TUBERCULOSIS – SCI & TECH

News: Will generic supply of bedaquiline be accessible?

 

What's in the news?

       Bedaquiline has now become the cornerstone to cure drug-resistant tuberculosis (DR-TB).

 

Key takeaways:

       Last week, a major barrier for drug resistant TB care ended, when Johnson & Johnson’s patent on bedaquiline expired.

       This long-awaited expiry will allow generic manufacturers to supply the drug, but J&J appears intent on maintaining its monopoly over the bedaquiline market.

 

Tuberculosis:

Backdrop:

       Worldwide, tuberculosis (TB) has surpassed HIV-AIDS as the leading cause of death due to infectious diseases.

       India had a little less than 20 percent of the world’s population, but had more than 25 percent of the total TB patients of the world.

       India, the TB capital of the world, the disease kills 1,400 persons every day.

 

Infection:

       Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis.

       TB commonly affects the lungs (pulmonary TB) but can also affect other parts (extrapulmonary TB).

       Pulmonary tuberculosis is a chronic consumptive disease, but it can be present as acute pneumonia.

       Pneumonia is an inflammatory condition of the lung affecting primarily the microscopic air sacs known as alveoli.

       Tuberculosis spreads from person to person through the air, when people who are infected with TB infection cough, sneeze or otherwise transmit respiratory fluids through the air.

       Most infections do not have symptoms, known as latent tuberculosis.

       About 10% of latent infections eventually progresses to active disease which, if left untreated, kills about half of those infected.

       HIV infection, diabetes, undernutrition, lung damage due to pollution, tobacco smoking, fall in immune functions due to chronic diseases, alcoholism, etc. were the main trigger causes behind it.

 

What is drug-resistant TB?

       As of 2017, India accounted for around one-fourth of the world’s burden of multi-drug-resistant (MDR) TB and of extensively-drug-resistant (XDR) TB.

 

MDR TB:

       MDR TB resists treatment by at least isoniazid and rifampicin, the two frontline drugs in TB treatment.

 

XDR TB:

       XDR TB resists these two drugs as well as fluoroquinolones and any second-line injectable drug.

       XDR TB is rarer than MDR TB - there were 1,24,000 cases of the latter in India (2021) versus 2,650 cases of the former (2019).

 

Concerns in India:

       TB incidence in India has been on the decline, but MDR TB and XDR TB endanger initiatives to locally eradicate the disease.

       During the COVID-19 pandemic, there were indications that TB treatment was hit by disrupted supply chains, availability of healthcare workers for non-pandemic work, and access to drug-distribution centres.

       A peer-reviewed 2020 study reported that TB becomes isoniazid-resistant when a person doesn’t fully adhere to the treatment regimen whereas rifampicin-resistance emerges due to other factors.

       It also found that the incidence of MDR TB (i.e. resistance to both drugs) was “strongly correlated with treatment failure and spread through contact, and not to treatment compliance”.

 

How is drug-resistant TB treated?

       TB is an infection of the bacterium Mycobacterium tuberculosis in the lungs, but often in other organs as well. It can be treated by strictly adhering to the doses and frequencies of drugs prescribed by a physician.

       Drug-resistant TB is harder to treat. One important option for those diagnosed with pulmonary MDR TB is bedaquiline.

       In 2018, the World Health Organization replaced two injectable drugs for MDR TB with an oral regimen that included bedaquiline.

 

Revised National TB Control Programme (National TB elimination program):

        RNTCP incorporates the principles of directly observed treatment-short course (DOTS). DOTS is a systematic strategy which has five components:

1. Political and administrative commitment: Since TB can be cured and the epidemic reversed, it warrants the topmost priority, which has been accorded by the Government of India.

2. Good quality diagnosis: Good quality microscopy allows health workers to see the tubercle bacilli and diagnose properly.

3. Good quality drugs: An uninterrupted supply of good quality anti-TB drugs must be available. RNTCP provides a box of medication for the entire treatment for every person registered.

4. Supervised treatment to ensure the right treatment: The RNTCP uses the best anti-TB medications available in a right way.

5. Systematic monitoring and accountability: Standard recording and reporting system, and the technique of cohort analyses are used to keep an account of every person treated.

 

       According to the United Nations Sustainable Development Goals, all nations have set the goal of eradicating TB by the year 2030.

       End TB strategy: India is committed to eliminating tuberculosis from the country by 2025, five years ahead of the global target by the World Health Organisation (WHO) i.e. 2030.

       Elimination as defined by the World Health Organisation (WHO), means that there should be less than 1 person with TB for a population of a million people.