London: A shortened four months treatment for tuberculosis may not be a successful alternative to the current six-month standard treatment, scientists have found.
Tuberculosis (TB) remains a significant public health problem worldwide. There were an estimated 8.6 million people who developed TB and 1.3 million died from the disease in 2012, researchers said.
A clinical drug trial conducted in five Sub-Sahara African countries shows that a shortened (four month) treatment for TB is well tolerated and may work well in subsets of TB patients, but overall could not be considered as an alternative to the current six month standard treatment.
The study was designed to verify whether replacing one of the four drugs of the standard regimen with gatifloxacin could shorten the overall treatment duration of TB from six to four months.
The new treatment was found to be safe and cleared the lungs from TB bacteria rapidly, but a proportion of patients relapsed within months after treatment ended. The shortened treatment appeared beneficial to patients with no TB cavitation in their lungs, undernourished patients, and people living with HIV, but it was less effective among other groups.
This shortened regimen could not be recommended to replace the current treatment, though the difference in effectiveness between the two treatments varied considerably across the different countries where the study took place. "The standard treatment is very effective if taken for the full six months," said Dr Christian Lienhardt, who initiated the study while at the Institut de Recherche pour le Development (IRD) in France and who now works at the World Health Organisation.
"But in reality, many do not do this. Poor patient adherence to treatment may increase the risk of TB becoming drug resistant and thus potentially fatal. Shortening treatment duration remains, therefore, a global priority, as it would lead to more patients following the complete treatment," said Lienhardt.
The study enrolled over 1,800 patients in five African countries (Benin, Guinea Conakry, Kenya, Senegal and South Africa). Half of the patients received the standard six month treatment, the other half received the shortened four month treatment.
"The study will help improve the way future studies of TB will be conducted, due to the investments made in strengthening capacities for quality clinical trials in highly endemic TB countries," said Dr Corinne Merle, the study coordinator from the London School of Hygiene and Tropical Medicine. The study was published in the New England Journal of Medicine.
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