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Study shows Otsuka's TB drug works even in worst cases

Deltybaeffective even in cases that are unlikely to respond to any other drug

OtsukaOtsuka's recently-approved tuberculosis therapy Deltyba is effective even in complicated infections caused by extensively drug-resistant (XDR) strains of the bacterium, says a new study.

The analysis of data from phase IIb trials of Deltyba (delamanid) reveals that the drug can be effective even in cases of TB that are unlikely to respond to any other drug regimen. 

According to the World Health Organization (WHO) cases of XDR-TB have been encountered in around 100 countries worldwide, typically because of mismanagement of second-line TB drugs that need to be used with care to guard against resistance. Typically, it occurs in patients who do not take their drugs as indicated by their doctor, and was first identified as a sub-category of MDR-TB in 2006.

Deltyba was approved for marketing last year in Europe, joining Johnson & Johnson's Sirturo (bedaquiline) as the first new therapies for multidrug-resistant TB in decades. 

The new data - reported in the New England Journal of Medicine (NEJM) - found that around 44% of patients given Deltyba on top of background therapy for TB were no longer infectious after two months on the basis of a sputum sample. In comparison, just 10% of a group given placebo plus background therapy achieved the same objective. 

The study also suggested that patients who had received Deltyba for at least six months had a lower risk of death compared to placebo, although this was not statistically significant at the point of follow-up.

Lead study investigator Andra Cirule of Riga East University Hospital in Latvia said: "XDR-TB is one of the most deadly and difficult forms of TB to treat. 

"More new medicines are urgently needed to prevent XDR-TB from becoming a death sentence and this analysis shows that delamanid may be an effective option to improve the current standard of care."

The WHO defines XDR-TB as resistance to first-line drugs isoniazid and rifampicin, as well as resistance to at least one fluoroquinolone and another second-line injectable such as amikacin, kanamycin, or capreomycin, dramatically reducing treatment options.

Patients often have worse treatment outcomes, and XDR-TB is a particular concern in patients with HIV or other conditions that weaken the immune system.

While still rare, recent experience shows that XDR-TB can be a threat even in countries with sophisticated healthcare systems.  Just last month a case was recorded in Chicago in the US in a woman who had been treated for TB in India. 

The case resulted in a three-state search for people who had come into contact with the patient in an attempt to block the transmission of the strain. All told, there have been 63 reported cases of XDR-TB in the US between 1993 and 2011. 

Around 9% of the 480,000 MDR-TB cases estimated to have occurred in 2013 are thought to actually be caused by XDR-TB strains. 

A second, smaller study in the NEJM looked at Pfizer's older antibiotic Zyvox (linezolid) and concluded it could also be effective against XDR-TB, although treatment was often associated with serious side effects that required dose reduction.

Article by
Phil Taylor

16th July 2015

From: Research



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