Robert S Wallis, MD, FIDSA, FRCPE
TUBERCULOSIS DRUG DEVELOPMENT
I am a physician scientist with training in Internal Medicine and Infectious Diseases, and expertise in the development of biologics, vaccines, and small molecules. I hold academic appointments as Professor of Medicine at Case Western Reserve University and Rutgers-New Jersey Medical School, universities where I previously held full time positions. I have published approximately 140 manuscripts, review articles, and book chapters, mainly in the areas of biomarkers, immunotherapy, and anti-infective drug development. My publication indices are summarized here at Google Scholar. I have particular expertise in the use of innovative models (biological and mathematical) to assess the efficacy of new anti-infective treatments, and to assess the infection risks posed by novel immunosuppressive treatments. I was the first to differentiate soluble TNF receptor from anti-TNF antibodies with regard to granulomatous infection risks. A biomarker I developed, measuring viability of intracellular M tuberculosis in whole blood culture, has been used extensively in TB drug and vaccine development. I have also examined the effects of biologic therapies on TB-induced gene expression profiles in this model as way to predict the infection risks they might pose.
My career shifted from academia to industry in 2004, when I led a successful bid by PPD, a contract research organization, to win what at the time was the largest contract in the history of the US NIAID, managing the international trials of its Division of AIDS. I worked closely with PPD’s business development group to review RFPs for global trials of anti-infectives, vaccines, and biologic therapies, and to prepare scientifically sound proposals for these trials. I came to Pfizer in 2008 as the Therapeutic Area Clinical Lead for Infectious Diseases, where my responsibilities included clinical development of a wide range of antibacterials, antivirals, antifungals, sepsis therapies, and therapeutic antibodies, for which I provided oversight of trial designs, development plans, and regulatory strategies. I also served as clinical lead for the development of sutezolid, an oxazolidinone antimicrobial for the treatment of tuberculosis. Pfizer completed the first study of sutezolid in TB patients.
In 2014 I joined the Aurum Institute as Chief Science Officer, where I am responsible for developing Aurum's program of biomedical research on TB and HIV. Our current projects include studies of host-directed TB therapy funded by the Gates foundation, the German Ministry of Education and Research (BMBF), and US NIH, and studies of individuals who have been heavily exposed to active TB cases but who have remained tuberculin skin test (TST) and IFNg (QFT) negative, funded by NIH. I serve as a member of the editorial board of the Journal of Infectious Diseases and am member of the external scientific advisory board of the German Center for Infection Research (DZIF).
18F-FDG PET/CT scan in the evaluation of host-directed adjunctive TB therapies (TB-HDT). AIDS 2018 (abstract)
Immunologic mechanisms of human resistance to MTB infection. Nature Rev Immunol 2018
Pan-tuberculosis regimens: an argument for. Lancet Respir Med 2018
Mycobacterium tuberculosis in a high tuberculosis burden population. PLoS ONE 2017
Vitamin D as adjunctive host-directed therapy in TB: A systematic review. Open Forum Infect Dis 2016
Safety and immunogenicity of rBCG AERAS-422 in healthy adults. eBioMedicine 2016
Tuberculosis - Advances in drugs, regimens, HDT and biomarkers. Lancet Infect Dis 2016
Mathematical models of tuberculosis relapse and reactivation. Frontiers Microbiol 2016
