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  1. Article ; Online: Artemether-lumefantrine efficacy among adults on antiretroviral therapy in Malawi.

    Nyangulu, Wongani / Mungwira, Randy G / Divala, Titus H / Nampota-Nkomba, Nginache / Nyirenda, Osward M / Buchwald, Andrea G / Miller, Jernelle / Earland, Dominique E / Adams, Matthew / Plowe, Christopher V / Taylor, Terrie E / Mallewa, Jane E / van Oosterhout, Joep J / Parikh, Sunil / Laurens, Matthew B / Laufer, Miriam K

    Malaria journal

    2023  Volume 22, Issue 1, Page(s) 32

    Abstract: Background: When people with human immunodeficiency virus (HIV) infection (PWH) develop malaria, they are at risk of poor anti-malarial treatment efficacy resulting from impairment in the immune response and/or drug-drug interactions that alter anti- ... ...

    Abstract Background: When people with human immunodeficiency virus (HIV) infection (PWH) develop malaria, they are at risk of poor anti-malarial treatment efficacy resulting from impairment in the immune response and/or drug-drug interactions that alter anti-malarial metabolism. The therapeutic efficacy of artemether-lumefantrine was evaluated in a cohort of PWH on antiretroviral therapy (ART) and included measurement of day 7 lumefantrine levels in a subset to evaluate for associations between lumefantrine exposure and treatment response.
    Methods: Adults living with HIV (≥ 18 years), on ART for ≥ 6 months with undetectable HIV RNA viral load and CD4 count ≥ 250/mm
    Results: 411 malaria episodes were observed among 186 participants over 5 years. The unadjusted ACPR rate was 81% (95% CI 77-86). However, after PCR correction to exclude new infections, ACPR rate was 94% (95% CI 92-97). Increasing age and living in Ndirande were associated with decreased hazard of treatment failure. In this population of adults with HIV on ART, 54% (51/94) had levels below a previously defined optimal day 7 lumefantrine level of 200 ng/ml. This occurred more commonly among participants who were receiving an efavirenz-based ART compared to other ART regimens (OR 5.09 [95% CI 1.52-7.9]). Participants who experienced treatment failure had lower day 7 median lumefantrine levels (91 ng/ml [95% CI 48-231]) than participants who experienced ACPR (190 ng/ml [95% CI 101-378], p-value < 0.008).
    Conclusion: Recurrent malaria infections are frequent in this population of PWH on ART. The PCR-adjusted efficacy of AL meets the WHO criteria for acceptable treatment efficacy. Nevertheless, lumefantrine levels tend to be low in this population, particularly in those on efavirenz-based regimens, with lower concentrations associated with more frequent malaria infections following treatment. These results highlight the importance of understanding drug-drug interactions when diseases commonly co-occur.
    MeSH term(s) Humans ; Adult ; Antimalarials/therapeutic use ; Malawi ; Artemisinins/therapeutic use ; Artemether/therapeutic use ; Drug Combinations ; Artemether, Lumefantrine Drug Combination/therapeutic use ; Malaria/drug therapy ; Malaria, Falciparum/drug therapy ; Malaria, Falciparum/prevention & control ; Lumefantrine/therapeutic use ; HIV Infections/drug therapy ; Treatment Outcome ; Ethanolamines/therapeutic use ; Fluorenes/therapeutic use
    Chemical Substances Antimalarials ; efavirenz (JE6H2O27P8) ; Artemisinins ; Artemether (C7D6T3H22J) ; Drug Combinations ; Artemether, Lumefantrine Drug Combination ; Lumefantrine (F38R0JR742) ; Ethanolamines ; Fluorenes
    Language English
    Publishing date 2023-01-27
    Publishing country England
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 2091229-8
    ISSN 1475-2875 ; 1475-2875
    ISSN (online) 1475-2875
    ISSN 1475-2875
    DOI 10.1186/s12936-023-04466-w
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  2. Article ; Online: Colonization dynamics of extended-spectrum beta-lactamase-producing Enterobacterales in the gut of Malawian adults.

