SOME EXPERTS OPPOSE THE DRUG

New drug cuts treatment time for drug-resistant TB to 6 months

The drug - called pretomanid - was approved in the US last Friday but the developers said they are targeting high burden countries like South Africa and Kenya.

In Summary

•There are approximately 1,300 Kenyans with the multi-drug resistant TB variety, and only about half are successfully treated.

•Last week, some exprts opposed pretomanid, citing insufficient evidence on efficacy and safety.

A billboard advertises TB testing in Eldoret, on March 20, 2016 / FILE
A billboard advertises TB testing in Eldoret, on March 20, 2016 / FILE

Kenyans with extremely drug-resistant TB could benefit from a new combination of drugs that shortens the treatment period from two years to six months.

The drug - called pretomanid - was approved in the US last Friday but the developers said they are targeting high burden countries like South Africa and Kenya. 

“The goal is not just to get it registered and to have it available in the US, but especially to have it available in the countries that have major TB problems," said Mel Spigelman, the head of TB Alliance, the non-profit that developed the combination. 

 
 

Pretomanid is used in combination with bedaquiline and linezolid for treating adult patients with treatment-intolerant pulmonary TB. 

Current treatment of the drug-resistant TB consists of injections and about 20 tablets taken daily often for more than a year.

Experts said a six-month treatment regime with pretomanid during clinical trials in South Africa returned an 89 per cent success rate.

"This significantly exceeded the historical success rates for treatment of extensively drug-resistant TB," the US Food and Drugs Administration said in a statement.

TB kills between 5,000 and 15,000 Kenyans every year, according to Stephen Muleshe, who heads the National Tuberculosis, Leprosy and Lung Disease Programme.

There are approximately 1,300 Kenyans with the multi-drug resistant TB variety, and only about half are successfully treated.

MDR and extensively drug-resistant (XDR) TB forms do not respond to first-line anti-TB drugs. 

 
 
 

According to National TB Prevalence Survey Report 2016, Kisumu, Mombasa, Nairobi, Nakuru, Kiambu, and Meru had Kenya's highest TB infections.

Doctors Without Borders (MSF) in Nairobi yesterday said the new drug combination must be made affordable to everyone who needs it.

“Having access to effective treatment regimens will give people hope of a cure, and help programmes limit transmission of this deadly bacteria. While safer, simpler regimens are still needed, the shorter treatment duration of this novel regimen is an important step in the right direction," said Jay Achar, infectious disease specialist and TB medical advisor at MSF. 

Another specialist at MSF said it is not yet time to celebrate. 

Pharmacy and Poisons Board has to licence the combination for it to be used in Kenya.

“The approval of this new regimen by the US FDA is just the first step. We now need pretomanid to be registered and available at an affordable price in all countries, prioritising those with the highest TB burden,” said Sharonann Lynch, HIV & TB policy advisor for MSF’s Access Campaign.

Although Pretomanid was developed by TB Alliance, it will be marketed by US drugs maker Mylan. 

“TB Alliance and Mylan must not squander this opportunity. They must make good on TB Alliance’s mandate to deliver affordable treatment – which is why they received the support of government and philanthropic funding that went into the development of pretomanid and this combination,” said Lynch.

TB, a bacterial infection transmitted through the air often requires treatment through a combination of antibiotics. It also is the leading cause of death among people with HIV/Aids.

Last week, four out of the 18 independent experts advising the US regulatory agency did not approve of pretomanid, citing insufficient evidence on efficacy and safety.