Tuesday, April 22, 2014

Entecavir therapy improved LSM among chronic HBV patients

Chronic hepatitis B virus patients had a greater chance of improving their liver stiffness measurement value with Entecavir therapy, according to data from a recent study.
Researchers analyzed 233 chronic hepatitis B virus (HBV) patients who underwent entecavir (ETV) therapy and received at least two liver stiffness measurements (LSM) between August 2008 and February 2012 at Kaohsiung Chang Gung Memorial hospital in Taiwan. The mean age of patients was 51.4 years (168 male and 65 female). Group one consisted of 132 (56.6%) patients without cirrhosis and group two included 101 (43.4%) patients with cirrhosis. ETV therapy was given to patients in a daily dose of 0.5 mg. Ten LSMs were used from each patient.


Oklahoma Dental Groups Split On Oral Surgery Legislation

"Dr. W. Scott Harrington, the Tulsa oral surgeon who may have exposed at least 5,000 patients to HIV, hepatitis B and hepatitis C last year, was found to be allowing his assistants to perform IV sedation and was cited by the state Board of Dentistry."

Some Oklahoma dental groups are opposing a bill in the state Legislature dealing with training requirements for oral surgery dental assistants.

But the head of the state dental board says the language in the bill has been misunderstood.

The Tulsa World reports the bill would set forth the training required to obtain a permit as an oral surgery dental assistant.

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Monday, April 21, 2014

Some Immigrants In Columbus At Risk For Silent Killer

Central Ohio is home to some 70,000 Asian immigrants. And advocates worry a silent deadly disease is hidden in the population. Immigrants from Asia and some African nations face a greater risk for Hepatitis B and may not know they have it. That’s why local health workers are screening them for the contagious disease.

“Do you have a family doctor? Yes, but I don’t know the name of the doctor.”

18 year old Assa Zautam translates health care questions for her neighbor at the Saraga International Grocery store on Morse Road. Zautam is from the newest group of South Asian immigrants called the Butanese-Nepali. Her family is from Nepal but was forced to flee to nearby Butan. The family lived in a refugee camp for two decades before arriving in Columbus this year.

Zautam decides that she will get tested for Hepatitis B.

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Friday, April 18, 2014

Arzerra, HBV Reactivation and Liver Damage

Fatal infection due to hepatitis B in patients who have not been previously infected has been observed with Arzerra. Patients should be monitored for clinical and laboratory signs of hepatitis.

COPENHAGEN, Denmark, April 17, 2014 (GLOBE NEWSWIRE) -- Copenhagen, Denmark; April 17, 2014 - GlaxoSmithKline plc(LSE:GSK) and Genmab A/S(Copenhagen:GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra(r) (ofatumumab), a CD20-directed monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.1(p.1)

The FDA approval of the first-line indication is based on results from a Phase III study (COMPLEMENT 1) which demonstrated statistically significant improvement in median progression-free survival (PFS) in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.1(p.16)

"CLL is the most common form of leukemia amongst adults in Western countries, many of whom are elderly with multiple health issues," said Dr. Paolo Paoletti, President of Oncology, GSK. "Today's approval by the FDA for the use of Arzerra in the first-line setting means that appropriate patients with CLL have a new treatment option."

Warnings:


WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY1(p.2)

-     Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including Arzerra(r), in some cases resulting in fulminant hepatitis, hepatic failure, and death.


Hepatitis B Virus Reactivation1(p.6)

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has occurred in patients treated with Arzerra.  Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [anti-HBs] positive).

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death.
Hepatitis B Virus Infection1(p.7)

Fatal infection due to hepatitis B in patients who have not been previously infected has been observed with Arzerra. Patients should be monitored for clinical and laboratory signs of hepatitis.

Wednesday, April 16, 2014

Dynavax Starts Phase III Study on Heplisav-B

Dynavax Technologies Corp. (DVAX - Snapshot Report) commenced a new phase III study (HBV-23) on its hepatitis B vaccine candidate, Heplisav-B. Dynavax is seeking to get Heplisav-B approved in the U.S. and EU.

The randomized, active-controlled, HBV-23 (n=8,000) study will randomize (2:1) patients to receive a 2-dose series of Heplisav-B and 3-dose series of GlaxoSmithKline’s  Engerix-B.

The primary endpoints of the study are for evaluation of the overall safety of the candidate and demonstrate the non-inferiority of the seroprotection rate induced by Heplisav-B compared with Engerix-B at week 28 in type II diabetes patients.

Secondary endpoints include safety profile of Heplisav-B with respect to specific outcomes and assessment of immunogenicity in subpopulations.

Saturday, April 12, 2014

Assembly Pharma, BioCrossroads to advance potentially curative therapy for chronic hepatitis B virus

Assembly Pharmaceuticals, a virology-focused biopharmaceutical company, and BioCrossroads announced that the BioCrossroads Indiana Seed Fund II has made an investment in Assembly Pharmaceuticals. Assembly is developing novel drugs for the treatment and potential cure of chronic hepatitis B virus (HBV) infection. Johnson & Johnson Development Corporation, Twilight Ventures, Luson Bioventures and private investors also participated in the financing round.

Assembly Pharmaceuticals is applying its novel science to develop agents with the potential to cure chronic HBV. HBV is an under-appreciated global epidemic with more than 350 million people worldwide chronically infected, including two million in the US Chronic HBV causes cirrhosis and liver failure, and it is a leading cause of liver cancer. Over 600,000 deaths each year are attributable to HBV. Current treatments can suppress the infection but require lifelong therapy since they are not curative.

Assembly Pharmaceuticals was formed in 2012 to develop drugs based on the breakthrough science of co-founder and Indiana University professor Adam Zlotnick,  Dr. Zlotnick is a pioneer in the biophysics of viral capsid assembly. His research has led to the discovery of multiple families of small molecules known as Core Protein Allosteric Modulators (CpAMs), which target the HBV core protein, a unique viral protein with no human analogue that is involved in multiple stages of the HBV life cycle.

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