emtricitabine / Generic mfg. - LARVOL DELTA

The anti-retroviral therapy emtricitabine affects skeletal muscle DNA methylation and transcriptome patterns in a male HIV mouse model. (PubMed, bioRxiv) - "The current study provides insights into mechanisms by which a clinically relevant ART may influence DNA methylation and transcriptome changes in skeletal muscle in the context of HIV biology. The differentially regulated pathways suggest novel targets for understanding, and eventually abrogating, the harmful effects of long-term ART use in PLWH on skeletal muscle mass and function."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • Sarcopenia • MYF6 • PPARA

HIV-1 genetic diversity and pretreatment drug resistance survey prior to dolutegravir introduction in Senegal. (PubMed, IJID Reg) - "Among NRTIs, the most frequent mutation was M184V (3/6), conferring high-level resistance to lamivudine and emtricitabine, and K103N (11/12) among NNRTIs, conferring resistance to efavirenz and nevirapine. Through a quasi-national survey, an intermediate level of NNRTI resistance was observed, with regional disparities in Senegal. These findings highlight the limitations of NNRTI-based first-line regimens in Senegal and support the transition to other antiretroviral therapy regimens, such as dolutegravir-based therapy in newly infected individuals as well as in treated patients."

Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Low risk of HBV reactivation in HBcAb-positive/HBsAg-negative persons with HIV switching to non-tenofovir-based antiretroviral therapy (EACS 2025) - "We matched participants switching to ART without HBV activity (non-lamivudine or emtricitabine [non-XTC] group) 1:1 to participants switching to XTC-containing ART (XTC group) based on sex, age (±5 years) and time on tenofovir (±90 days)...All measurements remained below the quantification limit. HBV reactivation does not seem to be of clinical concern in this context."

Late-breaking abstract • Hepatitis B • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease

Enhanced degradation of pharmaceutical contaminants by medium-pressure UV irradiation in the presence of nitrate: Reactive species, toxicity and DBPs formation. (PubMed, Environ Res) - "This study comparatively investigated the degradation kinetics and mechanisms, changes in toxicity, and formation of disinfection byproducts (DBPs) for two pharmaceutical contaminants (PCs), emtricitabine (FTC) and trimethoprim (TMP), using the medium-pressure UV/nitrate (MPUV/NO3-) process...Additionally, chloramination outperforms chlorination in controlling DBPs formation and their associated toxicity. Overall, this study provides critical insights into the transformation pathways and ecological risk assessment of PCs in nitrate-rich wastewater under polychromatic UV irradiation."

Journal

Monitoring HIV Antiretroviral Therapy via Aptamer-Based Measurements in Preclinical Animal Models, in Human Plasma. (PubMed, Adv Sens Res) - "The aptamer has clinically relevant sensitivity in biofluids and is highly selective relative to close analogs such as cytosine, cytidine, fluorocytidine, and lamivudine (a.k.a. Using this aptamer, two analytical assays are developed, one for continuous, in-vivo emtricitabine monitoring in rodent research models, and one for rapid and high-throughput screening of emtricitabine levels in human plasma. Through blinded analytical validation, this clinical assay achieved an 86.9% positive and 100% negative correlation, with an overall agreement rate of 95% relative to the benchmark LC-MS method."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease

Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients (clinicaltrials.gov) - P4 | N=19 | Completed | Sponsor: Fundacion Clinic per a la Recerca Biomédica | Unknown status ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • Solid Organ Transplantation • Transplantation

HAIROBS: Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and/or Total Non-compliance With Treatment (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: University Hospital, Toulouse | Not yet recruiting ➔ Active, not recruiting

Compliance • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

MAFALDA-R: Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load (clinicaltrials.gov) - P4 | N=63 | Completed | Sponsor: Fundacion SEIMC-GESIDA | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

The impact of immune reconstitution inflammatory syndrome (IRIS) in HIV-positive people with CD4 <200 Cells/mm³ Initiating dolutegravir/lamivudine dual therapy: DOLCE study findings (IAS-HIV 2025) - "However, there is limited data on IRIS in dual therapy.This study aims to report the incidence of IRIS. The DOLCE study,a randomized trial in Argentina and Brazil, reported similar virologic suppression rates between dual therapy (DT) with Dolutegravir/Lamivudine and triple therapy (TT) with Dolutegravir, tenofovir disoproxil fumarate, and lamivudine or emtricitabine in PLWH with CD4 counts below 200 cells/mL.Participants were monitored for IRIS development over 48 weeks,diagnosed using clinical criteria(French Criteria, 2004) excluding other causes of symptoms. The IRIS incidence in this study is within the expected range, reflecting the typical early presentation in PLHIV with low CD4 counts starting ART. No significant differences were observed between the DT and TT regimens. These results highlight the importance of early IRIS monitoring, particularly in individuals with low baseline CD4 counts and pre-existing opportunistic diseases"

Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Oncology • CD4

Kinetic investigation of resistance to Islatravir conferred by mutations in HIV-1 reverse transcriptase (ACS-Fall 2025) - "The M184V mutation, commonly associated with resistance to nucleoside reverse transcriptase inhibitors (NRTIs) such as lamivudine and emtricitabine, and the M184V/A114S mutations, both located within the hydrophobic pocket, were shown to reduce Islatravir susceptibility in cell-based viral resistance selection assays. These reductions were primarily attributable to corresponding decreases in EFdA-TP incorporation rate constants of 18-fold and 105-fold, respectively. These results suggest that, unlike FDA-approved NRTIs, the clinical efficacy of Islatravir, may not be substantially compromised by the M184V mutation alone but could be significantly reduced by the M184V/A114S mutations."

Human Immunodeficiency Virus • Infectious Disease

Recovery of aptamer-based sensor signaling in biofluids for plasma antiretroviral concentration monitoring (ACS-Fall 2025) - "Emtricitabine (FTC) is a cytidine analogue with reverse transcriptase inhibitory activity...Challenges arose when the system was translated from buffer to biofluids due to the nonspecific binding of plasma and serum proteins to the aptamer. Here I demonstrate a solution to recover sensitivity through simplification of the biofluid matrix."

Human Immunodeficiency Virus • Infectious Disease

Tenofovir to Prevent HIV Infection in Western China: Pragmatic Randomized Controlled Trial. (PubMed, JMIR Public Health Surveill) - P=N/A | "Most trials used tenofovir combined with emtricitabine as the intervention; yet, the use of tenofovir disoproxil fumarate (TDF) (ie, Tenofovir) alone has not been thoroughly evaluated. The TDF-based PrEP is ineffective without good adherence. However, when medication compliance is achieved, event-driven dosing is recommended as an optimal PrEP regimen."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

HAIROBS: Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and/or Total Non-compliance With Treatment (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: University Hospital, Toulouse

Compliance • New trial • Human Immunodeficiency Virus • Infectious Disease

Drug resistance mutations among people living with HIV and ART failure in Bangladesh: a cross-sectional study. (PubMed, Lancet Reg Health Southeast Asia) - "Seven participants showed resistance against Efavirenz, the common drug received from ART centres, and three of them were additionally resistant against Tenofovir Disoproxil Fumarate. Other drugs supplied by ART centres were also found resistant for participants; i.e. 6 against Emtricitabine, 6 against Lamivudine, and 1 against Etravirine...This study also advocates for exploring barriers to ART adherence and implementing personalized ART strategies in national ART programs. The Global Fund."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Structure-Activity Relationship Studies of Emtricitabine Prodrugs toward Long-Acting Antiretroviral Formulations. (PubMed, ACS Omega) - "We show that 5'-modifications displaying a range of hydrolytic stabilities in biomatrices are compatible with the LAI formulation by the emulsion-templated freeze-drying (ETFD) method. The results demonstrate the feasibility of tuning prodrug activation kinetics while maintaining LAI compatibility, which is critical for the development of nucleoside reverse transcriptase inhibitor (NRTI)-containing LAI-ARV therapies."

Journal • Human Immunodeficiency Virus • Infectious Disease

Sensitive RP-HPLC method with fluorimetric detection for concurrent quantification of emtricitabine, Daclatasvir and Ledipasvir in human urine. (PubMed, Sci Rep) - "Stability assays reveal that the three studied drugs were stable during preparation, injection and storage. The method can be applied for the quantification of the three drugs co-administered to HIV/HCV co-infected patients' urine which aids in therapeutic drug monitoring and dosage adjustment for chronic patients."

Journal • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Recommendations for interpreting intraerythrocytic tenofovir-diphosphate and emtricitabine-triphosphate for PrEP adherence assessment. (PubMed, J Acquir Immune Defic Syndr) - "Proper interpretation of TFV-DP and FTC-TP in DBS requires accounting for the factors identified above to maximize the value of these measurements."

