TODAY -

Will SimpliciTB make TB treatment simpler ?

Shobha Shukla *



Taking the encouraging results of its N-005 study one step forward, TB Alliance has initiated SimpliciTB a pivotal clinical study to evaluate the efficacy, safety and tolerability of a novel and potentially shorter 4 drug regimen for patients with drug-sensitive (DS) as well as multi drug-resistant (MDR) pulmonary TB.

The new drug regimen BPaMZ comprising four different antibiotics Bedaquiline (B), Pretomanid (Pa), Moxifloxacin (M) and Pyrazinamide (Z) will be administered for 4 months to patients of DS-TB, and for 6 months to patients with MDR-TB with mono-resistance to rifampicin or isonaizid.

What is SimpliciTB?

SimpliciTB is a pivotal, multi-centric, open-label partially randomized clinical study targeting at least 26 centres in 10 countries in Africa, Asia, Europe and South America. A total of 450 participants (150 per treatment group) will be enrolled and assigned to the following treatment arms:

o Participants with DS-TB will receive BPaMZ daily for 4 months;
o Participants with DS-TB will receive HRZE/HR combination tablets daily for 6 months; and
o Participants with DR-TB (MDR-TB as well as mono-resistance to isonaizid or rifampicin) will receive BPaMZ daily for 6 months.

The study would evaluate if an all-oral BPaMZ drug regimen has the potential to shorten and simplify treatment for both DS-TB and MDR-TB. It will test and compare the efficacy of a 4 month treatment with the BPaMZ regimen, in people with DS-TB, to that of the current 6 month treatment regimen of isoniazid, rifampicin, pyrazinamide and ethambutol (HRZE), to determine whether BPaMZ can shorten the duration of therapy. The study will also assess BPaMZ’s potential to treat DR-TB (with mono-resistance to rifampicin or isonaizid) in 6 months. Currently, treatment for MDR-TB is complicated, expensive, and lengthy- lasting for 9 to 24 months- involving a wide variety of medicines that have debilitating side-effects.

The N-005 study

As mentioned earlier, the BPaMZ regimen has been previously studied in a 2 month long Phase 2b N-005 clinical study conducted on 240 patients (180 patients with DS-TB and 60 patients with DR-TB) at 10 sites in 3 countries (Uganda, South Africa, and Tanzania). Study results showed that the best regimen was a combination of all four drugs- BPaMZ-, that resulted in the highest level of bactericidal activity among all its four parallel treatment arms.

At the end of 2 months, participants receiving BPaMZ cleared TB bacteria from their sputum 3 times faster than those on the standard (HRZE) treatment regimen, with almost all of them having culture conversion after 2 months of treatment. The study also found that a daily dose of Bedaquiline (200 mg) is at least as active and safe as the labelled dose. This could lead to a simpler daily dosing with fewer pills and an overall less complicated treatment for patients.

How is SimpliciTB different from N-005?

SimpliciTB will build on the encouraging results of N-005. While NC-005 only examined BPaMZ in multi drug-resistant TB (it also looked at other combinations of B, Pa and Z in DS-TB), SimpliciTB will test BPaMZ regimen in both, drug-sensitive and drug-resistant TB patients, over a longer period of time, with many more participants, and with a much larger geographic scope.

The study is expected to enrol 450 people with TB, (including 150 who are mono-resistant to isoniazid or rifampicin) across 26 centres in 10 countries in Africa, Asia, Europe and Latin America. It will examine the time to culture negative status over 8 weeks, as well as durable cure, through 12 and 24 month follow-ups.

The first patients have already been enrolled at the National Centre for Tuberculosis and Lung Disease in Tbilisi, Georgia. The study is slated to end in 2021, with the potential for making interim results available earlier.

