Improving efficacy and safety of TB and HIV treatment by nutritional supplementation

Project summary

The two infectious diseases: Tuberculosis (TB) and HIV are closely linked with crowding, poverty and under-nutrition. The severe wasting seen with both diseases, and more so if co-infecting patients, may affect the absorption of drugs and conversion to active metabolites. The adverse effects may be enhanced and the drug levels less predictable in malnourished patients. The emergence of extremely drug resistant TB in HIV patients could be a result of suboptimal treatment of a population of largely HIV positive TB patients. This project will assess the effect of nutritional supplements to HIV positive patients initiating anti-HIV treatment (ART) in Ethiopia and a group of HIV positive or HIV negative, newly diagnosed TB patients in Tanzania. The nutritional supplements will be given for a two or three months time period and the effect on drug levels in the blood, various laboratory derived proxy-parameters and on the physical activity and experience of adverse effects will be registered.
The nutritional supplements are in “Ready to Use Format” either in a biscuit format or as water free, peanut butter based paste (Plumpynut-like) that may be produced locally and with an extremely long shelf life. The project will produce two African PhD candidates; improve patient care and local capacity within drug monitoring and laboratory facilities. The project will strengthen an already initiated African-Scandinavian research network, the results will be readily available for organizations and programs responsible for HIV and TB treatment in Tanzania and Ethiopia and countries facing similar problems.
 

Outputs

Completion Report - Summary:

The prognosis of HIV-infected patients has improved dramatically in recent years but mortality remains high, particularly within the first few months of therapy. Malnutrition is a strong independent predictor of death. We tested the hypothesis that providing nutritional supplements at the time of antiretroviral therapy (ART) initiation would accelerate weight gain of the patients and improve immune recovery.
The study showed that the patients increased lean body mass three times compared to those only receiving ART and that immunerecovery was enhanced. The project established a method to measure efavirenz (one of the antiretroviral drugs) locally. Further studies of renal function during ART was initiated.
Similarly TB, HIV and malnutrition are closely intertwined health problems and the emergence of MDR or XDR TB especially among HIV-coinfected TB patients is a matter of great concern. A major finding of this project was that HIV coinfected TB patients had low plasma drug concentrations of especially rifampicin - a key TB drug - but also ethambutol. The administration of energy- and micronutrient enriched bisquits during the intesive phase of TB treatment increased drug levels especially in HIV infected TB patients. This may constitute a simple intervention to protect the efficacy of existing TB drugs and contain development of resistance problems. The trial site in Mwanza proved capable of conducting clinical trials obtaining pharmacokinetic profiles from 100 TB pts.

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