Sputum culture conversion in new TB regimens. Lancet Respir Med 2015
Early biomarkers and regulatory innovation in MDR-TB. Clin Infect Dis 2015
PLoS ONE 2015
Advancing host-directed therapy for tuberculosis. Nature Rev Immunol 2015
Lancet Respir Med 2015
Corticosteroid effects on sputum culture in pulmonary tuberculosis. Open Forum Infect Dis 2014
PLoS ONE 2014
(PNU-101603) against intracellular Mtb in ex vivo whole blood cultures (WBA) of patients with
pulmonary tuberculosis. AAC 2014
Clin Vaccine Immunol 2013
regression model. PLoS ONE 2013
Tuberculosis biomarkers discovery: developments, needs, and challenges. Lancet Infect Dis 2013
mycobacterial infection in patients treated with TNF inhibitors. PLoS ONE 2013
tuberculosis. Antimicrob Agents Chemother 2012
Rapid evaluation in whole blood culture of regimens for XDR-TB containing PNU-100480 (sutezolid),
TMC207, PA-824, SQ109, and pyrazinamide. PLoS One 2012
SQ109 and PNU-100480 interact to kill M. tuberculosis in vitro. J Antimicrob Chemother 2012
Biologics and infections: lessons from tumor necrosis factor blocking agents. Infect Dis Clin North Am 2011
Biomarker-assisted dose selection for safety and efficacy in early development of PNU-100480 for
tuberculosis. Antimicrob Agents Chemother 2011
Pulmonary infectious complications of tumor necrosis factor blockade. Infect Dis Clin North Am 2010
doses of PNU-100480 in healthy volunteers. J Infect Dis 2010
statement. Eur Respir J 2010
Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice. Lancet 2010
Lancet Infect Dis 2010
Treatment of HIV-related inflammatory cerebral cryptococcoma with adalimumab. Clin Infect Dis 2010
Biomarkers of disease activity, cure, and relapse in tuberculosis. Clin Chest Med 2009
Advances in immunotherapy for tuberculosis treatment. Clin Chest Med 2009
Infectious complications of tumor necrosis factor blockade. Curr Opin Infect Dis 2009
J Infect Dis 2009
Biomarkers for tuberculosis disease status and diagnosis. Curr Opin Pulm Med 2009
Adalimumab treatment of life-threatening tuberculosis. Clin Infect Dis 2009
Biomarkers for tuberculosis disease activity, cure, and relapse. Lancet Infect Dis 2009
Mycobacterial disease attributable to tumor necrosis factor-alpha blockers. Clin Infect Dis 2008
Tumour necrosis factor antagonists: structure, function, and tuberculosis risks. Lancet Infect Dis 2008
Clin Infect Dis 2008
Mathematical modeling of the cause of TB during TNF blockade. Arthritis Rheum 2008
Acquired rifamycin resistance: pharmacology and biology. Expert Rev Anti Infect Ther 2008
J Investig Dermatol Symp Proc 2007
J Investig Dermatol Symp Proc 2007
Persistence, not resistance, is the cause of loss of isoniazid effect. J Infect Dis 2007
Corticosteroids and HIV infection: a review of experience. Curr Opin HIV AIDS 2007
Surrogate markers to assess new therapies for drug-resistant TB. Expert Rev Anti Infect Ther 2007
differences in the risk for developing granulomatous infection. Semin Arthritis Rheum 2006
AIDS Res Hum Retroviruses 2005
Anti-tuberculosis treatment and infliximab. Respir Med 2005
Reconsidering adjuvant immunotherapy for tuberculosis. Clin Infect Dis 2005
Reactivation of latent granulomatous infections by infliximab. Clin Infect Dis 2005
Am J Respir Crit Care Med 2005
Semin Arthritis Rheum 2005
Infect Immun 2005
Sutton's law. Int J Tuberc Lung Dis 2005
Mechanisms of action of TNF antagonist and granulomatous infections. J Rheumatol 2004
Granulomatous infections due to tumor necrosis factor blockade & Correction. Clin Infect Dis 2004
whole-blood culture. Antimicrob Agents Chemother 2004
