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Alan Franciscus
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated October 13, 2014

Friday, October 31, 2014

Triple Therapy for Hepatitis C Infection: Bacterial Infection Risk Rises, Changes

A good adjective to describe hepatitis C virus (HCV) infection is “tricky.” Many Americans are infected and don’t know it, and are chronic carriers of the virus. Patients who have HCV infection are at high risk for arthralgia, myalgias, pruritus, neuropathy, and decompensated livers. Until recently the sole available treatment was interferon. After the US Food and Drug Administration (FDA) approved ribavirin, patients who took ribavirin plus interferon responded better. Now, the FDA has approved a small selection of oral antivirals to treat hepatitis C. Collectively, these drugs successfully induce sustained virologic response in more than 90% of patients.

Studies showed that HCV-infected patients who have comorbid HCV-related cirrhosis who receive double therapy (interferon and ribavirin) are at elevated risk of bacterial infections. Recent guidelines recommend adding a protease inhibitor (telaprevir or boceprevir, called triple therapy) to the interferon and ribavirin regimen to increase the likelihood of sustained virologic response. A team of European researchers, curious about how infection rates might be affected, set out to compare infection rates between treatments. Their study appeared in the October 2014 issue of the Journal of Hepatology.

Triple therapy was associated with a significantly higher infection rate (25%) compared to double therapy (9%). Patients who received double therapy; however, were more likely to develop respiratory tract infections (12%) than those on triple therapy (1%).

- See more at: http://www.hcplive.com/publications/internal-medicine-world-report/2014/October-2014/Triple-Therapy-for-Hepatitis-C-Infection-Bacterial-Infection-Risk-Rises-Changes-#sthash.j9TMqJuX.dpuf

Egypt: Egyptian Health Ministry accused of using unapproved drugs

CAIRO — The Egyptian Health Ministry faces accusations by the Syndicate of Pharmacists, a number of pharmaceutical companies and medical professionals of exploiting Egyptians afflicted with the hepatitis C virus (HCV). The patients allegedly have been used to test a new drug, Sovaldi. Summary⎙ Print Egyptian pharmacists have accused the ministry of distributing an unapproved drug to hepatitis C patients and violating drug importation, registration and trade regulations.

A major dispute arose between the Syndicate of Pharmacists and the Egyptian Health Ministry, after it was revealed that the active ingredient in this drug has yet to be approved. Thousands of patients had applied to the ministry to obtain the drug, which was indeed provided to them by the ministry and distributed for sale in major pharmacies in Egypt. The ministry also faces charges of violating the terms of the importation, registration and trading of this drug.

Syndicate of Pharmacists spokesman Mohamed Saudi told Al-Monitor: “Experiments were conducted in the US on only 28 cases of patients with HCV genotype 4, and Egypt conducted experiments on only 100 cases. These numbers are statistically insufficient to use this drug on millions of patients with this type of hepatitis.”

Read more: http://www.al-monitor.com/pulse/originals/2014/10/egypt-health-ministry-new-drug-experiment.html##ixzz3HlW2H8rQ

New Drug Cures Local Woman Of Hepatitis C

Medical breakthroughs are being made in the fight against Hepatitis C. In fact, a woman from Springdale has become one of the first people in the country to be cured of the disease that attacks the liver, and she spoke with 5NEWS about the new treatment option that saved her life.

Now, with a new outlook on life, Carlette is on a mission to make sure others know about the new treatment options.

“This could save their life. This could change their whole family. They can be there to see their kids. They can be there to see their grandkids. I’m going to be there to see my son play the next time, in the next tournament,” Carlette exclaimed with tears in her eyes.


Thursday, October 30, 2014

Australia: New resource helps GPs manage patients with chronic hepatitis B and C

GPs across Western Australia will receive a new chronic hepatitis B and C primary care pathway later this month. WA Health has developed the pathway to assist GPs and primary health care providers assess and manage patients with hepatitis B or hepatitis C in the community.

Across Australia, only a small proportion of those living with chronic hepatitis B or C are accessing treatment. Treatment with antiviral medication can significantly reduce the risk of complications such as cirrhosis and liver failure.

The clinical pathway has been developed in close collaboration with key stakeholders, and contains up-to-date evidence-based recommendations as well as links to a range of patient and health professional resources.

It provides a quick guide for GPs and summarises:
  • what patients can do to optimise their own health
  • how to manage their long-term care
  • which patients to refer
  • how to refer
  • where to go for more information.
Thanks to all the clinicians, GPs, Communicable Disease Control Directorate staff and non-government organisations that supported the development of this resource.

For more information, visit the Public Health website (external site) and download the primary care pathway (PDF 810KB).

