India to roll out new treatment regimen for drug-resistant TB

Context: Tuberculosis (TB) is a silent crisis that impacts the physical as well as mental health of millions of people in India. India needs to scale up investment and formulate new strategies to meet its goal of Tuberculosis eradication by 2025.

Tuberculosis (TB)

• TB is an airborne communicable disease caused by the bacteria Mycobacterium tuberculosis.
  • Typically, the bacteria grow in the body where oxygen and blood are in high amounts. 
  • As a result, 80% of TB cases are pulmonary which infect the lungs and 20% of cases are extra-pulmonary which infect the brain, uterus, stomach, mouth, kidneys and bones.
• Mode of transmission: Airborne- through coughing, sneezing or spitting.
• High-risk groups: People with weak immunity like those infected with HIV, Under-nutrition, Diabetes, Smoking and Alcohol consumption.

​​Present Status of TB:

• India tops the list of 20 TB high-burden countries in the world. India accounts for 27% of the total TB patients in the world. In 2022, 2.42 million Indians were diagnosed with tuberculosis. 
• Target for TB elimination:
  • The United Nations’ Sustainable Development Goals has a target to ending the TB epidemic by 2030. 
  • India aims to eliminate TB in the country by 2025.
• WHO has acknowledged India’s success on two major fronts:
  • In reducing TB incidence by 16% from 2015 to 2022 (close to double the pace at which global TB incidence is declining).
  • In reducing TB mortality by 18% during the same period, keeping in line with the global trend.

Read also: Global Tuberculosis Report 2023

Prevention and Treatment:

• Prevention:
  • BCG vaccine for children. 
  • Currently no effective vaccine for adults.
• Diagnosis:
  • Early diagnosis is extremely important in fighting TB. 
  • Widely followed diagnosis methods include- Sputum smear microscopy which studies the phenotype of the pathogen from the sputum sample of infected patients.
• Treatment: 
  • Strategy: DOTS strategy (Directly Observed Treatment Short Course) is a WHO-recommended cost-effective strategy to reduce the disease burden of TB. 
  • Antibiotics: Administering commonly used antibiotics like rifampin.
• Challenge: Mycobacterium tuberculosis has developed drug resistance.

Existing challenges associated with TB: 

• High-prevalence of TB: The reasons include-
  • ​​Lack of widespread awareness about the disease, lack of access to quality care, under-reportion of cases.
    • The National TB Prevalence Survey (in India) found that 64% of people with infectious TB did not seek care. This results in under-reporting of TB incidences and hence, widespread TB prevalence. 
  • Excessive focus on affected patients only, while ignoring the ‘potential’ patient who might be in contact with the patients. 
• Non-compliance to Follow-up period: Premature treatment cessation fosters the development of drug-resistant strains like multi-drug resistant TB (MDR-TB) and extensively drug resistant TB (XDR-TB). 
• Mental Health crisis: TB is associated with a deep stigma, and those affected are still ostracised and mistreated by families, communities, and even the health system. All of this has a significant impact on their mental health. 
• Gendered issue: There is a significant difference in how males, females and transgenders receive such health care services. Females and transgenders have greater risk of discontinuing treatments, facing greater stigma from society and apathy of healthcare systems. 
• Re-lapse of TB: The healthcare crisis during the COVID-19 pandemic has reversed the previous gains and increased the TB burden. 

Efforts towards eradicating TB: 

Global initiatives:

• End TB Strategy: Global strategy developed by WHO that aims to reduce TB deaths by 90% and to cut new cases by 80% by 2030..
• Global Fund to Fight AIDS, TB and Malaria (2003): Single largest channel of additional money for global TB control.
• Stop TB Partnership: Global partnership of organisations, governments, and individuals working to eliminate TB advocating political commitment & technical assistance. 

India’s Initiatives:

• National TB Elimination Programme (NTEP):
  • Adopted in 1997 after WHO declared TB as a global epidemic in 1993. 
  • Previously known as the Revised National Tuberculosis Control Programme or RNTCP.
  • RNTCP focuses on Early Diagnosis and Treatment in accordance with DOTS strategy. 
  • Under RNTCP about 4 lakh DOTS centres have been established so far. Patients are supported with free diagnostics and medicines.

