A study published on 23rd July 2012 in the medical journal 'The Lancet' has raised hopes for a novel combination drug regimen that promises to make multidrug-resistant TB (MDR-TB) treatment shorter, simpler, safer, and more cost effective. The findings of this study from researchers and the non-profit Global Alliance For TB Drug Development (TB Alliance), which were presented at the XIX International AIDS Conference (AIDS 2012) reveal that a novel TB drug combination PaMZ (consisting of PA- 824, moxifloxacin and pyrazinamide) has shown the potential to dramatically shorten the length of multi drug resistant TB treatment by 80%, from the existing 24 months to 4 months; reduce the pill burden by 97%, from the existing 12,600 pills to 360 pills; and eliminates the need of injections and daily powdered drug formulations completely. (Currently patients have to take a daily dose of very painful injections for 6 months).
The new regimen not only simplifies and improves the treatment of MDR-TB, but is expected to be 90% cheaper than the existing treatment. The results also reveal progress in the pursuit of an antiretroviral-compatible TB treatment, which is critical to treating the millions of people with TB/HIV co-infection and raise hope for a treatment breakthrough amid the growing and dangerous epidemic of drug-resistant forms of TB that, in some cases, are becoming untreatable.
“Treating drug sensitive and drug resistant TB with the same regimen can simplify the delivery of TB treatment worldwide. The results of this study give healthcare providers on the frontlines of the TB epidemic hope for better faster tools needed to stop the disease,” said Dr Andreas Diacon MD, the trial’s principal investigator and lead author of the Lancet study.
TB is one of the world’s most ancient and deadly infectious diseases, dating back thousands of years. Today, TB remains the largest killer of people with AIDS, but very often, TB and HIV treatments cannot be given together because of drug-drug interactions and side effects. An estimated 1.4 million people die from TB and nearly 9 million people develop the disease each year. Yet there have been no new TB drugs in approximately 50 years. This lack of activity stems mostly from the fact that TB is a disease of poverty which dissuades for profit companies from investing in new TB treatment research.
Novel TB regimens are potential game changers due to their expected impact on scaling up MDR TB treatment. The results of NC-001 (New Combination 1), a two week Phase II clinical trial showed that PaMZ killed more than 99% of the patients’ TB bacteria within two weeks. These results add to a growing body of evidence that PaMZ could work in patients with drug sensitive and some forms of drug resistant TB ushering in a new treatment paradigm for the disease. By treating both drug sensitive (DS) and drug resistant (DR) forms of TB PaMZ signals a major paradigm switch in the way to approach TB treatment. The regimen promises to reduce treatment time for both DS TB and DR TB, but shows particular promise for transforming treatment of MDR TB.
A second trial called NC-002 (New Combination2) is currently underway and is enrolling patients at 8 sites in South Africa, Tanzania, and Brazil, to test PaMZ combination over a period of two months.
The NC-001 trial also validated the approach to development of novel regimens. Mario Raviglione, MD, Director of the Stop TB Department at the World Health Organization said that testing multiple new TB drug candidates simultaneously has already proven to be a major advance. “Because of testing drugs in combination, we have already saved several years in the research process to find new, effective regimens to treat TB. The results look strongly promising from this early trial. If further testing holds up these results and the regimen is affordable in poor countries, it is huge progress. We could shorten drug regimens substantially for everyone, regardless of whether the form of TB is sensitive or multi-drug resistant. That would be a dramatic step forward," said Raviglione. (CNS)
(The author is the Managing Editor of Citizen News Service (CNS). She is a J2J Fellow of National Press Foundation (NPF) USA. She is supported by the Lilly MDR-TB Partnership to report on-site on TB related issues from XIX International AIDS Conference (AIDS 2012). She has worked earlier with State Planning Institute, UP and taught physics at India's prestigious Loreto Convent. She also authored a book on childhood TB (2012), co-authored a book (translated in three languages) "Voices from the field on childhood pneumonia" and a report on Hepatitis C and HIV treatment access issues in 2011. Email: firstname.lastname@example.org, website: http://www.citizen-news.org)