By Andrew Mews and Vuyiseka Dubula
Tuberculosis remains South Africa’s leading cause of death. This year alone, the country will see 500 000 cases, of which about 3% will be resistant to both of the most commonly used anti-TB drugs. The majority of these patients will have caught drug-resistant TB from someone in their community, most will never have had TB before in their life.
In the wake of World TB Day, we take stock of South Africa’s fight against TB.
Highlighting the successes
South Africa is improving the percentage of TB patients it is curing in recent years but more than 15% of all TB patients failed treatment last year.
One of the critical issues in treating TB is early identification of patients so that you can treat them early to avoid unnecessary, preventable deaths. We welcome the continued roll out of the GeneXpert, a new tool that allows for better and faster diagnosis of TB and drug-resistant TB (DR-TB) — including multidrug-resistant TB (MDR-TB).
Today, South Africa remains the leading buyer of GeneXpert instruments and more than 190 GeneXpert instruments are in use around the country. According to the director general of health, Precious Matsoso, 134 more are slated to arrive before the end of the year.
Delivering results in just 90 minutes, GeneXpert should drastically reduce the time to diagnose active TB disease and DR-TB. In theory this should lead to faster initiation of effective TB treatment, and reduce the risk of TB transmission and drug resistance within communities.
Early access to TB medicines
But this new technology will not be used to its full potential without a steady supply of the testing cartridges used to run the tests. Similarly, more access to better, faster tests only matters if patients can actually start and stick to their treatment.
A steady supply of drugs would be a start but DR-TB treatment also needs to move into communities and out of specialised TB hospitals where limited beds mean many people die before being admitted for treatment and remain infectious.
It has been two years since the department of health introduced its policy to decentralise DR-TB moving it closer to communities, but today provincial operational plans remain undrafted and proposed decentralised treatment sites have not been assessed, while doctors and nurses remain untrained.
The department of health should report on progress with decentralisation of DR-TB treatment and a plan of action to ensure that provinces are initiating and treating stable adult and paediatric DR-TB patients in local clinics by the end of the year.
Pills, patents and pocketbooks
Today we are still treating patients with old TB drugs developed in the 1950s. The first new anti-TB drug in 60 years, bedaquiline is one example.
Although some safety concerns remain, bedaquiline is more effective and patients may be able to take the drug as little as three times a week instead of the usual daily doses. The drug has already been approved for use in the United States and may soon be approved for use in the European Union.
While the Medicines Control Council’s authorisation for a clinical access programme to expand access to bedaquiline is welcome, there is currently only one primary healthcare site involved — meaning again that access to this drug will be confined to hospitals with too few beds that are too far from patients’ homes.
As with other DR-TB treatments, bedaquiline will need to be given in a regimen alongside other drugs like linezolid. This drug is effective against both MDR and extremely drug-resistant TB but it is extremely expensive in South Africa. Pfizer holds the patent in South Africa and sells linezolid for R676 a tablet in the private sector and R287 a tablet to the government. TB patients require a linezolid tablet every day for many months. Government has the means to allow the drug to be imported from an Indian generic drug manufacturer at a price of R10 a tablet. Government could guarantee access to affordable new and effective anti-TB drugs through a compulsory licence authorised both by article 31 of the Trips agreement, as well as by the South African Patent Act of 1978, but sadly it hasn’t yet taken this opportunity.
To protect and expand on these flexibilities the department of health must take active interest in the development of South Africa’s draft policy on intellectual property rights. The department of trade and Industry meanwhile must take page from the book of fellow Brics country, India, who has used its patent regimen to grow industry and protect public health.
To make a dent in South Africa’s massive TB burden, we need steady supplies of tests and medicines that move testing and treatment for TB closer to communities, making it easier for patients to stick to treatment that can last for more than two years.