NTEP implements key activities as under:

-State and District Specific Strategic plan for targeted interventions in high-burden areas.
-Provision of free drugs and diagnostics to TB patients including for drug-resistant TB.
-Active TB case-finding campaign in key vulnerable and co-morbid populations.
-Integration with Ayushman Bharat - Health & Wellness Centres to decentralise screening and treatment services closer to the community.
-Private sector engagement including incentives for notification and management of TB cases.
-Scale-up of molecular diagnostic laboratories to sub-district levels.
-Intensified IEC campaigns to reduce stigma, raise community awareness and improve health-seeking behaviour.
-Multi-sectoral response with involvement of line ministries.
-Scale up TB preventive therapy to contacts of pulmonary TB.
-Tracking of notified TB cases through a case-based web-based portal namely Ni-kshay. Nikshay Portal [Ni-Kshay-(Ni=End, Kshay=TB)] is the web enabled patient management system for TB control under the National Tuberculosis Elimination Programme (NTEP).
-Ni-kshay Poshan Yojana for nutritional support to TB patients. It has been implemented from April 2018, wherein 500 rupees per month is being provided to All TB patients towards nutritional support for the duration of their treatment.

• National Strategic Plan for TB Elimination 2017-2025:
  • Adopted in 2018 in line with the TB Elimination Strategy of the WHO and SDG of the UN. (India has set ambitious targets for reducing TB incidence, prevalence and mortality rates by 2025).
  • Includes 4 strategic pillars: "Detect – Treat – Prevent – Build".
  • Specific targets include:
    • 80% reduction in TB incidence 
    • 90% reduction in TB mortality 
    • 0% patients having catastrophic expenditure due to TB. 
• Pradhan Mantri TB Mukt Bharat Abhiyan:
  • Launched in September 2022 where the community is encouraged to adopt TB patients and support them.
  • Support can be provided in the form of nutritional support, nutritional supplements, additional investigations, and vocational support for a minimum period of six months or maximum period of up to three years. 
• Establishment of Centres of Excellence:
  • Facilitates collaboration between Indian Council of Medical Research laboratories and the private sector to strengthen and expand research and development efforts for TB.

 Way Forward:

• Prioritise TB vaccine trials: Bacille Calmette-Guérin (BCG) vaccine for TB does not adequately protect adolescents and adults who are at the highest risk for developing and spreading TB. Streamline clinical trials for over 15 TB vaccine candidates in the pipeline.
• Leveraging technology and innovation:
  • Diagnosing TB needs to become more accessible and affordable: E.g.,
    • New innovations such as nasal and tongue swab-based tests for TB can reduce diagnostic delays. E.g., Scaling up Nucleic Acid Amplification Test (NAAT) coverage. 
    • Handheld digital X-ray machines (with artificial intelligence-based software) can offer mobility to test risk-risk individuals in villages.
  • Develop new therapeutic models: Invest more in drug discovery, introduction and development of new therapeutic molecules which have short time-periods.
  • Adoption of AI and digital health solutions for TB diagnosis, adherence and surveillance.  
• Regulatory frameworks: Need to create regulatory and policy frameworks for strict enforcement of drug control and non-compliance with treatment regimens to tackle antibiotic resistance.
• Address socio-economic determinants of TB: Multi-sectoral approach is needed like poverty alleviation, improvement in nutritional status, well-ventilated housing and better air quality.

Nucleic Acid Amplification Test (NAAT):Nucleic Acid Amplification Tests (NAATs) are molecular diagnostic tests that detect the presence of specific genetic material (DNA or RNA) from pathogens such as bacteria and viruses. It is a powerful tool for diagnosing a wide range of infections, including, COVID-19, influenza, HIV, hepatitis, tuberculosis etc. In case of TB, NAAT is used to detect the DNA of Mycobacterium tuberculosis complex (MTBC) in a sputum or other respiratory sample. How does NAAT work? Sample Collection: A sample is collected from the patient, such as a swab from the nose or throat, blood, or urine. Extraction: The nucleic acid (DNA or RNA) is extracted from the sample. Amplification: The target nucleic acid sequence is multiplied (amplified) millions of times using specific techniques like Polymerase Chain Reaction (PCR). Detection: The amplified nucleic acid is detected and identified, confirming the presence of the target organism.