scholarly journals Comparing rates of mycobacterial clearance in sputum smear-negative and smear-positive adults living with HIV

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Edith E. Machowski ◽  
Matebogo Letutu ◽  
Limakatso Lebina ◽  
Ziyaad Waja ◽  
Reginah Msandiwa ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Response ◽  
Bacterial Load ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
People Living With Hiv ◽  
Treatment Regimens ◽  
Early Treatment Response ◽  
Smear Negative ◽  
Living With Hiv

Abstract Background Pulmonary tuberculosis (TB) in people living with HIV (PLH) frequently presents as sputum smear-negative. However, clinical trials of TB in adults often use smear-positive individuals to ensure measurable bacterial responses following initiation of treatment, thereby excluding HIV-infected patients from trials. Methods In this prospective case cohort study, 118 HIV-seropositive TB patients were assessed prior to initiation of standard four-drug TB therapy and at several time points through 35 days. Sputum bacillary load, as a marker of treatment response, was determined serially by: smear microscopy, Xpert MTB/RIF, liquid culture, and colony counts on agar medium. Results By all four measures, patients who were baseline smear-positive had higher bacterial loads than those presenting as smear-negative, until day 35. However, most smear-negative PLH had significant bacillary load at enrolment and their mycobacteria were cleared more rapidly than smear-positive patients. Smear-negative patients’ decline in bacillary load, determined by colony counts, was linear to day 7 suggesting measurable bactericidal activity. Moreover, the decrease in bacterial counts was comparable to smear-positive individuals. Increasing cycle threshold values (Ct) on the Xpert assay in smear-positive patients to day 14 implied decreasing bacterial load. Conclusion Our data suggest that smear-negative PLH can be included in clinical trials of novel treatment regimens as they contain sufficient viable bacteria, but allowances for late exclusions would have to be made in sample size estimations. We also show that increases in Ct in smear-positive patients to day 14 reflect treatment responses and the Xpert MTB/RIF assay could be used as biomarker for early treatment response.

scholarly journals Tuberculosis treatment outcomes among people living with HIV diagnosed using Xpert MTB/RIF versus sputum-smear microscopy in Botswana: a stepped-wedge cluster randomised trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Tefera Agizew ◽  
Violet Chihota ◽  
Sambayawo Nyirenda ◽  
Zegabriel Tedla ◽  
Andrew F. Auld ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
People Living With Hiv ◽  
Sputum Smear Microscopy ◽  
Stepped Wedge ◽  
Empiric Treatment ◽  
Tb Treatment ◽  
Living With Hiv

Abstract Background Xpert® MTB/RIF (Xpert) has high sensitivity for diagnosing tuberculosis (TB) compared to sputum-smear microscopy (smear) and can reduce time-to-diagnosis, time-to-treatment and potentially unfavorable patient-level treatment outcome. Methods People living with HIV (PLHIV) initiating antiretroviral therapy at 22 HIV clinics were enrolled and underwent systematic screening for TB (August 2012–November 2014). GeneXpert instruments were deployed following a stepped-wedge design at 13 centers from October 2012–June 2013. Treatment outcomes classified as an unfavorable outcome (died, treatment failure or loss-to-follow-up) or favorable outcome (cured and treatment completed). To determine outcome, smear was performed at month 5 or 6. Empiric treatment was defined as initiating treatment without/before receiving TB-positive results. Adjusting for intra-facility correlation, we compared patient-level treatment outcomes between patients screened using smear (smear arm)- and Xpert-based algorithms (Xpert arm). Results Among 6041 patients enrolled (smear arm, 1816; Xpert arm, 4225), 256 (199 per 2985 and 57 per 1582 person-years of follow-up in Xpert and smear arms, respectively; adjusted incidence rate ratio, 9.07; 95% confidence interval [CI]: 4.70–17.48; p < 0.001) received TB diagnosis and were treated. TB treatment outcomes were available for 203 patients (79.3%; Xpert, 157; smear, 46). Unfavorable outcomes were reported for 21.7% (10/46) in the smear and 13.4% (21/157) in Xpert arm (adjusted hazard ratio, 1.40; 95% CI: 0.75–2.26; p = 0.268). Compared to smear, in Xpert arm median days from sputum collection to TB treatment was 6 days (interquartile range [IQR] 2–17 versus 22 days [IQR] 3–51), p = 0.005; patients with available sputum test result had microbiologically confirmed TB in 59.0% (102/173) versus 41.9% (18/43), adjusted Odds Ratio [aOR], 2.00, 95% CI: 1.01–3.96, p = 0.048). In smear arm empiric treatment was 68.4% (39/57) versus 48.7% (97/199), aOR, 2.28, 95% CI: 1.24–4.20, p = 0.011), compared to Xpert arm. Conclusions TB treatment outcomes were similar between the smear and Xpert arms. However, compared to the smear arm, more patients in the Xpert arm received a TB diagnosis, had a microbiologically confirmed TB, and had a shorter time-to-treatment, and had a lower empiric treatment. Further research is recommended to identify potential gaps in the Botswana health system and similar settings. Trial registration ClinicalTrials.gov Identifier: NCT02538952. Retrospectively registered on 2 September 2015.

