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  1. Article: The importance of adherence in tuberculosis treatment clinical trials and its relevance in explanatory and pragmatic trials

    Vernon, Andrew / Nahid, Payam

    PLoS medicine, 16(12):e1002884

    2019  

    Abstract: SUMMARY POINTS: (*) Adherence to prescribed treatment remains a critical component of clinical trials in tuberculosis (TB) treatment. Recent evidence indicates that adherence strongly influences the outcome of therapy; attention to its quantification and ...

    Abstract SUMMARY POINTS: (*) Adherence to prescribed treatment remains a critical component of clinical trials in tuberculosis (TB) treatment. Recent evidence indicates that adherence strongly influences the outcome of therapy; attention to its quantification and measures to assure its implementation should increase. (*) In the context of a World Health Organization (WHO) Technical Consultation on “Advances in Clinical Trial Design for Development of New TB Treatments,” we reviewed the challenges related to adherence confronting the trials community. (*) We discuss the importance of adherence to therapy in TB clinical trials, consider several definitions and measures of adherence, comment on the standard provided by directly observed therapy (DOT), and briefly review evolving electronic methods for the assessment of adherence. (*) Adherence affects both the outcome of therapy and the risk of acquired drug resistance. Assessment of adherence should consider not only overall adherence but also the timing and intensity of nonadherence. (*) Appropriate methods for pooling and analyzing electronic data on adherence are needed. (*) Better methods are needed for linking information on adherence to individual pharmacokinetics and pharmacodynamics and to individual patient outcomes.
    Keywords Drug therapy ; Clinical trials ; Drug adherence ; Ingestion ; Medical risk factors ; Pharmacokinetics ; Tuberculosis ; Urine
    Language English
    Document type Article
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  2. Article: Keeping phase III tuberculosis trials relevant: Adapting to a rapidly changing landscape

    Phillips, Patrick / Mitnick, Carole / Nahid, Payam

    PLoS medicine, 16(3):e1002767

    2019  

    Abstract: SUMMARY POINTS: (*) The landscape of tuberculosis (TB) treatment has evolved considerably over the last 10 years, necessitating careful consideration of various trial design aspects to ensure that TB phase III trials are still impactful at trial ... ...

    Abstract SUMMARY POINTS: (*) The landscape of tuberculosis (TB) treatment has evolved considerably over the last 10 years, necessitating careful consideration of various trial design aspects to ensure that TB phase III trials are still impactful at trial completion, often more than 4–5 years after initial design. (*) The choice of control is guided by the specific trial objectives, weighing the relative merits of internal validity and external generalizability alongside randomization in making the correct inference. A particular challenge occurs when international or national guidelines change during the trial. (*) Improved execution and relevance of noninferiority trials for TB require greater emphasis on study quality, especially maximizing treatment adherence and minimizing missing outcome data; preferred use of intention-to-treat rather than per-protocol analyses; more careful justification of the margin of noninferiority; and consideration of recent innovations such as a Bayesian approach to noninferiority. (*) Many adaptive trial designs are well suited to optimization of TB treatment. A thorough understanding of type I error rates and biases in treatment effect estimates is critical for regulatory approval and consideration in establishing World Health Organization (WHO) guidelines. (*) Treatment stratification is an area of limited experience for TB trials, and trialists must learn from well-established methodology in other disease areas. (*) Explanatory trials are important for evaluating the efficacy of an intervention under close to ideal conditions. However, no single trial can address all relevant questions about a given therapeutic intervention at one time, and pragmatic trials will be essential for public health and policy decision-making purposes. (*) TB treatment trials today should favor bold and creative approaches that can produce high-quality evidence for effective, patient-centered care made accessible to all 10 million new TB patients, including the half-million with drug-resistant TB (DR-TB), each year.
    Keywords Clinical trials ; Drug therapy ; Extensively drug-resistant tuberculosis ; Multi-drug-resistant tuberculosis ; Phase III clinical investigation ; Treatment guidelines ; Tuberculosis ; Tuberculosis diagnosis and management
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  3. Article ; Online: Promise and Peril of Pretomanid-Rifamycin Regimens for Drug-susceptible Tuberculosis.

