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  • 1
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    Pharmacogenetics of plasma efavirenz exposure in HIV‐infected adults and children in South Africa
    Wiley ; 2015
    In:  British Journal of Clinical Pharmacology Vol. 80, No. 1 ( 2015-07), p. 146-156
    Details
    In: British Journal of Clinical Pharmacology, Wiley, Vol. 80, No. 1 ( 2015-07), p. 146-156
    Abstract: Genetic factors, notably CYP2B6 516G→T [rs3745274] and 983T→C [rs28399499] , explain much of the interindividual variability in efavirenz pharmacokinetics, but data from Africa are limited. We characterized relationships between genetic polymorphisms and plasma efavirenz concentrations in HIV‐infected Black South African adults and children. Methods Steady‐state mid‐dosing interval efavirenz concentrations were measured. We genotyped 241 polymorphisms in genes potentially relevant to efavirenz metabolism and transport, including ABCB1 , CYP2A6 , CYP2B6 , CYP3A4 , CYP3A5 , NR1I2 and NR1I3 . Results Among 113 participants (59 adults and 54 children), minor allele frequencies for CYP2B6 516G→T, 983T→C, and 15582C→T [rs4803419] were 0.36, 0.07, and 0.09, respectively. Based on composite CYP2B6 15582/516/983 genotype, there were 33 extensive metabolizer, 62 intermediate metabolizer and 18 slow metabolizer genotypes. Median (IQR) mid‐dose efavirenz concentrations were 1.44 (1.21–1.93) µg ml –1 , 2.08 (1.68–2.94) µg ml –1 and 7.26 (4.82–8.34) µg ml –1 for extensive, intermediate and slow metabolizers, respectively. In univariate analyses, a model that included composite genotype best predicted efavirenz concentrations (β = 0.28, 95% CI 0.21, 0.35, P  = 2.4 × 10 –11 ). Among individual CYP2B6 polymorphisms, 516G→T best predicted efavirenz concentrations (β = 0.22, 95% CI 0.13, 0.30, P  = 1.27 × 10 −6 ). There was also associations with 983T→C (β = 0.27, 95% CI 0.10, 0.44, P  = 0.002) and 15582C→T (β = 0.11, 95% CI 0.01, 0.22, P  = 0.04). Associations were consistent in adults and children. No other polymorphisms were independently associated with efavirenz concentrations. Conclusions Composite CYP2B6 genotype based on CYP2B6 516G→T, 983T→C, and 15582C→T best described efavirenz exposure in HIV‐infected Black South African adults and children.
    Type of Medium: Online Resource
    ISSN: 0306-5251 , 1365-2125
    URL: Issue
    URL: Article
    DOI: 10.1111/bcp.v80.1
    DOI: 10.1111/bcp.12590
    RVK:
    XA 33650
    Language: English
    Publisher: Wiley
    Publication Date: 2015
    detail.hit.zdb_id: 1498142-7
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  • 2
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    Drug–drug interaction between rifabutin and dolutegravir: A population pharmacokinetic model
    Wiley ; 2023
    In:  British Journal of Clinical Pharmacology Vol. 89, No. 3 ( 2023-03), p. 1216-1221
    Details
    In: British Journal of Clinical Pharmacology, Wiley, Vol. 89, No. 3 ( 2023-03), p. 1216-1221
    Abstract: Rifampicin, a potent enzyme inducer, causes marked reduction of dolutegravir exposure. Rifabutin, a less potent enzyme inducer, may offer an alternative to rifampicin. We aimed to characterize the population pharmacokinetics of dolutegravir when co‐administered with rifabutin. We extended an existing dolutegravir model to include data from volunteers co‐administered with dolutegravir 50 mg and rifabutin 300 mg once daily. We ran simulations of dolutegravir with and without rifabutin co‐administration and compare dolutegravir trough concentrations with the IC 90 and EC 90 of 0.064 and 0.3 mg/L, respectively. Rifabutin decreased dolutegravir's volume of distribution by 33.1% (95% confidence interval 25.1%–42.3%) but did not affect the area under the concentration–time curve. Simulations showed that when 50 mg dolutegravir is co‐administered with rifabutin once daily, the probability to attain trough concentrations above the IC 90 of 0.064 mg/L is more than 99%. Therefore, there is no need for dolutegravir dose adjustment. Rifabutin may offer an alternative to rifampicin for the treatment of HIV/tuberculosis co‐infected individuals.