TB chemotherapy: antagonism between immunity and sterilization. Am J Respir Crit Care Med 2004
counts of 200 to 700 mm-3. J Acquir Immune Defic Syndr 2003
Whole blood bactericidal activity during treatment of pulmonary tuberculosis. J Infect Dis 2003
tuberculosis. Clin Diagn Lab Immunol 2002
Curr Opin Pulm Med 2001
A whole blood bactericidal assay for tuberculosis. J Infect Dis 2001
potential surrogate marker in tuberculosis chemotherapy trials. Antimicrob Agents Chemother 2001
alpha (TNF-alpha) and IL-6 but not anti-inflammatory cytokine IL-10 in mycobacterial antigen-
stimulated monocytes-implications for pathogenesis. Clin Exp Immunol 2001
Predicting the outcome of therapy for pulmonary tuberculosis. Am J Respir Crit Care Med 2000
virus-infected ugandan adults with newly diagnosed pulmonary tuberculosis. J Infect Dis 2000
monocytes: possible link with disease pathogenesis in tuberculosis. Clin Exp Immunol 2000
replacement of low-usage codons. Infect Immun 2000
mechanisms and modulation with therapy. J Infect Dis 1999
Drug tolerance in Mycobacterium tuberculosis. Antimicrob Agents Chemother 1999
Pentoxifylline in HIV-TB: safety at 4 years. J Infect Dis 1998
in pulmonary tuberculosis treatment. J Infect Dis 1998
active pulmonary tuberculosis. J Infect Dis 1998
Clin Diagn Lab Immunol 1998
avium complex bacteremia in advanced AIDS. J Infect Dis 1998
blood mononuclear cells from patients with Kaposi's sarcoma in Uganda. J Infect Dis 1997
Tuberculosis vaccines: how close to human testing? Tuber Lung Dis 1997
suppression/anergy. Tuber Lung Dis 1997
Immune activation, allergic drug toxicity and mortality in HIV-positive tuberculosis. Tuber Lung Dis 1996
randomized, controlled trial. J Infect Dis 1996
Mycobacterium tuberculosis and synergism with fibronectin. J Clin Invest 1996
Am J Respir Crit Care Med 1996
New approaches to identification of antigens of Mycobacterium tuberculosis. Infect Agents Dis 1996
Guérin in purified protein derivative (PPD)-positive individuals. J Immunol 1995
Res Microbiol 1993
protein of Mycobacterium tuberculosis. Infect Immun 1993
elevated beta 2-microglobulin in HIV-1-associated tuberculosis. J Infect Dis 1993
regulating viral replication. Res Microbiol 1992
Duration of fever during treatment of infective endocarditis. Medicine (Baltimore) 1992
PROBIT: a computer program analysis. J Immunol Methods 1991
cytokine production, and cytotoxicity for mononuclear phagocytes. Infect Immun 1991
Direct mitogenic properties of interleukin-1. J Lab Clin Med 1991
T cell activation by mycobacterial antigens in inflammatory synovitis. Cell Immunol 1991
Human immune response to Mycobacterium tuberculosis antigens. Infect Immun 1991
Proc Natl Acad Sci USA 1990
Cell membrane is a major locus for UV B-induced alterations in accessory cells. J Clin Invest 1990
More on zidovudine and HIV-related thrombocytopenia. N Engl J Med 1989
Identification of antigens of M tuberculosis using human monoclonal antibodies. J Clin Invest 1989
Immunologic aspects of mycobacterial infections. Rev Infect Dis 1989
Mycobacterium bovis BCG and mycobacterial antigens. Infect Immun 1988
The immunology of tuberculous pleurisy. Semin Respir Infect 1988
mature human neutrophils. Blood 1988
Clin Exp Immunol 1987
Clinical Immunology of Tuberculosis. In: Davies P (ed): Clinical Tuberculosis. London, CRC Press. 2014.
Assessment of whole blood bactericidal activity in the evaluation of new TB drugs. In: Donald PR, van
Helden (eds): Antituberculosis Chemotherapy. Progress in Respiratory Research. Basel, Karger. 2011
Immunotherapy of tuberculosis. In: Schaaf S and Zumla A (eds): Tuberculosis: A comprehensive clinical
reference. Saunders/Elsevier 2009.
