FDA Approved Hepatitis C Treatment

The US Food and Drug Administration (FDA) approved an all-oral regimen of ombitasvir/paritaprevir/ritonavir (Viekira, AbbVie) and dasabuvir (Exviera, AbbVie), with or without ribavirin, for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. The drug regimen contains 3 distinct mechanisms of action that attack the virus at 3 separate stages of the disease lifecycle to inhibit its reproduction.

In 6 phase 3 studies involving 2300 patients in 25 countries, the regimen cured 95% to 100% of patients with GT1a and GT1b patients with HCV, according to a press release. Enrollment criteria for the trials allowed inclusion of patients previously treated for HCV, treatment-naïve patients, and patients with compensated cirrhosis. Less than 2% of patients experienced virologic failure, and more than 98% of the patients in clinical trials completed a full course of therapy. In phase 2 trials, the regimen cured 97% of liver transplant recipients, according to a press release.

HCV affects more than 3.2 million Americans, 70% of whom have GT1 infection.

FDA Approved Treatment for Multiple Sclerosis

The FDA approved the moloclonal antibody alemtuzumab (Lemtrada, Sanofi) for treatment of relapsing forms of multiple sclerosis.

Approval of the drug was based on data from a phase 3 trial comparing alemtuzumab with interferon beta-1a (Rebif, Merck KGaA). Patients in the trial were either treatment-naïve or had relapsed on prior therapy.

The drug will carry a warning of risk of “serious, sometimes fatal autoimmune conditions” and “serious and life-threatening infusion reactions.”

The drug was already approved in 40 markets, including Brazil, Australia, Canada, and several European nations.

CDC Released Effectiveness Data for Influenza Vaccine

The US Centers for Disease Control and Prevention (CDC) estimated that this season's influenza vaccine is 23% effective among people of all ages.

The CDC determines the effectiveness of an influenza vaccine by finding similarities in the viruses used in vaccine production and the viruses actually circulating. The vaccine's overall effectiveness was likely diminished by circulatory H3N2 viruses that were not covered by the vaccine.

About 70% of circulating H3N2 viruses detected by global influenza surveillance programs did not match the particular strain chosen for this year's vaccine, according to the CDC.

The vaccine's effectiveness against H3N2 influenza was 26% in patients 6 months to 17 years, 12% in patients 18 to 49 years, and 14% in patients 50 years and older. These differences were not statistically significant.

Most Cancers Caused by Random Mutations

Genetic mutations appear to be the causative factor in almost two-thirds of cancers, according to a report published in Science.1

Researchers determined that the lifetime risk of cancer is strongly correlated (0.81) with the total number of divisions of the normal self-renewing cells that maintain a tissue's homeostasis.

“These results suggest that only a third of the variation in cancer risk among tissues is attributable to environmental factors or inherited predispositions,” researchers said. “The majority is due to ‘bad luck,' that is, random mutations arising during DNA replication in normal, noncancerous stem cells.”

1. Tomasetti C, Vogelstein B. Variation in cancer risk among tissues can be explained by the number of stem cell divisions. Science. 2015;347(6217):78-81.

Survey: Diabetic Patients Unsure How to Manage Hypoglycemia

Among 1000 patients with type 1 or type 2 diabetes who took an online survey, 62% were concerned about experiencing hypoglycemia, but many survey respondents were unaware of the causes, symptoms, and methods of preventing and managing the condition, according to a press release from the American Association of Diabetes Educators.

Participants took the survey between September 23, 2014 and October 1, 2014. Of the respondents who had never experienced hypoglycemia, 42% were unable to define it correctly. Fewer than a third (30%) of respondents cited avoiding alcohol as a method of preventing hypoglycemia, and 49% were unaware that glucose tablets were suitable treatment for low blood sugar events.

Hypoglycemia is defined as having a blood sugar level of less than 70 mg/dL.

“These survey findings illustrate the importance of educating about hypoglycemia,” said Andrew Purcell, vice president and head of US Diabetes at Sanofi US, which sponsored the survey.

Children's Consumption of Energy Drinks Responsible for More Than Half of Calls to Poison Control

Over half of calls to US poison control centers related to energy drinks were for children younger than 6 years, according to a Bloomberg report. Almost a third of callers to poison control centers involving children younger than 6 reported symptoms such as tremors, seizures, nausea, vomiting, chest pain, and erratic heart rhythms.

The study findings were presented by Steven Lipshultz, MD, at the American Heart Association's annual meeting in Chicago. Researchers analyzed calls involving energy drinks (n = 5156) to poison control centers from October 2010 to September 2013. In most cases, children less than 6 years old who consumed the drinks did so accidently. n

David S. Boyer, MD, is a clinical professor of ophthalmology at the University of Southern California Keck School of Medicine, Department of Ophthalmology, in Los Angeles. He is a member of the Retina Today Editorial Board. Dr. Boyer may be reached at +1-310-854-6201 or vitdoc@aol.com.