NHS England has published a new Clinical Commissioning Policy making Janssen’s Sirturo and Otsuka’s Deltyba routinely available on the National Health Service for the treatment of pulmonary multi-drug resistant tuberculosis, offering patients easier access to the first novel therapies in nearly 50 years.
According to the policy, doctors can now prescribe Sirturo (bedaquiline) and Deltyba (delamanid) more easily as part of appropriate combination therapies for adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Treatment of MDR-TB is difficult and expensive, requiring administration of large numbers of drugs, many of which are only partially effective and very toxic. Also, outcomes are poor with successful treatment completion rates of less than 50% around 15% mortality, and as well as this rates of the condition are on the rise, highlighting the urgent need for new options.
Sirturo has a novel mechanism of action in that it kills the bacterium that causes tuberculosis by targeting adenosine triphosphate synthase, an enzyme that is essential to generate its energy. Phase II data show that its can shorten the time to treatment response and improve cure rates compared to placebo.
Deltyba is also unique, inhibiting mycolic acid biosynthesis which is essential for cell wall formation in M. tuberculosis. Clinical data show that patients given the drug twice daily achieved a statistically significant increase in sputum culture conversion - a measurement used to show when a patient is no longer infectious - after two months (45.4%) compared to those on placebo (29.6%).
“The recent NHS England decision to commission bedaquiline and delamanid for multi-drug resistant tuberculosis represents a light on the horizon that novel agents are indeed being pursued and pioneered for this previously neglected disease, and offers hope that improved treatment regimens are within our grasp,” said Emily Wise, a Specialist Registrar in Infectious Diseases.