Report of the joint TDR/EC expert consultation to evaluate the potential roles of biomarkers in the
management of HIV-infected and HIV-uninfected patients with tuberculosis. WHO, Geneva 2008.
Report of the expert consultation on immunotherapeutic interventions for tuberculosis.
Nova Science Publishers 2006.
In vitro models to study immune control of intracellular M. tuberculosis infection.
In: S. Cole, K. Eisenach, D. McMurray and W. Jacobs (eds): Tuberculosis and the Tubercle
Bacillus. ASM Press, 2005..
Immunotherapy of tuberculosis and other mycobacterial infections. In Jacobson J,
Immunotherapy of infectious diseases, Humana Press, 2002.
Tuberculin and anergy panel skin testing. In Tan JS (ed): Expert's Guide to the Management of Common
Infectious Diseases. American College of Physicians, Philadelphia.
Immunology of M. tuberculosis and other mycobacteria. In: Chmel H (ed): Pulmonary Infections and
Immunity, Plenum Press, NY 1994.
Regulation of the immune response to M. tuberculosis, in Ayoub EM, Cassell GH, Branche WC, Henry TJ
(eds): Microbial determinants of virulence and host response. ASM Press, Washington, DC 1990.
FIDSSA Annual meeting, "21st Century development of pan-TB regimens", Cape Town SA, 2017
FDA workshop, "Predicting required duration of new TB regimens, Rockville MD, 2017
NIH workshop, "Host-directed therapy for CNS tuberculosis", Rockville MD, 2017
UCT Lung Institute, "Host-directed therapy for M/XDR-TB", Cape Town SA, 2017
NIH/WGND workshop, "21st Century paths to oxazolidinone pan-TB regimens", Rockville MD, 2016
NIH/BMGF Workshop, "Resistance to TB infection in S African miners", Rockville MD, 2016
NIH Workshop, "Endpoints in TB HDT clinical trials", Rockville MD, 2016
Gates Grand Challenges, "Personalized treatment of tuberculosis", London UK, 2016
INTERTB, "Host directed therapy of tuberculosis", London UK, 2016
ATS, "Host directed therapy of tuberculosis", San Francisco CA, 2016
ICID, "Advancing treatment of MDR-TB" and session chair, Hyderabad India, 2016
Gates Grand Challenges, "Host-directed therapy for tuberculosis", Beijing China 2015
SIgN symposium, "Host-directed therapy for tuberculosis", Singapore 2015
K-RITH symposium, "Host-directed therapy for tuberculosis", Durban South Africa, 2014
WHO Task Force, "Advancing regimens for MDR-TB", Washington DC, 2014
NIH workshop, "Advancing host-directed therapy for tuberculosis", Rockville MD, 2014
PanACEA, "Development of sutezolid regimens for tuberculosis", Dakar Senegal, 2013
Aurum Institute, "Host-directed therapies for tuberculosis", Johannesburg South Africa, 2013
CURE-TB Symposium and ITRC Scientific Retreat, "Oxazolidinone regimens for MDR-TB" and “PK-PD of sutezolid intracellular mycobactericidal activity” Chengdu China 2013
Critical Path for TB Regimens Annual Workshop, "Development of sutezolid-containing TB regimens", Washington DC, 2013
TB pharmacology conference, "PK/PD modeling of sutezolid", Denver CO, 2013
Gordon Conference on TB Drug Development, “Two month culture status and treatment duration as predictors of relapse risk”, Lucca (Barga) Italy, 2013
UCL TB Day Program, “TB Biomarkers”, London UK, 2013
Int’l Meeting on Childhood TB, “TB Diagnostics and Biomarkers” and “TB Drug Development Today”, Padua Italy, 2013
32nd semi-annual CDC TBTC meeting, “Accelerating development of new TB regimens”, Atlanta GA, 2012
Asia REACH Roundtable Meeting, “Best practices for LTBI screening and treatment prior to anti-TNF treatment”, Hong Kong, 2012
