Eleni Aklillu

I am a Professor of Tropical Pharmacology, senior researcher, and research group leader at the Department of Global Public Health, Karolinska Institutet.

My main area of research is Tropical Pharmacology, which is clinical pharmacology research focusing on major infectious diseases classified as public health problems, the most significant global burden, and the leading cause of death/disability, particularly in low and middle-income countries. My research projects address global public health issues, including maternal and child health problems, mainly in Sub-Saharan Africa, where the disease burden is paramount, and yet little is known about the impact of host-genetic factors, drug interactions, coinfections and comorbidity, and nutrition on both the safety and efficacy of therapy. My research group projects are designed to fill knowledge gaps and provide evidence-based recommendations for global and national policymakers.

Over the past two decades, my research group has investigated the impact of pharmacogenetic and environmental differences on drug metabolism and treatment outcomes in a range of communicable and non-communicable diseases, including HIV, TB, malaria infections, and Neglected Tropical Diseases, specifically lymphatic filariasis, schistosomiasis, soil-transmitted helminths and onchocerciasis and breast cancer in genetically diverse black-African populations.

Co-infections and disease comorbidities influence the treatment outcomes (safety and efficacy) in sub-Saharan Africa, where TB-HIV, HIV-malaria coinfections, and comorbidity with neglected tropical diseases are common. Concomitant therapy in co-infected patients is challenging due to drug-drug interaction, pill burden, overlapping toxicities, and adherence problems. We have conducted several prospective observational studies, randomized clinical trials, drug interaction, and dose optimization studies focusing on major public health problems, including treatment of the three most deadly infectious diseases (HIV/AIDS, tuberculosis, and malaria), neglected tropical diseases and antimicrobial resistance that claim millions of lives worldwide, especially in low-income countries.

We have conducted several major clinical trials, pharmacogenetics, pharmacokinetics, pharmacodynamics, drug interaction studies, biomarker discovery, and validation studies for drug-induced liver injury, antimicrobial resistance, and Hospital-acquired infections

Project 1: Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa- (Acronym - PROFORMA) (http://proforma.ki.se/).

PROFORMA is a 5-year project ( (2018 - 2022) funded by the European Union’s Framework Programme for Research and Innovation Horizon 2020 via the European and Developing Countries Clinical Trials Partnership (EDCTP2), with co-funding from Sida

In sub-Saharan Africa, access to medicine, including new drugs, vaccines, and microbicides for treating poverty-related diseases (PRD) is increasing. However, the capacities of the National Medicine Regulatory Authorities (NMRAs) to monitor the quality and public safety of new drugs and interventions are not coping, partly due to a shortage of qualified personnel and limited resources. PROFORMA aims to strengthen the national pharmacovigilance infrastructure and post-marketing surveillance system in Ethiopia, Kenya, Tanzania, and Rwanda by forging partnerships with local academic institutions (training-of-the-trainers for sustainable training programs), national medicine regulatory authorities (practical training to change policy into practice) and public health programs. We aim to generate a cohort of pharmacovigilance-trained human resources from all stockholders, including patients, healthcare providers, and regulatory staff engaged in pharmacovigilance data collection, analysis, interpretation, and data sharing. Our specific objective is to strengthen pharmacovigilance and post-marketing surveillance system focusing on public health programs involving mass drug administration for neglected tropical diseases and mass immunization programs. Twelve postgraduates will be trained to serve as part of the future PV expert regional task force in East Africa aligned with the large-scale African medicine regulatory harmonization and WHO’s Pharmacovigilance program.

Project 2: Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial (Acronym - PREGART) (https://www.pregart.eu/)

PREGART is a 5-year project (2019 - 2023) funded by the European Union’s Framework Programme for Research and Innovation Horizon 2020 via the European and Developing Countries Clinical Trials Partnership (EDCTP2).

Elimination of mother-to-child transmission of HIV is considered one of the priorities for the World Health Organization (WHO) and national programs. Safe and effective antiretroviral drugs during pregnancy and breastfeeding are crucial to achieving the elimination strategy. Dolutegravir (DTG), a second-generation integrase strand transfer inhibitor-based antiretroviral therapy(ART) regimen, demonstrated minimum drug interaction, lower risk of treatment discontinuation, and superior virological suppression against other first-line agents, including efavirenz and boosted protease inhibitors. DTG and low-dose EFV 400mg/day (EFV400) is recommended by WHO as an alternative first-line regimen for adults. Safety and efficacy data on using DTG and EFV400 in pregnant and breastfeeding women are unavailable. Both DTG and EFV are metabolized by genetically polymorphic enzymes UGT1A1 and CYP2B6, respectively. Investigating the pharmacokinetics (PK), pharmacodynamics (PD), and pharmacogenetics (PGx) of DTG in resource-limited genetically diverse African populations is an important step toward optimizing antiretroviral therapy during pregnancy and breastfeeding. We propose a multi-national, three-arm clinical trial to identify the optimal ART regimen for pregnant and breastfeeding women by comparing three alternative ART regimens. The specific objectives are: 1) To show that [TDF, 3TC, DTG] is non-inferior to [TDF, 3TC, EFV600]