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SA to expedite TB diagnosis/treatment as cases continue to soar

Over the next five years, the national Department of Health plans to initiate a system that supports potential tuberculosis patients from the moment they come into contact with a health provider – public, private or traditional – to know their test results and link them to help, all within a week, and will also introduce a shorter treatment regime for children with non-severe TB.

This was the pledge from Deputy Minister of Health Dr Sibongiseni Dhlomo during his keynote address at the opening plenary of the Seventh SA TB Conference held in Durban last week, reports News24.

Dhlomo said according to the World Health Organisation (WHO), more than 1m South Africans have succumbed to TB, which is preventable and curable, and that between 2020 and 2021, more than 110 000 people in this country died from the disease.

“South Africa is one of the high-burden countries for TB, HIV-associated TB and drug-resistant TB,” he said. “Yet year after year, we look at statistics and somehow, we have become immune to this reality. Behind these numbers are human individuals, families and communities facing unthinkable tragedies, afflicted by a disease that is preventable and curable. And, yet every year, we again come to forums like these, talk about incremental progress, and go back to our comfortable worlds.”

The Deputy Minister said the pandemic had exacerbated TB within the first six months of the lockdown.

“As a clinician, I can also tell you we cannot address a disease unless we sufficiently understand its epidemiology and have data to effectively combat it. A basic question to start with is why does the disease continue unabated, despite the remarkable biomedical progress we have made in the past decades? It is well known that TB is a by-product of poverty.”

Over the next few years, he added: “We will work toward a system that provides better care, through shorter regimens and tailored support in facilities and communities. We will work toward a system that values prevention as much as treatment and supports the people on the frontlines.”

Dhlomo said there were some new interventions and exciting developments. “For example, expanded screening activities with TB Check, as well digital chest X-ray for TB screening. Using SMS to provide patients with their TB results is also being introduced to link people to care faster and save them the trouble and cost of returning to the clinic when unnecessary.”

He added that government was planning to introduce more patient-friendly treatment regimens to help improve retention in care – including a new four-month regimen for children and a new six-month regimen for drug-resistant TB.

The country’s TB testing numbers have recovered from dramatic COVID-19-related declines in 2020, but while the recovery in TB testing numbers is a step in the right direction, speakers at the conference left little doubt as to the scale of the challenges facing South Africa’s TB response. Even before COVID-19-related disruptions, the country had some of the world’s highest TB rates, writes Tiyese Jeranji in Spotlight.

Dr Harry Moultrie, senior medical epidemiologist for geospatial modelling at the National Institute of Communicable Diseases, presented data showing how TB testing numbers (using the GeneXpert molecular test) were way below forecasted levels from April to August 2020, then within the forecasted bounds from September 2020 to November 2021, and have exceeded the upper bounds of forecasts since December 2021.

From April to August 2020, 448 000 fewer tests were done than anticipated and 25 400 fewer positive tests were recorded than expected.

Moultrie said there were substantial differences in testing between provinces, districts, and sub-districts and that the increase in testing volumes in 2022 was largely driven by women aged 25 to 44. In 2022, the percentage testing positive in men is roughly double that of women.

The Eastern Cape’s Nelson Mandela Bay Metro had the highest test positivity rate (>16%) of all districts. Bar the Overberg District, all Western Cape districts had test positivity rates from 14% to 16%, along with Mangaung in the Free State which was also in this percentage bracket.

The lowest test positivity rates were in KwaZulu-Natal’s uMzinyathi District (Dundee), Zululand, and uMkanyakude District in the north-east where between 0% and 2% of tests were positive.

In the future, said Moultrie, locally targeted interventions would be needed guide the TB programme.

Interestingly, as testing volumes have recovered, there hasn’t yet been a rebound in either the number of positive tests or test positivity above predicted levels. Though there is no definitive explanation for this, Moultrie suggested several possible theories – such as it simply being too soon to see a rebound, non-pharmaceutical interventions potentially having reduced community transmission of TB, and the impact of certain policy changes (recent changes in testing strategy).

The bigger picture

Away from the TB testing numbers, the news is less good.

Dr Norbert Ndjeka, chief director of TB control and management at the national Department of Health, presented data showing that in 2020, SA was underperforming on three key indicators in the WHO’s End TB Strategy (2035).

The TB incidence rate dropped by 11% from 2015 to 2020 (the WHO’s target was 20%), so South Africa is only about halfway there. TB deaths have decreased by 9.2% (the WHO’s 2020 target was 35%), and 47% of TB patients faced catastrophic costs in accessing medication (the WHO’s 2020 target was 0%). Though TB medicines are free in the public sector, patients face other costs, like the cost of transport to healthcare facilities.

Ndjeka said to reduce TB incidence and deaths, the country needs to improve TB testing and linkage to care. Finding people with undiagnosed TB was crucial. “We are not finding the people we should be finding,” he said.

“We need to be testing regardless of symptoms. We are struggling to find people with TB, to link them and retain them in care. We need look at how many we missed, [and] what if we had found them, and treat[ed] them. We need to find them all.”

This underlines the Health Department’s ‘targeted universal testing (TUT) strategy by which TB tests are now offered to people living with HIV, those who recently had TB, and close contacts of people with TB, irrespective of whether or not they have any TB symptoms. Ndjeka said such tests should be offered annually.

He presented a list of TB testing and screening targets forming part of the government’s TB recovery plan – which in addition to the molecular testing used in TUT programmes also includes targets for X-ray screening and testing of immunocompromised people living with HIV with a urine test (urinary LAM).

