Hepatitis C is a blood-borne virus that can infect and cause liver damage. The virus can cause both acute and chronic hepatitis infection that can last a lifetime or cause liver cirrhosis and cancer. It can be caused by using shared injections, blood transfusions, reusing inadequate sterilization of medical equipment like needles and can also be transmitted sexually.
The good news is AbbVie, the global research-based biopharmaceutical company, announced breakthrough results from phase-three study of all oral treatment for Hepatitis, which is also ribavirin free. AbbVie announced new, preliminary safety and efficacy data from the first group of phase 3b Ruby-I study. Ruby-I is evaluating Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) with or without ribavirin (RBV) in treatment-naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis. In the United States, the two-tablet regimen is marketed under a single name, Viekira Pak. During EASL, Scott Brun, M.D., vice president, pharmaceutical development, at AbbVie said: “Ruby-I is part of AbbVie's broader Phase 3b program and demonstrates our continued focus on people living with hepatitis C that have specific needs. Studies in our Phase 3b program will help to further expand our knowledge of the utility of Viekirax + Exviera in special populations encountered in clinical practice.”
Dr. Raphael who runs as the chair of health at Deusto University, spoke about health policies and the need to enforce planning for cure and control regarding Hepatitis C Virus (HCV). During the International Liver Congress in Vienna recently, he said: “We have looked at the big picture, we think it's a burning platform. We are encouraging countries to organize in a strategized way rather than just wait for patients to come in through the door, we are saying we want to have a policy that will help fight this disease. The number of people receiving treatment globally, which is really pathetic, is only 3-5%. This makes sense because there wasn't any awareness in the past about the disease. Now there is. We think still have to encourage awareness.” During the 50th annual meeting of the European Association for the Study of the Liver (EASL) in Vienna, Saudi Gazette caught up with Saudi Dr. Abdullah AlGhamdi who explained that genotype 4 is prevalent (as much as 60%) whereas genotype 5 is missing in Saudi Arabia. The Saudi Food and Drug Authority (SFDA) granted approval less than three months after receiving approval from the European commission. There are approximately 200,000 to 400,000 people living with hepatitis C in the Kingdom.
“The most common way of contracting the disease was through blood transfusion before 1992 or using the same shaving razors, infected needles and so on. Nowadays we can treat the disease at any stage, even at a later stage. Between 30-40% don't even know they have the disease,” AlGhamdi said.
Dr. Juan Carlos Lopez Talavera said chronic hepatitis is the first chronic viral disease to be cured. It took 25 years to do so till the development of the drug. The way we started curing this was with the use of the treatment of Interferon, which is a protein that the human body or animal has as part of their immune system. Only 10% people can be cured.” However the price patients pay for recovery is very high. The protein hyper-stimulates the effect and causes rashes or allergy, depression, bone marrow is suppressed and anemia. “The safety profile was very bad. We moved from managing it to killing the virus directly. But the immune system does not allow the virus to come back.”
He said AbbVie is the only one who assigned a specific study to answer that question. We had 380 patients. Dr.Talavera said he was extremely happy that patients with renal disease- to whom no treatments were provided earlier, were now finally available. “It is a total change. Now the patients are happy, they know there is a cure. One of the main concerns with patients earlier was that most of them did not qualify for testing. The best thing now is that now anyone can be treatment. It is reliable so most of them can be cured and can go through therapy.” Most patients still go for physiotherapy even after being cured. It takes 24 weeks to stop therapy. “In the Middle East it is very similar to Europe.
He spoke about long term studies and research that is part of commitment to patients. “The other liver diseases are in need of medical help. Knowing that this is a successful story we want to use this for other treatments of liver diseases.” He said phase four will have more characteristics that you want to polish can and it can also include how you want to expand the knowledge of your indications in other patients.