scholarly journals A Retrospective Cross-Sectional Study of the Utility of Cartridge-Based Nucleic Acid Amplification Test in Diagnosis of Pulmonary and Extrapulmonary Tuberculosis in People Living with HIV in Second Highest HIV Prevalent State in India

2021 ◽  
Author(s):  
Tade Bagbi ◽  
Ningthoukhongjam Reema ◽  
S. Bhagyabati Devi ◽  
Thangjam Gautam Singh ◽  
Mohammad Jaleel ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Cross Sectional Study ◽  
Nucleic Acid Amplification Test ◽  
Nucleic Acid Amplification ◽  
Rifampicin Resistance ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
Sectional Study ◽  
Cross Sectional ◽  
Smear Negative

Abstract Introduction Tuberculosis (TB) in people living with human immunodeficiency virus (PLHIV) is difficult to diagnose due to fewer organisms in sputum and extrapulmonary samples. Sputum culture takes 4 to 8 weeks for growth of the mycobacteria. Delayed treatment for TB in PLHIV leads to increased mortality. This study evaluated cartridge-based nucleic acid amplification test (CBNAAT) as a diagnostic tool for diagnosis of pulmonary TB (PTB) and extrapulmonary TB (EPTB) in PLHIV in the second most HIV prevalent state in India and for comparing its efficacy between Ziehl–Neelsen (ZN) staining sputum smear–positive and sputum smear–negative TB. Methods This cross-sectional study was conducted in RIMS, Imphal, with 167 PLHIV patients, age 15 years or older, having signs and symptoms of TB. Appropriate samples for sputum microscopy and CBNAAT were sent. Conclusion The overall sensitivity of sputum smear for acid-fast bacillus (AFB) was found to be 30.71% and that of CBNAAT was 38.57%. Sensitivity of CBNAAT for sputum smear–positive and sputum smear–negative TB was 100 and 11.3%, respectively. Sensitivity of ZN smear for AFB of EPTB sample was 48.1% and that of CBNAAT was 59.25%. In both PTB and EPTB, CBNAAT showed an increase in diagnosis of microbiologically confirmed PTB cases by 7.8 and 11.1%, respectively, over and above the cases diagnosed by ZN smear microscopy. Rifampicin resistance was detected in five patients. We conclude that CBNAAT is a rapid test with better sensitivity in diagnosis of PTB and EPTB in PLHIV, compared with ZN smear microscopy. It detects rifampicin resistance for multidrug-resistant TB and helps in early treatment intervention.

