artemether/lumefantrine / Generic mfg. - LARVOL DELTA

MEFI_IV: In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique (clinicaltrials.gov) - P4 | N=870 | Completed | Sponsor: Centro de Investigacao em Saude de Manhica | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Malaria

Physiologically based pharmacokinetic modelling to predict artemether and lumefantrine exposure in neonates weighing less than 5 kg treated with artemether-lumefantrine to supplement the clinical data from the CALINA study. (PubMed, Trop Med Health) - P2/3 | "Based on the success of the PBPK models for artemether and lumefantrine in predicting drug concentrations in adults and children, including neonates, modelling and simulation results can be used with confidence to supplement the limited available data for neonates (1-28 days old) < 5 kg BW obtained from the CALINA study for this rarer and more difficult to recruit patient population."

Clinical data • Journal • PK/PD data • Infectious Disease • Malaria • Pediatrics • CYP3A4

Drug-drug interaction between dolutegravir and artemether-lumefantrine in HIV and malaria mono- and co-infections: a pharmacogenetic analysis from Ghana. (PubMed, AIDS Res Ther) - "There is an observed decrease in plasma drug concentrations during the co-administration of artemether-lumefantrine and dolutegravir. Possible long-term effects from non-adherence may include sub-optimal levels that could result in clinical differences and outcomes."

Biomarker • Journal • Human Immunodeficiency Virus • Infectious Disease • Malaria • CYP3A4 • CYP3A5 • UGT1A1

Efficacy and gametocyte carriage in Plasmodium falciparum cases treated with artemether-lumefantrine alone versus with single-dose primaquine in Ethiopia: a randomized controlled study. (PubMed, Acta Trop) - "However, the low prevalence of gametocyte carriers among symptomatic cases at the study site, combined with the restriction of PQ administration to only those seeking treatment, may limit its overall impact on malaria transmission. Trial registration number: PACTR202502642820967."

Journal • Infectious Disease • Malaria

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=254 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Malaria • Pediatrics

Prevalence, safety evidence, and determinants of medicine use during breastfeeding among women in Kampala, Uganda. (PubMed, BMC Womens Health) - "The overall prevalence of medicine use among breastfeeding women was high, with frequent self-medication using over-the-counter drugs. There is urgent need for strengthened regulatory frameworks, enhanced healthcare provider training, with community based education to promote rational medicine use and improve public health literacy. Further pharmacokinetic research is critical to generate safety data on commonly used medications, hence informing clinical guidelines and supporting evidence-based decision-making among breastfeeding women."

Journal

Microhaplotype deep sequencing assays to capture Plasmodium vivax infection lineages. (PubMed, Nat Commun) - P4 | "IBD analysis in the RCT demonstrates a lower frequency of suspected relapses or recrudescence in patients treated with primaquine compared to those without primaquine; the impact is greater when paired with chloroquine than with artemether-lumefantrine. Our results demonstrate the potential to derive new information on P. vivax treatment and transmission using IBD generated by amplicon sequencing data that can be further improved with time-to-event models."

Clinical • Journal • Infectious Disease

Formulation development and optimization of artemether-lumefantrine self-nanoemulsifying drug delivery systems. (PubMed, Pharmazie) - "Compatibility studies revealed no prominent or significant incompatibilities between the drugs and selected excipients. The optimized formulation was stable as dispersions with nano-sized droplets and a loading capacity >99 % for both ART and LMF and a release >95% within 15 min for both drugs, reflecting a significant increase in the rate and extent of dissolution compared to that of the pure drug."

Journal

KALUMA: Efficacy, Safety and Tolerability of KLU156 in Adults and Children ≥ 5 kg Body Weight With Uncomplicated P. Falciparum Malaria (clinicaltrials.gov) - P3 | N=1720 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Malaria

Efficacy of artemether-lumefantrine, artesunate-amodiaquine, dihydroartemisinin-piperaquine and artesunate-pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in Mozambique, 2022. (PubMed, Malar J) - P4 | "AL and AS-AQ remain effective, as their efficacy remained above the 90% WHO-recommended cut-off. DP and AS-PY also showed therapeutic efficacy above the WHO-acceptable cut-off and could be used as first-line treatments when needed. All four artemisinin-based combinations were well tolerated, with minimal safety concerns."

