Hepatitis C Drugs
Three years ago, a 90 percent effective hepatitis C medication, called Sovaldi, was released by Gilead Sciences. A three-month round of treatment costs $84,000. Janssen Pharmaceuticals released its own drug, Simeprevir, at $66,000 per round of treatment, and other pharmaceutical companies like AbbVie and Zepatier charged similar prices as they released their own hepatitis C drugs.

Hepatitis C is a blood-borne disease that can lead to liver cirrhosis and liver cancer, as well as other neurological problems. Worldwide, there are four times as many patients infected with hepatitis C as there are with HIV. About 150 million people live with chronic hepatitis C and 500,000 people die of hepatitis C complications every year.

Before Gilead, Janssen and other companies developed their newer, more effective medications, hepatitis C patients were treated with ribivarin and interferon, an antiviral drug and an immune-system modulator. The drugs caused fatigue, nausea and depression, and after one year of treatment, only 50 percent of patients were cured.

The WHO added hepatitis C drugs to their list of essential medicines, which they update every two years and some pharmaceutical companies offered deals with low-income countries. Gilead, for example, sold Sovaldi for $900 per round of treatment in Egypt in 2014.

The Drugs for Neglected Diseases Initiative made a deal with an Egypt-based pharmaceutical company last spring to sell a highly effective drug combination for $300 per treatment round.

Hepatitis C is especially prevalent in Egypt, affecting over 10 percent of the population, because of a vaccination campaign in the 1960s and 70s where syringes were reused for multiple patients. The disease is so widespread that barbers wear gloves and use disposable razors. Hepatitis C has even been spread between family members through sharing toothbrushes and nail clippers.

However, 80 percent of new infections happen in medical centers; in response to these figures, UNICEF and the WHO are working with the Egyptian government to educate both clinicians and the general population about hepatitis C.

Many patients await treatment, but the Egyptian government anticipates treating 1 million people for hepatitis C in 2016. As the cost of treatment decreases and sterilization and infection control practices are improved, the presence of hepatitis C in Egypt and elsewhere will diminish.

Madeline Reding

Photo: Flickr

The Hepatitis C virus affects an estimated 180 million men, women and children worldwide. Patients in low to moderate income nations benefit from treatment at the same rate as those in developed regions. Yet, the high cost of this treatment prevents many from recovering.

One of the largest biopharmaceutical companies, Gilead Sciences, developed an $84,000 cure in 2013 with one pill priced at a thousand dollars. The total cost for a three-month regimen far exceeds most patients’ price range.

Solvadi, the pill, offers a solution to the pressing danger of this disease in developing countries. Egypt (22%), Pakistan (4.2%) and China (3.2%) rank the highest in disease prevalence, bearing most of the burden today.

How, though, can patients in these nations afford an $84,000 bill?

Gilead answered this question with a promising discount in sixty developing countries. Negotiating with generic drugmakers in India, the company plans to offer the treatment at 2 percent of the cost in the United States.

Rohit Malpani, a policy director at Doctors Without Borders, hopes for a more reasonable price. The company could produce Solvadi at a far lower cost, he contends. Malpani and other advocates estimate Gilead could cut the cost to $68 to $136 for a twelve-week treatment regime.

The company must revaluate how much the drug costs compared to patients’ ability to pay, Malpani asserts.

“If we want to see Hepatitis C treatment scaled up globally, we are going to need much lower prices in all countries with a high burden of the disease,” he remarks in a recent Doctors Without Borders statement.

Gregg Alton of Gilead reports future partnerships with three to five different companies. Gilead, he notes, plans to allow flexibility of price from the Indian companies. Alton also contends the starting point of $2,000 is “substantially less” that current costs in India – for inferior drugs. He promoted Solvadi in The Hindu Business Line, highlighting the drug as “more effective, less toxic…and without side-effects.”

Ideally, Alton remarks, the company signs voluntary licensing deals “in the next couple months” and market availability in two years. Last November, the Initiative for Medicines, Access and Knowledge(I-MAK) filed a legal challenge against its patent application.

I-MAK claims Solvadi relies on “on science” with a “known compound.” Voluntary licensure protects Gilead from patent problems, adds Malpani. These licensing agreements prevent generic companies from overturning patents. Without these agreements, the Indian manufacturers could sell Solvadi at any cost and without paying royalties to the company.

The company also plans to limit the scale of these licensing agreements, allowing generic drugmakers to sell in 60 countries. In contrast, Gilead sells HIV drugs in more than 100.

The pricing and limited access to this drug threatens the health of more than 180 million patients. Brook Baker, an advisor to the Health Global Access Project, sees delinkage as the solution. With this system, governments fund pharmaceutical research and development as a public service.

Today, pharmaceutical companies absorb about 60 percent of the total cost. Treating these drugs as a public good offers the most in need. And though these companies need to profit, Hepatitis C patients around the world also need treatment.

Ellery Spahr 

Sources: NPR, WHO
Photo: Don’t Trade Our Lives Away

Approximately 150 million people around the world are afflicted with Hepatitis C, a deadly liver infection that causes severe complications among its patients. It looks as if this viral infection might have finally met its match with the introduction of Sovaldi (sofosbuvir), a supposedly highly effective new drug made by California-based pharmaceutical company Gilead Sciences Inc.

Gilead’s executive vice president, Gregg H. Alton, claims that the drug is among “the biggest breakthroughs in medicine in the last 10 years.”

Countries around the globe will be the judge of that, as the current high price of the drug is unaffordable to all but the wealthiest in most low and middle-income countries. In the United States, Sovaldi sells for $1,000 per pill, meaning that a twelve-week regimen would cost an estimated $84,000.

As most people afflicted with the virus are poor or incarcerated, this is fueling anger even in one of the world’s wealthiest nations. Gilead Sciences is attempting to solve this issue by licensing the drug to a number of generic pharmaceutical manufacturers in India. Discussions are still underway but the price for a 24-week regimen of Sovaldi would run at about $2,500 for patients in public hospitals, community clinics, and NGOs.

This amounts to 2% of the U.S. price and the deal is slated to affect up to 60 low-income countries.

That said, activists continue to raise concerns about the cost of the drug.

Rohit Malpani, a policy director of Doctors Without Borders, agrees with other critics that Sovaldi could be sold for as little as $136 for a twelve-week regimen, substantially less than the licensing deal currently underway with Gilead. However, it is important to note that the pharmaceutical companies in India are the only players who will be able to bring the price of the drug down, depending upon the amount of competition.

Gilead has created programs for lower-cost versions of its HIV/AIDS drugs, so why not allow similar access to the Hepatitis C drug? Either way, Gilead Sciences will be making its fair share of money.

Analysts estimate that the drug will generate billions of dollars in annual sales, as about 3% of the world’s population has been infected with the virus. The last three weeks of 2013 alone generated more than $139 million for the medication.

With the price of Sovaldi in India currently up for debate, clinical trials are already being conducted to test the drug on the local population. If the licensing deal goes through with Gilead Sciences, it will take about two years before the product is actually available in India, and hopefully a number of other countries.

The hopes are that Sovaldi will eventually be accessible in resource-limited settings where it is most needed.

– Mollie O’Brien

Sources: NPR, The Hindu Business Line
Photo: NPR