Background: A dolutegravir (DTG)-based antiretroviral regimen has been rolled out for pregnant women in low- and middle-income countries since 2020. However, available safety data are limited to a few clinical trials and observational studies. Hence, we present real-world pregnancy and birth outcome safety data from a large sample multicenter cohort study in Ethiopia.
View Article and Find Full Text PDFContinuous professional development among stakeholders involved in drug safety monitoring and surveillance is imperative in strengthening pharmacovigilance (PV) systems. The "Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa" (PROFORMA) project aims to enhance the national PV infrastructure, post-marketing surveillance systems and clinical trial regulatory capabilities in Ethiopia, Tanzania, Kenya and Rwanda. To achieve this, training, including short-term training (STT) activities, at various levels is required.
View Article and Find Full Text PDFMetabolism of praziquantel (PZQ), a racemic mixture and the only drug approved to treat S. mansoni infection, is mediated by genetically polymorphic enzymes. Periodic school-based mass drug administration (MDA) with PZQ is the core intervention to control schistosomiasis.
View Article and Find Full Text PDFBackground: Diabetes mellitus (DM) increases cardiovascular disease (CVD) incidence and mortality. While guidelines endorse statin use in type 2 DM (T2DM) to mitigate cardiovascular risks and mortality, challenges like statin initiation and prompt treatment adjustments affect patient outcomes. This study aimed to assess the appropriateness of indications for and dose intensification of statin therapy among T2DM patients at Tikur Anbessa Specialized Hospital (TASH).
View Article and Find Full Text PDFBackground: Rifampicin, a key drug against tuberculosis (TB), displays wide between-patient pharmacokinetics variability and concentration-dependent antimicrobial effect. We investigated variability in plasma rifampicin concentrations and the role of , , arylacetamide deacetylase () and carboxylesterase 2 () genotypes in Ethiopian patients with TB.
Methods: We enrolled adult patients with newly diagnosed TB ( = 119) who had received 2 weeks of rifampicin-based anti-TB therapy.
Background: Mass drug administration (MDA) program of albendazole to at-risk populations as preventive chemotherapy is the core public health intervention to control soil-transmitted helminths (STHs). Achieving this goal relies on drug effectiveness in reducing the parasite reservoirs in the community and preventing reinfection. We assessed the efficacy of albendazole against STH parasite infection and reinfection status after cure.
View Article and Find Full Text PDFBackground: Preventive chemotherapy with a single dose of praziquantel given to an all-at-risk population through mass drug administration is the cornerstone intervention to control and eliminate schistosomiasis as a public health problem. This intervention mainly targets school age children, and pre-school age children (pre-SAC) are excluded from receiving preventive chemotherapy, partly due to scarcity of data on praziquantel treatment outcomes.
Methods: We conducted active efficacy and safety surveillance of praziquantel treatment among 240 Schistosoma mansoni-infected pre-SAC who received a single dose of praziquantel (40 mg/kg) in southern Ethiopia.
School-based deworming program is implemented to control and eliminate infection in many endemic countries, including Ethiopia. However, pre-school-age children (pre-SAC) are not targeted to receive preventive chemotherapy against infection, partly due to a lack of information on the disease burden. We assessed the prevalence and correlates of infection among pre-SAC in Southern Ethiopia.
View Article and Find Full Text PDFUnfavorable treatment outcomes for tuberculosis (TB) treatment might result from altered plasma exposure to antitubercular drugs in TB patients. The present study investigated the distribution of the N-Acetyltransferase 2 (NAT2) genotype, isoniazid acetylation status, genotype-phenotype concordance of NAT2, and isoniazid plasma exposure among Ethiopian tuberculosis patients. Blood samples were collected from newly diagnosed TB patients receiving a fixed dose combination of first-line antitubercular drugs daily.
View Article and Find Full Text PDFBackground: Globally, the prevalence of diabetes mellitus is rising. Due to the scarcity, high cost, and many adverse effects of modern treatments, traditional medicine is commonly used in rural areas to treat a variety of illnesses, including diabetes mellitus. The aim of this study was to assess the antihyperglycemic and hypoglycemic effects of Hochst ex Benth leaves.
View Article and Find Full Text PDFBackground: Tetanus remains a severe life-threatening infectious disease and neurological disorder in many parts of the world, where immunization programs are suboptimal. Any human injury or trauma has the possibility of getting infected with Clostridium tetani which is the sole causative bacterium of tetanus. Evidence is available that TAT may cause anaphylaxis and late serum sickness, while there has been no study conducted in Ethiopia.
View Article and Find Full Text PDFThe World Health Organization recommends efficacy and safety surveillance of anti-helminths used in mass drug administration campaigns. We evaluated the effectiveness of single-dose praziquantel against infection, and the safety of praziquantel plus albendazole preventive chemotherapy (PC) in infected school children (n = 512) in Southern Ethiopia. Stool examinations were done using thick smear Kato-Katz at baseline, week-4, and week-8 of post-Mass drug administration (MDA) to assess praziquantel efficacy.