    Velásquez, Gustavo E / Nahid, Payam

    American journal of respiratory and critical care medicine

    2023  Volume 207, Issue 7, Page(s) 816–818

    MeSH term(s) Humans ; Tuberculosis/drug therapy ; Antitubercular Agents/therapeutic use ; Nitroimidazoles ; Rifamycins
    Chemical Substances pretomanid ; Antitubercular Agents ; Nitroimidazoles ; Rifamycins
    Language English
    Publishing date 2023-01-10
    Publishing country United States
    Document type Editorial ; Research Support, N.I.H., Extramural ; Comment
    ZDB-ID 1180953-x
    ISSN 1535-4970 ; 0003-0805 ; 1073-449X
    ISSN (online) 1535-4970
    ISSN 0003-0805 ; 1073-449X
    DOI 10.1164/rccm.202212-2262ED
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  4. Article ; Online: Triumph and Tragedy of 21st Century Tuberculosis Drug Development.

    Thwaites, Guy / Nahid, Payam

    The New England journal of medicine

    2020  Volume 382, Issue 10, Page(s) 959–960

    MeSH term(s) Drug Development ; Humans ; Iodine ; Tuberculosis ; Tuberculosis, Multidrug-Resistant ; Tuberculosis, Pulmonary
    Chemical Substances Iodine (9679TC07X4)
    Language English
    Publishing date 2020-03-04
    Publishing country United States
    Document type Editorial ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMe2000860
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  5. Article ; Online: Treatment of Drug-Susceptible Tuberculosis.

    Zha, Beth Shoshana / Nahid, Payam

    Clinics in chest medicine

    2019  Volume 40, Issue 4, Page(s) 763–774

    Abstract: Mycobacterium tuberculosis is a major public health concern and requires prompt treatment. Goals of treatment include curing the individual patient and protecting the community from ongoing tuberculosis transmission. To achieve durable cure, regimens ... ...

    Abstract Mycobacterium tuberculosis is a major public health concern and requires prompt treatment. Goals of treatment include curing the individual patient and protecting the community from ongoing tuberculosis transmission. To achieve durable cure, regimens must include multiple agents given concurrently and in a manner to ensure completion of therapy. This article focuses on preferred regimens of drug-susceptible tuberculosis under current guidelines by the American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America and World Health Organization. In addition, topics including patient centered care, poor treatment outcomes, and adverse effects are also discussed.
    MeSH term(s) Antitubercular Agents/pharmacology ; Antitubercular Agents/therapeutic use ; Humans ; Treatment Outcome ; Tuberculosis/therapy
    Chemical Substances Antitubercular Agents
    Language English
    Publishing date 2019-11-15
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 447455-7
    ISSN 1557-8216 ; 0272-5231
    ISSN (online) 1557-8216
    ISSN 0272-5231
    DOI 10.1016/j.ccm.2019.07.006
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  6. Article ; Online: Advances in clinical trial design for development of new TB treatments: A call for innovation.

    Lienhardt, Christian / Nahid, Payam

    PLoS medicine

    2019  Volume 16, Issue 3, Page(s) e1002769

    Abstract: Christian Lienhardt and Payam Nahid launch the Collection on Advances in Clinical Trial Design for Development of New Tuberculosis Treatments. ...

