Mobilise against TB. 18/8/11

Treatment Action Campaign (TAC) Report on the Meeting of 10 August 2011 on TB

TAC Report on the Meeting of 10 August 2011.

On 10 August 2011 Treatment Action Campaign, Médecins Sans Frontières (MSF), the HIV Clinicians Society of Southern Africa (HIVSOC) and SECTION27 (formerly the AIDS Law Project) hosted a meeting of scientists, clinicians, policy makers and activists to ignite South Africa’s response to the tuberculosis (TB) epidemic.

The meeting heard about the problems with the epidemic as well as opportunities to improve the country's response to it so that we can reduce new TB cases and improve the cure rate.

Recorded TB deaths tripled between 1997 and 2005 in South Africa. TB is the number one cause of death for people living with HIV. Yet, despite the health crisis posed by TB, the disease is neglected. Political will, access to new drugs and diagnostics and expanded funding will improve the response to TB.

We need bold approaches: new diagnostics like the Gene Xpert must be rolled out –but much more money must be invested in research for highly sensitive and specific point-of-care tests–, HIV co-infected patients should be initiated on antiretroviral treatment, patients with drug-resistant TB should have access to experimental drugs like bedaquiline (formerly TMC207) and delamanid (formerly OPC-67683), there must be routine contact tracing and health facility waiting rooms should have working infection control.

We need a different approach to TB patients. People co-infected with HIV should be treated by the same health-care team for both conditions. As with HIV, treatment literacy must become part of the package of care. The paternalistic Directly Observed Treatment model, in which patients have to take their drugs daily under direct observation of a health worker, interferes excessively in the daily routines of people. It must be phased out and replaced with adherence models similar to those used for HIV.

Community mobilisation is vital. We need a campaign encouraging TB screening, similar to the campaign for HIV testing. By treating people with active TB much earlier, we can reduce the time that people are infectious and therefore also reduce the number of new infections.

As with HIV, there needs to be a TB budget. By developing a budget for TB, government can ensure that the response to the disease is adequately funded and planned. As with HIV, this funding might have to be in the form of a conditional grant.

Miners and former-miners are disproportionately affected by TB. It is critical for the mining industry to improve work and living conditions, including the replacement of hostels with decent housing and lowering dust levels. The mines have to assist with regular check-ups of former miners, because they remain at very high risk of developing lung disease.

The South African National AIDS Council released the first draft of the new National Strategic Plan for HIV and AIDS, STIs and TB (NSP) on the day of the meeting. The deadline for submissions is 7 September. The NSP is an excellent opportunity to turn the recommendations of this meeting into a policy that is implemented and saves millions of lives.

TB: What needs to be done?

1. Expand screening for and diagnosis of TB

By screening more people for TB and diagnosing them quicker and more accurately, we can treat more people, reduce mortality and reduce new TB infections. TB incidence is estimated to be at around 1% of the population, yet active case finding reveals that the figure is closer to 3.5%. (Source: Presentation by Kerrigan McCarthy)

Through the HIV Counselling and Testing (HCT) campaign, more people have been screened for TB. Approximately one million people were found to have TB symptoms. Referral and follow up systems must be strengthened so that people are not lost to follow-up and those diagnosed with active TB are initiated onto treatment.

Tracing contacts of people with TB is an essential intervention. During the 2011 Budget Speech Health Minister Aaron Motsoaledi announced that the Department of Health has begun rolling this out in some areas. This must be urgently expanded to all health facilities that treat TB.

2. Implement the Gene Xpert and invest in better diagnostics

TB diagnostics remain far inferior to diagnostic tools developed for HIV. Today the gold standard for diagnosing TB is to grow it in culture from a patient's sputum. This is a process that takes weeks.

Most TB diagnosis is therefore carried out by looking for TB bacilli in sputum under a microscope. The turnaround time for this is about a day, but it is not accurate. Many people with active TB, especially people with advanced HIV disease, have very few bacilli in sputum and are therefore not diagnosed.

Unlike smear microscopy, the Gene Xpert is able to diagnose both drug susceptible TB and resistance to one of the most important first-line TB drugs, rifampicin. Resistance to rifampicin is highly correlated with resistance to isoniazid in South Africa and therefore with Multi-Drug Resistant (MDR) TB. The Gene Xpert is also able to detect TB in many of the false negatives given by smear microscopy.

The Gene Xpert provides test results in 2 hours. However the planned rollout of the gene xpert is largely at laboratories and not at the health facilities where people with TB present themselves. Slow laboratory turnaround times will continue to delay results. Therefore it is essential to make the Gene Xpert available at or near health facilities, where the patient can receive his or her diagnosis on the same day. This has been done at Ubuntu Clinic in Khayelitsha.

A costing in South Africa demonstrated that placing the Xpert in health facilities will increase the costs by 70%. (Source: G Meyer-Rath) But the test will only realise its true value if it is decentralised. It is therefore essential to put pressure on the manufacturer, CEPHEID, to reduce costs further.

We must rapidly scale-up the Xpert. It is possibly the best available diagnostic tool. However we still need an affordable, rapid, electricity free and point of care TB diagnostic.

Diagnosing TB in infants and young children is very difficult and under-researched. Many children cannot produce a sputum sample. Private care facilities and NGOs generally use a nebuliser (mist machine) to produce a sputum sample from a child. Nebulisers are urgently needed in public health facilities to scale up diagnosis of TB in infants and children. Nebulisers can also help adults to produce sputum.