    Lewis, Joseph M / Mphasa, Madalitso / Banda, Rachel / Beale, Mathew A / Heinz, Eva / Mallewa, Jane / Jewell, Christopher / Faragher, Brian / Thomson, Nicholas R / Feasey, Nicholas A

    Nature microbiology

    2022  Volume 7, Issue 10, Page(s) 1593–1604

    Abstract: ... beta-lactamase enzymes (ESBL-Enterobacterales, ESBL-E) are global priority pathogens. Antimicrobial stewardship ... whole-genome sequencing to understand colonization dynamics of ESBL-E. Models suggest a prolonged effect ... acquired isolates, hence some apparent acquisition of ESBL-E during hospitalization may instead represent ...

    Abstract Drug-resistant bacteria of the order Enterobacterales which produce extended-spectrum beta-lactamase enzymes (ESBL-Enterobacterales, ESBL-E) are global priority pathogens. Antimicrobial stewardship interventions proposed to curb their spread include shorter courses of antimicrobials to reduce selection pressure but individual-level acquisition and selection dynamics are poorly understood. We sampled stool of 425 adults (aged 16-76 years) in Blantyre, Malawi, over 6 months and used multistate modelling and whole-genome sequencing to understand colonization dynamics of ESBL-E. Models suggest a prolonged effect of antimicrobials such that truncating an antimicrobial course at 2 days has a limited effect in reducing colonization. Genomic analysis shows largely indistinguishable diversity of healthcare-associated and community-acquired isolates, hence some apparent acquisition of ESBL-E during hospitalization may instead represent selection from a patient's microbiota by antimicrobial exposure. Our approach could help guide stewardship protocols; interventions that aim to review and truncate courses of unneeded antimicrobials may be of limited use in preventing ESBL-E colonization.
    MeSH term(s) Adult ; Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Bacteria ; Feces/microbiology ; Gammaproteobacteria ; Humans ; Intestines ; beta-Lactamases/genetics
    Chemical Substances Anti-Bacterial Agents ; beta-Lactamases (EC 3.5.2.6)
    Language English
    Publishing date 2022-09-05
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2058-5276
    ISSN (online) 2058-5276
    DOI 10.1038/s41564-022-01216-7
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  3. Article ; Online: Genomic and antigenic diversity of colonizing

    Lewis, Joseph M / Mphasa, Madalitso / Banda, Rachel / Beale, Mathew A / Mallewa, Jane / Heinz, Eva / Thomson, Nicholas R / Feasey, Nicholas A

    Microbial genomics

    2022  Volume 8, Issue 3

    Abstract: Members of ... ...

    Abstract Members of the
    MeSH term(s) Anti-Bacterial Agents/pharmacology ; Antigenic Variation ; Drug Resistance, Multiple, Bacterial/genetics ; Genomics ; Humans ; Kenya ; Klebsiella ; Klebsiella Infections/epidemiology ; Klebsiella pneumoniae ; Malawi/epidemiology ; Microbial Sensitivity Tests ; O Antigens ; Phylogeny ; beta-Lactamases/genetics
    Chemical Substances Anti-Bacterial Agents ; O Antigens ; beta-Lactamases (EC 3.5.2.6)
    Language English
    Publishing date 2022-03-17
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2835258-0
    ISSN 2057-5858 ; 2057-5858
    ISSN (online) 2057-5858
    ISSN 2057-5858
    DOI 10.1099/mgen.0.000778
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  4. Article ; Online: Individual and population level costs and health-related quality of life outcomes of third-generation cephalosporin resistant bloodstream infection in Blantyre, Malawi.

    Lester, Rebecca / Mango, James / Mallewa, Jane / Jewell, Christopher P / Lalloo, David A / Feasey, Nicholas A / Maheswaran, Hendramoorthy

    PLOS global public health

    2023  Volume 3, Issue 6, Page(s) e0001589

    Abstract: ... future economic burden to society as a result of 3GC-R E. coli and Klebsiella spp. BSI, data urgently ...

