Egypt - Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission

The Arab Republic of Egypt has the highest rates of new hepatitis C virus (HCV) infection in the world, according to a new study published today in the prestigious Proceedings of the National Academy of Sciences. The study also estimates more than 500,000 new HCV infections occur in Egypt every year, likely signaling an epidemic in a country of more than 77 million people. This high rate of HCV transmission may be due to the lack of sufficient standard safety precautions in medical and dental facilities, the authors suggest. “Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission. This is the highest level of HCV transmission ever recorded at a national level for a blood borne infectious disease transmitted parenterally, that is, by use of non-sterile medical instruments,” said Dr. F. DeWolfe Miller, lead author of this study and professor of epidemiology at the Department of Tropical Medicine and Medical Microbiology and Pharmacology at the University of Hawaii.Although the high prevalence of hepatitis C in Egypt has been well established for many years, and linked in part to limited safety measures during anti-bilharzia campaigns, published estimates of prevalence from different Egyptian communities failed to provide a nationwide picture of the magnitude of ongoing HCV infection transmission.

To estimate the rate of new HCV cases of infection in Egypt, the authors of the study performed epidemiologic modeling of data from a range of studies, including a 2008 national HCV survey with a representative sample and well-documented study design.“The study opened our eyes to a disease burden similar in scale and challenge to the HIV problem in sub-Saharan Africa: Millions of cases of an infection for which there is no vaccine, no effective treatment, and where case management is so expensive that it is beyond the reach of most patients,” said Dr. Laith J. Abu-Raddad, co-author of the study and assistant professor of public health at the Infectious Disease Epidemiology Group at the Weill Cornell Medical College–Qatar.

The study necessitates not only further analysis of HCV transmission in Egypt but also justifies the immediate increase of resources to strengthen public health measures aimed at reducing the transmission of HCV in clinical and non-clinical settings, according to the authors. Failure to address this problem will result in a massive disease burden in the nation in terms of HCV infection complications, including active liver disease, liver failure, or liver cancer.
“There is only one way to deal with the HCV challenge in this country: HCV prevention,” warned Dr. Miller. “Effective and stronger HCV prevention programs are urgently needed in Egypt. Failure to act could swamp the public health system over the coming decades with millions of cases of HCV disease complications with an economic and social cost that this nation does not have the means to confront.”
Key scientific findings of the study
• Nearly 7 out of each 1,000 Egyptians acquire HCV infection every year for a total of 537,000 new HCV infections every year. This is by far the largest ever recorded rate of occurrence of HCV at a national level of all countries in the world.
• One in every 10 Egyptians is a carrier of the HCV infection, which means that there are at least 4,459,000 persons infected with HCV who are infectious to others. This is the largest reservoir of HCV infection in the world.
• Contrary to the widely-held perception that this rate of occurrence reflects merely the limited safety measures during anti-bilharzia campaigns, HCV incidence likely continues at alarming levels due to limitations in the implementation and enforcement of stringent standard precautions in public and private medical and dental facilities.

FDA APPROVES 8 MG VIAL OF NOVOSEVEN®

Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8 mg vial size, making the hemophilia A or B with inhibitors treatment available in 1, 2, 5 and 8 mg vials. The 8 mg vial allows a rapid initiation and administration of this medication for those patients who need a larger dose. In addition, FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (at or below 77 degrees Fahrenheit).

NovoSeven® RT is specially formulated to treat people with hemophilia A or B with inhibitors. Hemophilia, which is typically diagnosed in childhood, is a chronic, inherited bleeding disorder that occurs when certain blood clotting factors are missing or do not work properly, resulting in easy bruising and prolonged bleeding from trauma. Spontaneous internal bleeding can occur as well, particularly in the joints and muscles. Inhibitors, a serious complication that can occur after treatment, develop in as many as 30 percent of those with hemophilia. In these cases, antibodies form that neutralize or attack the blood coagulation agents contained in the treatment, resulting in joint disease and making it more difficult to manage bleeds.

"When I get a bleed, I want to infuse my treatment right away. The faster I treat a bleed, the sooner I can continue with my daily routine," said Bob Hoyt, a member of the Novo Nordisk Changing Possibilities Coalition. "Using fewer vials will be a positive change for patients." Hoyt has been living with hemophilia with inhibitors most of his life.

For many people living with hemophilia with inhibitors, the 8 mg vial will allow for faster reconstitution - the time it takes to prepare the injection - than their current NovoSeven® RT regimen. Those who previously had to use three vials to deliver an 8 mg dose will now have to reconstitute only one vial. Though the amount of powder in the 8 mg vial is larger than the 5 mg vial, the vial will be the same size and will have a yellow cap to distinguish it from the smaller dose.

"We have heard from patients and physicians alike that when they are treating a bleed, every second counts. We at Novo Nordisk are committed to improving the lives of people living with hemophilia with inhibitors," said Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. "The NovoSeven® RT 8 mg vial will allow patients to get the medicine they need much faster when experiencing a bleed, without having to manage multiple vials. We're also pleased that it will have a positive environmental impact as well - fewer vials may mean less waste."

The new vial size is expected to be available by November.