New hepatitis drugs raise political pressure in Spain

MADRID - The arrival in Europe of better but pricier hepatitis C drugs has raised pressure on Spanish leaders over health spending cuts which sufferers say deprive them of life-saving treatments.

Hundreds of people have marched in Madrid and other Spanish towns demanding the government authorise doctors to prescribe the latest treatments for the deadly liver disease for whoever needs them.

Discussions over the new treatments have also erupted in the United States and France as the hopes raised by more effective treatments clash with public health budget restrictions.

- See more at: http://yourhealth.asiaone.com/content/new-hepatitis-drugs-raise-political-pressure-spain#sthash.augOhfHP.dpuf

UK: Victims of contaminated NHS blood launch legal case

Three men who contracted hepatitis C from contaminated imported blood have begun a legal case in the UK to challenge the compensation scheme.

They say it is unfair under disability discrimination because other patients in the same scandal have more favourable terms.

A new parliamentary report says around 7,500 patients were infected by imported blood products.

The government said it was considering improvements to the support system.

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Merck to Seek Approval of New Hepatitis C Drug by Midyear

If all goes as planned, Merck will soon take a major step forward in the hot pursuit among pharmaceutical companies to produce a newer, better, faster-working drug to treat the millions of people who have chronic hepatitis C infection.

By midyear the company expects to submit a New Drug Application to the Food and Drug Administration for approval of grazoprevir/elbasvir, a combination regimen investigational drug designed to be taken once daily as treatment of chronic hepatitis C virus infection. Grazoprevir is an NS3/4A second-generation protease inhibitor and elbasvir is an NS5A inhibitor.

 - See more at: http://www.hcplive.com/articles/Merck-to-Seek-Approval-of-New-Hepatitis-C-Drug-by-Midyear#sthash.maxgPR9Q.dpuf

Key Hepatitis C Patent Rejected In India For Lack Of Novelty, Inventive Step

Today’s rejection by the Patent Office Controller of India of a patent application by Gilead company for a key drug against hepatitis C is being hailed by advocates as a path to dramatically lower costs of treatment for the disease. Hepatitis C has made news for the emergence of exorbitantly priced medicines over the past year. A look at the decision shows that a provision in India’s law continues to stop patent applications if they fail to show sufficient novelty and inventive step – and are subject to opposition.

The patent office decision dated 13 January is available here [pdf].

The decision states that oppositions to several patent applications on sofosbuvir were filed by the Initiative for Medicines, Access & Knowledge (I-MAK), and the Delhi Network of Positive People (DNP+), in November 2013 and March 2014, arguing that they were not sufficiently novel and inventive as required for a patent. Gilead then made arguments explaining why these oppositions were not valid.

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UK: Diana Johnson MP: Final settlement of the contaminated blood scandal

Diana Johnson MP is Co-Chair of the All-Party Parliamentary Group on Haemophilia & Contaminated Blood. Today it publishes a report into the current support for individuals affected by the contaminated blood scandal.

From the 1970s through to the early-1990s, thousands of people underwent treatment with NHS-supplied blood products. Many of these products are now known to have been contaminated with HIV and/or Hepatitis C. Although this scandal only affected a small proportion of the population, it infected almost the entire community of people with haemophilia; and for everyone who was affected by these conditions, their lives were changed forever.

The tragic psychological and financial damage caused by these conditions is considerable, and stretches across generations. Primary earners’ careers were ruined by infection. Many affected found themselves completely unable to work, others were forced to cut down their hours and never enjoyed the career progression they would have had if the viruses never affected them. The scandal also spilled over to the carers, partners and dependants of those affected, who often had to sacrifice their own careers to support their loved ones. Should their partners die before they do, they find themselves unable to support themselves, having lost the skills necessary to get by in today’s labour market.

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New study casts doubt on wisdom of mass hepatitis C testing

Widespread screening for hepatitis C — a recommendation that has been aggressively pushed by public health officials, with the advent of new, expensive drugs to cure the viral infection and prevent liver-disease deaths — may be premature, a group of scientists is arguing.

In a paper published Tuesday in the British Medical Journal, the scientists say there’s little concrete evidence that screening all Baby Boomers for hepatitis C — a policy endorsed by the U.S. Centers for Disease Control and Prevention and other public health agencies — will save lives. Plus screening and treatment could cause unnecessary harm to millions of people who test positive for the virus but never experience any ill effects from it, they say.

“The question is whether these aggressive screening policies are justified and whether they would result in more benefit than harm,” said Dr. John Ioannidis, a Stanford epidemiologist and an author of the paper. “We know very little about the potential harms of these drugs, especially in the long-term. And we don’t know how they will translate into long-term benefits.”

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Aetna CEO says no decision yet on how to cover hepatitis C drugs

Jan 13 (Reuters) - The chief executive of health insurer Aetna Inc on Tuesday said that the company had not yet decided which hepatitis C drugs to cover now that there are two breakthrough treatments on the market, but said that the company was actively working on a decision.

Investors are watching closely to see how insurers decide to cover these drugs, which cost tens of thousands of dollars per treatment, after AbbVie Inc started a competitor to Gilead Sciences' breakthrough hepatitis C treatment.

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