Journal • Infectious Disease • Malaria

Imported plasmodium ovale malaria from Côte d'Ivoire: a case report. (PubMed, Trop Dis Travel Med Vaccines) - "Given that P. ovale is not endemic to Colombia, increased awareness among clinicians is necessary for accurate diagnosis and management of imported malaria cases. Enhanced surveillance and advanced diagnostic techniques are essential to prevent misdiagnosis and ensure appropriate treatment."

Journal • Infectious Disease • Malaria • Musculoskeletal Pain • Pain

The transmission blocking activity of artemisinin-combination, non-artemisinin, and 8-aminoquinoline antimalarial therapies: A pooled analysis of individual participant data. (PubMed, PLoS Med) - "We found marked differences among ACTs and single low-dose 8-aminoquinoline drugs in their ability and speed to block transmission. The findings from this analysis can support treatment policy decisions for malaria elimination and be integrated into mathematical models to improve the accuracy of predictions regarding community transmission and the spread of drug resistance under varying treatment guidelines."

Journal • Retrospective data • Infectious Disease • Malaria

Efficacies of artemether-lumefantrine, artesunate-amodiaquine, dihydroartemisinin-piperaquine, and artesunate-pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 10 years in Uganda: a randomised, open-label, phase 4 clinical trial. (PubMed, Lancet Infect Dis) - "Artemether-lumefantrine was associated with a higher risk of recurrent malaria than other antimalarial combinations tested, and K13 mutations were associated with delayed parasite clearance. Changes in first-line therapy for uncomplicated malaria must be considered in response to suboptimal efficacy of artemether-lumefantrine."

Journal • P4 data • Hematological Disorders • Infectious Disease • Malaria • Respiratory Diseases

Can hair concentrations of artemether-lumefantrine be used as a tool to retrospectively determine drug exposure during malaria treatment? (PubMed, New Microbes New Infect) - "A larger study is warranted to evaluate correlations between lumefantrine hair and plasma concentrations. If validated, this approach could aid in distinguishing inadequate drug exposure from reduced parasite susceptibility to AL, optimizing malaria treatment strategies."

Journal • Retrospective data • Infectious Disease • Malaria

Artemisinin Partial Resistance Mutations in Zanzibar and Tanzania Suggest Regional Spread and African Origins, 2023. (PubMed, J Infect Dis) - "Frequent parasite importation appears to maintain partner drug mutation frequencies similar to the mainland, where artemether-lumefantrine selects for mutations favoring artesunate-amodiaquine sensitivity. Ongoing molecular surveillance remains essential to track these patterns."

Journal • Infectious Disease • Malaria

Artemisinin Partial Resistance Mutations in Zanzibar and Tanzania Suggest Regional Spread and African Origins, 2023. (PubMed, medRxiv) - "Frequent parasite importation appears to maintain partner drug mutation frequencies similar to the mainland, where artemether-lumefantrine selects for mutations favoring artesunate-amodiaquine sensitivity. Whole genome sequencing suggests an African origin with regional spread of mutations. Continued surveillance is critical to monitor evolving resistance and drug selection dynamics."

Journal • Infectious Disease • Malaria

The role of emergency departments in the treatment of imported severe and uncomplicated malaria - a retrospective monocentric observational study in a German university hospital. (PubMed, Acta Trop) - "ED play a crucial role in the care of patients with malaria. Our work presents for the first time extensive and detailed data on diagnosis, patient characteristics, laboratory and clinical parameters, therapy, and outcomes of these patients in the ED of a large German university hospital."

Journal • Observational data • Retrospective data • Infectious Disease • Malaria

Successful Treatment of Two Cases of Plasmodium falciparum Malaria that Developed Recrudescence after Artemether-Lumefantrine Therapy (PubMed, Mikrobiyol Bul) - "Artemisinin bazlı kombinasyonlardan olan AL Türkiye'de de görülen sıtma olgularının tedavisi için sık tercih edilen bir preparattır. Üç günlük uygun AL tedavisinden sonra periferik kan yaymasında paraziteminin temizlendiği tespit edilmiş olsa bile, hastalarda tedavi başarısızlığı görülebileceği ve bu tedavi başarısızlığının Afrika kaynaklı P.falciparum sıtması olgularını da kapsayabileceği akılda tutulmalıdır."

