Biopeer

Asian neighbors rev up fight against Hepatitis B

In a major relief to those suffering from Hepatitis B in India, the first homegrown Hepatitis-B Vaccine called Elovac-B has been launched by the Human Biologicals Institute (HBI). With India emerging as a global medical hub—world class health care is available here at an affordable price—this launch is yet another milestone towards cementing the country’s numero uno position in the sphere. The Andhra Pradesh Finance minister, Rosaiah said on the occasion while complimenting HBI that immunity has been made affordable with the launch of Elovac-B. “There’s a need to achieve 100 per cent immunization among children and for that the Government as well NGOs should come forward to eliminate such diseases.” The vaccine, which has been prepared by HBI at a state-of-the-art plant, offers best purity and ensures best protection. The purity of Hepatitis-B surface antigen exceeds the purity specification provided by regulatory authorities.

In neighboring China, the Ministry of Health has begun a yearlong nationwide survey of the Hepatitis B situation. The survey will run till September 2007, and involves collecting blood serum samples, conducting lab tests, filing archives and making reports for future control plans. With about 100 million people suffering from Hepatitis B in China (of these approximately 20 million are chronic patients), the situation is indeed grim. Further, the government has started a two-year program aimed at preventing the spread of Hepatitis B from mother to child in four counties of Shaanxi and Gansu provinces.

The program will be first carried out in rural areas for women of childbearing age. The USD 200,000 program aims to teach nearly 340,000 women of childbearing age and nearly 600 grassroots doctors in pilot counties how to prevent Hepatitis B.

Powered by Qumana

New drug more effective in Hepatitis B treatment

Two international studies carried out and published in the ‘The New England Journal of Medicine’ have shown that the new drug Barclude (Entecavir) manufactured by Bristol Myers Squibb Company is far more effective for battling the life threatening Hepatitis B than Epivir (Lamivudine) manufactured by GlaxoSmithkline.

The studies have shown that the new drug, Entecavir, not only battles the disease more effectively but also helps in reducing the Hepatitis B virus levels in the blood. Another important aspect discovered in the course of the study is that the virus is far less resistant to the new drug than to Epivir. DNA based tests are important to understand the levels of Hepatitis B virus per milliliter of blood as well as the effects of the virus on liver cancer or liver cirrhosis in the future.

Hepatitis B virus affects the liver and causes acute illness. It is the ninth most common cause of death that claims about 2 million people worldwide annually. It is more readily transmitted than the dreaded HIV/AIDS virus. Treatment is available for the disease but the cure so far has been temporary. The disease can remain in the human body for six months to sometimes lifetime with symptoms that seem to appear and disappear. Sadly, the virus cannot be completely removed once a person is infected, and can possibly lead to cirrhosis of liver or Liver cancer. The only mode of prevention is by vaccination. Also, as the virus easily mutates, 70 to 80 per cent of the patients treated become resistant to the drugs within three to four years.

The study brings hope to millions of peole worldwide as the drug’s excellent potency and low rate of resistance make it an outstanding candidate for treating chronic hepatitis. However, patients need to realize that it involves long term therapy.

Oral vaccines for diabetes and hepatitis B

Diabetes and hepatitis B are among the biggest killers in South and South-east Asia and the need to find an effective solution to combat them has been high on the agenda of both governments and drug companies. The latest advancement in this regard is the announcement of the development of new vaccines by Transgene Biotek Ltd. These oral vaccines (to be administered as a liquid) are meant for insulin delivery and hepatitis B. They have been developed in collaboration with the pharmacology division of the Indian Institute of Chemical Technology, Hyderabad.

Per the results of the pre-clinical trials, for those suffering from diabetes, the drug will not only help reduce blood glucose levels comparable to that of the injectable insulin, but also lessen plasma insulin levels, and shall be effective for up to 24 hours. The 24-hour relief is noteworthy since it could help in decreasing the frequency at which insulin would be required to be administered to diabetics. Pre-clinical trials of the hepatitis B oral vaccine have shown the generation of antibody titres to a single dose of oral delivery comparable to that of injectable hepatitis B vaccine.

Although hepatitis B can infect anyone, Asians have the highest rate of hepatitis B infection of all ethnic groups. Two-thirds of all 400 million chronic carriers of the hepatitis B virus in the world live in Asia. In many Asian countries, approximately 10 per cent of the population is chronically infected with hepatitis B. In the United States, more than half of the 1.25 million chronic carriers of HBV are of Asian descent.

With the pre-clinical trials providing enthusing results, Transgene Biotek has decided to undertake the next stage of clinical trials in India and Europe simultaneously. If successful, the drug would be a landmark development, as it would considerably ease the difficulty of administering the vaccine to infants and children as well as lower costs, thus aiding in the control of the illnesses across the world.

A new weapon to fight Hepatitis B

Doctors now have an important new medication to treat chronic Hepatitis B by suppressing viral replication and the risk of developing liver disease. A distinguished group of medical experts who have met in Bali, Indonesia, to fortify the fight against Hepatitis B, one of Asia Pacific’s most threatening chronic diseases, have announced the new treatment.

This is good news for the 350 million people worldwide who have developed chronic Hepatitis B infection and even more encouraging news for the Asia Pacific region because around 300 million of those infected with the virus live there.

This latest treatment option is entecavir, which is considered the most potent oral antiviral drug for Hepatitis to date. Based on data from three studies presented at the Bali meeting, entecavir was found to be superior or comparable to lamivudine, another Hepatitis B drug, in a wide variety of patients chronically infected with Hepatitis B virus.

The study comprised patients with compensated liver disease who were starting antiviral treatment for the first time (nucleoside-naive); had received prior antiviral treatment (other than entecavir); and those who were refractory to lamivudine. After one year of treatment, another study found that there was no evidence of resistance to entecavir in the nucleoside-naive Hepatitis B patient group.

Phase 3 studies analyzed the efficacy of entecavir in treating a variety of patients with chronic Hepatitis B infection. Among them were both Hepatitis B e-antigen (HBeAg) positive and HbeAg negative nucleoside-naive patients and lamivudine-refractory patients.

Launched in the USA earlier this year by Bristol-Myers Squibb under the name Baraclude, entecavir’s launch in the Asia Pacific region seems imminent. It only remains to be seen how soon the drug is introduced in the region’s markets.

New hepatitis B vaccine starts Phase III trials

Aiming to file a biologics license application in 2007, Dynavax Technologies has initiated a pivotal Phase III trial to test its Toll-like receptor 9 (TLR-9) hepatitis B (HBV) vaccine against the efficacy of Engerix-B, GlaxoSmithKline’s HBV vaccine, in older adults—a population that is hard to immunize. The trial, which will take place at study sites in Singapore, Taiwan, Korea and the Philippines, will enroll more than 400 adults aged between 40 and 70, with no detectable HBV antibodies.

Hepatitis B is the most common serious liver infection in the world with an estimated two billion persons having been exposed to the virus. Worldwide, about 400 million people are chronic carriers of HBV, of whom, more than 250,000 die from liver-related diseases each year. Around 75 per cent of chronic carriers live in Asia and the Western Pacific. HBV is a major cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma. According to data presented at the DDW 2005 conference held in Chicago last month, HBV may also favor the development of other types of cancer.

With its TLR-9 vaccine, Dynavax is targeting subjects who need an enhanced vaccine, such as hemodialysis patients, health care and emergency response personnel, people infected with HIV or hepatitis C, and those who get multiple transfusions. The company also plans to conduct Phase III trials in young adult population in Europe and Canada, in early 2006.