Dynavax Technologies Corporation says that their preliminary pivotal phase 3data for hepatitis B Vaccine showed statistically significant rate for seroprotection than the approved vaccine. The investigational two-dose hepatitis B vaccine targets adults having type 2 diabetes. The data was presented in the American Diabetes Association 76th Annual Scientific Sessions in New Orleans.
Centers for Disease Control and Prevention reported that adults with diabetes are vulnerable to acquiring hepatitis B infection. CDC reported that diabetic adults ages 23 to 59 have twice the risk of getting an acute hepatitis B infection as compared with adults without diabetes. Therefore, CDC recommends that adults ages 19 to 59 should be vaccinated with hepatitis B at the soonest possible time after a diagnosis of diabetes is established.
Adults ages 60 and older should be vaccinated at the discretion of their physician. In this age group, it is important to assess the patient’s immune response and the possible risk of infection. CDC reported that 20 million adults in US are suffering from diabetes. Approximately, 1.5 million of new diabetes cases are reported each year.
The HBV-23 or Phase 3 trial was a multi-center, observer-blinded, active-controlled, and randomized study that compared Dynavax candidate drug to Engerix-B in adults ages 18 to 70. In the study, two doses of HEPLISAV-B vaccine were compared with three doses for Engerix-B.
There were 8,000 randomized patients in the study where 1,144 have type 2 diabetes. Two thirds among this group had been suffering from diabetes for five years or more. The demographics in the two treatment arms were generally similar consisting of sex, age and race.
The study showed that HEPLISAV-B was able to provide a seroprotection of 90.0 percent among the study participants compared with only 65.1 percent seroprotection for Engerix-B. The result showed a statistically significant difference of almost 24.9 percent.
Larger differences were also noted among the study participants ages 60 to 70. With HEPLISAV-B, there was an 85.8 percent of seroprotection as compared with 58.5 percent for the Engerix-B. Participants with body mass index greater or equal to 30 HEPLISAV-B demonstrates an 89.5 percent of seroprotection as compared with 61.4 percent for Engerix-B.
In terms of serious adverse effects, the result showed that there was a similar result between HEPLISAV-B and Engerix-B groups in the total trial population. The adverse events noted were having a potential risk of an immune-mediated response. The results were reviewed by the Safety Evaluation and Adjudication Committee, a blinded and independent evaluating board. They classified the event as not related to the vaccination.
Rob Janssen M.D., Chief Medical Officer of Dynavax said in an interview that the hepatitis B virus spreads easily if a person has a contact with contaminated equipment like blood glucose monitors. This poses a serious health risk for people with diabetes. The results of the study have shown that two doses of HEPLISAV-B for one month provided a statistically higher significant rate of seroprotection as compared with a standard hepatitis B vaccine.
HEPLISAV-B was given a biologic license application by the US Food and Drug Administration on December 15, 2016. The specified action date is in compliance with the Prescription Drug User Fee Act (PDUFA).
The Fight against Hepatitis B and Diabetes: A Deadly Combo
Hepatitis B and diabetes is serious and life-threatening disease. The effect can be tremendous if these two deadly diseases are combined. Thus, there is a need for an effective preventive and control measures to stop the spread of the infection.
Dynavax’s HEPLISAV-B will be welcomed wholeheartedly by patients and the medical community to prevent the complications of diabetes and hepatitis B. Its significant and higher efficacy rate than the standard drug predicts that this might be the new first-line treatment in treating these diseases.