darunavir/ritonavir / Generic mfg. - LARVOL DELTA

CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: University College, London

New P3 trial • Human Immunodeficiency Virus • Infectious Disease

Longitudinal Clinical and Molecular Characterization of a Single Pediatric Case of Vertically Acquired HIV-1 Subtype C with Baseline Resistance to Protease Inhibitors. (PubMed, Microorganisms) - "Stanford HIVdb predicted high-level resistance to lopinavir/ritonavir, atazanavir/ritonavir, lamivudine, and emtricitabine; low-level resistance to darunavir/ritonavir and abacavir; and preserved susceptibility to tenofovir, zidovudine, and the evaluated NNRTIs...Following treatment optimization with an integrase inhibitor-based regimen and subsequent transition to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), HIV-1 RNA became Target Not Detected (TND) from November 2024 onward. At the latest follow-up, the CD4 count was 877 cells/µL, the CD8 count was 722 cells/µL, and the CD4:CD8 ratio had improved to 1.21, indicating substantial immune recovery. This single-patient case highlights the clinical value of baseline genotypic resistance testing and individualized, genotype-guided antiretroviral therapy in achieving durable virological suppression in pediatric HIV."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • CD4 • CD8

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Terminated | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Completed ➔ Terminated; The study was closed to accrual early based on Study Monitoring Committee review indicating that the study objectives had either been achieved or could not be met within a reasonable timeframe for the then-open arms.

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

Never Too Late: A Case Report of Severe Fanconi Syndrome Developing After More than a Decade of Silent Tenofovir Disoproxil Fumarate Exposure. (PubMed, Reports (MDPI)) - "TDF was discontinued, and her antiretroviral regimen was modified to tenofovir alafenamide fumarate (TAF), emtricitabine (FTC), darunavir, and ritonavir, combined with vitamin D supplementation. Over a 6-month follow-up period, renal function normalized, electrolyte wasting resolved, and metabolic acidosis completely reversed. This case highlights that TDF-induced proximal tubulopathy can manifest even after a decade of uneventful therapy, particularly when co-administered with a boosted protease inhibitor."

Journal • Endocrine Disorders • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • Secondary Hyperparathyroidism

Pharmacokinetic modeling to support WHO-weight band dosing of a new pediatric darunavir/ritonavir (120/20 mg) fixed-dose combination tablet for children at least 3 years old and weighing 10 to less than 35 kg. (PubMed, J Acquir Immune Defic Syndr) - "Model-based dosing supports once- and twice-daily of the pediatric DRV/r 120mg/20mg FDC tablet across WHO-weight bands."

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

National cross-sectional survey on acquired HIV drug resistance in Haiti in 2023: warnings resistance to dolutegravir (AIDS 2026) - "3.77% of HIVs were resistant to dolutegravir and bictegravir, 4.4% to cabotegravir, 4.72% to raltegravir, and 5.03% to elvitegravir. Additionally, 15.19% of the viral strains were resistant to abacavir, 13.92% to lamivudine and emtricitabine, 6.65% to zidovudine, 8.23% to stavudine and didanosine, and 4.13% to tenofovir...Furthermore, some HIVs strains developed resistance against efavirenz (49.37%), nevirapine (50%), Rilpivirine (20.25%), Etravirine (12.66%), and doravirine (3.61%). Finally, HIV genome resistance was 0.63% against atazanavir/ritonavir and indinavir/ritonavir, 0.95% against lopinavir/ritonavir and 0.32% against darunavir/ritonavir. HIV acquired pharmacoresistance is moderate in Haiti and requires innovating adapted strategy for preventing its development, its transmission, and for protecting PLHIV health, while emphasizing on children and male individuals."

Human Immunodeficiency Virus • Infectious Disease • Respiratory Diseases

Virologic outcomes of Ritonavir-boosted Darunavir-based ART in treatment-experienced youth with HIV in Malawi (AIDS 2026) - "Genotype-guided transition to DRV/r-based ART achieved high viral suppression rates among treatment-experienced patients with perinatally acquired HIV. Most clients suppressed soon after switching, with the exception of the youngest child, who had persistent high viral loads after the switch, likely due to drug administration challenges and limited pediatric formulations. These findings show that genotype-informed use of DRV/r can be effective, though child-friendly formulations and expanded resistance testing are needed."

