The Correlation of Mineral Density of Jaws With Skeletal Bone and Its Effect on Implant Stability in Osteoporotic Patients: A Review of Patient-Based Studies.

Osteoporosis has been an enigma in terms of the administration of implant therapy. It has been implicated as a cause of implant failure as it directly affects the quality of the bone. The diagnosis of osteoporosis is mainly done by measuring skeletal bone mineral density (BMD). During implant therapy, the BMD of jaws can be evaluated on routine orthopantomogram (OPG) or cone beam CT (CBCT). The various advantages of CBCT include establishing a correlation between skeletal bone density and bone density of jaws and estimating its effect on implant stability in osteoporotic patients, which in turn will help in determining the prognosis of the implant in osteoporotic patients. This review is a summary of all patient-related studies conducted in the mentioned context of implant placement in patients with osteoporosis, treatment modalities, and prognosis. We performed a search of relevant articles on Google Scholar, PubMed, and Cochrane, which yielded a total of 25 articles for full-text reviews. After excluding some articles based on the exclusion criteria, a review was conducted along with a pilot study on implant placement in osteoporotic patients. Regional bone density can be a helpful parameter in predicting primary implant stability and it can be a useful indicator of skeletal BMD. With a careful evaluation of BMD, dental implants can be placed in patients with osteoporosis with a better prognosis for the treatment.

Decision Analysis: Omadacycline Relative to Moxifloxacin Among Hospitalized Community-Acquired Bacterial Pneumonia Patients at Risk of Clostridioides difficile Infection.

BACKGROUND AND OBJECTIVE: Omadacycline is an aminomethylcycline antibiotic approved in the USA as once-daily intravenous/oral monotherapy for adults with community-acquired bacterial pneumonia (CABP). Omadacycline demonstrated noninferiority to the fluoroquinolone moxifloxacin in a phase III CABP trial; adverse-event rates were similar between treatment groups except for Clostridioides difficile infection (CDI), which occurred in 2% of moxifloxacin-treated patients and 0% of patients on omadacycline. Conceptual healthcare-decision analytic models were developed to better understand the economic implications of antibiotic selection and CDI risk in acute-care facilities. METHODS: A conceptual healthcare-decision analytic model was created to estimate incremental costs associated with treating 100 hospitalized CABP patients with an initial 5-day inpatient regimen of omadacycline instead of moxifloxacin. The underlying model assumption was that treatment with omadacycline has the potential to reduce CDI events relative to moxifloxacin. The model included excess costs associated with each treatment group from admission through discharge. Attributable CDI cost per case in the moxifloxacin group varied from $15,000 to $45,000 (US$). Omadacycline acquisition cost was $300-600/day for 5 days. RESULTS: At a CDI attributable cost per case of $30,000 (base-case analyses), the incremental treatment cost (US$) per 100 patients ranged from $300,000 to $- 120,000 (cost savings). The excess CDI incidence in moxifloxacin-treated patients would need to be 5-10% for omadacycline to be cost-saving, assuming the attributable CDI cost is approximately $30,000. CONCLUSION: Targeted omadacycline use may reduce economic burden associated with hospitalized CABP patients treated with moxifloxacin if it can reduce excess cases of moxifloxacin-associated CDI.

An appraisal of bone resorption in completely edentulous diabetic and nondiabetic patients at prospective implant site in anterior mandible using digital volumetric tomography and its correlation with glycemic control: A case-control study.

PURPOSE: The prospective case-control study aimed at comparing bone resorption at prospective implant sites in anterior mandible between diabetic and nondiabetic patients using digital volumetric tomography (DVT) and establishes a correlation between glycemic control and residual ridge resorption. MATERIALS AND METHODS: Twenty apparently healthy and 20 type 2 diabetic edentulous male patients between the age group of 55-65 years providing with written consent were recruited in the present study. First-time denture wearers were considered who were edentulous for at least 1 year. Glycated hemoglobin (HbA1c) analysis of all individuals were done to affirm the diagnosis and quantify glycemic control. DVT of all the individuals were performed and bone height was determined at 5 prospective implant sites were determined, on the same scans Wical and Swoope method was used to determine the residual ridge resorption on the right and left side of mandible for all the individuals. The data wer tabulated and descriptive and analytical statistics were performed to compare bone resorption between diabetic and nondiabetic groups. Pearson's correlation was carried out to establish correlation between glycemic control and residual ridge resorption. RESULTS: There was no statistical difference between the bone height measurements at prospective implant sites between diabetic and nondiabetic groups. The residual ridge resorption was more in diabetics when compared to nondiabetics, and a significant moderate negative correlation existed between the glycemic control and residual ridge resorption on left (r = -0.541; P ≤ 0.001) and right (r = -0.408; P = 0.009) side of the mandible. CONCLUSION: It can be concluded from the present study that bone resorption at prospective implant sites is statistically similar in diabetics when compared to nondiabetics. Patients with poor glycemic control show increased residual ridge resorption.