WHO Task Force for the Introduction of New TB Drugs and Regimens, “Update on sutezolid”, Geneva Switzerland, 2012
EUROMEDNET-TB Biomarkers Workshop, “TB Biomarkers: A drug developer’s perspective”, Marrakech Morocco, 2012
5th International workshop on Clinical Pharmacology of Tuberculosis Drugs, “Oxazolidinones for Tuberculosis”, San Francisco, 2012
Gates Foundation Special Program on TB Translational Pharmacology, “Alternatives to EBA”, Washington DC, 2012
UC San Diego 3rd Global Symposium on IGRAs, “Biologic therapies and reactivation of LTBI”, Waikoloa Hawaii, 2012
Critical Path for TB Regimens, 2nd annual meeting, “Update on PNU-100480”, Arlington VA, 2011
ACTG Leadership Retreat, TB Transformative Science Group, “Update on PNU-100480 and the whole blood model”, Washington DC, 2011
STOP-TB Working Group on New Drugs, “Update on PNU-100480”, Lille France, 2011
II Encontro sobre Pesquisas em Tuberculose na Bahia, “Biomarkers for tuberculosis: Near-term and distant horizons” and "Biomarker acceleration of development of PNU-100480 for TB", Salvador Brazil, 2011
Gordon Research Conference on TB Drug Development, “PNU-100480: Strategies for new TB drugs”, Lucca (Barga) Italy, 2011
Informa Life Sciences, “Translational Research in Tuberculosis”, Berlin Germany, 2011
NIH Conference on TB Biomarkers, keynote address, Bethesda MD, 2011
World PK/PD Summit, “The Role of Biomarkers to Reduce Risks in Early Development: Lessons from Tuberculosis”, Boston MA, 2011
University of Cape Town, “TB risks of TNF blockade: Lessons for biologist and clinicians”, Cape Town South Africa, 2011
STOP TB/World Conference Lung Health, “PNU-100480 update”, Berlin Germany, 2010
New York Medical College, “Biomarkers for Tuberculosis”, Valhalla NY, 2010
Kilimanjaro Medical Research Center, "Biomarker acceleration of early TB drug development" and "Infectious Complications of TNF Blockade", Moshi Tanzania, 2010.
Netherlands Society for Microbiology Annual Meeting, “Infectious Complications of TNF blockade”, Arnhem Netherlands, 2010.
Joint GCC and WHO/TDR workshop on priority setting for TB/HIV research, “Optimising TB diagnostics in the era of HIV/AIDS”, Riyadh Saudi Arabia, 2010.
Genopole International Conference on Biomarkers, “Biomarkers for Tuberculosis”, Paris France, 2009.
Hungarian Academy of Science, “Infectious complications of TNF blockers”, Budapest Hungary, 2009.
TB Alliance, “Symposium: Recent Advances in TB Drug Development”, in IUATLD 40th Union Conference on Lung Health, Cancun Mexico, 2009.
Global Fund AIDS TB Malaria, Lancet TB Series Theme Review, Geneva Switzerland, 2009.
RESIST-TB, “Workshop on TB trials design”, Amsterdam Netherlands, 2009.
ICAAC, “Infectious complications of TNF blockade”, San Francisco CA, 2009.
FDA workshop, “Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis”, Silver Spring MD, 2009.
IAS International Meeting. “Anti-TNF treatment of IRIS/PR”, in INSHI program, Cape Town SA, 2009.
Danish Society of Infectious Medicine Annual Meeting, “Infectious Complications of Anti-cytokine Therapy, Hindsgavl Castle, Denmark, 2009.
Arizona Infectious Disease Society Annual Meeting, “Infectious Complications of TNF Blockade”, Sedona AZ, 2009.
Keystone Conference, Tuberculosis: Biology, Pathology and Therapy. “Targeted Immunotherapy for TB: Lessons from biologics”, in program of the Stop TB Working Group for New Drugs. Keystone CO, 2009.
