Joshua Gini

University of Liverpool, Molecular & Clinical Pharmacology, Graduate Student

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Papers by Joshua Gini

Widespread use of herbal medicines by people living with human immunodeficiency virus and contamination of herbal medicines with antiretrovirals in Nigeria

International Journal of STD & AIDS, 2018

Herbal medication use amongst people living with human immunodeficiency virus (PLWH) is widesprea... more Herbal medication use amongst people living with human immunodeficiency virus (PLWH) is widespread and understudied. This study aimed to evaluate the prevalence of herbal medicine use amongst PLWH and possible contamination with antiretrovirals (ARVs). Countrywide collection of herbal samples sold by street vendors in Nigeria for the following indications: human immunodeficiency virus (HIV), acquired immune deficiency syndrome, fever and general weakness. Samples were screened using a validated liquid chromatography-mass spectrometry/mass spectrometry method for the presence of the following ARVs: efavirenz, nevirapine, lopinavir, darunavir, ritonavir, atazanavir, emtricitabine, tenofovir and lamivudine. A survey was conducted among 742 PLWH attending four HIV clinics in Nigeria. Data were collected using a structured questionnaire and analysed using IBM SPSS statistics version 22.0 (IBM Corp., 2013, Armond, NY). Of the 138 herbal medicines sampled, three (2%) contained detectable l...

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Impact of pharmacogenetics and pregnancy on tenofovir and emtricitabine pharmacokinetics

Pharmacogenomics, 2019

Aim: Treatment and prevention of mother-to-child transmission of HIV in pregnancy utilizes tenofo... more Aim: Treatment and prevention of mother-to-child transmission of HIV in pregnancy utilizes tenofovir (TFV) and emtricitabine (FTC) as NRTI backbone in combination with a third agent from a different class. We hypothesized that combined effect of pregnancy and pharmacogenetics significantly changes TFV and FTC pharmacokinetics (PK). Therefore, this study aims to evaluate the role of SNPs of transporters (ABCC2 and ABCC4) on TFV and FTC PK during pregnancy. Method: 61 pregnant or postpartum women on TFV and FTC were selected from a group of pregnant and postpartum Nigerian women and both SNPs and drug levels were evaluated. Results: Pregnancy decreases TFV plasma concentration by 26% (log10 β = -0.131 [-0.228, -0.034; p = 0.009] at median [range] time-point postdose 14 [7–18.5h]). FTC concentration in individuals with ABCC2 12:g.154962860T>C TT genotype were one- to twofold higher than heterozygous (CT) and homozygous (CC) women. All other evaluated SNPs were not significant. Concl...

Validation and clinical application of a novel LC–MS method for quantification of dolutegravir in breast milk

Bioanalysis, 2018

Aim: A novel, sensitive and reproducible method for quantification of dolutegravir (DTG) in dried... more Aim: A novel, sensitive and reproducible method for quantification of dolutegravir (DTG) in dried breast milk spots (DBMS) was developed and validated for use in clinical studies. Its application enabled measurement of DTG pharmacokinetics in breastfeeding mothers and their infants. Results/methodology: Sample extraction was by liquid–liquid extraction using tert-butyl methy-ether, with DTG–d5 as an internal standard. DTG was eluted on a reverse phase C18 Waters XBridge (3.5 μm: 2.1 × 50 mm) column using a gradient mobile phase consisting of 0.1% formic acid in deionised water or methanol. The assay was validated over a calibration range of 10–4000 ng/ml. Conclusion: Stability, inter and intra-assay variability were acceptable according to FDA and EMA bioanalytical method guidelines. The assay is robust, accurate, precise and can be reliably applied for analysis of clinical samples in trials from low resource settings.

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Drug Interactions Between Dolutegravir and Artemether-Lumefantrine or Artesunate-Amodiaquine

Antimicrobial Agents and Chemotherapy, 2018

Across sub-Saharan Africa, patients with HIV on antiretrovirals often get malaria and need co-tre... more Across sub-Saharan Africa, patients with HIV on antiretrovirals often get malaria and need co-treatment with artemisinin-containing therapies. We undertook two pharmacokinetic studies in healthy volunteers, using standard adult doses of artmether-lumefantrine or artesunate-amodiaquine given with 50mg once daily dolutegravir (DTG) to investigate the drug-drug interaction between artmether-lumefantrine or artesunate-amodiaquine and dolutegravir. The dolutegravir/artmether-lumefantrine interaction was evaluated in a two-way cross-over study and measured artemether, dihydroartemisinin, lumefantrine, desbutyl-lumefantrine over 264 hours. The dolutegravir/artesunate-amodiaquine interaction was investigated using a parallel study design due to long half-life of the amodiaquine metabolite, desethylamodiaquine and measured artesunate, amodiaquine, desethylamodiaquine over 624 hours. Non-compartmental analysis was performed, and geometric mean ratios and 90% confidence intervals generated for...

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Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: A randomised trial (DolPHIN-1 study)

PLOS Medicine, 2019

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Infant Exposure to Dolutegravir Through Placental and Breast Milk Transfer: A Population Pharmacokinetic Analysis of DolPHIN-1

Clinical Infectious Diseases

Background Rapid reduction in human immunodeficiency virus (HIV) load is paramount to prevent per... more Background Rapid reduction in human immunodeficiency virus (HIV) load is paramount to prevent peripartum transmission in women diagnosed late in pregnancy. We investigated dolutegravir population pharmacokinetics in maternal plasma, umbilical cord, breast milk, and infant plasma samples from DolPHIN-1 participants (NCT02245022) presenting with untreated HIV late in pregnancy (28–36 weeks gestation). Methods Pregnant women from Uganda and South Africa were randomized (1:1) to daily dolutegravir (50 mg/d) or efavirenz-based therapy. Dolutegravir pharmacokinetic sampling (0–24 hours) was undertaken 14 days after treatment initiation and within 1–3 weeks after delivery, with matched maternal and cord samples at delivery. Mothers were switched to efavirenz, and maternal and infant plasma and breast milk samples were obtained 24, 48, or 72 hours after the switch. Nonlinear mixed-effects modeling was used to describe dolutegravir in all matrices and to evaluate covariates. Results A total ...