lopinavir/ritonavir / Generic mfg. - LARVOL DELTA

Lopinavir/ritonavir induces hepatotoxicity in HepG2 cells through inhibition of the Nrf2 pathway, resulting in oxidative stress, endoplasmic reticulum stress, and cell cycle arrest. (PubMed, Toxicol Lett) - "Collectively, our findings demonstrate that LPV/r suppresses Nrf2 and HO-1 protein, promotes ROS accumulation, which induces oxidative stress and ER stress, ultimately leading to cell apoptosis and G0/G1 phase cell cycle arrest. This research provides novel mechanistic insights into the hepatotoxic effects of LPV/r."

Journal • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Liver Failure

A preliminary survey on the use of ART among blood donors in Shenzhen China and its implications to blood safety. (PubMed, BMC Infect Dis) - "ART drugs were detected in 4(4/100) anti-HIV reactive plasma samples screened from 440 000 donations in Shenzhen, which indicated some HIV-infected people who take ART drugs donate blood without disclosing their health and medical histories and this may endanger blood safety because ART may compromise current screening strategies by suppressing HIV RNA replication below the detectable level."

Journal • Human Immunodeficiency Virus • Infectious Disease

DB-1311-O-1001: A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=862 | Recruiting | Sponsor: DualityBio Inc. | Trial completion date: Jan 2028 ➔ May 2028 | Trial primary completion date: Sep 2027 ➔ Dec 2027

First-in-human • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • CD276 • EGFR • KRAS • MET • NTRK1 • NTRK2 • NTRK3 • ROS1

Risk factors associated with anti-tubercular therapy-induced hepatitis in human immunodeficiency virus seropositive and seronegative patients in India. (PubMed, Int J Risk Saf Med) - "The prevalence of ATT-IH in HIV-SPP was 53.6% and 46.4% in HIV-SNP. A higher incidence of 23 (10 %) of ATT-IH was reported with the Tenofovir + Lamivudine + Lopinavir+ Ritonavir ART regimen.ConclusionClinicians must focus on early detection of risk factors for ATT-IH in HIV-SPP in comparison with HIV-SNP to prevent significant hepatic complications."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Therapeutic potential of spiramycin-nanoparticles and Aluvia in experimental congenital toxoplasmosis. (PubMed, Exp Parasitol) - "In conclusion, spiramycin-loaded CSNPs and Aluvia demonstrated low parasite burden and successfully restored normal brain architecture in the offspring. However, congenital anomalies persisted and remained a significant concern."

Journal • Infectious Disease

The Prevalence and Determinants of Dyslipidemia and Lipodystrophy in Children on Highly-Active Antiretroviral Therapy at a Ghanaian Teaching Hospital: A Cross-Sectional Study. (PubMed, J Int Assoc Provid AIDS Care) - "Participants with lipodystrophy had lower odds of elevated triglycerides (OR: 0.1; 95% CI: 0.00-0.62 P = .029). Previous lopinavir/ritonavir use was significantly associated with reduced odds of dyslipidemia (OR: 0.21; 95% CI: 0.05-0.91, P = .036).ConclusionThe high prevalence of dyslipidemia and lipodystrophy emphasizes the need for routine lipid and other metabolic assessments among children and adolescents living with HIV."

Journal • Observational data • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Hypertriglyceridemia • Infectious Disease • Lipodystrophy • Metabolic Disorders

Safety Profile of COVID-19 Medication in Patients with CKD: Renal and Hepatic Dysfunction Associated with Antiviral and Tocilizumab Use, a Single-Centre Experience (KIDNEY WEEK 2025) - "Methods We conducted a retrospective study on 1425 COVID-19-infected patients, who received anti-viral therapy, i.e., Favipiravir, lopinavir-Ritonavir, Remdesivir and tocilizumab. Conclusion CKD patients had a significantly higher incidence of renal function deterioration and an increase in AST. Nevertheless, these abnormal lab parameters must be considered with other risk factors, associated with severe covid-19-infection, thus COVID medicine shouldn't be denied to CKD patients"

Clinical • Chronic Kidney Disease • Hepatology • Infectious Disease • Liver Failure • Nephrology • Novel Coronavirus Disease • Renal Disease

Efficacy and safety of switching from lopinavir/ritonavir-based regimens to bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV: A multicenter retrospective study. (PubMed, Virol Sin) - "These PLWH typically have a history of either treatment failure or intolerance to first-line efavirenz-based regimens. The median triglyceride level decreased from 2.4 mmol/L to 1.8 mmol/L (P < 0.001), while no difference in CD4 counts was observed. These findings demonstrate that BIC/FTC/TAF is an effective and metabolically favorable treatment option for PLWH switching from LPV/r based regimens, regardless of whether they have a prior history of virological failure."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

Would infant lamivudine prophylaxis during breastfeeding be an option to prevent from vertical transmission of HIV ? (EACS 2025) - P3 | "Children received either a lopinavir/ritonavir (LPV/r)-based regimen (n=92) for a median of 8.0 [3.1-11.0] months, or 3TC monotherapy (n=115) for a median of 10.5 [10.1-11.3] months. Conclusions : These findings suggest that the M184V variant is rare among African mothers, including those on ART, and that 3TC is a viable prophylaxis option to protect against vertical transmission, given its excellent safety profile, ease of administration, good palatability, and evidence of efficacy. Our findings can be applied to all breastfeeding mothers, including African migrant mothers in Europe."