Human Immunodeficiency Virus • Infectious Disease

High virological failure in people with major DTG-associated DRTs continuing on standard dose DTG: the Ndovu RCT (AIDS 2026) - "Participants on DTG for at least 6 months, with persistent viraemia of = 200 copies/ml despite enhanced adherence counselling, and = one major DTG-associated drug resistance mutations (DRMs) are randomised 1:1 to continue once daily DTG or to switch to ritonavir boosted darunavir (DRV/r), in combination with tenofovir (abacavir for children <30kg) and lamivudine...Country Kenya Lesotho Mozambique Tanzania 38 (100%) 0 0 0 33 (97.1%) 1 (2.9%) 0 0 Sex Female Male 25(65.8%) 13 (34.2%) 18 (52.9%) 16 (47.1%) Age (years) Median (IQR) =15 years 3-14 years 30.5 (18.0, 42.0) 32 (84.2%) 6 (15.8%) 37.5 (20.0, 44.0) 28 (82.4%) 6 (17.6%) Enrollment Viral Load Category 400-999 1,000-9,999 10,000-99,999 100,000-499,999 =500,000 1 (2.6%) 18 (47.4%) 12 (31.6%) 5 (13.2%) 2 (5.3%) 0 (0.0%) 15 (44.1%) 13 (38.2%) 5 (14.7%) 1 (2.9%) Major resistance mutations DTG associated DRMs G118R +/- (E138K, N155H, R263K) N155H +/- (E92Q) Q148HRK +/- (E138KA, G140A, N155H) R263K PI Major DRMs NRTI..."

Late-breaking abstract • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Cost-effectiveness of a hypothetical novel HIV genotypic resistance test for people with confirmed virologic failure on TLD in sub-Saharan Africa (AIDS 2026) - "Base case value Range (sensitivity analyses) Prevalence of resistance, % 1,2 DTG-R NRTI-R Susceptible 2.3 28.5 69.2 0.6- 19.6 -- 51.9- 70.9 Incident DTG-R among NRTI-R cohort at each VF episode, % 3 6 -- ART efficacy: probability of suppression at 6m, % 4-6 TLD DRV/r+TDF/3TC DTG-R NRTI-R Susceptible 20 87 69 86 86 59 -- -- -- ART cost, monthly, $ 7 2.87 20.50 -- nGRT characteristics 8,9 Sensitivity, % Specificity, % Cost, $ Implementation, % 90.0 97.5 40 80 60-100 76-100 10-157 50-100 Abbreviations: TLD: tenofovir-lamivudine-dolutegravir; VF, virologic failure; SSA: sub-Saharan Africa; DTG-R, dolutegravir-resistance; NRTI-R, nucleoside reverse-transcriptase inhibitor resistance; ART, antiretroviral therapy; DRV/r: darunavir/ritonavir; TDF/3TC: tenofovir-lamivudine; nGRT, novel genotypic resistance test. At WTP <$1,000/QALY, a novel GRT would be cost-effective if the test has high specificity and low cost, even at low DTG-R prevalence. At higher DTG-R prevalence among..."

Cost effectiveness • HEOR • Human Immunodeficiency Virus • Infectious Disease

Reversible HIV-Associated Nephropathy and Concomitant Encephalomyelopathy as the Initial Presentation of Advanced, Untreated HIV. (PubMed, Cureus) - "The patient was initiated on regular haemodialysis and an intensive antiretroviral regimen consisting of dolutegravir/lamivudine, darunavir, and ritonavir, alongside co-trimoxazole prophylaxis until her CD4 count was over 200 cells/mm3. This case underscores that advanced HIVAN requiring renal replacement therapy and extensive HIV-related central nervous system pathology can be profoundly reversed with timely, potent antiretroviral therapy. Clinicians must maintain a high index of suspicion for HIV in patients presenting with unexplained concurrent multiorgan dysfunction, as early intervention can avert permanent end-stage organ failure and severe neurological disability."

Journal • Acute Kidney Injury • Chronic Kidney Disease • CNS Disorders • Glomerulonephritis • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease • CD4

Outcomes for persons with triple-class resistant HIV and a history of virologic failure. (PubMed, Int J Antimicrob Agents) - "Although the most common outcome after TRIO was switch to another ≥3 drug regimen, almost one third of virologically suppressed PWH under TRIO (with a history of multi-drug resistance) switched to a drug-reducing regimen, the majority of whom maintained suppression."

Journal • Human Immunodeficiency Virus • Infectious Disease

Major protease inhibitor drug resistance mutations among patients with virological failure on second-line antiretroviral therapy in Zimbabwe: a retrospective cross-sectional study. (PubMed, Virol J) - "Major PI DRMs and multiclass HIVDR were common among PLWH with VF on PI-based second-line ART. Routine VL monitoring and early resistance testing are needed to detect and guide second-line ART failure in Zimbabwe."

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

Analysis of Viral Blips Through Week 192 of the DRIVE-FORWARD and DRIVE-AHEAD Phase 3 Studies of Doravirine-Based Regimens in Adults Living With Previously Untreated HIV-1. (PubMed, Open Forum Infect Dis) - P3 | "Adults living with untreated HIV-1 were randomized (1:1) to a DOR-containing regimen or comparator (darunavir/ritonavir- or efavirenz-containing), each with 2 nucleos(t)ide reverse transcriptase inhibitors, for 96 weeks (double-blind base), followed by 96 weeks of a DOR-containing regimen (open-label extension). Clinical Trials Registration.  ClinicalTrials.gov NCT02275780, NCT02403674."

