A new antibiotic called Fidaxomicin is now being marketed in the UK for treating Clostridium difficile infection (CDI), which is one of the most dangerous forms of hospital acquired infections (HAIs). Under the NHS, the new drug is accepted for restricted use within NHS Wales for the treatment of CDI in adults with severe cases of CDI and or CDI recurrence. From April 2011 to March 2012 CDI affected over 2,100 people in Wales.
So, how efficacious is the new drug? In clinical trials, fidaxomicin demonstrated a similar efficacy and safety profile to the current “gold standard” antibiotic, which is vancomycin (primary endpoint). However, perhaps of greater interest, more than halved the rate of recurrence in patients with CDI compared to vancomycin, (12.7% versus 26.9%). Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.
Cost
Treatment with Fidaxomicin costs £135 per day and so the cost of a ten day treatment course is £1,350.00.
NICE
The National Institute for Health and Clinical Excellence (NICE) has reviewed fidaxomicin under its new ‘Medicines and Prescribing Evidence summaries’. This is a summary of the best available evidence for fidaxomicin. The topics selected for these summaries are medicines that have recently gone into the UK market, or medicines that may be marketed in the UK in the next 6-12 months. It is not formal guidance.
Side effects
The overall incidence and type of adverse events reported in clinical trials were similar between patients receiving fidaxomicin or oral vancomycin. Fidaxomicin was generally well tolerated and few patients discontinued therapy. However, the safety profile of fidaxomicin is based on only data from 564 patients in phase 3 studies. The most common treatment related adverse reactions were vomiting (1.2%), nausea (2.7%) and constipation (1.2%).
