead CEO John C. Martin took home a reported $19 million last year in compensation--the spoils of untrammeled greed. 
Hepatitis C is a global public health crisis, called a "viral time bomb" by the World Health Organization. 150 million people or more worldwide are estimated to be living with the disease. Untreated Hepatitis C can progress to cirrhosis, liver failure, and liver cancer. Every year, at least 700,000 people die from these complications--although HCV can be easily cured with just 12 weeks of medicines being sold by Gilead.

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