    Abstract Data which accurately enumerate the economic costs of antimicrobial resistance (AMR) in low- and middle- income countries are essential. This study aimed to quantify the impact of third-generation cephalosporin resistant (3GC-R) bloodstream infection (BSI) on economic and health related quality of life outcomes for adult patients in Blantyre, Malawi. Participants were recruited from a prospective, longitudinal cohort study of hospitalised patients with bloodstream infection caused by Enterobacterales at Queen Elizabeth Central Hospital (QECH). Primary costing studies were used to estimate the direct medical costs associated with the inpatient stay. Recruited participants were asked about direct non-medical and indirect costs associated with their admission and their health-related quality of life was measured using the EuroQol EQ-5D questionnaire. Multiple imputation was undertaken to account for missing data. Costs were adjusted to 2019 US Dollars. Cost and microbiology surveillance data from QECH, Blantyre was used to model the annual cost of, and quality-adjusted life years lost to, 3GC-R and 3GC-Susceptible BSI from 1998 to 2030 in Malawi. The mean health provider cost per participant with 3GC-R BSI was US$110.27 (95%CR; 22.60-197.95), higher than for those with 3GC-S infection. Patients with resistant BSI incurred an additional indirect cost of US$155.48 (95%CR; -67.80, 378.78) and an additional direct non-medical cost of US$20.98 (95%CR; -36.47, 78.42). Health related quality of life outcomes were poor for all participants, but participants with resistant infections had an EQ-5D utility score that was 0.167 (95% CR: -0.035, 0.300) lower than those with sensitive infections. Population level burden estimates suggest that in 2016, 3GC-R accounted for 84% of annual societal costs from admission with bloodstream infection and 82% of QALYs lost. 3GC-R bloodstream infection was associated with higher health provider and patient level costs than 3GC-S infection, as well as poorer HRQoL outcomes. We demonstrate a substantial current and future economic burden to society as a result of 3GC-R E. coli and Klebsiella spp. BSI, data urgently needed by policy makers to provide impetus for implementing strategies to reduce AMR.
    Language English
    Publishing date 2023-06-22
    Publishing country United States
    Document type Journal Article
    ISSN 2767-3375
    ISSN (online) 2767-3375
    DOI 10.1371/journal.pgph.0001589
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  5. Article ; Online: Genomic analysis of extended-spectrum beta-lactamase (ESBL) producing

    Lewis, Joseph M / Mphasa, Madalitso / Banda, Rachel / Beale, Mathew A / Mallewa, Jane / Anscome, Catherine / Zuza, Allan / Roberts, Adam P / Heinz, Eva / Thomson, Nicholas R / Feasey, Nicholas A

    Microbial genomics

    2023  Volume 9, Issue 6

    MeSH term(s) Adult ; Humans ; Malawi/epidemiology ; Genomics ; beta-Lactamases/genetics
    Chemical Substances beta-Lactamases (EC 3.5.2.6)
    Language English
    Publishing date 2023-06-14
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2835258-0
    ISSN 2057-5858 ; 2057-5858
    ISSN (online) 2057-5858
    ISSN 2057-5858
    DOI 10.1099/mgen.0.001035
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: High burden of malaria among Malawian adults on antiretroviral therapy after discontinuing prophylaxis.

    Mungwira, Randy G / Laurens, Matthew B / Nyangulu, Wongani / Divala, Titus H / Nampota-Nkomba, Nginache / Buchwald, Andrea G / Nyirenda, Osward M / Mwinjiwa, Edson / Kanjala, Maxwell / Galileya, Lufina Tsirizani / Earland, Dominique E / Adams, Matthew / Plowe, Christopher V / Taylor, Terrie E / Mallewa, Jane / van Oosterhout, Joep J / Laufer, Miriam K

    AIDS (London, England)

    2022  Volume 36, Issue 12, Page(s) 1675–1682

    Abstract: Objective: Many individuals living with the human immunodeficiency virus (HIV) infection and receiving antiretroviral therapy (ART) reside in areas at high risk for malaria but how malaria affects clinical outcomes is not well described in this ... ...