Budget Impact Model of Omadacycline on Replacing a Proportion of Existing Treatment Options Among Patients Who Present to the Emergency Department with Acute Bacterial Skin and Skin Structure Infections.

BACKGROUND: Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). It has broad-spectrum activity against common causative pathogens of ABSSSI, including methicillin-resistant Staphylococcus aureus. Omadacycline has been shown to be noninferior to linezolid for the treatment of adults with ABSSSI across 2 phase 3 clinical trials. To date, no studies have assessed the budget impact for omadacycline in the treatment of ABSSSI. OBJECTIVES: To estimate the potential budget impact of introducing omadacycline as a treatment option in patients who present to the emergency department (ED) with ABSSSI from the hospital perspective (Medicare payer) in the United States. The ED's and observation units were assumed to be hospital-owned. METHODS: The base case of this decision model-based analysis was conducted from the perspective of a hospital for a theoretical cohort of 1 million covered Medicare members over a 3-year time horizon. Scenario analyses included the economic impact of (1) shifting inpatient care to the outpatient setting with omadacycline and (2) reducing hospital length of stay (LOS) among hospitalized patients with omadacycline IV to oral therapy relative to the current inpatient standard of care. Costs are presented in 2017 US dollars with no adjustments for inflation, based on the cost model estimates. RESULTS: The annual total incremental cost following the introduction of omadacycline as a treatment of ABSSSI was $11,168, $39,918, and $88,777 in years 1, 2, and 3, respectively. The incremental cost per member treated (cost per case) rose by $0.49, $1.74, and $3.86 over 3 years. Reducing hospital LOS by 1 day among hospitalized patients with omadacycline resulted in incremental costs of $4311, $15,231, and $33,919 in years 1, 2, and 3, respectively. Under the assumption that patients may be discharged sooner when an oral formulation of the same drug with which they are being treated is available, reducing hospital LOS by 2 days reduced costs by $2546, $9455, and $20,939 in years 1, 2, and 3, respectively. Shifting inpatient care to the outpatient setting with omadacycline reduced costs by $38,777, $139,885, and $310,784 in years 1, 2, and 3, respectively. CONCLUSION: This hypothetical, model-based study determined that omadacycline would result in a modest increase in total cost over 3 years when introduced as a treatment for ABSSSI in adults who present to the ED for their care.

Budget Impact of Omadacycline for the Treatment of Patients with Community-Acquired Bacterial Pneumonia in the United States from the Hospital Perspective.

BACKGROUND: Community-acquired bacterial pneumonia (CABP) is an acute, lower respiratory bacterial infection. Despite advances in medical care, CABP remains associated with considerable morbidity, mortality, and healthcare costs; early empiric treatment is recommended by the Infectious Diseases Society of America and by the American Thoracic Society. Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adult patients with CABP. OBJECTIVE: To estimate the budget impact of introducing omadacycline as a treatment option among patients with suspected or documented CABP from a US hospital perspective. METHODS: A budget impact model was developed in Microsoft Excel® 2010. Population, clinical, and cost inputs were based on the available literature, clinical trial data, and real-world evidence databases. Emergency departments and observation units were assumed to be hospital-owned as part of the analyses. Sensitivity analyses assessed the impact of key parameters on the model results, and scenario analyses were explored to analyze the budget impact of reducing length of hospital stay and avoiding hospitalization. RESULTS: The introduction of omadacycline as a treatment resulted in a total budget increase of $20,643 over 3 years. This increase was mainly attributed to treatment acquisition costs. In a scenario where the length of hospital stay was reduced by 1 day (under the assumption that an antibiotic with IV and oral formulations can facilitate earlier discharge from inpatient care), the 3-year total budget decreased to $2384; reducing the hospital stay by 2 days resulted in 3-year cost-savings of $15,875. Shifting inpatient care to the outpatient setting with omadacycline resulted in 3-year cumulative cost-savings of $112,843. CONCLUSION: This is the first omadacycline budget impact model developed for adult patients with suspected or documented CABP. The model projected a modest budget increase with the introduction of omadacycline, mainly due to treatment acquisition costs.