According to the World Health Organization’s most recent WHO Global Tuberculosis Report, there is growing resistance to available TB drugs, which means the disease is becoming more deadly and difficult to treat. WHO estimates that in 2016 there were 600,000 new cases with resistance to rifampicin – the most effective first-line drug—of which 490,000 had MDR-TB.

“As resistance to current TB treatments continues to grow, we need to introduce all-oral drug regimens that can treat every person with TB in 6 months or less, regardless of their resistance profile. If proven successful in SimpliciTB, the BPaMZ regimen would represent a major step toward this goal by bringing down the treatment duration for the vast majority of TB patients to as less as 3-4 months, thus reshaping the treatment landscape of TB, especially for people with MDR-TB, who currently face an arduous 9-24 month treatment journey that is too often unsuccessful”, said Mel Spigelman, President and CEO of TB Alliance.

If successful, the all-oral BPaMZ drug regimen tested in SimpliciTB will shorten TB treatment to a duration that would be more easily manageable by patients and public health services, and provide a more effective, safer and affordable treatment for the growing number of patients suffering from drug- resistant TB, bringing us nearer to the goal of ending TB by 2030.


* Shobha Shukla, CNS (Citizen News Service) wrote this article for e-pao.net
The writer is is the Managing Editor of CNS (Citizen News Service). Follow her on Twitter @Shobha1Shukla or @CNS_Health or visit www.citizen-news.org
This article was posted on 14 September, 2018 .


* Comments posted by users in this discussion thread and other parts of this site are opinions of the individuals posting them (whose user ID is displayed alongside) and not the views of e-pao.net. We strongly recommend that users exercise responsibility, sensitivity and caution over language while writing your opinions which will be seen and read by other users. Please read a complete Guideline on using comments on this website.