    Abstract Objective: Many individuals living with the human immunodeficiency virus (HIV) infection and receiving antiretroviral therapy (ART) reside in areas at high risk for malaria but how malaria affects clinical outcomes is not well described in this population. We evaluated the burden of malaria infection and clinical malaria, and impact on HIV viral load and CD4 + cell count among adults on ART.
    Design: We recruited Malawian adults on ART who had an undetectable viral load and ≥250 CD4 +  cells/μl to participate in this randomized trial to continue daily trimethoprim-sulfamethoxazole (TS), discontinue daily co-trimoxazole, or switch to weekly chloroquine (CQ).
    Methods: We defined clinical malaria as symptoms consistent with malaria and positive blood smear, and malaria infection as Plasmodium falciparum DNA detected from dried blood spots (collected every 4-12 weeks). CD4 + cell count and viral load were measured every 24 weeks. We used Poisson regression and survival analysis to compare the incidence of malaria infection and clinical malaria. Clinicaltrials.gov NCT01650558.
    Results: Among 1499 participants enrolled, clinical malaria incidence was 21.4/100 person-years of observation (PYO), 2.4/100 PYO and 1.9/100 PYO in the no prophylaxis, TS, and CQ arms, respectively. We identified twelve cases of malaria that led to hospitalization and all individuals recovered. The preventive effect of staying on prophylaxis was approximately 90% compared to no prophylaxis (TS: incidence rate ratio [IRR] 0.11, 95% confidence interval [CI] 0.08, 0.15 and CQ: IRR 0.09, 95% CI 0.06, 0.13). P. falciparum infection prevalence among all visits was 187/1475 (12.7%), 48/1563 (3.1%), and 29/1561 (1.9%) in the no prophylaxis, TS, and CQ arms, respectively. Malaria infection and clinical malaria were not associated with changes in CD4 + cell count or viral load.
    Conclusion: In clinically stable adults living with HIV on ART, clinical malaria was common after chemoprophylaxis stopped. However, neither malaria infection nor clinical illness appeared to affect HIV disease progression.
    MeSH term(s) Adult ; Antimalarials/therapeutic use ; CD4 Lymphocyte Count ; Chemoprevention ; HIV Infections/complications ; HIV Infections/drug therapy ; HIV Infections/epidemiology ; Humans ; Malaria/epidemiology ; Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use
    Chemical Substances Antimalarials ; Trimethoprim, Sulfamethoxazole Drug Combination (8064-90-2)
    Language English
    Publishing date 2022-07-15
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 639076-6
    ISSN 1473-5571 ; 0269-9370 ; 1350-2840
    ISSN (online) 1473-5571
    ISSN 0269-9370 ; 1350-2840
    DOI 10.1097/QAD.0000000000003317
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    Zs.A 2228: Show issues Location:
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  7. Article ; Online: High Intrapulmonary Rifampicin and Isoniazid Concentrations Are Associated With Rapid Sputum Bacillary Clearance in Patients With Pulmonary Tuberculosis.

    McCallum, Andrew D / Pertinez, Henry E / Chirambo, Aaron P / Sheha, Irene / Chasweka, Madalitso / Malamba, Rose / Shani, Doris / Chitani, Alex / Mallewa, Jane E / Meghji, Jamilah Z / Ghany, Jehan F / Corbett, Elizabeth L / Gordon, Stephen B / Davies, Geraint R / Khoo, Saye H / Sloan, Derek J / Mwandumba, Henry C

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2022  Volume 75, Issue 9, Page(s) 1520–1528

    Abstract: Background: Intrapulmonary pharmacokinetics may better explain response to tuberculosis (TB) treatment than plasma pharmacokinetics. We explored these relationships by modeling bacillary clearance in sputum in adult patients on first-line treatment in ... ...

