Strongest DR-TB drug approved

2018-07-05 06:00

The Department of Health has released new data on a reduction in tuberculosis (TB) mortality cases in South Africa through use of the latest medication, Bedaquiline.

Significantly, they include data on those suffering from drug-resistant tuberculosis (DR-TB).

South Africa has a large number of people with drug-resistant tuberculosis, many of whom were diagnosed since the expanded use of the latest diagnostic technology – GeneXpert – in 2011.

Treating patients with drug-resistant tuberculosis has been difficult with old medication, which had many negative side effects over long periods — often up to 24 months.

Developed especially for the treatment of drug-resistant tuberculosis, Bedaquiline became available in 2013, and the National Department of Health was granted permission by the then-named Medicines Control Council (MCC) to provide Bedaquiline to drug-resistant TB patients who had limited treatment options through the Bedaquiline Clinical Access Programme (BCAP).

Two hundred patients, who had either pre-extensively drug resistant (pre-XDR) TB or XDR TB, received the medication under controlled conditions.

Of the 200 between March 2013 and March 2015, three-quarters (146/200) had a favourable outcome (cure and treatment completion).

Twenty-five patients (12,5%) died, 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 effects.

According to the department, following registration of Bedaquiline by the MCC, now called South African Health Products Regulatory Authority (SAHPRA), the National TB Programme (NTP) made the medication available more widely.

About 15 000 Rifampicin Resistant Tuberculosis (RR-TB) patients have either received or are currently receiving Bedaquiline under programmatic conditions.

Rifampicin Resistant Tuberculosis is a severe form of TB, where the patients are resistant to the drug, the strongest TB medicine.

However, Bedaquiline has seen an effectiveness increase of 41% among such patients and a threefold reduction in mortality.

The department has now made Bedaquiline available to all eligible Rifampicin Resistant Tuberculosis patients, and not just the extensively drug-resistant TB patients.

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 expected to improve adherence and ensure success.

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