    Abstract Christian Lienhardt and Payam Nahid launch the Collection on Advances in Clinical Trial Design for Development of New Tuberculosis Treatments.
    MeSH term(s) Antitubercular Agents/pharmacology ; Antitubercular Agents/therapeutic use ; Clinical Trials as Topic/methods ; Humans ; Mycobacterium tuberculosis/drug effects ; Mycobacterium tuberculosis/physiology ; Research Design/trends ; Therapies, Investigational/methods ; Therapies, Investigational/trends ; Tuberculosis/diagnosis ; Tuberculosis/drug therapy ; Tuberculosis/epidemiology
    Chemical Substances Antitubercular Agents
    Language English
    Publishing date 2019-03-22
    Publishing country United States
    Document type Editorial
    ZDB-ID 2185925-5
    ISSN 1549-1676 ; 1549-1277
    ISSN (online) 1549-1676
    ISSN 1549-1277
    DOI 10.1371/journal.pmed.1002769
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  7. Article ; Online: Longitudinal analysis of host protein serum signatures of treatment and recovery in pulmonary tuberculosis.

    Powell, Samantha M / Jarsberg, Leah G / Zionce, Erin L M / Anderson, Lindsey N / Gritsenko, Marina A / Nahid, Payam / Jacobs, Jon M

    PloS one

    2024  Volume 19, Issue 2, Page(s) e0294603

    Abstract: Background: A better understanding of treatment progression and recovery in pulmonary tuberculosis (TB) infectious disease is crucial. This study analyzed longitudinal serum samples from pulmonary TB patients undergoing interventional treatment to ... ...

    Abstract Background: A better understanding of treatment progression and recovery in pulmonary tuberculosis (TB) infectious disease is crucial. This study analyzed longitudinal serum samples from pulmonary TB patients undergoing interventional treatment to identify surrogate markers for TB-related outcomes.
    Methods: Serum that was collected at baseline and 8, 17, 26, and 52 weeks from 30 TB patients experiencing durable cure were evaluated and compared using a sensitive LC-MS/MS proteomic platform for the detection and quantification of differential host protein signatures relative to timepoint. The global proteome signature was analyzed for statistical differences across the time course and between disease severity and treatment groups.
    Results: A total of 676 proteins showed differential expression in the serum over these timepoints relative to baseline. Comparisons to understand serum protein dynamics at 8 weeks, treatment endpoints at 17 and 26 weeks, and post-treatment at 52 weeks were performed. The largest protein abundance changes were observed at 8 weeks as the initial effects of antibiotic treatment strongly impacted inflammatory and immune modulated responses. However, the largest number of proteome changes was observed at the end of treatment time points 17 and 26 weeks respectively. Post-treatment 52-week results showed an abatement of differential proteome signatures from end of treatment, though interestingly those proteins uniquely significant at post-treatment were almost exclusively downregulated. Patients were additionally stratified based upon disease severity and compared across all timepoints, identifying 461 discriminating proteome signatures. These proteome signatures collapsed into discrete expression profiles with distinct pathways across immune activation and signaling, hemostasis, and metabolism annotations. Insulin-like growth factor (IGF) and Integrin signaling maintained a severity signature through 52 weeks, implying an intrinsic disease severity signature well into the post-treatment timeframe.
    Conclusion: Previous proteome studies have primarily focused on the 8-week timepoint in relation to culture conversion status. While this study confirms previous observations, it also highlights some differences. The inclusion of additional end of treatment and post-treatment time points offers a more comprehensive assessment of treatment progression within the serum proteome. Examining the expression dynamics at these later time periods will help in the investigation of relapse patients and has provided indicative markers of response and recovery.
    MeSH term(s) Humans ; Proteome ; Chromatography, Liquid ; Proteomics ; Tandem Mass Spectrometry ; Blood Proteins
    Chemical Substances Proteome ; Blood Proteins
    Language English
    Publishing date 2024-02-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0294603
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  8. Article ; Online: The continued hunt for the elusive standard short regimen for treatment of multidrug-resistant tuberculosis.