View Article and Find Full Text PDFIntroduction: Leishmaniasis is one of the neglected tropical diseases, threatening lives of about 350 million people globally. seeds are used for the treatment of cutaneous leishmaniasis in the traditional medicine in Ethiopia.
Objective: This study aimed to evaluate seeds' anti-leishmanial activity in vitro.
CPT Pharmacometrics Syst Pharmacol
June 2023
Despite the potential for efavirenz (EFV) to be an effective alternative antiretroviral agent, its sources of wide inter- and intra-individual pharmacokinetic (PK) variability are not well-characterized in children. We investigated the effects of genetic and non-genetic factors, including demographic, treatment duration, baseline clinical, and biochemical characteristics, on the PKs of EFV through population-PK modeling. Antiretroviral therapy (ART) naïve HIV infected children, 3-16 years (n = 100), were enrolled in Ethiopia and received EFV-based combination ART.
View Article and Find Full Text PDFBackground: Antimicrobial resistance is currently a recognized global health problem stemming from poor antibiotic stewardship by health workers and inappropriate antimicrobial use by patients. Data showing the extent of poor antimicrobial stewardship in low- and middle-income countries are scanty though high incidences of antimicrobial resistance are increasingly reported in many settings across the globe. The objective of the present study was, therefore, to evaluate prescriptions for antimicrobials in East Africa.
View Article and Find Full Text PDFBackground: To help distinguish vaccine-related adverse events following immunization (AEFI) from coincidental occurrences, active vaccine pharmacovigilance (VP) prospective surveillance programs are needed. From February to May 2021, we assessed the system and facility readiness for implementing active AEFI VP surveillance in Addis Ababa, Ethiopia.
Methods: Selected hospitals were assessed using a readiness assessment tool with scoring measures.
Background: and have long been used to treat diabetes, hypertension, asthma, and other ailments. Herbal tea of and leaves formulation showed better antidiabetic and antihypertensive activities. This study investigated the prenatal developmental toxicity potential of the herbal tea of leaves blend in rats.
View Article and Find Full Text PDFVariation in genes involved in the absorption, distribution, metabolism, and excretion of drugs (ADME) can influence individual response to a therapeutic treatment. The study of ADME genetic diversity in human populations has led to evolutionary hypotheses of adaptation to distinct chemical environments. Population differentiation in measured drug metabolism phenotypes is, however, scarcely documented, often indirectly estimated via genotype-predicted phenotypes.
View Article and Find Full Text PDFPreventive chemotherapy (PC) with praziquantel and albendazole co-administration to all at-risk populations is the global intervention strategy to eliminate schistosomiasis and soil-transmitted helminth (STH) from being public health problems. Due to weak pharmacovigilance systems, safety monitoring during a mass drug administration (MDA) is lacking, especially in sub-Saharan Africa. We conducted large-scale active safety surveillance to identify the incidence, types, severity, and associated risk factors of adverse events (AEs) following praziquantel and albendazole MDA in 5848 school children (5−15 years old).
View Article and Find Full Text PDFIntroduction: The Ethiopian Ministry of Health strongly recommends that anyone, regardless of vaccination status, wears a standard face mask consistently when in public. This study aimed to assess the self-reported use and predictors of wearing face masks in the general population in Ethiopia.
Methods: This was a population-based cross-sectional study using a telephone survey.
Background: is used for medicinal and nutritional purposes. This study was, therefore, conducted to assess the contribution of based diet in reducing under nutrition in under-five children in four districts of Southern Ethiopia.
Method: A community-based comparative cross-sectional study design was employed from August to September 2016 in randomly selected comparative sites among 732 under five children.
Background: Rifamycins are a novel class of antibiotics clinically approved for tuberculosis chemotherapy. They are characterized by high inter-individual variation in pharmacokinetics. This systematic review aims to present the contribution of genetic variations in drug-metabolizing enzymes and transporter proteins to the inter-individual variation of rifamycin pharmacokinetics.
View Article and Find Full Text PDFEfavirenz is metabolized by CYP2B6, an inducible enzyme whose expression is regulated by the constitutive androstane receptor and pregnane X receptor nuclear receptors. CAR and PXR are encoded by genetically polymorphic NR1I2 and NR1I3, respectively. We examined the impact of NR1I2 and NR1I3 genotype on plasma EFV concentration and CYP2B6 enzyme activity among TB-HIV co-infected patients in Ethiopia.
View Article and Find Full Text PDFBackground: is a well-known medicinal plant that has traditionally been used to treat a variety of ailments, including wound healing. Supporting the traditional claims, wound healing, antibacterial, anti-inflammatory, and antioxidant activities of the crude extracts of different parts of the plant were reported. The aim of this study was to evaluate the wound healing and antibacterial activities of solvent fractions of the menthol leaf extract of .
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