Health department’s plan
South Africa has the third highest burden of TB in the world after China and India – approximately 1% of the South African population gets active tuberculosis every year. While the number of TB patients initiated on treatment under the National TB Programme appears to be decreasing over the last four years, the number of multidrug-resistant TB (MDR-TB) and extensively-drug-resistant TB (XDR-TB) cases are escalating. The emergence of drug-resistant mycobacterium tuberculosis compromises the health department’s ability to address tuberculosis.
We have the fifth highest amount of MDR-TB patients on treatment (WHO Global TB Report 2013). This was based on our number of MDR-TB patients initiated on treatment during the year 2012, which was 6 494 against 14 161 diagnosed MDR-TB patients. Our provisional report indicates that 10,263 MDR-TB cases were initiated on treatment during the year 2013. We do not know yet how many MDR-TB cases were diagnosed by the National Health Laboratory Services (NHLS), however we do not expect this to exceed 13 000 because the preliminary report of the NHLS shows that 7 271 MDR-TB cases were diagnosed between January and September of 2013. This is work in progress, however it appears that we are initiating more MDR-TB cases on treatment, hence closing the gap between number diagnosed and number initiated on treatment.
Some of our key challenges include the centralisation of care in many areas of the country with its side effects; poor treatment success rate and high treatment defaulter rate; and limited access to new drugs to treat DR-TB. What are we doing differently to address these challenges? We are strengthening the decentralisation of MDR-TB services, we have organised workshops and meetings to draft and finalise policy on decentralisation of MDR-TB services and we have designed a tool for readiness assessment of facilities, as well as a monitoring and evaluation tool.
We also supported the development of provincial plans for decentralisation of MDR-TB care. Our target is to have one MDR-TB treatment decentralised site per district by 2016 and to strengthen community MDR-TB care. To date 38 districts have at least a treatment site, while 14 districts do not have any form of MDR-TB treatment initiation site. The number of treatment sites has increased from 11 to 63 since approval of the policy framework on decentralised management of MDR-TB. The Western Cape, KwaZulu-Natal and the Eastern Cape are moving faster than other provinces.
A grant provided recently by Global Fund and the United States Centers for Disease Control will help us train nurses as MDR-TB initiators. We are also aiming to have treatment linkage officers in each district to help us close the gap between number diagnosed and number initiated for treatment.
The treatment success rate has remained stagnant at 42% and the defaulter rate has been 20% on average over two years. Reasons for the low treatment outcomes are many, including poor linkage to care, poor tracing mechanisms and limited access to new agents (drugs) for treatment. In terms of new treatment agents I would like to comment about the use of Bedaquiline, Linezolid and Delamanid in South Africa.
- Linezolid: this medicine has proven effective in improving XDR-TB clinical outcomes. Pfizer are not willing to sell it to us (Pfizer is the only pharmaceutical with a registered Linezolid under the name Zyvox) because according to them this drug is not licenced for use in tuberculosis. At R 9 000 per patient per month Zyvox is costly as a XDR-TB treatment. A company named Hetero has applied for registration of a global drug facility and global fund approved generic version of Linezolid, which is likely to cost less than R 3 000. The Medicines Control Council (MCC) is reviewing the application for this product and has put it on the fast track. We are hopeful that Hetero will respond to all MCC queries satisfactorily and that the drug will be registered before the end of 2014. Linezolid is available globally through the Global Drug Facility.
- Bedaquiline is in use under an open label trial within the programme. So far 74 patients have received Bedaquiline. I have been informed that the Clinical Committee of MCC has approved registration of Bedaquiline in South Africa and we are awaiting formal communication from them. The proposed price seems affordable.
- Delamanid is not in use. We are waiting guidance document to be released by WHO within next three months.
My view is that Bedaquiline and Linezolid are within our reach. We shall seek to use Delamanid in accordance with WHO guidance notes and the decision by our Medicines Control Council. With these medicines available, we need to redesign our treatment regimens for MDR-TB and XDR-TB in order to include Linezolid and Bedaquiline.
Dr Njeka is director of drug-resistant TB, TB and HIV at the National Department of Health