Journal

Silent No More: Endogenous Retrovirus Activation and Its Impact on Sjögren's Disease Pathogenesis (EULAR 2025) - "The drugs were given from 3 weeks post the initial immunization via the drinking water as a solution of 3 × 10 -4 M nevirapine, 1.6 × 10 -4 M emtricitabine and 9.4 × 10 -5 M tenofovir. In this study, we found that ERV sequences significantly increased in saliva and salivary glands in patients with SjD compared to controls, indicating ERV activation in SjD. Inhibition of the retroviral activity of ERV in SjD mice model can inhibit the lymphocyte infiltration in the salivary gland and alleviate gland dysfuntion. The data suggest that ERV reactivation might be a pivotal mechanism in leading to persistent immune disturbance in SjD pathogenesis."

Human Immunodeficiency Virus • Infectious Disease • Inflammation • Sjogren's Syndrome

HPLC-Based Quantitative Assessment of Antiviral Agents in Artificial Saliva. (PubMed, Drug Dev Ind Pharm) - "A novel high-performance liquid chromatographic (HPLC) method for simultaneous analysis of three selected antivirals: Tenofovir Disoproxil Fumarate (TDF), Favipiravir (FAV), Ritonavir (RIT) and internal standard as another antiviral (emtricitabine) in artificial saliva was optimized and validated, including sample preparation using new extraction procedure. The method has been found according to ICH guidelines specific, accurate (recovery, 93.003% - 103.357%), sensitive (LOD and LOQ were values found as 0.03 and 0.1 µg/mL, respectively), and precise (RSD; 0.412% - 3.175%). A validated HPLC method was developed for the precise determination of different antiviral agents in artificial saliva."

Journal

QuEChERS and UPLC-MS/MS-Based Quantification of Human Plasma of Eight Nucleoside Reverse Transcriptase Inhibitors and Platinum Anticancer Drugs for Hepatocellular Carcinoma. (PubMed, Molecules) - "The target analytes-lamivudine, telbivudine, emtricitabine, entecavir, tenofovir, nedaplatin, oxaliplatin, and adefovir dipivoxil-exhibited strong linearity within the 10-1000 ng/mL and 1-100 ng/mL ranges, showing correlations (r2) ≥ 0.9962. Overall, this analytical approach can be used to detect the combination of eight NRTIs and platinum-based drugs in human plasma. This method enables plasma drug-level monitoring in real time, with applications for individualized treatment approaches."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

LINE-AD: Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Butler Hospital | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Aβ42 • CSF Aβ42 • CSF P-tau

Pharmacokinetics of Tenofovir Diphosphate, Lamivudine Triphosphate and Emtricitabine Triphosphate in Adolescents With HIV Infection With and Without Tuberculosis Coinfection. (PubMed, Pediatr Infect Dis J) - "The concentrations of the recommended NRTIs and pharmacokinetics-determined adherence were not significantly different in adolescents with TB or younger age."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Pharmacokinetic approaches to standardize antiviral exposure in cerebrospinal fluid. (PubMed, Pharmacotherapy) - "PK modeling successfully standardized ARV CSF concentrations to a given time point (i.e., CMAX or CTrough) to allow estimation of CSF penetration. This approach provides uniformity for the assessment of exposure, for the estimation of whether desired therapeutic drug goals are obtained in the CSF, and for further studies to investigate whether CSF exposure metrics calculated using this method are associated with measures of HIV persistence."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Kinetic investigation of resistance to Islatravir conferred by mutations in HIV-1 reverse transcriptase. (PubMed, J Mol Biol) - "The M184V mutation, commonly associated with resistance to NRTIs such as lamivudine and emtricitabine, and the M184V/A114S mutations, both located within the hydrophobic pocket, were shown to reduce Islatravir susceptibility in cell-based viral resistance selection assays. These reductions were primarily attributable to corresponding decreases in EFdA-TP incorporation rate constants of 18-fold and 105-fold, respectively. These results suggest that, unlike FDA-approved NRTIs, the clinical efficacy of Islatravir, may not be substantially compromised by the M184V mutation alone but will be significantly reduced by the M184V/A114S mutations."

Journal • Human Immunodeficiency Virus • Infectious Disease

ELDORADO: DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living with HIV-1 Infection (clinicaltrials.gov) - P3 | N=610 | Recruiting | Sponsor: ANRS, Emerging Infectious Diseases | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease