Gilead’s Hepatitis C Drug, Sovaldi, Is on Pace to Become a Blockbuster

Source: The New York Times

28 July 2014

Sales of the new hepatitis C drug Sovaldi reached $3.5 billion in the second quarter, a huge figure that puts it on track to become one of the world’s best-selling medicines but could intensify concerns about society’s ability to pay for it.

The sales, announced on Wednesday by Gilead Sciences, were an increase from the $2.3 billion in the first three months of the year, the first full quarter of sales since the drug’s approval in December.

The sales testify to the effectiveness of the drug, which can essentially cure more than 80 percent of patients with few side effects.

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Hepatitis C Pill Rockets Gilead Into Big Leagues

Source: The Wall Street Journal

28 July 2014

For decades, a liver disease that would slowly kill the infected person didn’t even have a name, let alone an effective medicine.

Now, a new pill promising to cure most cases of the disease, eventually called hepatitis C, is believed to be the biggest new drug launch ever, catapulting maker Gilead Sciences Inc. into the ranks of the top-selling pharmaceutical companies.

The pill, Sovaldi, notched $3.5 billion in second-quarter sales, Gilead said Wednesday. As a result of its lucrative move into hepatitis C treatment, the Foster City, Calif., company roughly doubled its revenue guidance for the year’s net product sales to $21 billion to $23 billion.

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Hepatitis C medicine being imported for Rs 1 crore

Source: Times of India

28 July 2014

MUMBAI: Even as a controversy rages on globally over the eye-popping price of US firm Gilead Science’s hepatitis C drug at $1,000 a pill, Indian patients have already begun importing the medicine from countries like Canada spending, in some cases, up to Rs 1 crore.

The drug, Sovaldi (sofosbuvir), is believed to cure about 90% of patients with the common form of hepatitis C. However, at around $84,000 for a 12-week course, it has many countries worried, with even US senators questioning the company’s pricing.

Estimates suggest that 20-25 patients in India are already on Sovaldi, with some 150 others having been given the prescription. The imported drug comes at around Rs 15 lakh a month, taking the cost to Rs 45-50 lakh for a three-month course.

Significantly, Gilead Sciences also applied for multiple patents in India on sofosbuvir, which have been opposed by civil society groups before the grant. The drug was approved by the US Food & Drug Administration last December.

Sources said Gilead has begun enrolling patients for clinical trials in 10-15 centres in India. “We anticipate seeing the first results by the end of 2015,” Gregg Alton, executive V-P (corporate and medical affairs), Gilead Sciences, told TOI. “Prices for India have not been finalized, but considering the GNI per capita of India and the burden of disease, we would expect the country to fall into our lowest pricing tier of approximately $300 per bottle.”

Malaysia-based Mahesh Keswani, a patient in the third week of treatment, says he got the medicine from Canada after a US-based doctor wrote him a prescription.

“Patients can import these products after taking a personal permit against the prescription of a qualified doctor when existing treatment options have been exhausted,” says Praveen Sikri of Ikris Pharma Network, a firm which connects patients with overseas suppliers.

Only a few doctors in Mumbai, Delhi and Bangalore have begun prescribing the pill. Among them is Dr Samir Shah, consultant hepatologist attached to Mumbai-based hospitals such as Jaslok and Global. “Any person who has received blood transfusion before 2002 carries the risk of hepatitis C virus and should get a simple blood test done,” Shah says.

The World Health Organization estimates that over 12 million Indians may be chronically infected, with a majority not knowing their status. About 30-50% of Indian patients need the new treatment, doctors say.

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India’s role in increasing access to HCV drugs

Source: Down to Earth

28 July 2014

Early intervention by the Indian government and civil society will be essential to overcome patent barriers to ensure that the new drugs available are not priced out of reach of most people in developing countries

Hepatitis C (HCV) is a virus that can cause liver disease. Those who are chronically infected often don’t know they have it, as disease progression is asymptomatic for many years. If undiagnosed and left untreated, chronic HCV is fatal, claiming many lives from liver cirrhosis and/or liver cancer.

Médecins Sans Frontières (MSF) has begun providing treatment for hepatitis C to a small number of HIV positive patients co-infected with HCV in its HIV clinic in Mumbai. However, its efforts have been hampered by the exorbitant cost (as high as Rs 3,75,000/$6,000 per patient), and the difficulty of administering the injectable drug, pegylated interferon, which prescribed together with the oral drug ribavirin has significant side effects. Patient numbers in HIV treatment projects have, therefore, remained extremely low in the region despite the considerable medical needs of HIV positive patients co-infected with the HCV virus.

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Posted in access to medicines, Drug Pricing, Hepatitis - C, HIV/Aids, Indian Patent Law, patent, Sofosbuvir, TRIPS | Leave a comment

Who can pay for hepatitis C treatment?

Source: Down to Earth

28 July 2014

Activists demand intervention of India’s health ministry to ensure availability of generic versions of hepatitis C drugs (file photo)

ctivists demand intervention of India’s health ministry to ensure availability of generic versions of hepatitis C drugs

On occasion of World Hepatitis Day on July 28, the World Health Organization (WHO) and its alliance partners have called on governments, civil society and people in the health sector to “think again” about the largely ignored “silent killer”, called so because its symptoms often go unnoticed for years.

Viral hepatitis – a group of infectious diseases known as hepatitis A, B, C, D, and E – affects hundreds of millions of people worldwide, causing acute and chronic liver disease and killing close to 1.4 million people every year.

