New Treatments May Defuse Viral Time Bomb

By Cam McGrath Reprint | | Print |

Egyptian HCV carriers will soon have cost-effective alternatives to interferon therapy. Credit: Cam McGrath/IPS.

CAIRO, Apr 9 2014 (IPS) - Mohamed Ibrahim first learned he had hepatitis C when he tried to donate blood. Weeks later he received a letter from the blood clinic telling him he carried antibodies of the hepatitis C virus (HCV). He most likely acquired the disease from a blood transfusion he received during surgery when he was a child.

“I needed a lot of blood, and this was at a time before they screened it,” Ibrahim recalls.

Now, at 24, Ibrahim is living with the blood-borne virus, knowing it is slowly eroding his liver. Unless treated, by the time he reaches his forties the disease will likely advance to cirrhosis or liver cancer.

While Ibrahim has been undergoing treatment since he first learned of his infection, the medication is costly and yet ineffective.

“Nothing has worked, and the side effects of the medicine are as bad as the disease,” he says. “I can’t work in [other places such as) Dubai or Saudi Arabia, because they require a clean blood test before issuing a work permit.”

Ibrahim is one of an estimated eight to 10 million Egyptians living with hepatitis C.

Egypt is said officially to have the highest prevalence of hepatitis C in the world, with 10 to 14 percent of its 85 million people infected, and about two million in dire need of treatment. HCV-related liver failure is one of the country’s leading causes of death, taking over 40,000 lives a year.

But Egyptians infected with HCV now have fresh hope in novel treatments.

The Egyptian government recently struck a deal with U.S. pharmaceutical firm Gilead Sciences to purchase its new hepatitis C pill Sovaldi at a fraction of its American price.

Under the agreement, Gilead will supply a 12-week regimen of Sovaldi to Egypt for 900 dollars, instead of the 84,000 dollars the medicine costs in the United States. Egypt’s health ministry is expected to make the drug available at specialised government clinics in the second half of 2014, once local drug registration procedures are completed.

Studies have shown that Sovaldi is up to 97 percent effective in curing HCV type-4, the most common strain of hepatitis C among Egyptians. The pill is seen as a significant improvement over the traditional HCV treatment in Egypt, which is a 48-week course of the anti-viral drug interferon taken in combination with ribavirin tablets.

The existing treatment costs up to 7,000 dollars using pegylated interferon supplied by multinational pharmaceutical firms Roche and Merck, and is only about 60 percent effective. Many patients also report severe side effects such as anaemia and chronic depression.

Interferon is available without a prescription at pharmacies in Egypt, but at 150 dollars per weekly injection, the 48-week regimen is well beyond the reach of most Egyptians. Reiferon Retard, a locally manufactured interferon, costs a third of that price, but critics claim it is less than 50 percent effective.

Since 2006, the Egyptian government has treated more than 250,000 HCV patients at specialised units affiliated to the National Committee for the Control of Viral Hepatitis, a government body formed to tackle the disease. Interferon injections are provided at reduced cost or free to uninsured Egyptians, but as many as half of the patients treated suffer a relapse within six months.

A 2010 study by the U.S.-based National Academy of Sciences estimates that more than 500,000 new cases of HCV infection occur in Egypt each year. Researchers attributed the spread of the disease to the high background prevalence of HCV in Egypt – about 20 times higher than the global average – and to poor medical hygiene practices, including the use of unsterilised medical equipment and unscreened blood.

Egypt’s government claims the figures are highly exaggerated, and that the high prevalence is the clinical outcome of infections decades earlier.

Many HCV carriers were infected during a national campaign in the 1960s and 1970s to stamp out the water-borne disease schistosomiasis, also known as bilharzia. Health authorities administered repeated injections of the bilharzia treatment to Egyptians in rural areas using unsterilised needles, inadvertently spreading hepatitis C among the population.

“Doctors at that time were unaware of HCV, which was only identified in 1987, and were using glass syringes instead of the plastic disposable syringes that is current practice,” explains Dr. Refaat Kamel, a surgeon and specialist in tropical diseases. “Once a needle got infected, the disease spread quickly.”

Kamel says a better understanding of the structure and reproductive mechanism of HCV has allowed scientists to devise more effective treatments.

Gilead’s Sovaldi received the approval of the U.S. Food and Drug Administration (FDA) in December 2013 after clinical trials demonstrated its effectiveness in curing HCV without significant adverse effects. The drug, one of a new line of direct-acting antiviral agents, combats the disease by targeting infected liver cells and inhibiting the enzymes that allow the virus to replicate.

The FDA has also approved Janssen Therapeutics’ Olysio, a direct-acting antiviral agent that is about 25 percent cheaper than Gilead’s pill. Pharmaceutical firms AbbVie, Bristol-Myers Squibb, Merck and others are all hustling to develop their own oral therapies.

Sovaldi’s effectiveness on HCV type-4 is proven only when used with interferon and ribavirin. Further testing will establish whether the drug can be taken without weekly interferon injections, or as a combined therapy with other direct-acting antiviral agents.

“Trials here of six months of Sovaldi without interferon but with ribavirin showed similar success rates, higher than 96 percent (cured),” says Dr. Mohamed Abdel Hamid, director of the government-run Viral Hepatitis Research Lab (VHRL). “The drug might also be effective taken for three months without interferon. We just don’t know yet.”

He says that apart from the reduced cost and greater efficacy of Sovaldi, oral medication could reduce the manifold problems associated with long-term intravenous interferon therapy.

“Obviously, over 48 weeks there is a lot more that can go wrong,” Abdel Hamid tells IPS. “Adherence is a problem as patients must visit the treatment centre at the same time every week to receive the injection. There are also problems keeping the interferon cold, and the medication has many side effects.”

But he cautions that even with new drugs showing promise in reversing cirrhosis, it may already be too late for late-stage HCV patients. With a limited healthcare budget, Egypt is expected to prioritise treatment for those in whom the disease has not yet manifested.