HIV detection from human serum with paper-based isotachophoretic RNA extraction and reverse transcription recombinase polymerase amplification

The Analyst ◽  
2021 ◽  
Author(s):  
Andrew T. Bender ◽  
Benjamin P. Sullivan ◽  
Jane Zhang ◽  
David C Juergens ◽  
Lorraine Lillis ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Human Serum ◽  
Reverse Transcription ◽  
Rna Extraction ◽  
Recombinase Polymerase Amplification ◽  
People Living With Hiv ◽  
Treatment Regimens ◽  
Living With Hiv

The number of people living with HIV continues to increase with the current total near 38 million, of which about 26 million are receiving antiretroviral therapy (ART). These treatment regimens...

scholarly journals Baseline Xpert MTB/RIF ct values predict sputum conversion during the intensive phase of anti-TB treatment in HIV infected patients in Kampala, Uganda: a retrospective study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Juliet Namugenyi ◽  
Joseph Musaazi ◽  
Achilles Katamba ◽  
Joan Kalyango ◽  
Emmanuel Sendaula ◽  
...  
Keyword(s):  
Bacterial Load ◽  
Sputum Smear ◽  
People Living With Hiv ◽  
Cd4 Cell Count ◽  
Cut Point ◽  
Ct Value ◽  
Tb Treatment ◽  
Drug Concentrations ◽  
Unit Increase ◽  
Sputum Conversion

Abstract Background In resource-limited settings, sputum smear conversion is used to document treatment response. Many People living with HIV (PLHIV) are smear-negative at baseline. The Xpert MTB/RIF test can indirectly measure bacterial load through cycle threshold (ct) values. This study aimed to determine if baseline Xpert MTB/RIF could predict time to culture negativity in PLHIV with newly diagnosed TB. Methods A subset of 138 PLHIV from the ‘SOUTH’ study on outcomes related to TB and antiretroviral drug concentrations were included. Bacterial load was estimated by Mycobacterium Growth Indicator Tubes (MGIT) culture time-to-positivity (TTP) and Lowenstein Jensen (LJ) colony counts. Changes in TTP and colony counts were analyzed with Poisson Generalised Estimating Equations (GEE) and multilevel ordered logistic regression models, respectively, while time to culture negativity analysed with Cox proportional hazard models. ROC curves were used to explore the accuracy of the ct value in predicting culture negativity. Results A total of 81 patients (58.7%) were males, median age 34 (IQR 29  ̶ 40) years, median CD4 cell count of 180 (IQR 68  ̶ 345) cells/μL and 77.5% were ART naive. The median baseline ct value was 25.1 (IQR 21.0  ̶ 30.1). A unit Increase in the ct value was associated with a 5% (IRR = 1.05 95% CI 1.04  ̶ 1.06) and 3% (IRR = 1.03 95% CI 1.03  ̶ 1.04) increase in TTP at week 2 and 4 respectively. With LJ culture, a patient’s colony grade was reduced by 0.86 times (0R = 0.86 95% CI 0.74  ̶ 0.97) at week 2 and 0.84 times (OR = 0.84 95% CI 0.79  ̶ 0.95 P = 0.002) at week 4 for every unit increase in the baseline ct value. There was a 3% higher likelihood of earlier conversion to negativity for every unit increase in the ct value. A ct cut point ≥28 best predicted culture negativity at week 4 with a sensitivity of 91. 7% & specificity 53.7% while a cut point ≥23 best predicted culture negativity at week 8. Conclusion Baseline Xpert MTB/RIF ct values predict sputum conversion in PLHIV on anti-TB treatment. Surrogate biomarkers for sputum conversion in PLHIV are still a research priority.

scholarly journals Use of GeneXpert and the Role of an Expert Panel in Improving Clinical Diagnosis of Smear-Negative Tuberculosis Cases

2019 ◽  
Author(s):  
Jovilia Abong ◽  
Victoria Dalay ◽  
Ivor Langley ◽  
Ewan Tomeny ◽  
Danaida Marcelo ◽  
...  
Keyword(s):  
Expert Panel ◽  
Cross Sectional Study ◽  
The Philippines ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
Cross Sectional ◽  
X Ray ◽  
Abnormal Chest ◽  
Smear Negative ◽  
The Impact

