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New treatment launched to reduce C. difficile recurrence

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A new therapy for the prevention of recurrence of Clostridium difficile infection has been launched in the UK.

Bezlotoxumab (Zinplava) is the first European Commission licensed non-antibiotic option indicated to prevent C. difficile infection recurrence in high-risk adults.

“Notably, bezlotoxumab reduces the risk of the recurrence of C. difficile infection for at least three month”

Mark Wilcox

It is administered as a single, one-off, one-hour intravenous infusion alongside standard-of-care antibiotic therapy, noted pharmaceutical company MSD.

Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity. It prevents infection recurrence by providing passive immunity against toxin B produced by the outgrowth of persistent or newly-acquired C. difficile spores.

There were 12, 840 cases of C. difficile infection in 2016-17 reported in England, according to figures from Public Health England.

Under National Institute for Health and Care Guidelines, patients who develop the infection are usually given an antibiotic, but it can often come back within weeks or months.

For patients in hospital, the rate of recurrence is around 20% after the first episode and 45-60% after a second episode of C. difficile. But MSD highlighted that bezlotoxumab was not a treatment for C. difficile and had no effect on the current episode.

The efficacy of drug was investigated in two large phase III studies called MODIFY I and MODIFY II. In both, patients received bezlotoxumab plus standard antibacterial therapy – metronidazole, vancomycin or fidaxomicin – or placebo plus the antibiotics.

The rate of recurrent infection was significantly lower with bezlotoxumab than with placebo – 17% versus 28% in MODIFY I 16% versus 26% in MODIFY II, respectively.

Bezlotoxumab also demonstrated reduced rates of recurrence in subgroups at high risk for C. difficile recurrence, including those over 65, those with a history of one or more episodes in the past six months, immunocompromised patients and patients with severe cases.

In the MODIFY I and MODIFY II studies, the most common adverse reactions following treatment with bezlotoxumab were nausea, diarrhoea, pyrexia and headache.

Dr Mike England, MSD’s interim medical director, said: “We hope with bezlotoxumab to not only help achieve a reduction in the number of recurrent episodes, but also a reduction in the amount of antibiotic prescriptions that would otherwise be needed to treat these recurrent episodes.”

Professor Mark Wilcox, from the University of Leeds, noted that bezlotoxumab was the first therapy for C. difficile that targets the toxin that causes this disease.

“Notably, bezlotoxumab reduces the risk of the recurrence of C. difficile infection for at least three months, compared with standard of care antibiotic therapy,” he said.

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