Optimal treatment and new drugs expected to save more lives
By David Bodapati
Bengaluru, 14 Oct 2019: A diminutive middle-aged woman, Pari Yusuf, woke up in the middle of the night and sat down on her bed. Frightening dreams and illusions are not new to her. “Suddenly, I was sweating and found myself in the middle of a huge raging fire. I was shouting for help and had no where to go. I woke up abruptly, and then everything seemed ok in a few minutes,” she said.
“Long back, I used to get these kind of illusions but the intensity seems to be more with the TB drugs,” she recalled. Pari (name changed) is living with HIV for over 15 years and survived drug-resistant Tuberculosis (TB). Later on due to side effects and other opportunistic infections, she literally recovered from her days on the death bed at the government Victoria hospital in Bengaluru, four years back. “These illusions and dreams are a part of the side effects of the drugs I had to take. I used to get these when I started ART (antiretroviral therapy) a decade ago. But now some of the TB drugs too have such side effects,” she explained. “Some of the injected DR-TB durgs can be brutal and can cause complete hearing loss,” she added.
Now Pari, who hails from a rural district in Karnataka, is an activist fighting for the cause of people living with HIV and TB. She fully supports the `TB Harega, Desh Jeetega’ campaign which was launched on Septemeber 25 by the Union Health Minister Harsh Vardhan, who also released the TB India Report 2019 and introduced the all-important, all-oral treatment regimen for Multi-drug resistant TB. But she feels that more needs to be done in terms of providing care after initiation of new drugs and providing access in rural and remote areas.
The Minister announced the roll out of an all-oral MDR regimen across the country based on providing access to one of the two new drugs – Bedaquiline or Delamanid to replace the injectable in the treatment regimen. The new all-oral treatment for drug-resistant TB is a welcome development as India. According to WHO’s Global TB Report 2018, the estimated number of DR-TB in India is 135,000, accounting for one-fourth of the global burden.
The all-oral treatment represents hope for people with DR-TB and their caregivers because they offer better cure rates and a fewer side effects. The World Health Organisation’s treatment guidelines prioritise the use of newer drugs as part of all-oral regimens for the treatment of MDR-TB and XDR-TB.
MSF urges more countries to make the switch from older, toxic treatments that need to be injected to all-oral regimens that contain the newer drugs, including bedaquiline and delamanid. “These newer drugs are critical to improving the otherwise abysmal cure rates of 55% and 34% for MDR-TB and XDR-TB, respectively. “Use of the newer TB drugs is also urgently needed for children with MDR-TB in order to improve treatment outcomes and reduce the risks of side effects,” Ms Yusuf says.
Treatment regimens for multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) and extremely drug-resistant TB (XDR-TB) have long consisted of toxic drugs, including those that cause psychosis and hearing loss. Treatment outcomes for people with MDR-TB and XDR-TB have remained unacceptably low for many years for numerous reasons, including drug toxicity, lack of new effective drugs, long treatment durations, and failure to put people at the centre of their care. Such treatments had a high pill burden, long treatment duration (of up to two years), painful daily injections (for up to eight months), and severe side effects (due to toxic drugs). The treatment success rates were only 55% for people with MDR TB) and 34% for people with XDR-TB.
A group of people affected by DR TB, and from different health organisation and People Living with HIV have made a representation to the Health Ministry last December to minimise injectible drugs and scale up all-oral new drugs for DR TB. They are happy that finally the government announced the switch to all-oral treatment which can save more lives with optimal treatment. But they feel that scaling up only Bedaquiline will not help and call for including access to Delamanid too, particularly for patients who have pre-XDR and XDR TB. In addition they call for adequate Drug Sensitivity Testing (DST) facilities throughout the country.
The new all-oral DR-TB regimens are a strong step in the right direction but they should be followed up to provide people with safer and more tolerable treatment, improve treatment outcomes and prevent unnecessary deaths. Importantly, the new all-oral regimens can also facilitate an evolution to a model of care that empowers people and supports them to complete treatment with less disruption to their lives. The benefits of implementing the new all-oral long regimen is very clear but having launched the switch, now the government must make a political commitment for sufficient financing, adequate healthcare worker training, policy updates and multi-sectoral engagement. The National programme should also keep in mind the access to treatment and drugs in rural and remote regions as well as guard against stock-outs which have become frequent in many states like Jharkhand and even in cities like Mumbai.
Now that the programme makes a shift to the all-oral treatment regimen to progress to the MDG goal by 2025, two things that need urgent attention are issuing a circular for minimising and removal of injectable from the Programmatic Managment of drug-resistant TB (PMDT), and making greater efforts to scale up universal Drug Susceptibility Testing (DST) as lack of quality assured testing facilities is a major barrier for DR-TB patients to access safer, effective and rational DR-TB regimens. As per CTD India Report 2018, only 257 of the 712 districts undertake DST on TB samples (2018).
Dr Vardhan says, “We are on track to achieve our target of a TB-free India by 2025, much ahead of the global target of 2030.” For that to happen our programme implementation should be made more robust without allowing any complacency to creep in. But the need of the hour is to attack DR TB with full force.