Setting A high proportion of notified tuberculosis cases in the Philippines are clinically diagnosed (63%) as opposed to bacteriologically confirmed. Better understanding of this phenomenon is required to improve tuberculosis control. Objectives To determine the percentage of Smear Negative Presumptive Tuberculosis patients that would be diagnosed by GeneXpert; compare clinical characteristics of patients diagnosed as tuberculosis cases; and review the impact that the current single government physician and a reconstituted Tuberculosis Diagnostic committee (Expert Panel) may have on tuberculosis over-diagnosis. Design This is a cross-sectional study of 152 patients 15-85 years old with two negative Direct Sputum Smear Microscopy results, with abnormal chest X-ray who underwent GeneXpert testing and review by an Expert Panel. Results 31% (48/152) of the sample were Xpert positive. 93% (97/104) of GeneXpert negatives were clinically diagnosed by a Single Physician. Typical symptoms and X-ray findings were higher in bacteriologically confirmed tuberculosis. When compared to GeneXpert results, the Expert panel&rsquo;s sensitivity for active tuberculosis was high (97.5%, 39/40) but specificity was low (40.2%, 35/87). Conclusion Using the GeneXpert would increase the level of bacteriologically confirmed tuberculosis substantially among presumptive Tuberculosis. An Expert panel will greatly reduce over-diagnosis usually seen when a decision is made by a Single Physician.

Complementary therapies for the treatment of HIV: in search of the evidence

2005 ◽  
Vol 16 (6) ◽  
pp. 395-403 ◽  
Author(s):  
Edward Mills ◽  
Ping Wu ◽  
Edzard Ernst
Keyword(s):  
Clinical Trials ◽  
Stress Management ◽  
Complementary Therapies ◽  
Randomized Clinical Trials ◽  
Therapeutic Touch ◽  
People Living With Hiv ◽  
Natural Health Products ◽  
Health Products ◽  
Living With Hiv ◽  
Hiv Aids

The use of complementary and alternative medicine (CAM) is widespread. Yet, little is known about the evidence supporting its use in HIV/AIDS. We conducted a systematic review of randomized clinical trials assessing the effectiveness of complementary therapies for HIV and HIV-related symptoms. Comprehensive literature searches were performed of seven electronic databases. Data were abstracted independently by two reviewers. Thirty trials met our predefined inclusion/exclusion criteria: 18 trials were of stress management; five of Natural Health Products; four of massage/therapeutic touch; one of acupuncture; two of homeopathy. The trials were published between 1989 and 2003. Most trials were small and of limited methodological rigour. The results suggest that stress management may prove to be an effective way to increase the quality of life. For all other treatments, data are insufficient for demonstrating effectiveness. Despite the widespread use of CAM by people living with HIV/AIDS, the effectiveness of these therapies has not been established. Vis à vis CAM's popularity, the paucity of clinical trials and their low methodological quality are concerning.

scholarly journals QUANTITATIVE REAL-TIME PCR (Q-PCR) FOR SPUTUM SMEAR DIAGNOSIS OF PULMONARY TUBERCULOSIS AMONG PEOPLE WITH HIV/AIDS

2014 ◽  
Vol 56 (2) ◽  
pp. 139-142 ◽  
Author(s):  
Yvana Maria Maia de Albuquerque ◽  
Ana Luiza Magalhães de Andrade Lima ◽  
Ana Kelly Lins ◽  
Marcelo Magalhães ◽  
Vera Magalhães
Keyword(s):  
Pulmonary Tuberculosis ◽  
Real Time ◽  
Clinical Suspicion ◽  
Sputum Smear ◽  
People Living With Hiv ◽  
Lowenstein Jensen ◽  
Sensitivity Specificity ◽  
A Prospective Study ◽  
Living With Hiv ◽  
Hiv Aids

Objective: To assess quantitative real-time polymerase chain reaction (q-PCR) for the sputum smear diagnosis of pulmonary tuberculosis (PTB) in patients living with HIV/AIDS with a clinical suspicion of PTB.Method: This is a prospective study to assess the accuracy of a diagnostic test, conducted on 140 sputum specimens from 140 patients living with HIV/AIDS with a clinical suspicion of PTB, attended at two referral hospitals for people living with HIV/AIDS in the city of Recife, Pernambuco, Brazil. A Löwenstein-Jensen medium culture and 7H9 broth were used as gold standard.Results: Of the 140 sputum samples, 47 (33.6%) were positive with the gold standard. q-PCR was positive in 42 (30%) of the 140 patients. Only one (0.71%) did not correspond to the culture. The sensitivity, specificity and accuracy of the q-PCR were 87.2%, 98.9% and 95% respectively. In 39 (93%) of the 42 q-PCR positive cases, the CT (threshold cycle) was equal to or less than 37.Conclusion: q-PCR performed on sputum smears from patients living with HIV/AIDS demonstrated satisfactory sensitivity, specificity and accuracy, and may therefore be recommended as a method for diagnosing PTB.