Cost-effectiveness analysis of ribociclib plus letrozole versus palbociclib plus letrozole in the United Kingdom.

OBJECTIVE: To evaluate the cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole in post-menopausal women with hormone receptor positive (HR+) and human epidermal growth receptor 2 negative (HER2-) advanced breast cancer from a UK payer perspective. METHODS: A cohort-based partitioned survival model was developed to evaluate the cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole in post-menopausal women with HR+/HER2- advanced breast cancer over a lifetime horizon. The analysis was carried out from a National Health Services and Personal Social Services perspective, and results are presented in incremental costs per quality adjusted life years. Clinical data from three randomized controlled trials (MONALEESA-2, PALOMA-1 and PALOMA-2 studies) were used, and supplemented with available real world evidence. Costs categories comprised of drug acquisition, medical management, and treatment of adverse events. Healthcare resource utilization data were identified from literature and unit costs sourced from secondary sources. Utility values were derived from MONALEESA-2 study and were supported with values identified from literature. Both deterministic and probabilistic analyses were carried out to assess uncertainty. RESULTS: In the base case, treatment with ribociclib plus letrozole increased mean progression free survival (PFS) by 4.1 months and overall survival by 5.0 months compared to palbociclib plus letrozole. Further, treatment with ribociclib plus letrozole resulted in cost-savings of £8464 and incremental QALYs of 0.261, demonstrating that treatment with ribociclib plus letrozole is dominant to treatment with palbociclib plus letrozole. The probabilistic analysis also yielded mean cost-savings of £7914 and mean QALY gain of 0.273. At willingness-to-pay threshold of £30 000 per QALY, treatment with ribociclib plus letrozole had a 92% probability of being cost-effective compared to palbociclib and letrozole. CONCLUSIONS: The results of the analysis demonstrate that ribociclib plus letrozole treatment is both cost-saving and a cost-effective option amongst the available cyclin dependent kinase 4/6 inhibitors for the treatment of post-menopausal women with advanced breast cancer. The biggest driver of the cost savings were the lower acquisition costs of ribociclib.

Budget impact of including ribociclib in combination with letrozole on US payer formulary: first-line treatment of post-menopausal women with HR+/HER2- advanced or metastatic breast cancer.

OBJECTIVES: The combination of a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor with the aromatase inhibitor letrozole is a safe and effective alternative to letrozole monotherapy for first-line hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This study evaluates the budget impact of using the CDK 4/6 inhibitor ribociclib plus letrozole as a first-line treatment option for postmenopausal women with HR+/HER2- advanced breast cancer, from a United States (US) payer perspective. METHODS: A cohort-based budget impact model was used to calculate the incremental cost of introducing ribociclib plus letrozole over three years for the target population. The analysis compared two scenarios: treatment options excluding or including ribociclib plus letrozole. Market shares were derived from market research and the assumption was the introduction of ribociclib plus letrozole would only displace existing CDK-based therapies. Treatment duration was based on the median time to treatment discontinuation or median progression-free survival for first-line treatment, and on clinical trial data for second- and third-line treatment. Acquisition costs were based on wholesale acquisition costs and considered co-payment. Costs for drug administration and monitoring, subsequent therapy, and relevant adverse events were included. RESULTS: Of 1 million insured members, 263 were eligible for CDK 4/6 inhibitor treatment. Cumulative total savings with ribociclib plus letrozole were $3.01M over three years, corresponding to a cumulative incremental cost saving of $318.11 per member treated per month. CONCLUSIONS: In the US, ribociclib plus letrozole represents a cost-saving first-line treatment option for postmenopausal women with HR+/HER2- advanced breast cancer.