LATEST IN E-PAO.NET
  • Meekap Thokpa Numit #2 : Gallery
  • Areinu, Chaohongba :: eMing
  • Cheirao-chingkaba [April 14] : Gallery
  • Governor's speech at Khongjom Day 2019
  • Gossiping :: Poem
  • Traditional warfare technique of NE native #2
  • Weak monsoon concern for farmers
  • Rag tag bunch of desperadoes
  • A thought on Khongjom Day
  • Khomlen Manglanda - A Play #1 : Gallery
  • Khongjom Numit: Commemoration
  • Licypriya Kangujam to address UN
  • Wu Cheng'en at Yuntai Mountain :: Review
  • Cleaning up Maram Bazar on Earth Day
  • Take action for mother earth
  • In between now and May 23
  • Challenges in Journalism
  • Shivaratri Shopping List #2 : Gallery
  • Pherzawl - a dying District! ?
  • Indo-Naga & other peace talks #2
  • Spotted Deer - Living with Natural Habitat
  • Northeast Fiesta at Jalandhar : Report
  • Environmental Sciences as career option
  • Serou: A microcosm of mosaic Manipur
  • 3 North East States to get DNA Testing
  • Protest against SC verdict on adultery
  • Mirabai misses bronze by a whisker
  • Post poll scenario in Manipur
  • Tributes to PLA killed #2 : Gallery
  • Romance of insurgency in 1970s #1
  • Earth Day 2019
  • Easter is a Day of Hope for all ...
  • Hide-and-seek in the Sky :: Poem
  • St Mary's Church: The 1st Anglican Church
  • Breaking the barrier
  • A talk with Ajit Ningthouja :: eRang
  • Realisation Day; Echoes the wake up call
  • Xavier Rutsa & Limatemsu Jamir
  • Revisiting Palm Sunday: Reflections..
  • Iceland - most safest & peaceful place
  • Easy fixes for summer hair problems
  • An evening of extreme shame !
  • Revisiting reality
  • LS : Voting for Inner : Gallery
  • Thang Ta @Sangai Festival #4: Gallery
  • The current status of Naga-Kuki relation #1
  • Traditional warfare technique of NE native #1
  • Cry Of A Dying River #72 :: Poem
  • Looking forward to May 23
  • Judgment day
  • Meekap Thokpa Numit #1 : Gallery
  • CC Meet Final: NEROCA Vs SU #2: Gallery
  • Floriculture : A booming industry in Mao
  • Positivity is the soul of life
  • Basic health competency by patients
  • Inner Line Permit (ILP) Demand :: Timeline
  • 7th Woodpecker International Film Festival
  • Cracking the repoll whip in Outer
  • Dirty game is a threat to Democracy
  • Ibendhou Kounu Haraoba #2: Gallery
  • Indo-Naga & other peace talks #1
  • Civil Society Forum Manifesto for Election
  • Life and Me :: Poem
  • The Killing Fields 2013-18 : News Timeline
  • Election jamboree & voters bonanza
  • Suspension Order for 7 MLAs : NPF
  • Chin Woman Dies after Tatmadaw Bomb
  • A reference to the party in power
  • An idea without fear
  • Sajibu Cheiraoba at Mysore #2: Gallery
  • Artillery Regiment in Battle of Imphal
  • Appraisal on LS election (Outer) #2
  • Minimum Income Guarantee is a promise
  • Northeast Fiesta 2019 at Jalandhar
  • Cyber Security - the need of the hour
  • Sunset Unplugged, Agartala: Event Report
  • Reality of casting vote in Outer PC
  • Real face of Indian election
  • Tributes to PLA killed #1 : Gallery
  • Khomlen Manglanda : Play synopsis
  • Download: Meetei Mayek Keyboard
  • Voting (PC) @ Kangpokpi #3: Gallery
  • Letter from a river most polluted
  • Truth commission in Manipur needed..
  • Vacancy at Makok Tech, Bishnupur
  • Cheirao Chingkaba #2 : Gallery
  • The sky is the SIYOM of the stars
  • An introspection of roots of AFSPA
  • A note on Cheiraoba ..
  • A well-known paradox :: Poem
  • The saga of EVMs
  • Festival of Democracy hypes
  • 14 girls sold to persons in Saudi Arabia
  • Took up boxing after watching Ali- Mary
  • Sajibu Cheiraoba at Mysore #1: Gallery
  • Mittong Khunou: The Battle Honour of INA
  • A Lifeline for the Assamese
  • Multiple posts at PiCaSoid, Imphal
  • NE Annual day of CNESPR , JMI
  • Essential summer travel tips
  • Discussion : Myanmar's Democratization
  • Violating election model code of conduct
  • Catapulting AFSPA in the limelight
  • Revisiting CAB issue
  • Voting (PC) @ Kangpokpi #2: Gallery
  • Voting (PC) @ Kangpokpi #1: Gallery
  • Bloody Phanek at Paris Film Festival
