atazanavir / Generic mfg. - LARVOL DELTA

Efficacy and safety of emtricitabine/tenofovir alafenamide (F/TAF) plus cobicistat-boosted protease inhibitors in children with HIV-1 aged 2-<12 years and weighing 14-<40 kg: Week 48 outcomes (IAS-HIV 2025) - P2/3 | "BACKGROUND: TAF is a nucleoside reverse transcriptase inhibitor with improved renal and bone safety compared with tenofovir disoproxil fumarate. F/TAF is approved in Europe and the US for use with boosted protease inhibitors in adults and older children, and is being evaluated with cobicistat-boosted atazanavir (ATV/co) or darunavir (DRV/co) in younger children in an ongoing open-label Phase 2/3 trial (NCT02016924)... Over 48 weeks of treatment, F/TAF + ATV/co or DRV/co in children aged 2-<12 years and weighing 14-<40 kg maintained high rates of virologic suppression, with an acceptable safety profile. There were no renal, bone, or weight gain/loss concerns, supporting further evaluation of these drug combinations in pediatric populations."

Clinical • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Model-based evaluation of the interaction between ritonavir-boosted atazanavir and rifampicin in Ugandan adults with HIV. (PubMed, Br J Clin Pharmacol) - P2/3 | "Metabolic induction by rifampicin accounts for the decrease in plasma exposure of ATV/r. Doubling the ATV/r dosing frequency to BID effectively mitigated this interaction. The plasma exposure of ATV/r mirrored that in PBMCs, suggesting that for these drugs, plasma concentrations provide a reliable reflection of site-of-action exposures."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Bictegravir, emtricitabine, and tenofovir alafenamide versus ritonavir-boosted protease inhibitor-based antiretroviral therapy in people with HIV and viral suppression on second-line therapy in Haiti: an open-label, randomised, non-inferiority trial. (PubMed, Lancet HIV) - P4 | "Switching adults with HIV and viral suppression on a second-line boosted protease inhibitor-based regimen to combination bictegravir, emtricitabine, and tenofovir alafenamide is non-inferior to continuing boosted protease inhibitor-based antiretroviral therapy. These findings support international treatment guideline recommendations to use second-generation integrase inhibitors for treatment-experienced patients."

Clinical • Head-to-Head • Journal • Human Immunodeficiency Virus • Infectious Disease

Untargeted Metabolite Profile Associations with Body Mass Index, Waist-Hip Ratio, and Antiretroviral Therapy in >1300 People with HIV: the Swiss HIV Cohort Study. (PubMed, J Infect Dis) - "In PWH from Switzerland, untargeted metabolite profiling revealed multiple unreported associations with different ART agents, and previously reported associations with BMI."

Journal • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Pregnancy and health outcomes among women living with HIV on different antiretroviral therapy in Malawi: a cohort study (IAS-HIV 2025) - "Women in both cohorts had similar pregnancy outcomes, but Cohort B experienced a higher frequency of Atazanavir and Zidovudine- associated clinical and laboratory events compared to those in Cohort C. These results emphasize importance of consistent ART management and monitoring to improve maternal and neonatal health outcomes."

Clinical • HEOR • Human Immunodeficiency Virus • Infectious Disease

Prevalence and durability of viral suppression among adults living with HIV transitioned from boosted protease inhibitors-based to dolutegravir-based regimens as second-line therapy from 2019 to 2021 in Tajikistan (IAS-HIV 2025) - "BACKGROUND: WHO recommends dolutegravir-based regimens (DBR) as preferred second-line therapy for those failing efavirenz-based regimens (EBRs) but there was no guidance on whether those who failed EBR and were switched to boosted protease inhibitor-based therapy (bPIBR) could be transitioned to DBRs. In Tajikistan, DBRs, primarily tenofovir/lamivudine/dolutegravir (TLD), became available in 2019...Median time on ART before TLD was 5 years (IQR:3-6) and on bPIBRs 1 year (IQR:1-2); 63% used lopinavir- and 35% atazanavir-based regimens; tenofovir was part of backbone regimen for 46% of PLHIV... Transitioning from second-line bPIBRs to TLD resulted in high rates of DVS among most PLHIV, including those previously suppressed and unsuppressed on bPIBRs. Our results suggest that transition from second-line bPIBR to DBRs may be an effective practice. Further investigation is needed to identify reasons for non-suppression among some PLHIV transitioned from second-line bPIBRs to..."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Osteosimply014: Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia (clinicaltrials.gov) - P=N/A | N=31 | Completed | Sponsor: Judit Pich | Unknown status ➔ Completed | N=45 ➔ 31

Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease • B2M

Bictegravir decreases expression of system L-amino acid transporters and inhibits leucine uptake activity in a human placental cell line. (PubMed, Biomed Pharmacother) - "Syncytialized BeWo cells were treated with atazanavir, darunavir, efavirenz, dolutegravir, raltegravir, bictegravir or cabotegravir for 24 h at Cmax and half Cmax therapeutic concentrations. Bictegravir, which has been recently added to perinatal treatment guidelines, was associated with downregulation of system L expression and function in BeWo cells. Further in vivo studies are warranted to confirm our findings."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease

Forecasting drug resistant HIV protease evolution. (PubMed, bioRxiv) - "We infer drug resistance along simulated evolutionary paths and predict that the combination PI-therapy of Atazanavir (ATV) and Ritonavir (RTV) is the least drug resistant. Without prior knowledge of PI-associated mutations, our model predicts known primary and secondary PI-resistant mutations as critical to drug resistance. This validates that our model learned mechanistic relations in the small data sets, tackling the challenge of sparse sequence data compared to the large combinatorial complexity of protein evolution and changing functionality in dynamic environments."