3. Treat all people with drug resistant (DR) TB and decentralise DR TB care

According to Médecins Sans Frontières, only 20% of cases of drug resistant TB are detected. (Eric Goemare, MSF) Of those diagnosed, we are failing to retain and initiate many of them onto treatment. Beyond that we are aiming to treat far fewer patients than those that are diagnosed. In 2010, nearly 10,000 cases of DR TB were diagnosed but only a little more than 5,000 were started on treatment. By the end of 2011, the Department of Health only aims to treat 6,500 DR TB patients. (Source: Norbert Ndjeka, Department of Health)

Without treatment, most patients with DR TB will die. Delaying treatment also increases the risk of transmitting DR TB. With the rollout of the Gene Xpert, we can predict a large increase in the number of patients diagnosed with DR TB and therefore save many lives.

A further challenge to expanding DR TB treatment is that there is not enough space in clinics to treat all patients. Also, treatment is highly centralised. The Department of Health estimated that as of April 2011, there was a shortage of over 750 beds for DR TB patients. There are 24 DR treatment sites in South Africa with 2,000 beds. It is recommended that an additional 10 beds are made available in each district. (Source: Norbert Ndjeka, Department of Health)

We must urgently scale up DR TB treatment to reach all people in need. The Community Health Worker must be finalised and implemented with enough funds. This will make it possible to trace more contacts of TB patients and treat more DR-TB patients in their homes.

4. Improve access to second-line TB medicines

Treating patients with DR TB is expensive and costs are expected to rise. In South Africa the average cost of treating a MDR TB patient is R1,200 per month during the injectable phase and R900 per month during the continuation phase. For XDR TB patients the prices rise to R6000 per patient per month during the injectable phase and R4000 per month during the continuation phase. (Source: Email Communication, Department of Health)

The shortage of suppliers of active pharmaceutical ingredients and finished DR TB medicines drives up the costs of these medicines and make them vulnerable to shortages.

Kanamycin, the injectable used in South Africa’s standard regimen for MDR TB, provides an example of some of the cost drivers in the TB medicines market. There is currently a worldwide shortage of the medicine as there is only one supplier of the active pharmaceutical ingredient.

A further challenge is delayed regulatory approval of TB medicines. Para-aminosalicylic acid (PAS) is used to treat XDR TB, costing on average of R2,000 per patient per month. The medicine is not yet registered and is being purchased via Section 21 authorisations. The price is expected to drop by around 20% once the medicine is registered but will still remain extremely expensive. (Source: Email communication, Department of Health)

For most DR TB medicines South Africa is paying higher prices than are available through the Green Light Committee, which is the procurement arm of the WHO for DR TB medicines. South Africa should consider procuring medicines at lower prices through this committee. It is vital that government take steps to curb the costs of DR TB treatment.

5. Compassionate access to experimental TB medicines

There are a number of new TB medicines in the pipeline. They need further testing and are not yet ready to be registered. However, patients with MDR and XDR TB have to take treatment for approximately two years and they have a poor prognosis. They should be offered compassionate access to promising experimental medicines if they so choose.

Bedaquiline is the most advanced in clinical trials. It has been in development since at least 2004 and must urgently be made available for compassionate use.

A phase II trial demonstrated that the addition of bedaquiline to MDR treatment regimens resulted in more patients converting much quicker to sputum-negative culture.

Clinicians in South Africa must apply to the Medicines Control Council for Section 21 authorisations to use bedaquiline. These authorisations are already being used to procure PAS, a far less effective and difficult to tolerate medicine.

Without scaled up treatment plans for DR TB, there is little incentive for companies to develop or market DR TB medicines. Governments should set ambitious targets to treat all people with DR TB. Further there is an urgent need for funders to expand funding for the research and development of new TB medicines, in line with the burden of the disease.

6. Scale up infection control measures

On 12 August 2011, Deputy President Kgalema Motlanthe announced that all patients with CD4 counts at or below 350 cells/mm3 will now be eligible for antiretroviral treatment (ART). Expanding ART eligibility is extremely important for reducing new TB infections and we congratulate government on taking this step. However the WHO recommends that all people co-infected with HIV and TB are immediately offered antiretroviral treatment. The Department of Health should consider implementing this measure to improve TB cure rates.

Isoniazid preventative therapy (IPT) is now available in public health facilities for people living with HIV. IPT can reduce a person’s risk of developing active TB from 6 up to 18 months after completion. It is usually taken for 6 months in South Africa, however increasing the duration to 36 months will increase the duration of the preventative benefit.

However, we are concerned that IPT is being implemented in South Africa without the condition that it only be offered to patients who are tuberculin skin test-positive (TST-positive). There is abundant evidence that IPT only benefits such patients. Moreover, it is potentially harmful to give IPT to TST-negative patients. A trial in Botswana demonstrated that IPT can be harmful to people without latent TB. TST negative people given IPT for 36 months had a significantly higher rate of mortality than TST-negative people given IPT for six months.

7. Reduce TB in the mines

Miners are at particularly high risk of developing TB, given their exposure to silica and heavy dust levels, as well as the crowded living conditions that many miners live in.

The risk of contracting TB is 3 to 5 times higher if you have silicosis. The risk of contracting TB is 3 to 5 times higher for people living with HIV. An HIV positive miner with silicosis is 16 times more at risk of developing TB than the rest of the population. (Source: Rodney Ehrlich)

For miners with silicosis or exposed to heavy dust levels, the increased risk of contracting TB is life-long. The high prevalence of TB in the mining population also exposes their families and communities to TB infection.

SANAC must convene a stakeholder summit to look at solutions to the crisis of TB in the mines. All miners should have access to decent lifelong healthcare. Interventions should be scaled up to reduce this group’s risk of contracting TB, sicilosis and HIV.