Statement by the Treatment Action Campaign, SECTION27, Médecins Sans Frontières and Oxfam.
On 12 June 2012, The Treatment Action Campaign (TAC), SECTION27, Médecins Sans Frontières and Oxfam hosted a meeting prior to the launch of the 3rd SA TB Conference. The meeting brought together TB clinicians, counsellors, patients, activists and academics. Speakers and participants drew attention to the many challenges and failures of the country’s response to TB and DR TB, but also highlighted important opportunities to begin to reduce new cases and reduce mortality.
TB is the number one cause of mortality in South Africa. Expanding diagnosis of and access to treatment for TB and DR TB is crucial to reducing mortality – these services must no longer be limited to certain areas and facilities. Additionally, facilities and patients must have access to better diagnostic tools and medicines, as well as improved access to existing diagnostic tools and medicines.
The group called for 5 crucial interventions to reduce TB cases and mortality:
1. Diagnose all people living with TB and DR TB
2. Ensure access to the best available medicines and regimens
3. Improve affordability of medicines
4. Decentralise DR TB care
5. Reduce crowding in prisons and implement active case finding and infection control measures
Reducing TB deaths and cases: What needs to be done?
1. Diagnose all people living with TB and DR TB
Far too few people living with TB and DR TB are diagnosed. Active case finding coupled with better diagnostics is needed to identify new TB cases. The Gene Xpert is now being used in 25 sites in South Africa. By March 2012, 311,117 samples were processed.
The use of the Gene Xpert will improve detection of TB and DR TB in South Africa. It is able to detect TB in many patients that currently test falsely negative using smear microscopy as well as detect rifampicin resistance. Resistance to rifampicin is highly correlated with resistance to isoniazid in South Africa and therefore with Multi-Drug Resistant (MDR) TB.
While we welcome the use of the Gene Xpert, civil society must continue to build pressure on Cepheid to reduce the cost of machines and cartridges. This will allow expanded use of Gene Xpert diagnostics in South Africa and other developing countries. Furthermore, ongoing research into TB diagnostics is needed. We still need cheap, laboratory free, point-of-care diagnostics for TB.
2. Ensure access to the best available medicines and regimens
In 2008, the treatment success rate for patients with DR TB was only 48%. Patients in whom DR-TB treatment is failing must be able to access new, promising medicines. Linezolid offers hope for patients failing on DR TB but is not widely available. Additionally, new medicines that have shown promising results in phase II trials, but have not yet been through phase III trials, such as bedaquiline and delaminid, can provide a potential chance of cure for select patients that have no other treatment options.
Access to bedaquiline is already available in a number of countries under compassionate use, but remains unavailable to patients in need in South Africa. The Department of Health and Medicines Control Council must facilitate access to important new medicines in the pipeline for patients in need of these medicines. Finally, once medicines in the pipeline receive pre-approval or approval from the Food Drug Administration, they must be fast-tracked by the Medicine Control Council for registration.
While patients must be provided with the best currently available medicines, there is still a huge need for new, better medicines. DR TB medicines are extremely difficult for patients, because they involve many pills and/or injections and cause side effects such as hearing loss, paranoia, depression and kidney failure. Additionally, TB regimens take six months to complete and DR TB regimens can take up to 2 years. Funding for research into new medicines, to shorten and simplify regimens and reduce side effects, is critically needed.
3. Improve affordability of medicines
While the Department of Health successfully brought down the prices of a number of TB medicines during the previous tender, South Africa continues to pay higher prices for many medicines than what is available internationally. Linezolid, for instance, is unaffordable and should be available at lower costs. Pfizer charges R8,460 per patient per month for use of linezolid in the public sector and more than double this for NGOs, such as MSF. South Africa should pursue strategies to further reduce prices. Strategies could include importing lower cost medicines from overseas or pooling procurement with other high burden countries.
The funders and developers of new medicines in the pipeline must ensure that, once these medicines are registered, they are made widely available at low costs.
4. Decentralise DR-TB care
Nearly half of patients diagnosed with DR TB in South Africa are not initiated onto treatment. With only 2,500 beds for DR TB patients, centralised care is no longer possible. Furthermore, it is not feasible for many potential patients because it requires them to travel long distances to access care. Pilot sites for decentralised DR TB care are showing far better treatment outcomes. Nationally, the treatment success rate for DR TB treatment was only 48% in 2008. Decentralised care in a pilot project in KZN, has improved cure rates to 66.7%. In Tugela Ferry, active case finding, decentralised care and infection control has decreased the rate of new MDR TB infections by half over the last six years.
The Department of Health has now developed a policy framework for decentralised care of TB and begun to provide decentralized care in some sites. Costing of decentralised care has shown that it will reduce the costs of the programme by reducing the number of patients who stay in specialised hospitals as well as the length of time patients stay.
Decentralised care should be rolled out nationally. To do this, nurses must be trained to manage treatment and community health care workers must be trained to support care.
5. Reduce crowding in prisons and implement active case finding and infection control measures
South African prisoners are facing a crisis of TB, but there is little political will to address the epidemic. Researchers from the University of Cape Town and Stellenbosch showed a 90% probability of TB transmission per patient per year in a large South African prison. The main driver of these high transmission rates is overcrowding of prisons. Prisoners are commonly held is mass cells in extremely close proximity for up to 23 hours per day. Proper implementation of regulations regarding national cell occupancy would reduce transmission by 30%. Implementation of international cell occupancy regulations, coupled with active case finding, ventilation, and reduced time in cells would reduce transmission by 94%.
The Department of Correctional Services and Department of Health must address the crises of TB in South African prisons by implementing measures, including reducing crowding, to reduce transmission. Further, prisoners that are TB positive must be diagnosed earlier and receive proper treatment to reduce mortality.
Treatment Action Campaign