Cost-Effectiveness of Ribociclib plus Letrozole Versus Palbociclib plus Letrozole and Letrozole Monotherapy in the First-Line Treatment of Postmenopausal Women with HR+/HER2- Advanced or Metastatic Breast Cancer: A U.S. Payer Perspective.

BACKGROUND: U.S. regulatory approvals of the cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors ribociclib and palbociclib as add-ons to letrozole greatly enhance the prospects for treating postmenopausal women with hormone receptor-positive (HR+)/human epidermal receptor 2-negative (HER2-) advanced or metastatic breast cancer. Clinical trials have established that the combination of a CDK 4/6 inhibitor with letrozole can significantly improve progression-free survival (PFS) versus letrozole monotherapy and is safe and well tolerated. Cost-effectiveness studies are required to inform payers and clinical decision makers on the money value of combination treatment in clinical practice. OBJECTIVE: To evaluate the cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole and versus letrozole monotherapy in the first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer from a U.S. private third-party payer perspective. METHODS: A partitioned survival model including 3 health states (progression free, with either overall response or stable disease; progressed disease; and death) simulated lifetime costs and outcomes over a 40-year lifetime horizon with a 1-month cycle length. Clinical efficacy data (PFS and overall survival [OS]) were derived from a phase III trial of ribociclib plus letrozole (MONALEESA-2; NCT01958021), a phase II trial of palbociclib plus letrozole (PALOMA-1; NCT00721409), and a Bayesian network meta-analysis. Health care costs included drug acquisition and monitoring, disease management, subsequent therapies, and serious drug-related adverse events. Effectiveness was measured in life-years, derived from survival projections, and in quality-adjusted life-years (QALYs), calculated from time spent in each state combined with health-state utility values. A one-way deterministic sensitivity analysis explored the impact of uncertainty in key model parameters on results, and probabilistic uncertainty was assessed through a Monte Carlo probabilistic sensitivity analysis. RESULTS: Ribociclib plus letrozole was dominant versus palbociclib plus letrozole, with a cost saving of $43,037 and a gain of 0.086 QALYs. Compared with letrozole monotherapy, ribociclib plus letrozole was associated with an incremental cost of $144,915 and an incremental QALY of 0.689, equating to an incremental cost-effectiveness ratio of $210,369 per QALY. Key model drivers included OS HRs for palbociclib plus letrozole versus letrozole and for ribociclib plus letrozole versus letrozole, the PFS HR for palbociclib plus letrozole versus letrozole, PD health-state costs, utility of response, and cost discount rate. The probabilities that ribociclib plus letrozole was cost-effective versus letrozole at thresholds of $50,000, $100,000 and $200,000 per QALY gained were 1.6%, 6.3%, and 50.5%, respectively. CONCLUSIONS: In the United States, ribociclib plus letrozole is a cost-effective alternative to palbociclib plus letrozole for the first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. Ribociclib plus letrozole is also cost-effective versus letrozole monotherapy at willingness-to-pay thresholds greater than $198,000 per QALY (for probabilistic analysis). DISCLOSURES: Funding for this study was provided by Novartis, which manufactures ribociclib and provided input on the study design and data collection, analysis, and interpretation. Mistry, May, Suri, and Young are employees of PAREXEL. Tang, Mishra, D. Bhattacharyya, and Dalal are employees of Novartis. S. Bhattacharyya was an employee of Novartis during the study period. Tang and Dalal hold stock in Novartis. Brixner, Oderda, and Biskupiak were paid by Millcreek Outcomes Group as consultants for work on this project. Brixner has also consulted for AstraZeneca, UCB, Regeneron, and Abbott.

Rapid detection of TEM-type extended-spectrum ß-lactamase (ESBL) mutations using lights-on/lights-off probes with single-stranded DNA amplification.