Wyeth, "Infectious Complications of Anti-TNF Therapies", Bogota, Medellin, Cali, Barranquilla and Bucaramanga, Colombia 2008
IDSA Annual Meeting, “Infectious Complications of Anti-TNF Therapies”, Washington DC, 2008. .
1st International Conference on Drug Discovery and Development, “Assessing the infection risks of new anti-inflammatory therapies”, Dubai, 2008. Invited lecturer and session chair.
Wyeth International Summit, “Infectious Complications of TNF Blockade: Where do we stand now?”, Munich Germany, 2007.
Annual Meeting, Saskatoon Rheumatological Society, “Infectious Complications of TNF Blockade” Saskatchewan Canada, 2006.
IDSA Annual Meeting, “Infectious Risks of TNF blockade”, Toronto Canada, 2006.
Gene Therapy Press, “Immunotherapy of tuberculosis”, 9th International Conference on Drug and Gene-based Therapeutics, Crete Greece, 2006
Wyeth, "Infectious risks of TNF blockade", Vancouver, Ottawa, Toronto, Quebec City, and Montreal, Canada, 2006
Johns Hopkins University Division of Infectious Diseases, “Differential effects of TNF blockade on mycobacterial immunity”, Baltimore MD, 2006
Wyeth, “Differential effects of TNF blockade on mycobacterial immunity”, Philadelphia PA, 2006.
Amgen, “TNF and human tuberculosis”, Thousand Oaks CA, 2005.
Global Alliance for TB Drug Development, “Whole blood bactericidal activity to assess new drugs for tuberculosis”, London UK, 2005.
IUATLD International Annual Meeting, “Immunotherapy of tuberculosis”, Paris France, 2004.
World Conference on Dosing of Anti-infectives, “Tuberculosis therapy: PK/PD, resistance, and persistence”, Nuremburg, Germany, 2004.
Mount Sinai School of Medicine, “Granulomatous infections and TNF antagonists”, New York NY, 2004.
Cleveland Clinic Foundation, “Granulomatous infections and TNF antagonists”, Cleveland OH, 2004.
Amgen, "International Conference on TNF Antagonists’ Mechanisms ", Montreal Canada, 2003.
Amgen, "TNF inhibition and infection risk", Thousand Oaks CA, 2003.
University of North Carolina, "AIDS and Tuberculosis: Challenges and Promises", Chapel Hill NC, 2003.
ACTG National Meeting, "Immunity and relapse in tuberculosis", Arlington VA, 2003
Amgen, “TNF inhibitors mechanisms of action”, New York, 2003.
South Africa TB Clinical Trials Consortium, "Advanced Technology Laboratories for Tuberculosis", Cape Town SA, 2003
Texas A&M University, "Models to evaluate TB vaccines and therapeutics", College Station TX, 2002
Astra Zeneca, "Improving therapy for tuberculosis", Bangalore India, 2002
Sequella Foundation, "A model to evaluate TB therapy", Washington DC 2001
Global Alliance for TB Drug Development, "Surrogate markers for TB therapy", Paris France 2001
Gordon Conference on TB Drug Development, , "A whole blood bactericidal assay for TB pathogenesis and treatment", New London NH 2001
Russian Academy of Medicine Conference on Nosocomial Tuberculosis, "A whole blood bactericidal assay for TB pathogenesis and treatment", Moscow Russia 2001
Astra Zeneca, "Surrogate markers for tuberculosis", Bangalore India 2001
NY Medical College, Research Conference, "Predicting TB relapse", Valhalla NY 2000
Beth Israel Hospital, ID Grand Rounds, "Predicting TB relapse", New York NY 2000
ICAAC, "Microbiologic monitoring of tuberculosis for therapeutic endpoints", Toronto Canada 2000
Cleveland Clinic Foundation, "The biology of granuloma formation", Cleveland OH 2000
Emilio Ribas Hospital of Infectious Diseases, “TB relapse: Immunologic and microbiologic factors”, Sao Paulo Brazil 1999
NIAID Forum on Therapy of MDR TB, “A whole blood bactericidal assay for tuberculosis”, Bethesda MD 1999