    Type of Medium: Online Resource
    ISSN: 0306-5251 , 1365-2125
    URL: Issue
    URL: Article
    DOI: 10.1111/bcp.v89.3
    DOI: 10.1111/bcp.15604
    RVK:
    XA 33650
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 1498142-7
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  • 3
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    Abdominal ultrasound for diagnosing abdominal tuberculosis or disseminated tuberculosis with abdominal involvement in HIV-positive individuals
    Wiley ; 2019
    In:  Cochrane Database of Systematic Reviews Vol. 2019, No. 9 ( 2019-09-30)
    Details
    In: Cochrane Database of Systematic Reviews, Wiley, Vol. 2019, No. 9 ( 2019-09-30)
    Type of Medium: Online Resource
    ISSN: 1465-1858
    URL: Article
    DOI: 10.1002/14651858.CD012777.pub2
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2038950-4
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  • 4
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    Abdominal ultrasound for diagnosing abdominal tuberculosis or disseminated tuberculosis with abdominal involvement in HIV-positive adults
    Wiley ; 2017
    In:  Cochrane Database of Systematic Reviews
    Details
    In: Cochrane Database of Systematic Reviews, Wiley
    Type of Medium: Online Resource
    ISSN: 1465-1858
    URL: Article
    DOI: 10.1002/14651858.CD012777
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2038950-4
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  • 5
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    Population pharmacokinetics of tenofovir given as either tenofovir disoproxil fumarate or tenofovir alafenamide in an African population
    Wiley ; 2023
    In:  CPT: Pharmacometrics & Systems Pharmacology Vol. 12, No. 6 ( 2023-06), p. 821-830
    Details
    In: CPT: Pharmacometrics & Systems Pharmacology, Wiley, Vol. 12, No. 6 ( 2023-06), p. 821-830
    Abstract: Tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are prodrugs of the nucleotide analogue tenofovir, which acts intracellularly to inhibit HIV replication. Whereas TDF converts to tenofovir in plasma and may cause kidney and bone toxicity, TAF mostly converts to tenofovir intracellularly, so it can be administered at lower doses. TAF leads to lower tenofovir plasma concentrations and lower toxicity, but there are limited data on its use in Africa. We used data from 41 South African adults living with HIV from the ADVANCE trial and described, with a joint model, the population pharmacokinetics of tenofovir given as TAF or TDF. The TDF was modeled to appear in plasma as tenofovir with a simple first‐order process. Instead, two parallel pathways were used for a TAF dose: an estimated 32.4% quickly appeared as tenofovir into the systemic circulation with first‐order absorption, whereas the rest was sequestered intracellularly and released into the systemic circulation as tenofovir slowly. Once in plasma (from either TAF or TDF), tenofovir disposition followed two‐compartment kinetics and had a clearance of 44.7 L/h (40.2–49.5), for a typical 70‐kg individual. This semimechanistic model describes the population pharmacokinetics of tenofovir when dosed as either TDF or TAF in an African population living with HIV and can be used as a tool for exposure prediction in patients, and to simulate alternative regimes to inform further clinical trials.
    Type of Medium: Online Resource
    ISSN: 2163-8306 , 2163-8306
    URL: Issue
    URL: Article
    DOI: 10.1002/psp4.v12.6
    DOI: 10.1002/psp4.12955
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2697010-7
    SSG: 15,3
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  • 6
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    Concentration–response relationships of dolutegravir and efavirenz with weight change after starting antiretroviral therapy
    Wiley ; 2022
    In:  British Journal of Clinical Pharmacology Vol. 88, No. 3 ( 2022-03), p. 883-893
    Details
    In: British Journal of Clinical Pharmacology, Wiley, Vol. 88, No. 3 ( 2022-03), p. 883-893
    Abstract: Dolutegravir is associated with more weight gain than efavirenz in people starting antiretroviral therapy (ART). We investigated the concentration–response relationships of efavirenz and dolutegravir with weight gain. We determined concentration–response relationships of dolutegravir and efavirenz (both combined with tenofovir disoproxil fumarate and emtricitabine) with changes in weight and fat distribution, derived from dual‐energy x‐ray absorptiometry scans, in a nested study of ART‐naïve participants from a randomised controlled trial. Pharmacokinetic parameters used in analyses were efavirenz mid‐dosing interval concentrations and estimated dolutegravir area under the concentration–time curve using a population pharmacokinetic model developed in the study population. Study outcomes were percentage changes from baseline to week 48 in weight, and visceral and subcutaneous adipose tissue mass. Pharmacokinetic data were available for 158 and 233 participants in the efavirenz arm and dolutegravir arms respectively; 57.0% were women. On multivariable linear regression there were independent negative associations between efavirenz concentrations and changes in both weight ( P  〈  .001) and subcutaneous adipose tissue mass ( P =  .002). Estimated dolutegravir area under the concentration–time curve up to 24 hours was not associated with change in weight ( P =  .109) but was negatively associated with change in visceral adipose tissue mass ( P =  .025). We found an independent negative concentration–response relationship between efavirenz concentrations and weight change in ART‐naïve participants. Dolutegravir concentrations were not independently associated with weight change. These findings suggest that weight gain differences between efavirenz and dolutegravir are driven by efavirenz toxicity impairing weight gain rather than by off‐target effects of dolutegravir causing weight gain.