scholarly journals Compliance of St Joseph’s Hospital Roma, Lesotho with the National Tuberculosis Programme of Lesotho, 2007 and 2008

2014 ◽  
Vol 6 (1) ◽  
Author(s):  
Oladoyinbo O. Samuel ◽  
Pierre J.T. De Villiers
Keyword(s):  
Treatment Failure ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
Sputum Smear Microscopy ◽  
X Ray ◽  
National Tuberculosis Programme ◽  
National Tuberculosis ◽  
Tuberculosis Programme ◽  
Chest X Ray ◽  
Smear Negative

Background: In 2009 Lesotho had an estimated TB prevalence of 696 cases/100 000 population − the 4th highest in the world. This epidemic was characterised by high rates of death, treatment failure and unknown treatment outcomes. These adverse outcomes were attributable to a high rate of TB and/or HIV co-infection and weaknesses in the implementation of Lesotho’s National Tuberculosis Programme (NTP). This study was conducted in St Joseph’s Hospital, Roma (SJHR) to assess the implementation of the NTP.Method: Records of 993 patients entered into the SJHR TB register between 2007 and 2008 were reviewed. Patients’ treatment details were extracted from the register, validated and analysed by STATA 10.0.Results: Of 993 patients registered: 88% were new patients, 37% were diagnosed on sputum smear microscopy alone, 35% were diagnosed on sputum smear microscopy with chest X-ray, whilst 25% were diagnosed on chest X-ray alone. In addition: 33% were sputum smear positive, 45% were sputum smear negative, and 22% had extra-pulmonary TB. As to treatment outcome: 26% were cured, 51% completed treatment, and 51% converted from sputum smear positive to sputum smear negative over six months, whilst 16% died. Regarding HIV, 77% of patients were tested for HIV and 59% had TB and/or HIV co-infection. Of ten NTP targets only the defaulter and treatment failure rate targets were met.Conclusion: Whilst only two out of ten NTP targets were met at SJHR in 2007–2008, improvements in TB case management were noted in 2008 which were probably due to the positive effects of audit on staff performance.

scholarly journals The exclusion of people living with HIV (PLWH) from clinical trials in lymphoma

2015 ◽  
Vol 113 (6) ◽  
pp. 861-863 ◽  
Author(s):  
Serena Venturelli ◽  
Alessia Dalla Pria ◽  
Katrina Stegmann ◽  
Paul Smith ◽  
Mark Bower
Keyword(s):  
Clinical Trials ◽  
People Living With Hiv ◽  
Living With Hiv

An Approach to the Management of Tuberculosis in HIV Endemic Areas

1992 ◽  
Vol 22 (4) ◽  
pp. 147-150 ◽  
Author(s):  
Alison M Elliott
Keyword(s):  
Adverse Reactions ◽  
The United States ◽  
Sub Saharan Africa ◽  
Hiv Positive ◽  
Sputum Smear ◽  
Tuberculosis Control ◽  
Treatment Regimens ◽  
Smear Negative ◽  
Sub Saharan ◽  
Cutaneous Adverse Reactions

The epidemic of HIV-associated tuberculosis is having a severe impact on tuberculosis control in sub-Saharan Africa, as well as the United States of America, and is expected to spread. Where facilities are limited, the association between HIV and sputum-smear negative tuberculosis hampers diagnosis; trials of anti-tuberculous therapy are indicated in some cases. Standard treatment regimens are effective, but thiacetazone should be avoided because of its association with severe, cutaneous adverse reactions. Treatment may have to be prolonged in HIV positive cases. Measures to maximize compliance with therapy are paramount. These include the use of the shortest possible regimens, of recognized potency, and emphasis on ensuring that the regimen is understood by and readily accessible to the patient.

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