Journal • Human Immunodeficiency Virus • Infectious Disease

Prenatal Antiretroviral Exposure and Concomitant Neurodevelopmental Problems among 5-year-old Children who are HIV-Exposed and Uninfected. (PubMed, J Acquir Immune Defic Syndr) - "Prenatal exposure to TDF/emtricitabine/atazanavir was associated with factor scores reflecting parent-reported behavioral concerns among CHEU whose mothers initiated ARVs during pregnancy."

Journal • Human Immunodeficiency Virus • Infectious Disease

HIV protease inhibitors restore amphotericin B activity against Candida. (PubMed, PLoS One) - "In this study, we identified four HIV protease inhibitors (atazanavir, saquinavir, lopinavir and ritonavir) as strong potentiators of amphotericin B against C. auris. The in vivo treatment with HIV protease inhibitors combined with amphotericin B resulted in a significant reduction of C. auris colony-forming units (CFU) by 1.7-2.6 Log10 in the C. elegans model. These findings suggest that HIV protease inhibitors, in combination with amphotericin B, are promising candidates for the development of novel antifungal drugs to treat Candida infections."

Journal • Candidiasis • Human Immunodeficiency Virus • Infectious Disease

Second-Line Antiretroviral Therapy for Children Living with HIV in Africa. (PubMed, N Engl J Med) - "Second-line ART regimens including TAF-emtricitabine and dolutegravir were effective for children, with no evidence of safety concerns. Ritonavir-boosted darunavir was also effective. (Funded by the European and Developing Countries Clinical Trials Partnership and others; CHAPAS-4 ISRCTN Registry number, ISRCTN22964075.)."

Journal • Human Immunodeficiency Virus • Infectious Disease

Viral suppression after failure of PI-based ART among adolescents and youths with and without drug resistance mutations: a longitudinal analysis in Tanzania. (PubMed, J Antimicrob Chemother) - "More than half of AY who had PI DRMs had a higher proportion of early VS (65%) compared with those without DRMs (45%). Optimal viral load monitoring, adherence intensification and routine drug resistance testing are key strategies to improve VS."

Journal • Human Immunodeficiency Virus • Infectious Disease

Nanotechnology-Driven Strategy Against SARS-CoV-2: Pluronic F127-Based Nanomicelles with or Without Atazanavir Reduce Viral Replication in Calu-3 Cells. (PubMed, Viruses) - "However, pre-exposure of Calu-3 cells led to significant viral replication reduction (>85% and >75% for 1:2 and 1:4 dilutions, respectively), as confirmed by transmission electron microscopy. These findings highlight Pluronic F127-based nanomicelles as a promising nanotechnology-driven strategy against SARS-CoV-2, reinforcing their potential for future antiviral therapies."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Virological Failure And HIV-1 Drug Resistance in Indian Adults and Adolescents on Protease Inhibitor Based Second-line Antiretroviral Therapy: A Five-year Follow-up Study. (PubMed, Curr HIV Res) - "This 5-year longitudinal study highlights the resilience of PIs in second-line ART. The incidence of VF with PI-resistance was notably low, indicating the ongoing effectiveness of PIs in managing PLH on second-line ART and the possibility of recycling PIs in subsequent ART regimens for these patients. Cross-resistance to DRV patients highlights the need for enhanced treatment monitoring."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Using the Simcyp R Package for PBPK Simulation Workflows With the Simcyp Simulator. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "The first demonstrates the verification of a drug-drug interaction model for Atazanavir, an antiretroviral drug indicated for the treatment of HIV/AIDS. The second is applied to the virtual bioequivalence assessment of paliperidone palmitate long-acting injectable suspensions. We show how simulations that could take days otherwise can be executed, analyzed, and displayed in a matter of hours."

Journal • Human Immunodeficiency Virus • Infectious Disease

Operation Triple Zero: Implementation, Processes, and Outcomes of an Asset-Based Approach to Achieving Viral Suppression Among Adolescents and Young Persons Living With HIV in Kenya, 2017-2021. (PubMed, J Adolesc Health) - "OTZ implementation led to improved HIV treatment outcomes among AYPLHIV, contributing to sustained epidemic control efforts complementing other interventions."