Journal • Infectious Disease • Malaria

Polymerase Chain Reaction Fails to Detect Mixed Malaria Infections in Siblings from Ethiopia. (PubMed, J Infect Chemother) - "This case highlights the limitations of current malaria diagnostics, which may fail to detect mixed infections and lead to delayed or incomplete treatment. Clinicians should maintain a high index of suspicion for malaria in patients returning from co-endemic regions, as mixed infections may emerge after a prolonged period without re-exposure to an endemic area."

Journal • Polymerase Chain Reaction • Infectious Disease • Malaria • Pediatrics

CYP2B6*6 single nucleotide polymorphism among patients with uncomplicated malaria in Adjumani district, Uganda: Implications on efficacy of artemether-lumefantrine. (PubMed, PLoS One) - "Interindividual variability in P. falciparum clearance exists, with heterozygous patients demonstrating slow artemether-lumefantrine P. falciparum parasite clearance. There is a need to consider incorporating host genomic factors, such as metabolising enzyme genotype into routine Therapeutic Efficacy Studies (TES)."

Journal • Infectious Disease • Malaria

Antimalarial Drug Repurposing of Epirubicin and Pelitinib in Combination with Artemether and Lumefantrine. (PubMed, Pharmaceuticals (Basel)) - "Most combinations of PEL with ART and LU showed antagonism (FIC50 > 1) when tested against strains of P. falciparum and clinical isolates. This study underscores the utility of alternative drug discovery and development strategies to bypass cost, time, and safety barriers, thereby enriching the antimalarial drug pipeline and accelerating the transition from lab to market."

Journal • Infectious Disease • Malaria

Assessing the quality of antimalarial drugs in Equatorial Guinea: a follow-up study. (PubMed, BMJ Glob Health) - "The prevalence of substandard and falsified antimalarials in EG has alarmingly increased from 9% in 2013 to 59.5% in 2018, highlighting the urgent need for enhanced regulatory measures. Immediate actions should include strengthening drug quality surveillance, particularly in private sector pharmacies, and implementing low-cost medicine screening methods for early detection of poor-quality medications. Ensuring the quality of antimalarials is critical to maintaining the efficacy of malaria control programmes and preventing the development of drug resistance."

Journal • Infectious Disease • Malaria

The prevalence and associated factors of potential drug-drug interactions in people living with HIV/AIDS: a retrospective study at a Nigerian tertiary hospital (IAS-HIV 2025) - "The primary contributors to serious drug-drug interactions (DDIs) were Erythromycin+Loratadine (56.8%), Rifampin+Pyrazinamide (20.0%), and Rifampin+Isoniazid (17.5%). The only contributors to contraindicated DDIs included Erythromycin+Artemether/Lumefantrine (58.3%) and Erythromycin+Fluconazole (41.7%). This study underscores the high prevalence of drug-drug interactions among individuals living with HIV/AIDS, particularly in older ones and those with advanced disease stages. These findings highlight the need for enhanced medication management strategies to improve safety and treatment outcomes."

Retrospective data • Cardiovascular • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Malaria • Respiratory Diseases • Tuberculosis

A Novel Plasmodium falciparum Kelch13 A675T Mutation and High Levels of Chloroquine and Sulfadoxine-Pyrimethamine Resistance in Burundi. (PubMed, medRxiv) - "The pfcrt IET triple mutant haplotype (94.9%) and pfmdr1 N-F-D mutant haplotype (57.9%) indicate sustained CQ resistance and efficacy of artemether-lumefantrine (AL). These findings indicate substantial SP resistance, posing a threat to the efficacy of IPTp and SMC strategies in Burundi. The findings also show potential ART-R and partner drug resistance in Burundi, highlighting the need for strengthened surveillance and coordinated regional efforts to mitigate resistance and sustain malaria control."

Journal • Infectious Disease • Malaria • ABCB1

Tracking Plasmodium falciparum antimalarial resistance markers during a malaria pre-elimination period in the Pacific coast of South America. (PubMed, Sci Rep) - "In conclusion, parasites resistant to chloroquine (Pfcrt) and pyrimethamine (Pfdhfr) increased in recent years, while parasites sensitive to sulfadoxine (Pfdhps) and artemisinin (Pfk13) prevail in Ecuador. These results suggest that the current first-line treatment (artemether-lumefantrine + primaquine) is still useful against P. falciparum."

Journal • Infectious Disease • Malaria • ABCB1