Imperial College of Medicine, "Drug tolerance in M. tuberculosis", London UK 1999
Institute for Human Virology, "Immune Reconstitution in HIV Infection", Bethesda MD 1999
Korea-US Forum, Fogarty Institute NIH, "Drug tolerance in M. tuberculosis", Bethesda MD 1999
Int. Soc. Tropical Medicine, Annual Meeting,, "Cytokines in HIV/TB pathogenesis", San Juan PR 1998
IBC Conference on Tuberculosis, "Predicting the outcome of therapy for pulmonary tuberculosis", Washington DC 1998
US-Japan Cooperative Medical Science Program, Annual Meeting, "Predicting the outcome of therapy for pulmonary tuberculosis", Osaka Japan 1998
Korean National Tuberculosis Hospital, "Predicting the outcome of therapy for pulmonary tuberculosis", Masan Korea 1998
CWRU Dept Biology, “Cytokines in HIV TB copathogenesis”, Cleveland OH 1997
NMHCC Biotechnology Conference Division, "Tuberculosis: cytokines in HIV/TB pathogenesis", Washington DC 1997
International Union Against Tuberculosis, “Antigen detection for TB diagnosis: applicability to low income countries”, Paris France 1997
CWRU/Makerere University Research Collaboration, “Immune activation and survival in HIV+ tuberculosis: opportunities for intervention”, Kampala Uganda 1997
Cleveland Clinic Foundation, “Immunology of tuberculosis”, Cleveland OH 1997
Litigation Management, Inc., “Chronic fatigue syndrome - an Infectious Disease perspective”, Cleveland OH 1995
Infectious Disease Society of America, “AIDS and tuberculosis: Prospects for interventions from an immunologic perspective”, IDSA Annual Meeting, Orlando FL 1994
Boston University/ Boston City Hosp., “Monocyte activation, tuberculosis and HIV”, BCH Division of Infectious Diseases, Boston MA 1993
Makerere University, “HIV and tuberculosis”, Kampala Uganda 1993
University of Akron, “AIDS in Uganda”, Akron OH 1993
Fairview General Hospital, “Current issues in tuberculosis”, Cleveland OH 1992
American Society for Microbiology, “Detection of mycobacterial antigens using human monoclonal antibodies”, ASM Annual Meeting, Division U (mycobacteriology), New Orleans LA 1991
Ohio State University, “Current approaches to diagnosis and management of HIV infection”, Columbus OH 1987
TB RELAPSE RISK CALCULATOR
The calculator to the right predicts TB relapse risk based on the proportion with positive cultures on solid medium after 2 months of treatment and the total duration of treatment. The risk of >10% relapses assumes a single phase 3 trial with 680 subjects per arm. The database now includes regimen-level outcome data from studies involving 11766 patients including the TBRU treatment shortening trial, 2 trials of a clofazimine-containing 12 month MDR-TB regimen conducted in Niger and Cameroon, as well as data from REMox, RIFAQUIN, and OFLOTUB. The overall correlation between observed and predicted relapse rates in the validation dataset is shown in the figure below. The predictions are all the more remarkable in that relapses in the fluoroquinolone trials were predicted without prior FQ data; those for the TBRU study, without prior host data: and those for the MDR-TB trials without prior data for clofazimine or MDR-TB.
Please cite as follows:
Wallis RS, Wang C, Meyer D, Thomas N. Month 2 culture status and treatment duration as predictors of tuberculosis relapse risk in a meta-regression model. PLoS One. 2013 Aug 5;8(8):e71116.
Wallis RS, Peppard T, Hermann D. Month 2 culture status and treatment duration as predictors of recurrence in pulmonary tuberculosis: model validation and update. PLoS One. 2015 Apr 29;10(4):e0125403.