Hope for patients as MDR-TB proves effective

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Lahja Nashuuta & Sharon Kavhu

Windhoek – The global community has been called to scale up the fight against tuberculosis (TB), with the deadline to curb deaths caused by the lung disease by 75% just on the horizon.

This clarion call was made during the World TB Day that was marked worldwide on Saturday, March 24 under the theme - ‘It’s time’.

The 2019 theme puts the accent on the urgency to act on the commitments made by global leaders, among others, to scale up access to prevention and treatment; build accountability; ensure sufficient and sustainable financing, including for research; promote an end to stigma and discrimination, and promote an equitable, rights-based and people-centred TB response.

In a statement released on Sunday, as part of International TB Day, UNAIDS called on the global community to step up efforts to meet the 2020 target of reducing TB deaths among people living with HIV by 75%, as outlined in the 2016 United Nations Political Declaration on Ending AIDS.

The day is commemorated annually to raise public awareness on the devastating health, social and economic consequences of TB, and to step up efforts to end the global TB epidemic, according to the World Health Organisation.

March 24, marks the day in 1882 when Dr Robert Koch announced that he had discovered the bacterium that causes TB, which opened the way towards diagnosing and curing this disease.

According to the WHO, tuberculosis remains the world’s deadliest infectious killer. Each day, nearly 4,500 people lose their lives to TB and close to 30,000 people fall ill with this preventable and curable disease.

The health organisation noted that global efforts to combat TB have saved an estimated 54 million lives since 2000 and reduced the TB mortality rate by 42%. To accelerate the TB response in countries to reach targets – Heads of State committed to ending TB at the first UN High-Level Meeting in September 2018, WHO said.

Several achievements have been recorded in the fight against TB. In its 2018 edition of the global TB report released in September 2018, WHO said so far only five low- and middle-income countries have achieved or exceeded the target of a 75% reduction in TB deaths among people living with HIV, three years ahead of schedule.

However, most countries are off the track and that deaths are rising in some regions and countries.

Among the countries that exceeded the target are India (84%), Eritrea (83%), Djibouti (78%), Malawi (78%) and Togo (75%) while 18 countries have reduced TB deaths among people living with HIV by more than 50% and are on track to achieve the target by the end of 2020.

TB deaths among people living with HIV have fallen by 42% since 2010 from 520,000 down to 300,000 in 2017. TB remains the leading cause of death among people living with HIV, causing one in three AIDS-related deaths.

In the same report, WHO also commended seven SADC countries for an impressive decline in TB cases and progress made towards meeting the target.

It reported that eSwatini, Lesotho, Namibia, South Africa, Zambia and Zimbabwe have recorded the highest TB reduction rates ranging between 4 and 8% per year while the rest of African countries are still below 4%.

This was attributed to intensified efforts made to reduce the burden of TB and scrutiny of progress from the highest political levels that include the expansion of TB and HIV prevention and care.

Pinehas Iipinge, the advocacy communication and social mobilisation officer of the National Tuberculosis and Leprosy Programme in the Ministry of Health and Social Services in Namibia, has confirmed that TB infections are on the decline and successful treatment cases are on the increase.

He said TB and leprosy are no longer a public health threat in Namibia. Iipinge said between 2010 and 2017, Namibia recorded a reduction of 25% from 2010, when 12,000 cases were reported, to 9,000 cases. The coverage of HIV counselling and testing for TB patients continued to improve, he added.

UNAIDS stressed that countries need to screen all people living with HIV for TB and all people with TB need to be tested for HIV. The quality of TB and HIV diagnosis also needs to be improved.

HIV and TB prevention efforts need scaling up, particularly for people at higher risk of infection. In addition, all people diagnosed with TB and HIV need immediate access to treatment and support to adhere to their treatment regimens.

“I cannot stress enough how critical it is to integrate TB and HIV services so that people can be screened, tested, treated and offered prevention for both diseases, ideally under the same roof, by the same health worker and on the same day. This is an approach that we know saves lives,” said Michel Sidibé, Executive Director of UNAIDS.

According to Sidibé “TB should be a disease of the past. It has been treatable and preventable for decades. Years of neglecting the rights of the world’s poor to basic health care, food and shelter have let TB take hold and allowed resistance to build. People living with HIV are especially at risk. There is still a chance for many countries to meet the target, but we have to act now―it’s time to end TB and AIDS.”

Meanwhile, there is hope for Multi-Drug Resistant Tuberculosis (MDR-TB) treatment as STREAM clinical trial stage 1 has proven that a nine-month treatment regimen is as effective as the 20-month regimen.

STREAM clinical trial is the world’s first multi-country randomised phase III clinical trial to test the efficacy, safety and economic impact of shortened MDR-TB treatment regimens.

The development comes at a time where the 20-month regimen, which is costly and characterised with challenges, is being used in several southern African countries. 

Challenges of the long regimen include treatment default due to the long period, nausea, body aches, deafness, psychosis and rashes, to mention just a few. Due to these side effects of the long regimen, the Word Health Organisation (WHO) in 2016 recommended a regimen of less than 12 months.

MDR-TB is a form of TB infection caused by bacteria that are resistant to treatment with at least two of the most powerful first-line drugs (Isoniazid and Rifampin).

The STREAM clinical trial, which was initiated by the International Union Against TB and Lung Diseases (The Union), funded by United States Agency for International Development (USAID) and Vital Strategies, has raised hope for a cure.

Outcomes of the trial, which was released on March 14, 2019, showed that a 9 to 11-month treatment regimen is as effective in treating MDR-TB when given under trial conditions, as the 20 to 24-month treatment regimen recommended in 2011 WHO guidelines.

Results of STREAM trial also show that the 9 to 11-month regimen was statistically non-inferior to the 20 to 24-month regimen, in terms of efficacy. According to the outcome, 78.8% of assessable participants had a favourable outcome, compared to 79.8% in the longer regimen.

While many people have been concerned about the shorter regimen treatment in HIV and MDR-TB co-infected patients, the STREAM trial results show that there was no difference in terms of efficacy between HIV negative and positive people. The treatment works efficiently despite the HIV status.

According to The Union, Stage 1 of the STREAM trial looked to determine whether a 9 to 11-month treatment regimen that demonstrated cure rates exceeding 85% during a pilot programme in Bangladesh is as effective as the longer regimen under clinical trial conditions.

In a statement, Dr Paula I Fujiwara, Scientific Director at The Union, said the shorter regimen is a clear advantage to MDR-TB patients, as it increases the likelihood of completing the treatment, with an earlier return of the patient to work and do social activities.

“The STREAM Stage 1 results come at a time when TB science is progressing quickly; we are very keen to keep this momentum going. There is still a very real and urgent need to improve the efficacy and safety of MDR-TB treatment and trials like STREAM and STREAM Stage 2, as well as other ongoing trials, are a vital part of this work,” she said.

The outcomes of STREAM clinical results will be useful for countries and programmes to decide whether and how to introduce shorter regimens for treatment of MDR-TB.

USAID’s Deputy Assistant Administrator in Global Health Bureau, said, “USAID is proud to have supported the STREAM study, the first randomised clinical trial for MDR-TB. This study has already served as a benchmark for other MDR-TB clinical trials and as a result, there are now more MDR-TB treatment regimens being studied than ever. In addition, data from this study, combined with data from observational studies, have demonstrated that shorter, less toxic, effective, and well-tolerated treatment regimens are now feasible.”

 

 

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