Source:  http://www.health.wa.gov.au/snapshots/hepatitisBC.cfm

Sweden: Medivir and county councils conclude agreement on Olysio®-based treatment for hepatitis C

HUDDINGE, Sweden--()--Regulatory News:

Medivir AB (STO:MVIR-B) announces that the company has entered into an agreement with Swedish county councils regarding the treatment of hepatitis C with Olysio® (simeprevir).
The Dental and Pharmaceutical Benefits Agency (TLV) has concluded that treatment with Olysio® (simeprevir) is beneficial from a health economics viewpoint in the treatment of HCV genotypes 1 and 4 with METAVIR scores of F3-F4, irrespective of previous treatment.

A risk-sharing agreement between Medivir and the Swedish county councils has been drawn up in parallel with TLV’s health economic evaluation. The agreement offers the county councils and Medivir an increased degree of predictability with regard to treatment costs and the use of Olysio®, in that the risk-sharing applies both in relation to treatment results and to the number of patients who will be treated.

“Treatment with Olysio® has already helped to cure a large number of people from hepatitis C, both in Sweden and globally. I believe that the agreement will help to ensure equal treatment across all of Sweden’s county councils and that more hepatitis C patients will get the opportunity to become cured through treatment with Olysio® , wherever they live,” says Henrik Krook, EVP Commercial at Medivir.

Joint county council recommendations related to the use of Olysio® will be designed by the New Pharmaceutical Product Therapies (NLT) group (a group within the Swedish Association of Local Authorities and Regions tasked with evaluating new pharmaceutical products and therapies). The NLT group will have a meeting October the 30th regarding a protocol for structured introduction of Olysio®.

Medivir is required under the Swedish Securities Market Act to make the information in this press release public. The information was submitted for publication at 08.30 CET on 30 October 2014.

About Simeprevir (Olysio®)
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Simeprevir efficacy has been established in HCV genotype 1 and HCV genotype 4 infected patients with compensated liver disease, including cirrhosis. Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen‐Cilag International NV. Simeprevir was approved for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. Simeprevir was approved in September 2013 in Japan, in November 2013 in Canada and the U.S., in March 2014 in Russia and in July 2014 in Mexico and Australia.

In May 2014, simeprevir was granted marketing authorisation by the European Commission (EC) for the treatment of adult patients with genotype 1 or genotype 4 chronic HCV. Following the EMA approval, it has so far been made available in several EU countries in conjunction with reimbursement. Simeprevir (Olysio) is marketed under the trade name Sovriad® in Japan and Russia, Galexos™ in Canada and Olysio® in the U.S. and European Union.

About Medivir
Medivir is an emerging and profitable research‐based pharmaceutical company with an established marketing and sales organisation in the Nordic region with a broad portfolio of prescription pharmaceuticals. Medivir receives royalties from Johnson & Johnson on the global sales of the hepatitis C pharmaceutical, Olysio®. In addition, revenues for sales of Olysio in the Nordic region are generated through the company’s own sales and marketing organisation. Medivir’s research and development portfolio of pharmaceuticals is based on the company’s expertise within protease inhibitor design and nucleoside/nucleotide science. The company’s research and development focus is within infectious diseases and oncology and the on-going clinical projects in osteoarthritis and neuropathic pain. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

This information was brought to you by Cision http://news.cision.com


For more information, please contact:
Henrik Krook, EVP Commercial
mobile: +46 705 616 999
Rein Piir, EVP Corporate Affairs & IR
mobile: +46 708 537 292

Press Release Source: 

Wednesday, October 29, 2014

UWM chemistry professor to talk on new Hepatitis C "wonder drugs"

David Frick, a chemistry professor at the University of Wisconsin-Milwaukee will give talks throughout November on new drugs that cure almost all patients with Hepatitis C.

The talks are free and will take place at 8 p.m. every Friday in November and 2 p.m. Sunday, Nov. 16 in room 137 of the Physics Building on the corner of Kenwood Boulevard and Cramer Street.

Frick, who had disease for many years without knowing it, received a life-saving liver transplant in 1995. His lab at UWM has searched for better treatments for Hepatitis C.


Report: Overdose deaths, hepatitis C climbing steadily on Cape

A report on health trends in Massachusetts released Tuesday takes Cape Cod to task for high youth rates of hepatitis C, opiate overdoses, a dearth of physicians for lower-income patients — and barely a trickle of fluoridated water.

The nonprofit Massachusetts Health Council takes a look at health indicators including obesity, tobacco smoking, asthma and access to care in its biennial report, "Common Health for the Commonwealth."

"The focus is on prevention and wellness," said Susan H. Servais, executive director of the Massachusetts Health Council.