Tuberculosis is a dreadful disease with a high mortality, and has consistently been a global health concern. India accounts for around 27% of TB cases worldwide – which is the world’s highest country-wise TB burden – thanks in part to its population of 1.3 billion.
In the last decade, the National Tuberculosis Elimination Programme (NTEP), along with the private sector, has successfully found and treated 17.14 million people with TB, including an estimated 1.4 million children. However, the COVID-19 pandemic adversely affected TB care and has threatened to reverse the gains made in reducing India’s burden. Additionally, the growing problem of drug-resistant TB also threatens the progress we have made in basic disease management.
Child unfriendly
TB is curable but treatment is challenging. For drug-sensitive TB, a patient must take the medication for six months, and this is a long period for most people. The treatment also includes three or four drugs that can have side effects and are also difficult to swallow at times.
This is particularly difficult when the patients in question are children, who need to abide by a fixed drug regimen under the NTEP. The size and the taste of the tablet are not child-friendly. The NTEP presently recommends a daily dose of medicines under direct observation for six months, which can be tiring for families as well.
It is not surprising that many paediatric as well as adult TB patients discontinue taking treatment due to its long duration and side effects. Sometimes, they feel better and assume that completing treatment is optional. This puts families and other people who are in close contact with a TB-affected person at risk of infection. Stopping treatment prematurely can also contribute to the TB bacteria becoming drug-resistant.
How can we address this issue? One critical way, especially in countries with a high TB burden like India, is to explore new treatment approaches for TB and to integrate them into national plans.
Shorter regimen
The effort to make TB medicines easier to take is underway worldwide, as well as in India. Recent studies in adults who have TB in their lungs considered using a combination of new drugs and existing ones that are currently used for other diseases. The results of these studies are promising, showing that the length of time patients need to stay on their regimen can be reduced from six months to four months.
The SHINE trial, conducted with 1,200 children from four countries (India, Zambia, Uganda, and South Africa), also found that based on the drugs available with the NTEP, children with non-severe TB can be effectively treated in four months instead of six.
That shortening the duration for TB medication cures the patient faster is transformational and also makes TB programme implementation more feasible.
Both studies had participants from India and their results have been included by the World Health Organization, in its TB treatment guidelines. However, India itself is yet to adopt the revised four-month treatment guidelines. There is, in fact, another study that reported recently that a two-month treatment course could be effective as well.
With a growing political commitment to India’s battle against TB, the Indian government must embrace innovation and new approaches to treating this disease.
As it happens, the identification of safe and effective four-month and two-month regimens is the first significant advance in treating the most common form of TB in almost 40 years, and is a monumental achievement. It is also encouraging that more than 30 new chemical compounds that can fight the TB bacterium are in the pipeline.
Eliminating TB
At this time, it is up to researchers to identify the best combinations of these new drugs that are highly efficacious, the least toxic, and can be easily implemented in programmatic settings.
For this kind of research, a highly concerted effort needs to take place that involves both global and local researchers, funders, and regulatory authorities, with firm national and international political support.
Costs are a determining factor but they can be mitigated as well. Global experience in costing has shown that the prices of newer drugs come down when there is political will and when community charters, funders, and the leaders of national programmes negotiate prices with drug manufacturers. Lower costs can in turn motivate the global adoption of newer, shorter-duration, and less toxic drug combinations for diseases like TB.
India’s aim to eliminate TB by 2025 is ambitious. The theme for World Tuberculosis Day (March 24) in 2023 was “Yes, we can end TB”, which reflects the worldwide desire to eliminate the disease by 2030.
To (re)invigorate this fight, and to align with the vision of being ‘TB Free’ ahead of the global target, India must consider active screening and case detection along with new guidelines for shorter TB treatment. Policymakers must also consider moving to a shorter treatment course for treating TB at the earliest. If we delay, we stand to lose the fight as well as millions of lives to an ultimately curable disease.
Vidya Mave, MD, MPH is director of Centre for Infectious Diseases in India and B.J. Government Medical College-Johns Hopkins University Clinical Research Centre, Pune. Aarti Kinikar, MD, is professor and head of Department of Paediatrics, B.J. Government Medical College and Sassoon General Hospital, Pune. Sanjay Gaikwad, MD is professor and head of Department of Pulmonary Medicine, B.J. Government Medical College and Sassoon General Hospital, Pune. The views expressed are the authors’ own.
