South Africa's 'bold' announcement that all drug-resistant tuberculosis (DR-TB) patients will be eligible to receive the new medicine, bedaquiline, move may influence the World Health Organisation to revise its own guidelines. Based on research findings, the DoH will also be cutting the DR-TB treatment duration to just nine months.
“The Department of Health’s (DoH’s) commitment on bedaquiline is momentous globally and marks a new era of DR-TB management where we are really prioritising the patient,” Médecins Sans Frontières' (MSF's) Dr Anja Reuters is quoted in Health-e News as saying.
Up until recently treating patients with DR-TB has been “difficult, with old medicines used, which had many negative side effects and over long periods – often up to 24 months”, noted the DoH. Even if patients take their full course of toxic medicines they have little chance of being cured and risk long-term disability, including permanent deafness.
The report says the World Health Organisation (WHO) recommends the drug, manufactured by Johnson & Johnson, for all XDR-TB patients, but it does not yet do the same for people with multi-drug resistant TB (MDR-TB). MDR-TB is resistant to two of the most common anti-TB drugs and XDR-TB is resistant to four – leaving very few effective drugs available.
For the first time, no patient will have to receive the injectable drugs that cause hearing loss in up to 60% of users, as they will be completely replaced by bedaquiline. “It will have a huge impact in terms of decreasing disability,” said Reuters. “Deafness for a child, for example, can prevent the development of speech and lead to social isolation and bullying.”
In an open letter to health minister Dr Aaron Motsoaledi local organisation TB Proof wrote: “We are ecstatic that no South African with this terrible disease will have to ‘choose’ between their hearing or their life again.”
And, according to Reuters, the country’s “bold” move may influence the WHO to shift its current “conservative” stance and revise their guidelines in line with our own.
In addition to announcing an all-access policy towards bedaquiline the DoH said that it would be cutting the DR-TB treatment duration to just nine months – in line with new and ongoing research.
“This is an evidence-based decision. This is a person-centred decision. It is visionary and courageous and marks a fundamental shift in how leaders and policy makers engage with people who have TB,” wrote TB Proof.
In 2012 less than one in 10 South African XDR-TB patients were cured. Three years later this figure more than doubled, according to new data revealed to Health-e News by the head of DR-TB at the Health Department Dr Norbert Ndjeka. “In 2015, 51% of XDR-TB patients were successfully treated, in other words cured,” said Ndjeka, speaking from the 5th SA TB Conference. In 2012, half of XDR-TB patients died, despite having access to treatment. In 2015 the death rate fell to 27%.
The report says most, including Ndjeka, attribute this dramatic improvement to the introduction of one of only two new anti-TB drugs developed in the last 50 years: bedaquiline.
DR-TB comes in two forms. Multi-drug resistant TB (MDR-TB) is resistant to two of the most common anti-TB drugs and XDR-TB is resistant to four – leaving very few drugs available. DR-TB treatment has traditionally equated to taking a cocktail of old and toxic drugs for about two years. The side-effects of this treatment are often debilitating, for example deafness, but even if patients take all their pills religiously they have a very slim chance of being cured.
In 2013, South Africa made “a bold and innovative move” to introduce a brand-new drug into the TB programme, according to Dr Francesca Conradie, a DR-TB expert from the Southern African HIV Clinicians Society. It was bold, she said, because bedaquiline’s manufacturer Janssen Pharmaceuticals had not completed the usually-required years of rigorous safety and efficacy testing. Early trials had shown promising results but health experts had safety concerns.
But because, with so few effective drugs available, patients were dying, the Health Department made the decision to introduce it to a small number of patients as part of a compassionate access programme. In 2014, access was rapidly scaled up and now two thirds of people receiving bedaquiline are in South Africa.
According to the WHO’s 2017 Global TB Report, only 27% of XDR-TB patients on treatment were cured. But, as shown in the new Department of Health data, more than half of South Africans with the same disease are cured.
The report says the chances of being cured of MDR-TB are usually higher, at around 50%. But for the first time in South Africa and the world, said Ndjeka, patients with MDR-TB and XDR-TB have similar chances of survival. This is because people with XDR-TB in South Africa are automatically given bedaquiline as soon as they start treatment, while MDR-TB patients only have access to the medicine if doctors find out that their drug regimen is causing serious side-effects.
Although initial trial results for bedaquiline showed promise, the new data from South Africa provides concrete evidence to the world that this drug is essential and saves lives, according to Conradie. But, asks the report, why, then, does South Africa, a developing country, have more access to this drug than other more wealthy nations? Conradie and Ndjeka said it comes down to political commitment, specifically the commitment of Motsoaledi.
Although Motsoaledi has come under fire in the past few weeks amid reports of the disastrous state of the country’s public health system, many of those in the TB field are quick to point out his contribution in putting this often-ignored disease on the global agenda.
“The reason other countries with DR-TB epidemics haven’t introduced bedaquiline in the same way we have simply comes down to a lack of political commitment,” said Conradie. “The South African government has put their money where mouth is and the result is we have much fewer people dying of DR-TB.”
This is why most see the scheduled UN High-Level Meeting on TB, taking place in New York in September, as a “momentous” opportunity to finally end TB as a public health threat.
MSF’ Julia Hill said that much of the progress achieved in tackling HIV can be attributed to the results of a similar UN meeting held on Aids, after which “HIV was seriously recognised as a global threat and heads of state started to take it seriously”.
Motsoaledi was in fact the person who initially suggested and then advocated, successfully, for a similar meeting to be held on TB. “Many people don’t regard TB as a threat and a problem. TB is a very silent killer. It doesn’t kill dramatically,” Motsoaledi is quoted in the report as saying. “But it is the number one infectious disease killer on the planet and also in South Africa but it does not make people afraid in the same way as Ebola or HIV for example, and this is our challenge,” he said.
He said that one of his priorities at the September meeting will be pushing for increased access to bedaquiline in every country where DR-TB exists. “I’ve been singing this song again and again. People ask whether new drugs like bedaquiline are affordable. If one person with TB on average infects 14 others, I ask: can we afford not to invest in life-saving drugs? This is the question I’m going to take to the UN,” he said. “We believe something very significant will happen around bedaquiline in September.”
Said Motsoaledi: “We have not been able to beat TB for centuries. But with these encouraging results and the meeting in New York in September, we believe that we might just be the generation to end this silent, but very effective killer.”
[link url="https://www.health-e.org.za/2018/06/19/sa-first-country-to-break-all-barriers-to-blockbuster-tb-drug/"]Health-e News report[/link]
[link url="https://www.health-e.org.za/2018/06/18/sa-results-on-blockbuster-tb-drug-a-breakthrough-for-the-world/"]Health-e News report[/link]