Journal • Human Immunodeficiency Virus • Infectious Disease

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

Week 24 Outcomes of F/TAF Plus Cobicistat-Boosted Protease Inhibitors in Children ≥2 y and ≥14 kg (CROI 2025) - P2/3 | "An ongoing Phase 2/3 open-label trial is evaluating F/TAF in combination with cobicistat-boosted atazanavir (ATV/co) or darunavir (DRV/co) in children with HIV-1 (NCT02016924). Changes in height, weight, and body mass index Z-scores; spine and TBLH BMD; and eGFR were not clinically significant (Table). Conclusions In this interim analysis, F/TAF in combination with ATV/co or DRV/co in children aged 2-<12 y and weighing 14-<40 kg was efficacious, with an acceptable safety profile and no renal, bone, or weight concerns, supporting further evaluation in pediatric populations."

Clinical • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • CD4

Plasma Concentrations of Lenacapavir in People Living With Multidrug-Resistant HIV: Real-Life Study (CROI 2025) - "Of note, 5 patients presented LEN Cpl above 150 ng/mL, corresponding to PWH with acute or chronic kidney disease and/or receiving ritonavir-boosted atazanavir containing regimens. Conclusions In our population of HTE HIV patients, PWH had adequate LEN Cpl. No drug-drug interaction was reported and tolerance of antiretroviral multitherapy was acceptable."

Clinical • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease

ART Exposure and Accelerated Aging in PLHIV: Insights From Proteomic and Methylation Clocks (CROI 2025) - P | "Longer cumulative exposure to dolutegravir (DTG), rilpivirine (RPV) and nelfinavir (NFV) was associated with lower age advancement scores on at least a biological clock. In contrast, longer exposure to tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), darunavir (DRV), atazanavir (ATV), and dideoxynucleoside analogues (d-drugs) was related to higher age advancement scores (Figure 1; P<0.05, adjusted for chronological age)...Conclusions Cumulative ART exposure influences age acceleration in PLHIV, with distinct effects across regimens and drug classes. Innate immune pathways appear to be key drivers of these effects and are promising therapeutic targets to mitigate accelerated aging."

Human Immunodeficiency Virus • Infectious Disease • Inflammation

High Incident TB Among Individuals Switched to Dolutegravir or Protease Inhibitor Based 2nd Line ART (CROI 2025) - "We, therefore, evaluated incident TB cases and associated risk among individuals enrolled under the VISEND clinical study, a 144 week clinical trial which evaluated virological outcomes among individuals switched from failing NNRTI based ART to DTG or boosted protease inhibitor (bPI) (lopinavir or atazanavir) based second line ART while recycling the NRTIs Methods We conducted an analysis of PLWH aged ≥ 18 years enrolled in the VISEND trial and screened negative for TB prior to regimen switch. Conclusions In the VISEND trial, incident TB was high especially in the first month of switching to DTG or bPI regimen and was associated with rapid viral decline, low baseline CD4 and malnutrition. There is need to intensively screen for TB among those individuals failing and switched to DTG second line ART"

Clinical • Human Immunodeficiency Virus • Infectious Disease • Respiratory Diseases • Tuberculosis • CD4

Population PK and CYP3A Inhibition Capacity of Ritonavir in Pregnancy: A Model-Based Meta-Analysis (CROI 2025) - "Background Ritonavir (RTV), a strong CYP3A inhibitor, is widely used as a pharmacokinetic (PK) enhancer to increase exposure to HIV-1 protease inhibitors (PIs) and more recently the SARS CoV-2 PI nirmatrelvir...Methods Pregnant participants receiving RTV as a PK enhancer for either lopinavir, darunavir, or atazanavir±TDF and who were ≥20 weeks gestational age were included in the analysis...Decreased RTV exposures during pregnancy are predicted to lead to a 1.8-fold reduction in RTV-mediated CYP3A inhibition. Dosing requirements of RTV and/or boosted CYP3A substrates may be altered during pregnancy."

Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Toward improved clearance predictions and distribution profiles employing the isolated perfused rat liver model: Experimental optimization. (PubMed, Drug Metab Dispos) - "Initially, in this study, acetaminophen and atazanavir, showing low or high protein binding, respectively, were tested in the IPRL system with 2 reperfusion media...Reliable disposition profiles and improved clearance predictions were obtained, employing biorelevant plasma protein concentrations alongside 10% blood to obtain in vivo-relevant unbound clearance values and to preserve liver viability and functionality. Robust conditions are critical in isolated perfused rat liver experiments to gain mechanistic insights into the in vitro to in vivo clearance gap, enabling optimization of in vitro to in vivo extrapolation methods."

Journal • Preclinical

Contemporary kidney stone analysis composition among U.S. adults and children in a large reference laboratory setting. (PubMed, Int Urol Nephrol) - "In contrast to previous findings, no difference in the prevalence of various stone types was observed by month of year. This may reflect evolving climate patterns, and warrants continued attention. The gender gap between men and women for stone formation is seen to be closing, with women submitting the majority of stones from individuals less than 50 years old. Whether this trend will persist as these women age in coming decades will be an important area of future study of stone epidemiology."

Journal • Nephrology • Renal Calculi • Urolithiasis