Bedaquiline roll-out to drastically change TB treatment

“The department has taken a decision to now make Bedaquiline available to all eligible Rifampicin-resistant tuberculosis patients, that is, not only the extensively drug resistant TB patients or those with limited treatment options as done previously,” says Norbert Ndjeka. the department’s drug-resistant TB director,.

According to Ndjeka, the roll-out of Bedaquiline will replace the old regimen, which makes use of injections to administer MDR-TB treatment.

“This means that for the first time, an injection-free regimen will be recommended for all patients with Rifampicin-resistant tuberculosis patients in South Africa. Additionally, patients with MDR-TB will now also receive Bedaquiline as part of a more patient-friendly short regimen, which is expected to improve adherence and ensure success,” he says.

The introduction of Bedaquiline has earned South Africa the top spot in being the first country in the world to dispense this type of treatment.

Effective treatment

The department says Bedaquilline has been hailed for its effective treatment and short turnaround time.

“Treating patients with drug-resistant tuberculosis has been difficult with old medicines used, which had many negative side effects and over long periods – often up to 24 months.

“However, a new medicine for the treatment of drug-resistant tuberculosis, became available in 2013 and the National Department of Health was granted permission by the Medicine Control Council (MCC) to provide Bedaquiline to drug-resistant TB patients who had limited treatment options, through the Bedaquiline Clinical Access Programme (BCAP),” said Njeka.

In addition, the treatment is also revered for reducing the number of deaths and having less side effects in comparison to its injectable counterpart, which resulted in hearing loss for many MDR-TB patients.

“Of the 200 patients between March 2013 and March 2015, three quarters (146/200) had a favourable outcome (cure and treatment completion). Twenty-five patients (12.5%) died, which was much lower than the 50% for patients not receiving Bedaquiline.

“It was also found that patients on a Bedaquiline regimen also reported far fewer adverse events,” says Ndjeka.

During the trial phases of Bedaquiline, Ndjeka says the department started with the sickest patients with limited options.

“We saw quite a lot of progress because we saw a dramatic decrease in the mortality rate of those patients. We then targeted patients who had started to lose their hearing as a side effect of the injection used to treat MDR-TB patients,” he says.

Roll-out in July

The registration of Bedaquiline by the MCC -- now called the South African Health Products Regulatory Authority (SAHPRA) -- has paved the way for the department to make the medication available more widely.

The department has set its sights on 1 July to begin its roll-out across the country.

“We will start our roll-out with facilities that are ready to implement. This will be done in a phase by phase approach. We will then assist and capacitate those provinces that need assistance,” says Ndjeka.

It is anticipated that the roll-out across the entire country will be concluded between the next three to six months.