SA makes history with replacement TB drug

SOUTH AFRICA has made history as the first country in the world to take the bold step of replacing an injectable drug shown to have toxic side effects, with a promising new oral medicine in the standard multidrug-resistant tuberculosis (MDR-TB) treatment regimens for adolescents and adults.

According to the National Department of Health, new data shows a reduction in TB mortality cases from drug-resistant tuberculosis (DR-TB) with the use of the medicine, Bedaquiline.

Department spokesperson Foster Mohale said treating patients with DR-TB had been difficult with medicines used having many negative side effects and needing to be taken over long periods – often 24 months.

Bedaquiline became available in 2013 and the department was granted permission to provide the medication to DR-TB patients who had limited treatment options.

Two hundred patients who had either extensively drug-resistant TB (XDR-TB) or DR-TB received the medicine under controlled conditions. Of the 200 patients between March 2013 and March 2015, 146 had a favourable outcome (cure and treatment completion).

Some 25 patients died, which was much fewer than the 50% for patients not receiving Bedaquiline.

It was also found that patients on a Bedaquiline regimen reported far fewer adverse events.

“The department has taken a decision to now make Bedaquiline available to all eligible R if ampic in resistant tuberculosis patients; that is, not only the extensively drug-resistant TB patients, or those with limited treatment options, as done previously.

“This means that for the first time an injection-free regimen will be recommended for all patients with Rifampicin-resistant tuberculosis (a severe form of TB where the patients have germs resistant to Rifampicin, the strongest TB medicine). Additionally, patients with MDR-TB will now also receive Bedaquiline as part of more patientfriendly short regimen, which is expected to improve adherence and ensure success,” Mohale said.

Doctors Without Borders (MSF) has urged other countries to follow South Africa’s progressive example.

They said the department’s announcement was a positive step aimed at making MDR-TB treatment more tolerable, and reducing the devastating impact of side effects caused by the injectable agents.

MSF’s DR-TB doctor in Khayelitsha, Anja Reuter, said: “The standard treatment for MDR-TB is effective only 50% of the time.”