  • Homoeopathy, a revolutionary science
  • The goodness of good fate does not smile..
  • Outer Constituency has voted
  • Helpless indignation
  • CC Meet Final: NEROCA Vs SU #1: Gallery
  • Yengkhom Roma : Lifetime Award
  • Appraisal on Lok Sabha election (Outer) #1
  • Cyber Crimes - Crimes by finger tips
  • Research Support Officer @ Amethyst
  • Condemns militarization of NEHU Campus
  • Shadow of CAB on Lok Sabha elections
  • "CAB" Factor Faded
  • Thabal Chongba @Khurai : Gallery
  • Military Sociology: Present, Past & Future
  • Know your MP - Election 2019
  • Dirty Dancing :: Poem
  • Democracy needs time for good admin
  • Travel at U-Factor
  • Shadow of NSCN (IM) in Outer PC
  • The great escape
  • Arambai Exhibition Show : Gallery
  • View of Premier State College Senior Assn
  • Distant One :: Poem
  • The hysteria of a first time voter
  • Course in Folkloristics & Semiotics
  • NDPP is 'Entertainment Govt' : Zeliang
  • On issue of "Letters signed by Neiphiu Rio"
  • The visit of PM Modi
  • If BJP win, people of Manipur support CAB
  • Cheirao Chingkaba #1 : Gallery
  • sekeN heN :: Seireng
  • Yangnu Golmei : Sangeetbhusan 2018
  • Victimizing only the Women & Children
  • Lest The North-East Fall Asleep
  • Naga Peace Process :: News Timeline
  • Driving a dangerous feat on Indian roads
  • Need to be democratic in a democracy
  • Cheiraoba Chak Katpa #1 : Gallery
  • Selfie da track :: e-pao Radio
  • Demand for ILP :: Articles/Photos...
  • The legend of the Laiyyars : Election tale
  • Sports for peace & development
  • What is peace ?
  • Rongali : Celebration of Assam & NE
  • Manipuris celebrate New Year
  • Imphal security beefed for Modi's visit
  • Sajibu Nongma Panba Shopping: Gallery
  • Sajibu Cheiraoba: Ritual festival of Meiteis
  • Sajibu Cheiraoba Meitei New Year Day
  • Stop War with Nature :: Artwork
  • Cry of a Dying River - 71 :: Poem
  • Pulmonary Valve Balloon dilatation
  • Supping with an ally of the foe
  • Deflected focus: The dress debacle
  • Nipalsuba Mapok #2 : Gallery
  • Running for LS polls: The candidate
  • Gift :: Poem
  • Architect/Architectural Designer @R-Square
  • Little things that help to enhance beauty
  • Congress Manifesto for Repeal AFSPA
  • Social Media - a boon or a curse?
  • Anti-CAB stand: Interesting take from PRISM
  • AFSPA on Congress Manifesto
  • Bamboo Cooking Competition #1 : Gallery
  • April Calendar for Year 2019 :: Tools
  • Yaoshang Sports @Keishampat #2 : Gallery
  • First Wave Feminism
  • JRF wanted at NERIST, Arunachal [Upd]
  • Cheiraoba Thabal 2019 at Bangalore
  • NPF to support Congress on issue based
  • Jyotishmita to represent Assam in Miss India
  • Paothang : Newsletter from Pune
  • Eyeing votes with promise on AFSPA
  • Together let's save the future
  • Shirarakhong Village, Ukhrul :: 360 View
  • Journey into Nature of Human Culture #4
  • Candidate accommodation at Aligarh
  • The globe is in your fist
  • Heartless :: Poem
  • Condemn Killing of Manjur Ahmed
  • Indifference bordering on arrogance
  • Modi's visit: Will it restored BJP image?
  • Yaoshang Halankar #1 : Gallery
  • No Budget at International Mime Festival
  • In defence of the "Meira Paibis"
  • Muhammad Abdur Rahman Khutheibam
  • Yaoshang Fancy Dress : Gallery
  • Meetei Tribe Bears More Tribal Characters
  • Phayeng Koubru Haraoba #3: Gallery
  • TabLlE :: Seireng
  • Yaoshang Marathon Race: Gallery
  • Abok :: Artwork & an Essay
  • Eyek Tamba :: Learn Manipuri script
  • Yaoshang Pichakari #2: Gallery
  • Yaoshang Cooking competition: Gallery
  • MSAC Literary Meet @Chandigarh : Gallery
  • Lamtagee Thabal @ Pune : Gallery
  • Abdur Rahaman : Gopal Sharma Award
  • Thokchom Sanatombi : Sangeetratna
  • Mukna Kangjei #2 : Gallery
  • Sory Wahengbam : eRang Actress Profile
  • Saroi Khangba @Imphal : Gallery
  • Featured Front Page Photo 2019 #1: Gallery
  • Maharaj Kumar Priyabarta Singh : Profile
  • Manipuri Calendar for 2019 : Download
  • List of Restricted Holidays for 2019
  • List of Public Holidays for 2019
  • List of General Holidays for 2019
  • SPONSORED ADS