TB Alliance ZeNix trial Show Effectiveness of BPaL Regimen for Highly Drug-Resistant TB
By 143 Comments on TB Alliance ZeNix trial Show Effectiveness of BPaL Regimen for Highly Drug-Resistant TB

ZeNix trial in South Africa and Eastern Europe sought to optimize the 6-month treatment regimen with reduced exposure to the drug linezolid

India has the leading number of TB cases globally

New Delhi/Berlin/Pretoria, July 16: The results of ZeNix, a Phase 3 clinical trial that took place in 11 sites across Georgia, Moldova, Russia, and South Africa, revealed that the BPaL treatment remains effective against highly drug-resistant strains of tuberculosis (TB) with either reduced dosage or duration of the linezolid component of the regimen. Simultaneously, with the maintenance of efficacy, there was a decrease in linezolid-associated side effects. The results from the trial, which was led by TB Alliance, a non-profit TB drug developer, were announced ahead of an oral abstract presentation next week at the 11th IAS Conference on HIV Science.

The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L)—received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB. Historically, treatment would take 18 months or longer, with reported global success rates averaging 43%.

“We now have evidence that the BPaL regimen can be optimized to make it even easier to use,” said Mel Spigelman, M.D., President and CEO of TB Alliance, which developed pretomanid for use in the regimen. “Until recently, patients with highly drug-resistant TB—among the most difficult infections to identify and treat—had to suffer through a combination of as many as eight antibiotics, some involving daily injections, for 18 months or longer.”

This Phase 3 clinical trial shows how TB Alliance’s new six-month three-drug treatment for highly drug-resistant TB can be administered by reducing the dosing of the drug linezolid. This regimen reduces the treatment time for highly drug-resistant forms of TB from 18 months or longer to six months duration.

India has the leading number of TB cases globally, accounting for more than 1 in 4 of all cases of active TB disease, including approximately 120,000 cases of drug-resistant forms of TB. India’s Prime Minister Mr. Narendra Modi has set an ambitious goal of TB eradication in India by 2025, ahead of the 2030 target of the Sustainable Development Goals. This bold commitment may face headwinds in the context of the unforeseen challenges posed by Covid-19, as well as the low success rates of current DR-TB treatments, which limit the potential of expanding TB services.

The ZeNix trial was a four-arm, randomized, double-blinded study as to dosage and duration of linezolid that enrolled 181 patients with highly drug-resistant forms of TB in South Africa, Russia, Georgia, and Moldova. Of these participants, 36 (20%) were HIV positive. Patients were treated for six months with bedaquiline, pretomanid, and varying doses and durations of linezolid, with follow-up, reported thus far to the primary endpoint six months after completion of treatment. The aim of the trial was to evaluate whether the efficacy of the BPaL regimen could be maintained while reducing a patient’s exposure to linezolid and its associated side effects.

The study enrolled participants with extensively drug-resistant (XDR) TB, pre-XDR-TB, or failed or treatment-intolerant multidrug-resistant TB. Per the intent to treat analysis, the success rate for participants receiving the highest dosage of linezolid (1200mg for 6 months) was 93%. The efficacy level was similarly high in the remaining arms, reported as 89% among participants receiving 1200mg of linezolid for 2 months, 91% for those receiving 600mg of linezolid for 6 months, and 84% among those receiving 600mg of linezolid for 2 months. Dosing of bedaquiline and pretomanid was consistent across the four arms.

Adverse reactions reported in at least 10% of trial participants included peripheral neuropathy (38% of those receiving 1200mg of linezolid for six months; 24% of those receiving 1200mg of linezolid for two months; 24% of those receiving 600mg of linezolid for six months; 13% of those receiving 600mg of linezolid for two months). An evaluation of myelosuppression, as manifest as anemia, found that patients had decreased hemoglobin levels related to linezolid exposure (22% of those receiving 1200mg of linezolid for six months; 17% of those receiving 1200mg of linezolid for two months; 2% of those receiving 600mg of linezolid for six months; 7% of those receiving 600mg of linezolid for two months).

“The results of this study are very reassuring. With a reduction in the dose and/or duration of linezolid, we can still offer patients a high chance of cure in only six months,” said Francesca Conradie, M.D., principal investigator for the ZeNix clinical trial as well as South Africa’s Clinical Access Program for the regimen.

TB Alliance plans to submit data from ZeNix to a peer-reviewed publication.

bedaquilineBPaL treatmentGeorgialinezolidMoldovapretomanidRussiaSouth AfricaTB Alliance ZeNix trial

143 Replies to “TB Alliance ZeNix trial Show Effectiveness of BPaL Regimen for Highly Drug-Resistant TB”

  26. Pingback: rick and morty sex games
  50. Pingback: kardinal stick

  64. Thank you, I’ve recently been searching for info approximately this subject for ages and yours is the greatest I’ve discovered till now. But, what in regards to the bottom line? Are you positive in regards to the supply?

