Hopes hinged on pretomanid, new anti-TB drug in over four decades | Mumbai news - Hindustan Times
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Hopes hinged on pretomanid, new anti-TB drug in over four decades

ByJyoti Shelar, Mumbai
Oct 16, 2021 08:27 PM IST

Pretomanid is prescribed as a part of the BPaL regimen, which includes two other drugs- bedaquiline and linezolid. Doctors and TB patients both have their hopes hinged on this new drug and the BPaL regimen

Two patients from Mumbai have been started on pretomanid, the newest and the third anti-tuberculosis drug developed over four decades after bedaquiline and delamanid. The clinical trial at the civic-run Shatabdi Hospital in Govandi will enrol a total of 75 patients. Altogether, 400 patients will be enrolled in nine clinical trial sites across India. Pretomanid is prescribed as a part of the BPaL regimen, which includes two other drugs- bedaquiline and linezolid. Doctors and patients both have their hopes hinged on this new drug and the BPaL regimen.

Pretomanid is prescribed as a part of the BPaL regimen, which includes two other drugs- bedaquiline and linezolid. Doctors and TB patients both have their hopes hinged on this new drug and the BPaL regimen (Representational picture.)
Pretomanid is prescribed as a part of the BPaL regimen, which includes two other drugs- bedaquiline and linezolid. Doctors and TB patients both have their hopes hinged on this new drug and the BPaL regimen (Representational picture.)

Pretomanid is a member of a class of compounds known as nitroimidazooxazines. Unlike other TB drugs developed by pharmaceutical companies, pretomanid was developed and registered by TB Alliance, a non-profit organisation. The US Food and Drug Administration (FDA) approved pretamonid in August 2019 as a part of the three-drug treatment for people with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive. The three-drug BPaL regimen was prescribed for a duration of six months.

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In July this year, results of phase 3 clinical trial called the ZeNix trial carried out in 11 sites across Georgia, Moldova, Russia and South Africa showed the efficacy of BPaL regimen between 84% to 93% in highly drug-resistant patients with a variation in dosage of lineozolid. “The results were very encouraging because the current treatment regimen, commonly known as the ‘all oral longer regimen’ has an efficacy of around 43%,” said Dr Vikas Oswal, the principal investigator of Mumbai’s BPaL trial that has commenced in Shatabdi Hospital.

From 14 pills to just 3

The ‘all oral drug regimen’ include nearly 14 different anti-TB drugs that a patient consumes every day. Some patients with a stubborn disease are also put on injections and the overall duration of treatment is anywhere between 18 to 24 months. If replaced by the BPaL regimen, patients will effectively take only three tablets for a period of six months.

“The longer duration of TB treatment is one of the main reasons for non-compliance,” said chest physician Dr Ashok Mahashur from Hinduja Hospital. “Most TB drugs have side effects due to which all patients have to be closely monitored. When the treatment goes on for a longer duration, the side effects are prolonged, which bothers the patients. Shorter treatment regimens with fewer tablets will be encouraging for the patients,” he said.

Similar to the ZeNix trial, the trial at Shatabdi Hospital will also involve variations in the dosage of linezolid. The first arm of patients will get 600 mg of linezolid for six months, the second arm will get 600 mg for two months and 300 mg for four months and the third arm will get 600 mg for three months and 300 mg for three months. The dosage of bedaquiline- 400mg for the first two weeks followed by 100 mg alternatively for 22 weeks- and pretomanid- 200mg for six months- will remain constant.

Side effects

The ZeNix trial has observed that adverse reactions reported in at least 10% of trial participants included peripheral neuropathy. Some patients also had decreased haemoglobin levels.

According to TB Alliance, common adverse reactions of pretomanid include peripheral neuropathy, acne, anaemia, nausea, vomiting, headache, increased transaminases, dyspepsia (upper abdominal discomfort), decreased appetite, rash, pruritus (skin irritability), abdominal pain, pleuritic pain, increased gamma-glutamyltransferase (a condition affecting the liver), lower respiratory tract infection, hyperamylasemia (a condition likely affecting pancreas), hemoptysis (coughing up blood), back pain, cough, visual impairment, hypoglycemia, abnormal loss of weight, and diarrhoea.

“Historically, side effects have been a major concern with all TB drugs,” said Ganesh Acharya, TB survivor and activist. “But we need newer compounds, newer drugs as the challenge of antimicrobial resistance is only getting serious every passing day. Close patient monitoring is therefore crucial. The entry of pretomanid is a glimmer of hope for TB patients. Once the trials conclude and if they have a positive result, our government should ensure speedy access to the drug for patients,” he said.

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