    Abstract Background: Intrapulmonary pharmacokinetics may better explain response to tuberculosis (TB) treatment than plasma pharmacokinetics. We explored these relationships by modeling bacillary clearance in sputum in adult patients on first-line treatment in Malawi.
    Methods: Bacillary elimination rates (BER) were estimated using linear mixed-effects modelling of serial time-to-positivity in mycobacterial growth indicator tubes for sputum collected during the intensive phase of treatment (weeks 0-8) for microbiologically confirmed TB. Population pharmacokinetic models used plasma and intrapulmonary drug levels at 8 and 16 weeks. Pharmacokinetic-pharmacodynamic relationships were investigated using individual-level measures of drug exposure (area-under-the-concentration-time-curve [AUC] and Cmax) for rifampicin, isoniazid, pyrazinamide, and ethambutol, in plasma, epithelial lining fluid, and alveolar cells as covariates in the bacillary elimination models.
    Results: Among 157 participants (58% human immunodeficiency virus [HIV] coinfected), drug exposure in plasma or alveolar cells was not associated with sputum bacillary clearance. Higher peak concentrations (Cmax) or exposure (AUC) to rifampicin or isoniazid in epithelial lining fluid was associated with more rapid bacillary elimination and shorter time to sputum negativity. More extensive disease on baseline chest radiograph was associated with slower bacillary elimination. Clinical outcome was captured in 133 participants, with 15 (11%) unfavorable outcomes recorded (recurrent TB, failed treatment, or death). No relationship between BER and late clinical outcome was identified.
    Conclusions: Greater intrapulmonary drug exposure to rifampicin or isoniazid in the epithelial lining fluid was associated with more rapid bacillary clearance. Higher doses of rifampicin and isoniazid may result in sustained high intrapulmonary drug exposure, rapid bacillary clearance, shorter treatment duration and better treatment outcomes.
    MeSH term(s) Adult ; Humans ; Isoniazid/therapeutic use ; Isoniazid/pharmacokinetics ; Rifampin/pharmacokinetics ; Sputum/microbiology ; Antitubercular Agents/pharmacokinetics ; Tuberculosis, Pulmonary/drug therapy ; Tuberculosis, Pulmonary/microbiology ; Pyrazinamide/pharmacokinetics ; Ethambutol/therapeutic use ; Bacillus
    Chemical Substances Isoniazid (V83O1VOZ8L) ; Rifampin (VJT6J7R4TR) ; Antitubercular Agents ; Pyrazinamide (2KNI5N06TI) ; Ethambutol (8G167061QZ)
    Language English
    Publishing date 2022-03-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciac228
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    Zs.A 1505: Show issues Location:
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    Zs.MO 480: Show issues

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  8. Article ; Online: Artemether-lumefantrine efficacy among adults on antiretroviral therapy in Malawi

    Wongani Nyangulu / Randy G. Mungwira / Titus H. Divala / Nginache Nampota-Nkomba / Osward M. Nyirenda / Andrea G. Buchwald / Jernelle Miller / Dominique E. Earland / Matthew Adams / Christopher V. Plowe / Terrie E. Taylor / Jane E. Mallewa / Joep J. van Oosterhout / Sunil Parikh / Matthew B. Laurens / Miriam K. Laufer / the TSCQ Study Team

    Malaria Journal, Vol 22, Iss 1, Pp 1-

    2023  Volume 8

    Abstract: Abstract Background When people with human immunodeficiency virus (HIV) infection (PWH) develop malaria, they are at risk of poor anti-malarial treatment efficacy resulting from impairment in the immune response and/or drug-drug interactions that alter ... ...

