• Gilead Sells Sofosbuvir to Egypt for About $10 per Pill

Gilead Sells Sofosbuvir to Egypt for About $10 per Pill

In Egypt, pharmaceutical companies are testing a complicated deal to sell hepatitis C drugs at a fraction of their usual cost while imposing tight restrictions intended to protect lucrative markets in the West.

According to the New York Times, Gilead Sciences Inc. is selling its sofosbuvir to the Egyptian government for about $10 per pill. The government distributes it to pharmacies across the country, where it is dispensed free to patients. In return, the Egyptian government imposes strict restrictions on every bottle to prevent the drug from being sold on the black market and undermining its business elsewhere.

These include having the medication being dispensed only by government pharmacies, patients having to turn in old bottles to get new ones, and patients immediately breaking the seal on a bottle and taking the first tablet in front of the pharmacist.

The Times wrote that this new approach could become the blueprint for providing other cutting-­edge medicines to the poor.

However, the system has produced “howls of outrage from public health advocates” who view the requirements as violations of patients’ rights.

The Times explained that 6 million Egyptians were infected with hepatitis C virus (HCV) by unsterile needles during the country’s vaccination campaign against schistosomiasis. Today, at least 10% of Egyptians, nearly 9 million people, are chronically infected with HCV—the highest rate in the world.

In Egypt there are an estimated 150,000 new infections each year, caused by reuse of disposable syringes, accidental needle sticks, tainted medical equipment, and even the sharing of nail clippers and toothbrushes among family members.

Each infected Egyptian passes the virus to an average 3 others on average, said Manal Hamdy El­Sayed, Director of Egypt’s National Hepatitis Awareness Campaign. Egypt’s National Liver Institute runs 50 treatment centers and consumes a third of the national health budget.

Pharmaceutical companies were demonized in 1997 for withholding lifesaving AIDS drugs from poor countries in Africa. So drug companies began testing an alternative strategy: a complicated deal to sell hepatitis drugs at a fraction of their usual cost while imposing tight restrictions intended to protect lucrative markets in the West.

After 1 year, the approach seems to be headed for success.

The Times tells the story of an air-conditioning repairman who took a 3 month regimen that included sofosbuvir and would have cost more than $84,000 in the United States. He got them free from the Egyptian government, which paid about $900.

However, the restrictions imposed to prevent drug resale have infuriated international activists, who see them as violations of patients’ rights.

Heba Wanis, a pharmacist who until recently worked at the Egyptian Initiative on Personal Rights, told the Times that she found the requirement to take a dose in front of the pharmacist “humiliating” and felt it “raised a lot of ethical issues.”

Jennifer Cohn, medical director of the drug access campaign at Doctors Without Borders, described the requirements as “a third party introduced into the doctor—patient relationship.” Giving a drug company control over who receives its products sets “an incredibly dangerous precedent,” she said.

But so far, no outrage is visible on the streets.

“I agree with this completely,” the air­-conditioning repairman told the Times. “I’m a poor man. If I did not have to hand in the bottle each time, I might have sold them to buy my son a house.”

Egypt’s health officials also say that the deal is fair. “We don’t have a problem with the rules,” said Gamal Esmat, a liver specialist at Cairo University Medical School and a co­author of the National Hepatitis Plan. He says that the rules are needed to prevent the black market from moving the drugs to other countries.

The Egyptian government’s goals are to treat 300,000 hepatitis patients a year starting in 2016 and to drive the national infection rate below 2% by 2025.

The first year was successful: A total of 125,000 patients have been treated with sofosbuvir. Now that licensed generic versions are available for as little as $4 a pill, Egypt is even phasing out purchases from Gilead. Gilead allows 11 Indian and 2 Egyptian companies to make sofosbuvir under license and to sell it at any price they like, in return for a 7% royalty.

Instead, the company’s next­ generation product, Harvoni, a sofosbuvir and ledipasvir combination that does not require interferon or ribavirin, is being tested for rollout at about $14 a day.

The arrangement that Gilead struck with the Egyptian government has been emulated by other pharmaceutical companies.

In August, the Egyptian government announced that it would import the rival 3-drug combination, Viekira from AbbVie. Like Gilead, AbbVie offered the pills at about 1% of the price in the US, or about $13 a day. In an anti-­resale measure, AbbVie renamed it Qurevo for the Egyptian market.

In October, the government began importing Daklinza, a hepatitis drug from Bristol­Myers Squibb.

The sudden availability of highly effective hepatitis medicines has prompted “great excitement in Egypt,” said Wahid Doss, dean of the Liver Institute in Cairo and head of the National Committee for Control of Viral Hepatitis, who added “people are getting cured.”

The Times wrote that some Egyptian patients seem mystified by their good fortune. ”Do you Americans love Egyptians more than yourselves?” asked a private equity specialist who in 2014 was the first Egyptian to receive sofosbuvir. “Why aren’t you putting pressure on Gilead to sell to you at a reasonable price, too?”

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