  69. I wanted to check up and let you know how, a great deal I cherished discovering your blog today. I might consider it an honor to work at my office and be able to utilize the tips provided on your blog and also be a part of visitors’ reviews like this. Should a position associated with guest writer become on offer at your end, make sure you let me know.

  70. Hi there! I just wanted to ask if you ever have any trouble with hackers? My last blog (wordpress) was hacked and I ended up losing several weeks of hard work due to no back up. Do you have any solutions to protect against hackers?

  72. Your thing regarding creating will be practically nothing in short supply of awesome. This informative article is incredibly useful and contains offered myself a better solution to be able to my own issues. Which can be the specific purpose MY PARTNER AND I has been doing a search online. I am advocating this informative article with a good friend. I know they are going to get the write-up since beneficial as i would. Yet again many thanks.

  77. I have to say this post was certainly informative and contains useful content for enthusiastic visitors. I will definitely bookmark this website for future reference and further viewing. cheers a bunch for sharing this with us!

  80. Pretty impressive article. I just stumbled upon your site and wanted to say that I have really enjoyed reading your opinions. Any way I’ll be coming back and I hope you post again soon.

  81. This is my first time i visit here. I found so many helpful stuff in your website especially its discussion. From the tons of responses on your posts, I guess I am not the only one having all the enjoyment here! keep up the excellent work

  82. Spot on with this write-up, I truly believe this website requirements a lot much more consideration. I’ll probably be once more to read much much more, thanks for that info.

  85. This is really interesting, You’re a very skilled blogger. I have joined your feed and look forward to seeking more of your fantastic post. Also, I have shared your website in my social networks!

  87. I dont think Ive caught all the angles of this subject the way youve pointed them out. Youre a true star, a rock star man. Youve got so much to say and know so much about the subject that I think you should just teach a class about it

  93. Hello this is kinda of off topic but I was wondering if blogs use WYSIWYG editors or if you have to manually code with HTML. I’m starting a blog soon but have no coding knowledge so I wanted to get advice from someone with experience. Any help would be enormously appreciated!

  99. I think I will become a great follower.Just want to say your post is striking. The clarity in your post is simply striking and i can take for granted you are an expert on this subject.

  101. I feel that is among the so much significant info for me. And i am satisfied studying your article. However should commentary on some basic issues, The site style is ideal, the articles is in reality excellent : D. Excellent activity, cheers

  103. Spot on with this write-up, I actually assume this website needs far more consideration. I will in all probability be once more to learn rather more, thanks for that info.

  105. Appreciation for taking the time to discuss this topic, I would love to discover more on this topic. If viable, as you gain expertise, would you object to updating the website with further information? It is tremendously beneficial for me.

  110. This is my first time i visit here. I found so many helpful stuff in your website especially its discussion. From the tons of responses on your posts, I guess I am not the only one having all the enjoyment here! keep up the excellent work

  111. Thanks for sharing the information. I found the information very useful. That’s a awesome story you posted. I will come back to scan some more.

  112. I like to spend my free time by scanning various internet resources. Today I came across your website and I found it has some of the most practical and helpful information I’ve seen.

  118. I just couldn’t leave your web site prior to suggesting that I really enjoyed the standard info an individual supply to your guests? Is going to be again continuously in order to inspect new posts

  122. I like the helpful information you provide in your articles. I’ll bookmark your blog and check again here frequently. I am quite certain I’ll learn many new stuff right here! Best of luck for the next!

  130. I have to say this post was certainly informative and contains useful content for enthusiastic visitors. I will definitely bookmark this website for future reference and further viewing. cheers a bunch for sharing this with us!

  131. A motivating discussion is definitely worth comment. I believe that you should publish more about this subject, it might not be a taboo subject but generally folks don’t talk about such issues. “성인웹툰” To the next! Many thanks!!Anyone who knows the answer will you kindly respond? Thanx!!

  133. Easily, the post is really the greatest on this laudable topic. I concur with your conclusions and will thirstily look forward to your future updates. Saying thank will not just be sufficient, for the wonderful c lucidity in your writing. I will instantly grab your rss feed to stay privy of any updates. Solid work and much success in your business enterprise!

  136. I think this is among the so much vital info for me. And i’m happy reading your article. But wanna remark on few common issues, The site style is wonderful, the articles is really excellent : D. Just right job, cheers

  140. 365PowerSupply.com is a professional and reliable power supply trading and wholesale provider that offers a wide range of replacement power supplies for popular brands like Dell, HP, Lenovo/IBM, and server workstation components. With a focus on quality and affordability, they offer an extensive selection of products at competitive prices. Whether you need a power supply for your business or personal use, 365PowerSupply.com is committed to providing excellent service and support to ensure that you get the right product for your needs.

  142. Good site! I truly love how it is easy on my eyes it is. I am wondering how I might be notified when a new post has been made. I’ve subscribed to your RSS which may do the trick? Have a great day!

Leave a Reply

Your email address will not be published.