Center for the Biology of Chronic Disease (CBCD)

FDA Places Partial Clinical Hold on Hepatitis B Drug in Development; CBCD Reviews a Report

“News sent shares of Arrowhead down nearly 22% in recent premarket trading,” according to a report in the Wall Street Journal on January 12, 2015. (1) The CBCD reviews the report and recommends two natural, effective hepatitis B remedies.


Rochester, NY -- (ReleaseWire) -- 01/15/2015 --"Infected with the hepatitis B virus (HBV)? The CBCD recommends taking Novirin or Gene-Eden-VIR." - Greg Bennett, CBCD

U.S. regulators from the FDA have put a partial hold on clinical trials of a hepatitis B drug in development from the Arrowhead Research Group. During a preliminary call, the FDA "placed a partial clinical hold on testing ARC-520 (the drug in development) in patients suffering from chronic hepatitis B … instead of Arrowhead's proposed multiple-dose Phase 2b study at two milligrams of the drug per 4 kilograms, the FDA requested it start with one milligram per kilogram." (1) In the meantime, the company is expected to file with European and Asian regulators "for approval to begin additional Phase 2b studies in the coming weeks." (1) Developing an effective, therapeutic drug against the hepatitis B virus (HBV) and gaining FDA approval takes time. Until Arrowhead's drug is approved by the FDA, the CBCD recommends that infected individuals take Novirin or Gene-Eden-VIR. The formula of these natural HBV remedies is backed by clinical studies that followed FDA guidelines.

Click to learn about HBV symptoms.

The formula of Novirin and Gene-Eden-VIR was tested by Hanan Polansky and Edan Itzkovitz from the CBCD in two clinical studies that followed FDA guidelines. The studies showed that the Novirin and Gene-Eden-VIR formula is effective against the HBV, and other viruses. The clinical studies were published in the peer reviewed, medical journal Pharmacology & Pharmacy, the first, in a special edition on Advances in Antiviral Drugs. Study authors wrote that, "individuals infected with the (hepatitis B and other viruses)…reported a safe decrease in their symptoms following treatment with Gene-Eden-VIR." (2) The study authors also wrote that, "We observed a statistically significant decrease in the severity, duration, and frequency of symptoms." (2)

Both products can be ordered online on the Novirin and Gene-Eden-VIR websites.

About Gene-Eden-VIR and Novirin
Gene-Eden-VIR and Novirin are natural antiviral dietary supplements. Their formula contains five natural ingredients: Selenium, Camellia Sinesis Extract, Quercetin, Cinnamomum Extract, and Licorice Extract. The first ingredient is a trace element, and the other four are plant extracts. Each ingredient and its dose was chosen through a scientific approach. Scientists at polyDNA, the company that invented and patented the formula, scanned thousands of scientific and medical papers published in various medical and scientific journals, and identified the safest and most effective natural ingredients against latent viruses. To date, Gene-Eden-VIR and Novirin are the only natural antiviral products on the market with published clinical studies that support their claims.

According to the World Health Organization, "Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus. It is a major global health problem. It can cause chronic liver disease and chronic infection and puts people at high risk of death from cirrhosis of the liver and liver cancer. More than 240 million people have chronic (long-term) liver infections. More than 780,000 people die every year due to the acute or chronic consequences of hepatitis B." (See the World Health Organization, last updated on July 2014) (3)

In many cases, there are no symptoms to let an individual know that he or she is infected. However, when symptoms do occur, they "appear 90 days (or 3 months) after exposure, but they can appear any time between 6 weeks and 6 months after exposure." (See the CDC, from June 9, 2009) (4) They can include "fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay-colored bowel movements, joint pain, and jaundice (yellow color in the skin or the eyes)." (4)

"Based on the above information, we recommend that HBV infected individuals take Novirin or Gene-Eden-VIR." - Greg Bennett, CBCD

All orders of Gene-Eden-VIR are completely confidential, and no information is shared or sold to any third party. Privacy is assured.

Click to learn more about Novirin and the hepatitis B virus, or Gene-Eden-VIR and the hepatitis B virus.


(1) Calia, M. "FDA Informs Arrowhead of Partial Clinical Hold for Hepatitis B Drug." Wall Street Journal. Published on January 12, 2015.

(2) Polansky, H. Itzkovitz, E. Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study. Published in September 2013.

(3) - Hepatitis B. Updated July 2014.

(4) CDC - Hepatitis B Information for the Public - Hepatitis B FAQs for the Public. June 9, 2009.