    Cegielski, J Peter / Nahid, Payam / Sotgiu, Giovanni

    The European respiratory journal

    2020  Volume 55, Issue 3

    MeSH term(s) Antitubercular Agents ; Clinical Protocols ; Humans ; Rifampin ; Tuberculosis, Multidrug-Resistant
    Chemical Substances Antitubercular Agents ; Rifampin (VJT6J7R4TR)
    Language English
    Publishing date 2020-03-20
    Publishing country England
    Document type Editorial ; Comment
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/13993003.00224-2020
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  9. Article ; Online: Precision-Enhancing Risk Stratification Tools for Selecting Optimal Treatment Durations in Tuberculosis Clinical Trials.

    Imperial, Marjorie Z / Phillips, Patrick P J / Nahid, Payam / Savic, Radojka M

    American journal of respiratory and critical care medicine

    2021  Volume 204, Issue 9, Page(s) 1086–1096

    Abstract: Rationale: ...

    Abstract Rationale:
    MeSH term(s) Adult ; Antitubercular Agents/standards ; Antitubercular Agents/therapeutic use ; Clinical Trials as Topic/standards ; Drug Administration Schedule ; Duration of Therapy ; Female ; Humans ; Male ; Practice Guidelines as Topic ; Precision Medicine/standards ; Rifampin/standards ; Rifampin/therapeutic use ; Risk Assessment/standards ; Tuberculosis, Pulmonary/drug therapy ; Young Adult
    Chemical Substances Antitubercular Agents ; Rifampin (VJT6J7R4TR)
    Language English
    Publishing date 2021-07-20
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1180953-x
    ISSN 1535-4970 ; 0003-0805 ; 1073-449X
    ISSN (online) 1535-4970
    ISSN 0003-0805 ; 1073-449X
    DOI 10.1164/rccm.202101-0117OC
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  10. Article ; Online: Innovative COVID-19 point-of-care diagnostics suitable for tuberculosis diagnosis: a scoping review protocol.

    Yerlikaya, Seda / Holtgrewe, Lydia Marie-Luise / Broger, Tobias / Isaacs, Chris / Nahid, Payam / Cattamanchi, Adithya / Denkinger, Claudia M

    BMJ open

    2023  Volume 13, Issue 2, Page(s) e065194

    Abstract: Introduction: In 2014, the WHO published high-priority target product profiles (TPPs) for new tuberculosis (TB) diagnostics to align end-user needs with test targets and specifications; nevertheless, no TB test meets these targets to date. The COVID-19- ... ...

    Abstract Introduction: In 2014, the WHO published high-priority target product profiles (TPPs) for new tuberculosis (TB) diagnostics to align end-user needs with test targets and specifications; nevertheless, no TB test meets these targets to date. The COVID-19-driven momentum in the diagnostics world offers an opportunity to address the long-standing lack of innovation in the field of TB diagnostics. This scoping review aims to summarise point-of-care (POC) molecular and antigen tests for COVID-19 diagnosis that, when applied to TB, potentially meet WHO TPPs. This summary of currently available innovative diagnostic tools will guide the development of novel TB diagnostics toward the WHO-set targets.
    Methods and analysis: We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension Scoping Reviews recommendations. MEDLINE (via PubMed), bioRxiv, MedRxiv and other publicly available in vitro diagnostic test databases were searched on 23 November 2022. POC antigen or molecular tests developed for SARS-CoV-2 detection that meet the eligibility criteria will be included in the review. Developer description, test description, operation characteristics, pricing information, performance and commercialisation status of diagnostic tests identified will be extracted using a predefined standardised data extraction form. Two reviewers will independently perform the screening and data extraction. A narrative synthesis of the final data will be provided.
    Ethics and dissemination: No ethical approval is required because individual patient data will not be included. The findings will be published in open-access scientific journals.
    MeSH term(s) Humans ; COVID-19/diagnosis ; COVID-19 Testing ; Point-of-Care Testing ; Research Design ; Review Literature as Topic ; SARS-CoV-2 ; Tuberculosis/diagnosis
    Language English
    Publishing date 2023-02-08
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2022-065194
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