A highly advanced drug for treatment of multi-drug resistance tuberculosis (MDR-TB) could be available by 2018. The TB Alliance has announced that it is advancing the global clinical trial into phase 3, the last stage of clinical trials, to determine the safety and effectiveness of the new TB drug regimen known as PaMZ. The Phase 3 trials are scheduled to start later this year in Uganda, Tanzania, Kenya, Zambia and South Africa. Other studies will be conducted in Asia, Eastern Europe and Latin America. PaMZ is expected to significantly reduce the time required to cure drug-resistant TB from two years to just six months, and it could cut the cost of curing drug-resistant TB in low-income countries. Results from early research suggest that this new drug regimen could provide the breakthrough to finding a cure for this deadly disease. It is expected to save the more than 1.3 million people who die annually from the disease, especially those co-infected with HIV/Aids. In a statement, the TB Alliance president Mel Spigelman said the results are expected in 2017 and, if successful, the organisation will pursue registration of the drug combination to make it available to all who need it. “If the phase 3 trials are completed without delay and results are positive, the PaMZ regimen could reach the market by 2018,” Dr Spigelman said. “If successful, the regimen will help eliminate the need for injectable drugs and reduce the cost of MDR-TB therapy in some countries by more than 90 per cent in those patients whose TB organisms are sensitive to the three drugs,” Dr Spigelman added. Dr Michel Gasana, the head of TB division at the Rwanda Biomedical Centre (RBC) welcomed the move. “As long as the drug is endorsed by the World Health Organisation, we shall be glad to use it since it promises to reduce the dosage lifespan; many patients have been deeply concerned with,” Gasana said yesterday. Gasana added that the development could help cut the country’s TB mortality rate which currently stands at 10 people out of every 100,000 patients, according to the 2013 World Health Organisation report. “We noticed that many people abandon the dosage because its tiringly long and this exposes them to mortality,” he said. Dr Olivier Manzi, a specialist in infectious diseases at the University Teaching Hospital of Kigali (CHUK), said they are currently using a drug combination that takes about 20 months to cure drug-resistant TB. “A patient does not only take these drugs for 20 months, but also receives daily injections for the first six months, and this usually presents side effects like hearing impairment, blurred vision and kidney problems,” he said yesterday. Dr Frederick Fundi Gatare, the medical director of Rutongo Hospital in Rulindo District, echoed a similar message, saying the development could help reduce the bulk of drugs patients take, hence reducing the side effects. “We have had TB patients under treatment running out of patience and escaping from hospital increasing chances of spreading the disease,” he noted. “Because the cure of that kind of TB takes long, some patients become depressed for fear that the disease may never cure after all,”Gatare added. Earlier studies show that PaMZ’s potential to treat both drug-sensitive and drug-resistant patients with the same oral therapy. In July 2012, a two-week study, whose results were published in The Lancet, showed that PaMZ appeared to kill the patients’ bacteria faster than standard therapy after starting treatment. Findings from a subsequent two-month study are expected to be published later this year. According to the 2013 World Health Organisation Report, Rwanda ranks third lowest in the region on newly confirmed cases of MDR-TB, with 58 cases, behind Tanzania and Burundi with 42 and 24, respectively. Kenya and Uganda have the highest cases, standing at 225 and 89, respectively.