Rapid identification of specific TEM-type ß-lactamase genes in bacterial infections is important for determining appropriate clinical treatment. We report here the design and initial testing of a molecular diagnostic assay capable of amplifying a large segment of the blaTEM gene, as well as detecting widely spaced extended-spectrum ß-lactamase (ESBL) mutations and inhibitor-resistant TEM (IRT) mutations (eg, clavulanic acid resistance). Single-stranded DNA is generated using linear-after-the-exponential PCR (LATE-PCR) and is analyzed at the endpoint, using a set of four fluorescently labeled and four quencher-labeled probes in a single closed tube. These lights-on/lights-off probes work in concert to generate sequence-specific fluorescence contours over a temperature range from 25°C to 75°C. Mutant sequences from synthetic TEM gene variants and from TEM gene variants in bacterial strains generated large increases in fluorescent signal relative to that from the reference sequence for TEM-1. Clinical use of this convenient, single-closed-tube assay would make it possible to rapidly distinguish ESBL from non-ESBL variants and thereby to begin early treatment with suitable antibiotics.

Rapid detection of sequence variation in Clostridium difficile genes using LATE-PCR with multiple mismatch-tolerant hybridization probes.

A novel molecular assay for Clostridium difficile was developed using Linear-After-The-Exponential polymerase chain reaction (LATE-PCR). Single-stranded DNA products generated by LATE-PCR were detected and distinguished by hybridization to fluorescent mismatch-tolerant probes, as the temperature was lowered after amplification in 5(°)C intervals between 65°C and 25°C. Single-tube multiplex reactions for tcdA, tcdB, tcdC, and cdtB (binary toxin) sequences were initially optimized using synthetic targets and were subsequently done using genomic DNA; each target was detected and characterized by hybridization to one or more probes of a different fluorescent color. In the case of tcdC, three probes, each labeled with a Quasar fluorophore, hybridize to different locations with known mutations, including the deletion at nucleotide 117 in ribotype 027 strains and the premature stop codon mutation at nucleotide 184 in ribotype 078 strains, each of which is associated with hypervirulent infections. These and other tcdC mutations were distinguished from the reference sequence, as well as from each other by changes in the fluorescent contour generated from the combined Quasar-labeled probes. Specific variations in tcdA and tcdB were also identified in the multiplex assay, including those that identified strains lacking toxin A production. This single closed-tube assay generates substantially more information about virulent C. difficile than currently available commercial assays and could be further expanded to provide strain typing.

Pan-serotypic detection of foot-and-mouth disease virus by RT linear-after-the-exponential PCR.

A reverse transcription Linear-After-The-Exponential polymerase chain reaction (RT LATE-PCR) assay was evaluated for detection of foot-and-mouth disease virus (FMDV). This pan-serotypic assay targets highly conserved sequences within the 3D (RNA polymerase) region of the FMDV genome, and uses end-point hybridisation analysis of a single mismatch-tolerant low temperature probe to confirm the identity of the amplicons. An Armored RNA served as an internal control to validate virus negative results. The ability of the assay to identify FMDV was directly compared to a real-time RT-PCR assay routinely used by reference laboratories. The analytical sensitivity of the RT LATE-PCR assay was 10 genomic copies and the dynamic range of the test was identical to real-time RT-PCR based on decimal dilutions of an FMDV-positive sample. This pan-serotypic assay was able to detect FMDV in a broad range of clinical samples collected from field cases of FMD (n = 121), while samples of other viruses causing vesicular disease in livestock and genetic relatives of FMDV were negative. In addition to the laboratory-based utility of this diagnostic test, the RT LATE-PCR assay format has potential application for use in a portable ("point-of-care") device designed to achieve rapid detection of FMDV in the field.

Gene-expression patterns in whole blood identify subjects at risk for recurrent tuberculosis.

BACKGROUND: The majority of patients with tuberculosis who comply with appropriate treatment are cured. However, approximately 5% subsequently have a repeat disease episode, usually within 2 years of successful combination therapy. Presently, there is no way of predicting which patients will experience a relapse. METHODS: We identified 10 subjects who had previously experienced recurrent tuberculosis and carefully matched them to cured subjects who had had only 1 episode of tuberculosis, to patients with active tuberculosis, and to latently infected healthy subjects. We compared their ex vivo whole-blood gene-expression profiles by use of DNA array technology and confirmed the results by use of quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR). RESULTS: The 4 clinical tuberculosis groups exhibited distinct patterns of gene expression. The gene-transcript profiles of the patients with recurrent tuberculosis were more similar to those of the patients with active tuberculosis than to those of the cured or latently infected subjects. Discriminant analysis of a training data set showed that 9 genes were sufficient to classify the subjects. We confirmed that measurement of the expression of these genes by qRT-PCR can accurately discriminate between subjects in a test set of samples. CONCLUSIONS: A simple test based on gene-expression patterns may be used as a biomarker of cure while identifying patients who are at risk for relapse. This would facilitate the introduction of new tuberculosis drugs.