The department set itself a quarterly target of 740 831 TB tests (using GeneXpert). In Quarter 1 (between January and March this year), they achieved 82% (610 378) of this target. In the second quarter (April to June), they showed a slight improvement, with 86% of the quarterly target reached.

The quarterly target for urinary LAM tests was set at 14 059 but they only managed 69% (9 634) in the first quarter. In the second quarter, they over-performed with a figure of 128%, managing 18 054 LAM tests.

The quarterly target for digital X-ray screenings was set at 75 000 but by the first quarter, they only managed 38% and also 38% for the second quarter. The department also set itself the target of 250 000 screenings conducted on TB HealthCheck each quarter but only managed 2% in the first quarter and 3% in the second quarter.

Not ‘business as usual’

Delegates also heard that SA last published comprehensive guidelines for the management of childhood TB in 2013 and these needed to be updated.

At the event, the country’s national TB Think Tank – a network of experts working with government on the national TB response – launched a paediatric, adolescent, and maternal TB working group, announced by the Desmond Tutu TB Centre’s Dr Karen du Preez, writes Catherine Tomlinson for Spotlight.

Professor Anneke Hesseling, director of the Desmond Tutu TB Centre at the Department of Paediatrics and Child Health at Stellenbosch University, said, “The SA TB Think Tank will now have a dedicated group integrated with the [other working groups] to address specifically the needs of kids, adolescents, and pregnant women who often get neglected in research, policy and implementation.”

In tackling the update of the national guidelines for managing childhood TB, the new Think Tank working group and the Desmond Tutu TB Centre will, with with the Department of Health, take a modular approach – as done by the WHO.

The first priority will be updating paediatric treatment guidelines to reflect new scientific advancements, focusing on incorporating evidence from the recent SHINE trial, in support of using shorter treatment regimens in children with non-severe TB.

The SHINE trial compared the efficacy and safety of a shorter, four-month treatment regimen for drug-susceptible TB with the six-month standard of care regimen in children with non-severe, smear-negative pulmonary TB in South Africa, Zambia, Uganda, and India.

Taking account of evidence from SHINE, the WHO published new recommendations for treatment of TB in children in March, recommending the four-month treatment regimens in children with non-severe TB.

Why shorter TB treatment is important for kids

Around two-thirds of children with TB have non-severe TB and can benefit from a shorter treatment regimen. “The whole idea was that kids, in general, don’t have a lot of bugs on board… so if there are fewer bugs to kill, perhaps they need less aggressive treatment,” said Hesseling.

The shorter treatment has important benefits for children and their caregivers.

Wieda Human from TB Proof, an advocacy organisation, said, “It remains difficult to give medication to children, especially if multiple tablets are taken over a prolonged period of time.”

“A shorter, more child-friendly regimen makes it easier for children to stick to and complete treatment with a lower likelihood of drug toxicity.”

While fixed-dose combinations that combine multiple TB medicines into a single tablet were used in the SHINE trial, the delayed registration of fixed-dose combinations of drug-susceptible TB medicines in child-appropriate doses by the South African Health Products Authority (SAHPRA) has blocked their use in the public sector.

That has now been resolved. The Health Department issued a circular in June 2021 announcing the registration of fixed-dose combinations of first-line TB medicines for infants and children and providing guidance on their use.

How will children eligible for shorter treatment regimens be identified?

Diagnostic tools for TB include laboratory and clinic-based tests to confirm the presence of TB bacteria in patient samples (typically sputum, but also in urine and stool samples). Young children, however, often have difficulty coughing up a sputum sample.

Most children with TB test smear-negative, meaning TB is not detected in their sputum sample when using standard diagnostic tests.

When the results of diagnostic testing are negative but TB remains suspected, when a sputum sample cannot be collected, or when diagnostic tests are unavailable, clinical assessments can be used to diagnose TB in children, advises the WHO.

The new operational handbook published by the WHO provides guidance on how to clinically diagnose TB in children in the absence of a positive diagnostic result – with or without a chest X-ray.

When available, chest X-ray images can aid diagnosis of TB in infants and children, and also provide insight into the severity of disease.

In March, the International Union Against TB and Lung Disease (the Union) published a guide for chest X-rays in diagnosing TB in children, produced by researchers at Desmond Tutu TB Centre, Department of Paediatrics and Child Health, and Faculty of Medicine and Health Science at Stellenbosch University led by Dr Megan Palmer.

“South Africa is quite well resourced, but we have many different scenarios. If you are sitting in a rural clinic in the Eastern Cape versus sitting in Khayelitsha in Cape Town, you might have access to an X-ray or not, you might be able to do a sputum sample or not. So it’s important to ensure guidelines consider the local context,” says Hesseling.

“But the bottom line is if a child is sick, has been investigated with what you have, it’s fine to start TB treatment based on clinical grounds, once you have excluded other obvious pathology. Clinical follow-up remains critically important to verify the diagnosis and to evaluate treatment response. If children don’t get better on TB treatment, then you should think of something else.”

TB guidelines WHO

 

News24 article – More than 110 000 South Africans died from TB between 2020 and 2021 (Open access)

 

Spotlight article – TB treatment to be shortened to 4 months for most kids (Creative Commons Licence)

 

Spotlight article – As testing volumes improve, government outlines TB recovery plan (Creative Commons Licence)

 

See more from MedicalBrief archives:

 

Shorter, simpler DR-TB regimen in the pipeline for South Africa

 

More than half of South Africans do not seek TB treatment – HSRC survey

 

When three epidemics collide: TB, HIV and COVID-19 in South Africa

 

Encouraging results from South African TB vaccination trial

 

 

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