Hepatitis Treatment News
Bethlehem-based OraSure gets FDA approval for hepatitis C test
OraSure Technologies in Bethlehem has received U.S. Food and Drug Administration approval for a rapid hepatitis C test, the company announced today.
The approval for the new OraQuick HCV Rapid Antibody finger-stick test follows about eight months after the FDA approved a similar blood-draw test for the blood-borne pathogen.
The difference between the tests is how the sample is obtained, said Ron Ticho, OraSure’s vice president of communications.
“This particular procedure now does not require … a blood draw. Instead it can be done with a simple prick of the finger and a smaller sample of blood,” similar to a diabetes blood test, Ticho said.
The approval makes the test more “versatile,” he said, and “will help health care professionals to identify more individuals with this disease.”
Hepatitis C affects an estimated 4.1 million Americans and 180 million people worldwide. The virus can cause cirrhosis, liver failure and liver cancer.
The test was recognized by Popular Science magazine as one of the top 100 technology innovations of 2010.
The company has plans to make it even less invasive, eventually looking to obtain approval for an oral fluid version of the test, similar to the process used to develop its HIV tests, Ticho said.
Children With Hepatitis C May Benefit From Ribavirin
The combination of pegylated interferon (PEG) plus ribavirin is better than PEG plus placebo for treating children infected with hepatitis C virus, according to a study published in the February issue of Gastroenterology.
TUESDAY, Feb. 15 (HealthDay News) — The combination of pegylated interferon (PEG) plus ribavirin is better than PEG plus placebo for treating children infected with hepatitis C virus (HCV), according to a study published in the February issue of Gastroenterology.
Kathleen B. Schwarz, M.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues compared the outcomes of HCV patients aged 5 to 17 treated with either PEG and ribavirin or PEG and placebo. Fifty-five children received PEG alfa-2a subcutaneously each week, plus 15 mg/kg of ribavirin orally twice a day, and 59 children were treated with PEG and placebo. The primary end point was sustained virological response (SVR) for at least 24 weeks after ceasing therapy.
The investigators found a significantly improved SVR with PEG and ribavirin compared to PEG and placebo. Of the children receiving PEG and ribavirin, 53 percent achieved SVR, compared to 21 percent receiving PEG and placebo. Compliance at the two-year follow up was 82 percent with PEG plus ribavirin and 86 percent for PEG plus placebo, and virologic response was 100 percent durable in both groups.
“These results indicate that children with chronic hepatitis C should not receive PEG monotherapy,” the authors write.
Several authors disclosed financial relationships with the pharmaceutical industry, including Roche, which provided the medications for this study.
Equitable hepatitis settlement
Hepatitis B sufferers and bereaved families who had filed lawsuits at 10 district courts in and after March 2008 for state compensation are holding negotiations with the government for a settlement. But the progress of the talks mediated by courts is hampered by the government’s position that people who have suffered from hepatitis B symptoms for more than 20 years as a result of mass vaccinations have no right to claim compensation because the statutory limit of 20 years has passed.
According to the health and welfare ministry, 1.1 million to 1.4 million people are infected with hepatitis B virus, with 90 percent of them not yet having developed symptoms. Up to 440,000 carriers are believed to have been infected through shared needles during mass vaccinations carried out since 1948 under the Preventive Vaccination Law. Only in January 1988 did the ministry issue instructions mandating a one-use policy for needles and syringes.
Under the terms of the negotiations, deceased patients and sufferers of liver cancer or serious cirrhosis would receive ¥36 million, sufferers of a mild case of cirrhosis ¥25 million and sufferers of chronic hepatitis B ¥12.5 million. A carrier without symptoms would receive ¥500,000 as “reconciliation money.”
A June 2006 Supreme Court ruling said that the state was responsible for causing hepatitis B infection because of its failure to order local governments to take preventive steps during mass vaccinations such as not reusing needles. The top court ordered the state to pay ¥5.5 million each in compensation to five sufferers.
The government says that it has a separate plan to take some relief measures for people who have suffered from hepatitis B symptoms for more than 20 years. But excluding them from compensation under the court-mediated settlement would be far from an equitable solution. The government estimates that the settlement would cost ¥3.2 trillion over 30 years. This is an enormous amount. It should seek a fair way of raising the necessary funds as part of its social welfare policy.