Shortening and simplifying TB treatment
Gatifloxacin treatment-shortening study
The current treatment for people with TB is to have a six-month treatment, requiring a daily visit to a health centre. TDR is investigating a regimen that could shorten that treatment time down to four months – saving two months of patient time and two months of treatment costs. A multi-centre randomized controlled trial comparing a four-month gatifloxacin-containing regimen against the standard six-month therapy for newly diagnosed pulmonary TB patients has taken place in five sub-Saharan African countries (Benin, Guinea, Kenya, Senegal and South Africa). The trial sites are members of the Ofloxacin-Tuberculosis study (OFLOTUB) consortium, which also includes European partner institutions in the United Kingdom, Belgium and France. The trial is completed and results are expected later in 2012.
Four fixed dose combination (4FDC) safety and efficacy study
Fixed-dose combination treatments are often used for TB patients because they are simpler than the standard loose-pill treatment, so patients stick with the treatment. This means that compliance is enhanced and standard formulations of TB drugs are available, reducing the probability for drug resistance developing. However, there is limited scientific evidence on the efficacy and safety of these treatments, especially among HIV-infected TB patients, who have an increased incidence of adverse drug events and difficulty to stay on the treatment regimen. TDR is comparing the safety and efficacy of these formulations in mixed populations of HIV-infected and uninfected TB patients in Nigeria and Ethiopia.