Characterization of the ovine ortholog of secretory leukoprotease inhibitor.

There is great interest in the use of the sheep as a model for the investigation of inflammation in the lung. The serine antiproteases secretory leukoprotease inhibitor (SLPI) and elafin are important "alarm antiproteases" in the lung and have potentially important roles in the innate immune response. SLPI was first characterized in man and subsequently in murine, porcine, and rat tissues. Here we present the first data concerning the gene and cDNA sequence encoding for the ovine ortholog of SLPI, a protein of 132 amino acids with 66% sequence identity at the amino acid level with human SLPI. A 24-amino-acid signal sequence signifies that, like the other mammalian orthologs, ovine SLPI is a secreted protein. Tissue distribution of expression is demonstrated by reverse transcription polymerase chain reaction (RT-PCR) and shows features similar to SLPI expression in other mammals, specifically at mucosal surfaces such as the upper respiratory and intestinal tracts, and also the skin, liver, and kidney. This distribution lends credence to SLPI having important roles in innate immunity. We have also cloned the ovine SLPI cDNA into an expression vector and expressed the ovine SLPI protein in vitro. This has enabled us to demonstrate that ovine SLPI is correctly processed (Western blot analysis and SELDI-TOF mass spectrometry analysis) and has biological antihuman neutrophil elastase activity. In summary, the ovine ortholog of SLPI shows similarities to other members of the SLPI family and has all the features of a modulator of innate immunity.

Trappin ovine molecule (TOM), the ovine ortholog of elafin, is an acute phase reactant in the lung.

As large animal models continue to play an important role in translating lung-directed therapeutic strategies from laboratory animals to humans, there is an increasing interest in the analysis of endogenous regulators of inflammation at both a genomic and a therapeutic level. To this end, we have sought to characterize the ovine ortholog of elafin, an important regulator of inflammation in humans. We have isolated both the elafin cDNA and gene, which have a similar structure to other species' orthologs. Interestingly, we have isolated two alleles for ovine elafin, which contain a very high number of transglutamination repeats, thought to be important in binding elafin to the interstitium. The mainly mucosal mRNA distribution for ovine elafin suggests that ovine elafin may, like its human ortholog, have functions in innate immunity. This is supported by analysis of elafin and the related protein secretory leukocyte protease inhibitor (SLPI) in ovine bronchoalveolar fluid in response to locally administered lipopolysaccharide and confirmation of them acting as "alarm" antiproteases. We have also cloned the ovine elafin cDNA into an adenoviral vector and have demonstrated correct processing of the secreted protein as well as biological activity. Overexpression of ovine elafin in a lung-derived epithelial cell line has a protective effect against the enzymes human neutrophil and porcine pancreatic elastase. The identification of the ovine elafin gene and its translated protein are important in developing practical strategies aimed at regulating inflammation in the large mammalian lung.

Differential gene expression identifies novel markers of CD4+ and CD8+ T cell activation following stimulation by Mycobacterium tuberculosis.

T cell activation in response to antigenic stimulation is a complex process, involving changes in the expression level of a large number of genes. We have used cDNA array technology to characterize the differences in gene expression between human CD4+ and CD8+ T cells. PBMC from six healthy donors were stimulated with live Mycobacterium tuberculosis, and the gene expression profiles of each donor's CD4+ and CD8+ T cells were analyzed separately. ANOVA revealed 518 genes that were consistently differentially expressed between CD4+ and CD8+ T cells. These differentially expressed genes include a combination of well-known, previously characterized genes with a range of biological functions and unknown in silico predicted hypothetical genes. Where possible, the novel genes have been characterized using bioinformatics, and putative transcription factors, signaling molecules, transmembrane, and secreted factors have been identified. A subset of these differentially expressed genes could be exploited as markers of CD4+ and CD8+ T cell activation for use in vaccine trials. These observed differences in the gene expression profile of CD4+ and CD8+ T cells following activation by a human pathogen contribute to an increased understanding of T cell activation and differentiation and the roles these T cell subsets may play in immunity to infection.