    Abstract Abstract Background When people with human immunodeficiency virus (HIV) infection (PWH) develop malaria, they are at risk of poor anti-malarial treatment efficacy resulting from impairment in the immune response and/or drug-drug interactions that alter anti-malarial metabolism. The therapeutic efficacy of artemether-lumefantrine was evaluated in a cohort of PWH on antiretroviral therapy (ART) and included measurement of day 7 lumefantrine levels in a subset to evaluate for associations between lumefantrine exposure and treatment response. Methods Adults living with HIV (≥ 18 years), on ART for ≥ 6 months with undetectable HIV RNA viral load and CD4 count ≥ 250/mm3 were randomized to daily trimethoprim-sulfamethoxazole (TS), weekly chloroquine (CQ) or no prophylaxis. After diagnosis of uncomplicated Plasmodium falciparum malaria, a therapeutic efficacy monitoring was conducted with PCR-correction according to WHO guidelines. The plasma lumefantrine levels on day 7 in 100 episodes of uncomplicated malaria was measured. A frailty proportional hazards model with random effects models to account for clustering examined the relationship between participant characteristics and malaria treatment failure within 28 days. Pearson’s Chi—squared test was used to compare lumefantrine concentrations among patients with treatment failure and adequate clinical and parasitological response (ACPR). Results 411 malaria episodes were observed among 186 participants over 5 years. The unadjusted ACPR rate was 81% (95% CI 77–86). However, after PCR correction to exclude new infections, ACPR rate was 94% (95% CI 92–97). Increasing age and living in Ndirande were associated with decreased hazard of treatment failure. In this population of adults with HIV on ART, 54% (51/94) had levels below a previously defined optimal day 7 lumefantrine level of 200 ng/ml. This occurred more commonly among participants who were receiving an efavirenz-based ART compared to other ART regimens (OR 5.09 [95% CI 1.52–7.9]). Participants who experienced ...
    Keywords Arctic medicine. Tropical medicine ; RC955-962 ; Infectious and parasitic diseases ; RC109-216
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
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  9. Article ; Online: Isoniazid preventive therapy-related adverse events among Malawian adults on antiretroviral therapy: A cohort study.

    Tsirizani-Galileya, Lufina / Milanzi, Elasma / Mungwira, Randy / Divala, Titus / Mallewa, Jane / Mategula, Donnie / Nampota, Nginache / Mwapasa, Victor / Buchwald, Andrea / Laurens, Matthew B / Laufer, Miriam K / Van Oosterhout, Joep J

    Medicine

    2022  Volume 101, Issue 39, Page(s) e30591

    Abstract: Adverse events may be a cause of observed poor completion of isoniazid preventive therapy (IPT) among people living with HIV in high tuberculosis burden areas. Data on IPT-related adverse events (AE) from sub-Saharan Africa are scarce. We report IPT- ... ...

    Abstract Adverse events may be a cause of observed poor completion of isoniazid preventive therapy (IPT) among people living with HIV in high tuberculosis burden areas. Data on IPT-related adverse events (AE) from sub-Saharan Africa are scarce. We report IPT-related AEs, associated clinical characteristics, and IPT discontinuations in adults who were stable on antiretroviral therapy (ART) when they initiated IPT. Cohort study nested within a randomized, controlled, clinical trial of cotrimoxazole and chloroquine prophylaxis in Malawians aged ≥ 18 years and virologically suppressed on ART. Eight hundred sixty-nine patients were followed for a median of 6 months after IPT initiation. IPT relatedness of AEs was determined retrospectively with the World Health Organization case-causality tool. Frailty survival regression modeling identified factors associated with time to first probably IPT-related AE. The overall IPT-related AE incidence rate was 1.1/person year of observation. IPT relatedness was mostly uncertain and few AEs were severe. Most common were liver and hematological toxicities. Higher age increased risk of a probably IPT-related AE (aHR = 1.02; 95% CI 1.00-1.06; P = .06) and higher weight reduced this risk (aHR = 0.98; 95% CI 0.96-1.00; P = .03). Of 869 patients, 114 (13%) discontinued IPT and 94/114 (82%) discontinuations occurred at the time of a possibly or probably IPT-related AE. We observed a high incidence of mostly mild IPT-related AEs among individuals who were stable on ART. More than 1 in 8 persons discontinued IPT. These findings inform strategies to improve implementation of IPT in adults on ART, including close monitoring of groups at higher risk of IPT-related AEs.
    MeSH term(s) Adult ; Antitubercular Agents/adverse effects ; Chloroquine/therapeutic use ; Cohort Studies ; HIV Infections/epidemiology ; Humans ; Isoniazid/adverse effects ; Retrospective Studies ; Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use
    Chemical Substances Antitubercular Agents ; Trimethoprim, Sulfamethoxazole Drug Combination (8064-90-2) ; Chloroquine (886U3H6UFF) ; Isoniazid (V83O1VOZ8L)
    Language English
    Publishing date 2022-09-30
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 80184-7
    ISSN 1536-5964 ; 0025-7974
    ISSN (online) 1536-5964
    ISSN 0025-7974
    DOI 10.1097/MD.0000000000030591
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  10. Article ; Online: Revisiting Co-trimoxazole Prophylaxis for African Adults in the Era of Antiretroviral Therapy: A Randomized Controlled Clinical Trial.