    Type of Medium: Online Resource
    ISSN: 0306-5251 , 1365-2125
    URL: Issue
    URL: Article
    DOI: 10.1111/bcp.v88.3
    DOI: 10.1111/bcp.15177
    RVK:
    XA 33650
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 1498142-7
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  • 7
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    Assessing Prolongation of the Corrected QT Interval with Bedaquiline and Delamanid Coadministration to Predict the Cardiac Safety of Simplified Dosing Regimens
    Wiley ; 2022
    In:  Clinical Pharmacology & Therapeutics Vol. 112, No. 4 ( 2022-10), p. 873-881
    Details
    In: Clinical Pharmacology & Therapeutics, Wiley, Vol. 112, No. 4 ( 2022-10), p. 873-881
    Abstract: Delamanid and bedaquiline are two drugs approved to treat drug‐resistant tuberculosis, and each have been associated with corrected QT interval (QTc) prolongation. We aimed to investigate the relationships between the drugs' plasma concentrations and the prolongation of observed QT interval corrected using Fridericia’s formula (QTcF) and to evaluate their combined effects on QTcF, using a model‐based population approach. Furthermore, we predicted the safety profiles of once daily regimens. Data were obtained from a trial where participants were randomized 1:1:1 to receive delamanid, bedaquiline, or delamanid + bedaquiline. The effect on QTcF of delamanid and/or its metabolite (DM‐6705) and the pharmacodynamic interactions under coadministration were explored based on a published model between bedaquiline's metabolite (M2) and QTcF. The metabolites of each drug were found to be responsible for the drug‐related QTcF prolongation. The final drug‐effect model included a competitive interaction between M2 and DM‐6705 acting on the same cardiac receptor and thereby reducing each other's apparent potency, by 28% (95% confidence interval (CI), 22–40%) for M2 and 33% (95% CI, 24–54%) for DM‐6705. The generated combined effect was not greater but close to “additivity” in the analyzed concentration range. Predictions with the final model suggested a similar QT prolonging potential with simplified, once‐daily dosing regimens compared with the approved regimens, with a maximum median change from baseline QTcF increase of 20 milliseconds in both regimens. The concentrations–QTcF relationship of the combination of bedaquiline and delamanid was best described by a competitive binding model involving the two main metabolites. Model predictions demonstrated that QTcF prolongation with simplified once daily regimens would be comparable to currently used dosing regimens.
    Type of Medium: Online Resource
    ISSN: 0009-9236 , 1532-6535
    URL: Issue
    URL: Article
    DOI: 10.1002/cpt.v112.4
    DOI: 10.1002/cpt.2685
    RVK:
    XA 36900
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2040184-X
    SSG: 15,3
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  • 8
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    Changes in estimated glomerular filtration rate over time in South African HIV‐1‐infected patients receiving tenofovir: a retrospective cohort study
    Wiley ; 2017
    In:  Journal of the International AIDS Society Vol. 20, No. 1 ( 2017-01)
    Details
    In: Journal of the International AIDS Society, Wiley, Vol. 20, No. 1 ( 2017-01)
    Abstract: Introduction : Tenofovir has been associated with decline in kidney function, but in patients with low baseline kidney function, improvements over time have been reported. Additionally, the magnitude and trajectory of estimated glomerular filtration rate (eGFR) changes may differ according to how eGFR is calculated. We described changes in eGFR over time, and the incidence of, and risk factors for, kidney toxicity, in a South African cohort. Methods : We included antiretroviral‐naïve patients ≥16 years old who started tenofovir‐containing antiretroviral therapy (ART) between 2002 and 2013. We calculated eGFR using the Modification of Diet in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI), and Cockcroft‐Gault equations. We described changes in eGFR from ART initiation using linear mixed effects regression. We described the incidence of eGFR 〈 30 mL/min on treatment, and identified associations with low eGFR using Cox regression. Results : We included 15156 patients with median age of 35.4 years (IQR 29.9–42.0), median CD4 cell count of 168 cells/µL (IQR 83–243), and median eGFR (MDRD) of 98.6 mL/min (IQR 84.4–115.6). Median duration of follow up on tenofovir was 12.9 months (IQR 5.1–23.3). Amongst those with a baseline and subsequent eGFR  available, mean eGFR change from baseline at 12 months was −4.4 mL/min (95% CI −4.9 to −4.0), −2.3 (−2.5 to −2.1), and 0.6 (0.04 to 1.2) in those with baseline eGFR ≥90 mL/min; and 11.9 mL/min (11.0 to 12.7), 14.6 (13.5 to 15.7), and 11.0 (10.3 to 11.7) in those with baseline eGFR 〈 90 mL/min, according to the MDRD, CKD‐EPI (n = 11 112), and Cockcroft‐Gault (n = 9 283) equations, respectively. Overall, 292 (1.9%) patients developed eGFR 〈 30 mL/min. Significant associations with low eGFR included older age, baseline eGFR 〈 60 mL/min, CD4 count 〈 200 cells/µL, body weight 〈 60 kg, and concomitant protease inhibitor use. Conclusions : Patients on tenofovir with baseline eGFR ≥90 mL/min experienced small but significant declines in eGFR over time when eGFR was estimated using the MDRD or CKD‐EPI equations. However, eGFR increased in patients with eGFR 〈 90 mL/min, regardless of which estimating equation was used. Decreases to below 30 mL/min were uncommon. In settings with limited access to laboratory testing, monitoring guidelines should consider focusing on higher risk patients.
