Top Infectious Disease News Stories Week of December 6 - December 12

FDA Approves Zoliflodacin for Uncomplicated Urogenital Gonorrhea

the FDA approved Innoviva Specialty Therapeutics’ zoliflodacin (Nuzolvence), a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. This approval was based from data of a phase 3 trial, which was published in The Lancet, showing that the antibiotic was noninferior to a combination regimen of ceftriaxone and azithromycin.

FDA Approves GSK’s Gepotidacin for Gonorrhea

The FDA approved GSK’s antibiotic, gepotidacin, for the treatment of uncomplicated urogenital gonorrhea in patients 12 years or older (weighing ≥ 45 kg [99.2 lb]). This approval was based from data of the EAGLE-1 phase 3 trial results, which were published in The Lancet, showing that gepotidacin (oral, 2 doses of 3000 mg) was noninferior, with a 92.6% (187 of 202; 95% CI, 88.0%-95.8%) success rate at urogenital site when compared with a 91.2% (186 of 204; 95% CI, 86.4%-94.7%) success rate for intramuscular ceftriaxone (500 mg) plus oral azithromycin (1000 mg) combined therapy.¹

Further Phase 3 Study Insights for Newly Approved Gepotidacin for Gonorrhea

Contagion spoke to GSK VP Head of Infectious Disease Research David Payne, PhD, who offered more information about the study including its safety profile, efficacy results, and the importance of the lack of bacterial persistence at the urogenital site.

A Pediatrician’s Perspective on the Latest ACIP Hepatitis B Vaccine Recommendations

Last week, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) had a 2-day meeting to discuss the birth dose of the hepatitis B vaccine. Infectious disease pediatrician Sharon Nachman, MD, talks about how the new recommendations will defer immunization, leading to potential negative impacts on long-term public health.

"Complicating the Decision-Making" for the Universal Birth Dose of the Hepatitis B Vaccine

Robert Hopkins Jr, MD, medical director of the National Foundation for Infectious Diseases, discusses the changes in the new vaccine recommendations and what potential serious consequences may be seen as a result.