Of these, hepatitis C or HCV is emerging as an epidemic in developing countries. It is spread primarily by blood-to-blood contact, through infected syringes and unsafe sex.

India is one of the worst affected, second only after China. According to WHO, India is home to 12 million chronically infected patients. The cost of treatment, which is estimated to be $6000 or INR 3,75,000 for treatment course of two to four years, is out of bounds for most patients.

New drugs: more effective, but prohibitive

But does the cost need to be so high? Apparently not, especially in light of new generation of drugs available in countries like United States and Egypt. But the patent regime and interests of pharamecutical companies don’t let the prices to come down for Indian patients, even though productions costs are very low.

The new drugs can cure 90 per cent of people with HCV within 12 weeks, says a paper by Andrew Hill of Department of Pharmacology and Therapeutics, University of Liverpool, the UK. However, these new generation drugs cost $84,000 (sofosbuvir) and $66,000 (simeprevir) per person for 12-week course in the US. The production cost for the same is as low as $68–$136 for sofosbuvir and $130–$270 for simeprevir. The high costs are explained by patents held by their researchers which are not letting generic drug industry to produce them for consumption for the poor.

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The drug that’s forcing America’s most important – and uncomfortable – health-care debate

Source: The Washington Post

25 July 2014

Allan Hurst, 53, had to appeal to state officials to get his insurer to pay for hepatitis C treatments. He recently finished a regiment of Sovaldi, which costs $84,000 and has prompted fears among insurers and state officials across the country that the revolutionary drug could explode their budgets. (Nick Otto for The Washington Post)

Months before Gilead Sciences’ breakthrough hepatitis C treatment hit the market, Oregon Medicaid official Tom Burns started worrying about how the state could afford to cover every enrollee infected with the disease. He figured the cost might even reach $36,000 per patient.

Then the price for the drug was released last December: $84,000 for a 12-week treatment course.

At that price, the state would have to spend $360 million to provide its Medicaid beneficiaries with the drug called Sovaldi, just slightly less than the $377 million the Oregon Medicaid program spent on all prescription drugs for about 600,000 members in 2013. It potentially would be a backbreaker.

Faced with those steep costs, Oregon and several other states are looking to limit who has access to the drug that nearly everyone acknowledges is a revolutionary treatment for the disease affecting more than 3 million Americans.

Expensive specialty drugs aren’t new to health care. But Sovaldi stands out because it is aimed at helping millions of Americans who carry hepatitis C, and a large share of those infected are low-income and qualify for government coverage. Its arrival also coincides with the aggressive expansion of Medicaid and private coverage under the Affordable Care Act, whose purpose was to extend health care to tens of millions Americans who previously couldn’t afford it.

Sovaldi has prompted fears among insurers and state officials that the breakthrough drug, despite its benefits, could explode their budgets. And that has sparked an urgent and highly sensitive debate in Medicaid offices across the country: How far should society go to make sure the poor get the best available treatments?

“The purpose of health care and the purpose of the Affordable Care Act was supposed to provide — and now mandates — access to quality and affordable treatment,” said Ryan Clary, executive director of the National Viral Hepatitis Roundtable, a patient group partly sponsored by drugmakers. “They’re now finding that they’re not able to get cured for the condition that’d been keeping them from being in the health care system.”

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On this World Hepatitis Day (28 July 2014), Support MSF India’s #TestnTreatHCV Campaign

Why the campaign?

Hepatitis C (Hep-C or HCV) is a virus that can cause liver disease, and if untreated, can be fatal. It is a blood- borne virus that gets transmitted through unsafe injection practices; inadequate sterilization of medical equipment and blood transfusions. Chronic HCV is a “silent killer” as usually people do not have any symptoms until they have serious liver damage, which takes many years to develop. Many deaths from serious liver disease or liver cancer can be prevented with early diagnosis and treatment.

In India, Hep-C is a ‘hidden epidemic’. According to the World Health Organization (WHO), there are about 12 million people chronically infected with Hep-C in India, the majority of whom do not know their status. Yet, the cost is (as high Rs. 3,75,000/$6000) and complexity (24-48 weeks of injectables) associated with the current treatment has deterred many countries, including India, from investing in a testing and treatment program for controlling this virus.

Doctors Without Borders/Médecins Sans Frontières (MSF) India has started providing Hepatitis C treatment for a small number of people co-infected with HIV in its clinic in Mumbai.

This year the World Health Organization (WHO) released its guidelines for hepatitis C providing countries with a road map for screening and treating this disease. The guidelines include new oral drugs known as direct antivirals (DAA) that promise to revolutionise treatment with higher levels of cure, simplified regimens and fewer side effects.

On this World Hepatitis Day, let us urge our health minister, Dr. Harsh Vardhan to initiate a public health response to control this epidemic by beginning to test, diagnose and treat Hepatitis C.

Who can Join this Campaign?
Anyone who is willing to use social media (such as Twitter or Facebook) can send this message to Indian Government.

What do we do?
Tweet and Post to @drharshvardhan
Please tweet and post your messages on Twitter and Facebook and add #TestnTreatHCV.

You can direct your messages to the Indian Health Minister – Dr. Harsh Vardhan (@drharshvardhan) through social media conversations by adding #TestnTreatHCV to your Tweets.

What to post?
We have some suggested tweets and Facebook messages that we will share on MSF India’s Facebook Page and Twitter handle which you too can use and share widely.
Click here for the tweets: http://www.msfindia.in/testntreathcv

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