Human Immunodeficiency Virus • Infectious Disease

Virologic Outcomes of Dolutegravir-Based ART Among Thai people with HIV Previously Treated with Lopinavir/ritonavir based Second-line regimens: A National Program Analysis (EACS 2025) - "Conclusions : Most PWH with suppressed VL at the time of DTG switch maintained virologic suppression. However, VF was substantially higher among those with detectable VL at switch, particularly in adolescents and young adults, highlighting the need for improved adherence support, routine resistance monitoring and consideration of novel ART regimen in this population."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Virological Remission in Two HIV-Infected Children After Early cART in Libreville, Gabon. (PubMed, Case Rep Pediatr) - "After a positive GenXpert PCR at 7 weeks, triple therapy was started with abacavir-lamivudine and ritonavir-boosted lopinavir (2IN-1IP)...We switched the antiprotease with an anti-integrase (dolutegravir, which was available)... Virological remission with seroreversion of a previously HIV-infected infant is possible in Gabon. Further immunological (Ac assay) and virological (ultrasensitive proviral DNA on blood mononuclear cells) tests are needed in this infant to determine his definitive status."

Journal • Human Immunodeficiency Virus • Infectious Disease

Evaluation of the Dual Antiviral and Immunomodulatory Effects of Phallus indusiatus in a Feline Infectious Peritonitis Model Using PBMCs. (PubMed, Vet Sci) - "indusiatus exhibited the strongest FIPV Mpro inhibitory activity among the 17 mushroom extracts tested (69.2%), showing a notable level of inhibition relative to standard antiviral agents such as lopinavir and ritonavir...In healthy PBMCs, P. indusiatus significantly reduced nitrite levels, with effects similar to dexamethasone...These findings suggest that P. indusiatus possesses both antiviral and anti-inflammatory properties, positioning it as a potential dual-action therapeutic candidate for FIP. Further investigation into cytokine signaling pathways is warranted to clarify its mechanisms of action and advance future therapeutic development."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease

Population pharmacokinetics of ritonavir as a booster of lopinavir, atazanavir, or darunavir in African children with HIV. (PubMed, Antimicrob Agents Chemother) - "We conducted a pharmacokinetic sub-study within the CHAPAS-4 (ISRCTN22964075) trial, which randomized children to two NRTIs with twice-daily lopinavir/ritonavir, once-daily atazanavir/ritonavir, or once-daily darunavir/ritonavir, as second-line ART. Ritonavir exposure is higher with atazanavir than with lopinavir or darunavir. These data provide greater insight into the use of ritonavir for boosting PIs in children and help reduce the knowledge gap regarding its exposure in children."

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

Uptake and 24-month Outcomes of Dolutegravir- Versus Lopinavir-based Second-line Antiretroviral Therapy for People With HIV in South Africa: A Retrospective Cohort Study and Emulated Target Trial. (PubMed, Open Forum Infect Dis) - "Aligning with the World Health Organization, South Africa has replaced ritonavir-boosted lopinavir (LPV/r) with dolutegravir (DTG) in second-line antiretroviral therapy (ART) after treatment failure with tenofovir disoproxil fumarate (TDF)/lamivudine or emtricitabine (XTC)/efavirenz (EFV)...Of 2321 people switched before July 2021, 915 (39%) switched to AZT/XTC/LPV/r, 415 (18%) to zidovudine (AZT)/XTC/DTG, and 991 (43%) to TDF/XTC/DTG...Per-protocol analyses gave similar results. While retention was similar across regimens, viremia was less common on DTG-based ART, supporting current guidelines."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

DB-1311-O-1001: A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=750 | Recruiting | Sponsor: DualityBio Inc. | Trial completion date: Sep 2026 ➔ Jan 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • CD276 • EGFR • KRAS • MET • NTRK1 • NTRK2 • NTRK3 • ROS1

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Pharmacokinetics of dexamethasone in tuberculosis meningitis. (PubMed, medRxiv) - "This pharmacokinetic study was nested in a randomised controlled trial comparing the safety of high-dose rifampicin (oral, 35 mg/kg; intravenous, 20 mg/kg) plus linezolid, with or without aspirin, vs standard-dose rifampicin (10 mg/kg) for adults with HIV-associated TBM...Eight (18%) participants were on efavirenz-based ART and five (11%) were on a lopinavir/ritonavir-based regimen...This pharmacokinetic analysis of dexamethasone in adults with HIV-associated tuberculosis meningitis found high oral clearance (131 L/h), likely due to a drug-drug interaction with rifampicin. High-dose rifampicin had no additional effect on dexamethasone exposure compared with standard dose."