    Type of Medium: Online Resource
    ISSN: 1758-2652 , 1758-2652
    URL: Article
    DOI: 10.7448/IAS.20.01/21317
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2467110-1
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  • 9
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    Undisclosed HIV status and antiretroviral therapy use among South African blood donors
    Wiley ; 2021
    In:  Transfusion Vol. 61, No. 8 ( 2021-08), p. 2392-2400
    Details
    In: Transfusion, Wiley, Vol. 61, No. 8 ( 2021-08), p. 2392-2400
    Abstract: Undisclosed antiretroviral drug (ARV) use among blood donors who tested HIV antibody positive, but RNA negative, was previously described by our group. Undisclosed ARV use represents a risk to blood transfusion safety. We assessed the prevalence of and associations with undisclosed ARV use among HIV‐positive donors who donated during 2017. Study design and methods South African National Blood Service (SANBS) blood donors are screened by self‐administered questionnaire, semi‐structured interview, and individual donation nucleic acid amplification testing for HIV. Stored samples from HIV‐positive donations were tested for ARV and characterized as recent/longstanding using lag avidity testing. Results Of the 1462 HIV‐positive donations in 2017, 1250 had plasma availability for testing of which 122 (9.8%) tested positive for ARV. Undisclosed ARV use did not differ by gender ( p  = .205) or ethnicity ( p  = .505) but did differ by age category ( p   〈  .0001), donor ( p   〈  .0001), clinic type ( p  = .012), home province ( p  = .01), and recency ( p   〈  .0001). Multivariable logistic regression found older age (adjusted odds ratio [aOR] 3.73, 95% confidence interval [CI] 1.98–7.04 for donors 〉 40 compared with those 〈 21), first‐time donation (aOR 5.24; 95% CI 2.48–11.11), and donation in a high HIV‐prevalence province (aOR 9.10; 95% CI 2.70–30.72) compared with Northern Rural provinces to be independently associated with undisclosed ARV use. Discussion Almost 1 in 10 HIV‐positive blood donors neglected to disclose their HIV status and ARV use. Demographic characteristics of donors with undisclosed ARV use differed from those noted in other study. Underlying motivations for nondisclosure among blood donors remain unclear and may differ from those in other populations with significant undisclosed ARV use.
    Type of Medium: Online Resource
    ISSN: 0041-1132 , 1537-2995
    URL: Issue
    URL: Article
    DOI: 10.1111/trf.v61.8
    DOI: 10.1111/trf.16571
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2018415-3
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  • 10
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    Cerebral angioedema associated with enalapril
    Wiley ; 2009
    In:  British Journal of Clinical Pharmacology Vol. 68, No. 2 ( 2009-08), p. 271-273
    Details
    In: British Journal of Clinical Pharmacology, Wiley, Vol. 68, No. 2 ( 2009-08), p. 271-273
    Type of Medium: Online Resource
    ISSN: 0306-5251 , 1365-2125
    URL: Issue
    URL: Article
    DOI: 10.1111/bcp.2009.68.issue-2
    DOI: 10.1111/j.1365-2125.2009.03452.x
    RVK:
    XA 33650
    Language: English
    Publisher: Wiley
    Publication Date: 2009
    detail.hit.zdb_id: 1498142-7
    SSG: 15,3
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