    Laurens, Matthew B / Mungwira, Randy G / Nampota, Nginache / Nyirenda, Osward M / Divala, Titus H / Kanjala, Maxwell / Mkandawire, Felix A / Galileya, Lufina Tsirizani / Nyangulu, Wongani / Mwinjiwa, Edson / Downs, Matthew / Tillman, Amy / Taylor, Terrie E / Mallewa, Jane / Plowe, Christopher V / van Oosterhout, Joep J / Laufer, Miriam K

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2021  Volume 73, Issue 6, Page(s) 1058–1065

    Abstract: Background: Daily co-trimoxazole is recommended for African adults living with human immunodeficiency virus (HIV) irrespective of antiretroviral treatment, immune status, or disease stage. Benefits of continued prophylaxis and whether co-trimoxazole can ...

    Abstract Background: Daily co-trimoxazole is recommended for African adults living with human immunodeficiency virus (HIV) irrespective of antiretroviral treatment, immune status, or disease stage. Benefits of continued prophylaxis and whether co-trimoxazole can be stopped following immune reconstitution are unknown.
    Methods: We conducted a randomized controlled trial at 2 sites in Malawi that enrolled adults with HIV with undetectable viral load and CD4 count of >250/mm3 and randomized them to continue daily co-trimoxazole, discontinue daily co-trimoxazole and begin weekly chloroquine, or discontinue daily co-trimoxazole. The primary endpoint was the preventive effect of co-trimoxazole prophylaxis against death or World Health Organization (WHO) HIV/AIDS stage 3-4 events, using Cox proportional hazards modeling, in an intention-to-treat population.
    Results: 1499 adults were enrolled. The preventive effect of co-trimoxazole on the primary endpoint was 22% (95% CI: -14%-47%; P = .20) versus no prophylaxis and 25% (-10%-48%; P = .14) versus chloroquine. When WHO HIV/AIDS stage 2 events were added to the primary endpoint, preventive effect increased to 31% (3-51%; P = .032) and 32% (4-51%; P = .026), respectively. Co-trimoxazole and chloroquine prophylaxis effectively prevented clinical malaria episodes (3.8 and 3.0, respectively, vs 28/100 person-years; P < .001).
    Conclusions: Malawian adults with HIV who immune reconstituted on ART and continued co-trimoxazole prophylaxis experienced fewer deaths and WHO HIV/AIDS stage 3-4 events compared with prophylaxis discontinuation, although statistical significance was not achieved. Co-trimoxazole prevented a composite of death plus WHO HIV/AIDS stage 2-4 events. Given poor healthcare access and lack of routine viral load monitoring, co-trimoxazole prophylaxis should continue in adults on ART after immune reconstitution in sub-Saharan Africa. Clinical Trials Registration. NCT01650558.
    MeSH term(s) Adult ; Anti-Retroviral Agents/therapeutic use ; CD4 Lymphocyte Count ; HIV Infections/drug therapy ; HIV Infections/prevention & control ; Humans ; Malawi/epidemiology ; Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use
    Chemical Substances Anti-Retroviral Agents ; Trimethoprim, Sulfamethoxazole Drug Combination (8064-90-2)
    Language English
    Publishing date 2021-03-17
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciab252
    Database MEDical Literature Analysis and Retrieval System OnLINE

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