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

Research on the Psychological Status of Patients With HIV-1 Infection (clinicaltrials.gov) - P=N/A | N=500 | Not yet recruiting | Sponsor: Shanxi Bethune Hospital

New trial • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry

Pharmacokinetics of lopinavir/ritonavir in second-line treatment of children living with HIV in the CHAPAS-4 trial. (PubMed, AIDS) - "Children (3-15 years), weighing ≥14 kg and taking LPV/r in second-line treatment achieve adequate exposure of LPV within limits reported to be safe and well tolerated. These data support the use of a LPV/r based regimen and the adult formulation of 200/50 mg in children 25-34.9 kg."

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

Comparative adherence and effectiveness of Dolutegravir vs Lopinavir in Tanzanian children with HIV: retrospective cohort study (IAS-HIV 2025) - "The study included 340 children who had been on either dolutegravir (DTG) or lopinavir/ritonavir (LPV/r) regimens for at least 6 to 12 months. The DTG regimen demonstrates significantly better adherence and effectiveness compared to the LPV/r regimen in pediatric HIV patients. These findings support the adoption of DTG as the preferred regimen for children in Tanzania."

Adherence • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Determinants of successful ART outcomes in children and adolescents in Kenya, 2021-2023 (IAS-HIV 2025) - "In regression, VF was higher among those initiating lopinavir/ritonavir (LPV/r) than efavirenz (EFV)-based ART (prevalence ratio [PR] 1.29, [95% confidence interval 1.05-1.58]; p=0.01) and was similar between those initiating dolutegravir and EFV-based ART (PR 0.92 [0.69-1.23]; p=0.6). Our findings highlight the importance of historical use of LPV/r and lower likelihood of maintaining suppression for 10-19 years adolescents. Strengthening care systems with adolescent-centered services may improve viral suppression in pediatric HIV care."

Clinical • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Clinical and virologic outcomes in children with TB/HIV coinfection are poor compared to children with HIV on WHO-recommended antiretroviral therapy (IAS-HIV 2025) - "This study examined the clinical and virologic outcomes in children with TB/HIV coinfection on concomitant TB therapy compared to those with HIV. A prospective study of ART outcomes in children with TB/HIV coinfection on rifampin-containing TB treatment and those with HIV alone was conducted at a teaching hospital in Ghana between 2019 and 2024...Children with TB coinfection on first-line antituberculosis therapy were prescribed a double dose of lopinavir/ritonavir (LPV/r) or dolutegravir (DTG) while on TB treatment according to WHO guidelines... Children with TB/HIV coinfection had more severe HIV disease, poor clinical outcomes and high rates of HIV non-suppression on WHO-recommended ART. Strategies to improve the outcomes of children with TB/HIV coinfection are needed."

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

Persistent and long-acting intracellular three HIV drug concentrations in participants after subcutaneous TLC-ART 101 (IAS-HIV 2025) - "Injectable TLC-ART101, a Drug-combination NanoParticle (DcNP) platform with lopinavir, ritonavir, and tenofovir, targets lymphoid tissues during first-pass distribution... Current oral or injectable ART exhibits PBMC-to-plasma ratios below 1. TLC-ART101, using a DcNP platform, achieved higher intracellular than plasma drug levels. This study provides evidence that a cell-targeted, long-acting product can enhance intracellular concentrations."

Human Immunodeficiency Virus • Infectious Disease

The predominant effects of ART and sex on the plasma metabolomes of virally suppressed children living with perinatally acquired HIV: implications for cure studies (IAS-HIV 2025) - "CLWH were on efavirenz (EFV, n=101) or lopinavir/ritonavir (LPV, n=54)-based antiretroviral therapy (ART) regimens. The specific ART regimen dominated the plasma metabolic profile and significantly influenced the presentation of metabolic sexual dimorphism in CLWH. Two metabotypes among CLWH on the same regimen suggested divergent, sub-clinical responses to the same treatment even among those with long-term viral control and CD4% approaching healthy levels. It is unlikely that metabolic biomarkers will be reliable in predicting or monitoring intervention outcomes across regimens."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Successful viral suppression in a two-year-old child with human immunodeficiency virus infection treated with bictegravir/emtricitabine/tenofovir alafenamide. (PubMed, Turk J Pediatr) - "The mother received zidovudine prophylaxis during delivery, and the infant was started on zidovudine (AZT) prophylaxis on the first day of life. The patient's ART history included AZT monotherapy at birth, followed by combination therapy with lamivudine (3TC), lopinavir/ritonavir (LPV/r), and later tenofovir/emtricitabine (TDF/FTC) with dolutegravir (DTG)...Its high genetic barrier to resistance and favorable tolerability make it a promising option when standard therapies fail. Further research is needed to optimize pediatric ART strategies and expand access to STRs globally."

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