Quick, Safe, and Efficient Treatment Plans
The nine-month oral regimen and the six-month regimen plus eight weeks of second-line injectables both had higher efficacy, according to the Lancet study. However, experts warn that due to India's obstinate opposition, the new administration may not be as successful.
An encouraging development for patients with multi-drug resistant tuberculosis (MDR-TB), a dangerous lung infection, is the discovery that two novel, condensed therapy regimens utilising the medication Bedaquiline are secure and efficient.
Even the Union World Conference on Lung Health 2022, which is currently taking place, announced them (WCOLH). The new treatment plans also cost less, resulting in decreased patient expenditures. While acknowledging that the study may be a step in the right direction, local lung health experts are already raising questions about its relevance to MDR-TB patients in India.
About what is the study?
It is the first extensive, multi-national clinical trial to look at streamlined regimens for treating the lung infection. It is also the first phase-III trial to examine the effectiveness and security of Bedaquiline, a novel medication with a condensed treatment schedule. The Standardised Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB (STREAM) studies were used to evaluate the effectiveness of the treatment plan.
Since 2012, more than 1,000 patients have been enrolled in STREAM, making it the largest MDR-TB clinical trial ever. 1,436 people were screened as part of the phase III studies between March 28, 2016, and January 28, 2020, and 588 of them were given a randomly assigned treatment between the long regimen, control regimen, oral regimen, or six-month regimen.
Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, and Uganda were among the countries where participants were sought out.
What were the outcomes of the study trial?
A nine-month oral regimen and a six-month regimen with eight weeks of second-line injectables both contained bedaquiline, and the trial demonstrated that both of these regimens were more effective than the control group. There were fewer occurrences of hearing loss reported with the nine-month injectable-containing regimen. The totally oral nine-month treatment was more successful than the control regimen, with a favourable outcome shown in 82.7% of patients in the former against 71.1% in the latter.
The outcomes also demonstrated that the six-month therapy, which included Bedaquiline and an injectable medication for a condensed two-month period, was more efficient than the control regimen. On a six-month treatment, 90% of individuals experienced a favourable outcome, compared to 68.5% in concurrent controls. These two regimens provide hopeful treatment alternatives for patients with MDR or rifampicin-resistant tuberculosis.
Why is treating MDR-TB so difficult? What is the current schedule?
According to the WHO, the two most efficient first-line TB medications, isoniazid and rifampicin, do not work against the bacteria that cause MDR-TB. Second-line medications can be used to treat and cure MDR-TB. However, there are few treatment options available, and those that are needed must be taken for at least nine months and maybe up to 20 months.
These medications are harmful and pricey. Patients with MDR-TB experienced a 60% treatment success rate globally in 2019.
According to the study's authors, barely one in three people who acquired MDR or rifampicin-resistant tuberculosis worldwide in 2020 began receiving treatment. According to research, people find it simpler to follow the regimen than longer ones that run up to 20 months.
How realistic is the India short course strategy?
According to Dr. Zarir Udwadia, consulting chest physician at PD Hinduja Hospital in Mumbai, the six- to nine-month programme is a step in the right direction. The applicability of this regimen to the bulk of MDR-TB patients in India, however, is in doubt. Where this regimen cannot be considered, the majority of our MDR strains also exhibit fluoroquinolone resistance, the doctor continues. Both STREAM protocols contain high dosage INH (isoniazid).
But the majority of INH-resistant bacteria from India had katG mutations (INH resistance commonly occurs due to mutations in the katG gene). This resistance cannot be broken even with high doses of INH. Additionally, we have demonstrated through research that a large number of the regimen's individual elements are resistant to the strains found at the Hinduja Hospital. Dr. Udwadia acknowledges that MDR-TB treatment choices are complicated.
Dr. Udwadia and his colleagues discovered in their study, which was published in the BMC Infectious Diseases journal in January 2019, that few patients were qualified for the WHO's recently-recommended short course for MDR-TB at a sizable Mumbai private clinic.
What causes worry regarding relapse cases? What public health initiatives need to be strengthened?
WHO estimates that India is responsible for 28% of the 10.6 million new TB cases. The prevalence of MDR-TB is likewise high in the nation (resistant to both isoniazid and rifampicin). Dr. Vikas Oswal, a pulmonologist in Mumbai, notes that drug resistance can affect treatment and that certain patients may need a lengthier course of therapy. According to him, there may not be a general rule that applies to a short course of treatment, and studies are needed to determine the relapse rates. The National TB Elimination Programme's (West Zone) zonal task force chair, Dr. Sanjay Gaikwad, claims that using shorter regimens can increase adherence in addition to lowering costs. Each patient must first undergo a screening to see whether the shorter regimen is right for them.
Dr. Gaikwad continues, "The positive thing is oral consumption and less utilisation of injectables." But he is adamant that the Covid epidemic must serve as a lesson. "The health system should be proactive and screen anybody who comes into contact with the TB patient, whether it be at home or at work. Let's act responsibly and safeguard our loved ones, coworkers, and the nation, he exhorts.
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