Clinical • Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • CD4

Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Federal University of São Paulo | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Nov 2026

Enrollment closed • IO biomarker • Trial completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Letter to the editor regarding "Dosing of ritonavir-boosted darunavir for treatment of HIV in pregnancy". (PubMed, AIDS) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Pharmacogenomics of current antiretroviral drugs. (PubMed, Pharmacogenomics) - "We searched Pharmacogenomics Knowledgebase (PharmGKB®) for abacavir, tenofovir disoproxil fumarate, tenofovir alafenamide, lamivudine, emtricitabine, dolutegravir, elvitegravir, raltegravir, bictegravir, cabotegravir, atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir, lenacapavir, rilpivirine and doravirine. Actionable pharmacogenetic associations with antiretroviral drugs remain limited to abacavir. Future research should prioritize replicating pharmacogenetic associations across diverse populations and establishing clinical relevance."

Biomarker • Journal • Review • Human Immunodeficiency Virus • Infectious Disease • HLA-B • UGT1A1

Physiologically Based Pharmacokinetic Modeling to Assess Antiretroviral-BTK Inhibitor Interactions and Provide Recommendations for Co-Administration Regimens. (PubMed, Pharmaceutics) - "Model performance was verified by comparing simulated pharmacokinetic parameters and DDI magnitudes with probe drugs (midazolam or maraviroc) with reported clinical data. The PBPK models accurately predicted the in vivo pharmacokinetics of ibrutinib, zanubrutinib, acalabrutinib, and those of the antiretrovirals darunavir/ritonavir, efavirenz, and etravirine, and the DDIs between them. The dose adjustment strategies provided information valuable to the optimization of antineoplastic therapy in HIV-related lymphoma (HRL) patients."

Journal • PK/PD data • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Oncology

Longitudinal changes in plasma biomarkers of immune activation, neuronal inflammation and injury in persons with HIV initiating ART. (PubMed, HIV Med) - "Plasma biomarkers of brain health improved following ART initiation, associated predominantly with improvements in CD4 count and partly with treatment arm."

Biomarker • Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CXCL10 • GFAP • IL6 • Plasma NfL

The dolutegravir failure cohort: A multi-country longitudinal cohort with a randomised clinical trial of continued dolutegravir versus switch to darunavir in people with viraemia while on dolutegravir in Sub-Saharan Africa (The Ndovu Study) protocol. (PubMed, PLoS One) - P, P3 | "The Ndovu study will address critical gaps in the management of DTG failure including the emergence, determinants and implications of DTG resistance. Further, it will evaluate the optimal ART regimens to use in the setting of DTG resistance in adults and children."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

Cardiometabolic impact of dolutegravir as second-line therapy: secondary analysis of a randomized controlled trial. (PubMed, AIDS) - P3b/4 | "Dolutegravir-based second-line regimens were associated with weight gain, which was further influenced by gender, ethnicity and HIV-related factors. DTG-based second-line regimens had no significant effect on blood pressure at 96 weeks; DTG + TDF/XTC was associated with a more favourable lipid profile than darunavir-containing regimens."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Dolutegravir restores gut microbiota in late-stage HIV-1 unlike darunavir: an open-label, randomized clinical trial. (PubMed, Nat Commun) - P4 | "After two years, participants on dolutegravir-based therapy had gut microbiota profiles more closely resembling those of people without HIV, compared to individuals taking darunavir/ritonavir. In summary, dolutegravir-based therapy restores the gut microbiota more effectively than darunavir/ritonavir in patients who present late with HIV."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Body Composition Changes in Children Living With HIV Initiated on Dolutegravir or Protease Inhibitors in the CHAPAS-4 Trial. (PubMed, Pediatr Infect Dis J) - "DTG and ATV/r were associated with greater gains in fat-free mass and muscle mass than LPV/r, while DRV/r, TAF and prior nevirapine exposure were associated with fat mass accrual. Fat gain may initially reflect return to health but sustained increases may have metabolic implications. These findings suggest the need to monitor fat compartments with long-term exposure."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Longitudinal changes in bone mineral density among children living with HIV over 96 weeks following switch to second-line antiretroviral therapy in Uganda. (PubMed, PLOS Glob Public Health) - "CLWH aged 3-15 years switched to second-line ART including tenofovir alafenamide fumarate-emtricitabine (TAF/FTC) or standard-of-care (SOC) (abacavir (ABC) or zidovudine (ZDV) with dolutegravir (DTG), atazanavir/ritonavir (ATV/r), darunavir/ritonavir (DRV/r) or lopinavir/ritonavir (LPV/r)...-0.30,95% CI: -0.46, -0.15], p < 0.001) and first-line nevirapine (NVP) exposure (-0.25,95% CI: -0.43, -0.06, p = 0.009)...Smaller declines in TBLH BMD were associated with higher baseline fat mass, higher LS HA BMD, and use of DRV/r, DTG, or ATV/r compared with LPV/r. These findings emphasize the importance of ART selection and body composition in supporting bone health among CLWH."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Dosing of ritonavir-boosted darunavir for treatment of HIV in pregnancy. (PubMed, AIDS) - "This analysis provides some reassurance that once-daily DRV/r can be used successfully in pregnancy. However, given the possibility of reduced drug levels in pregnancy with once-daily dosing, viral load monitoring during pregnancy remains essential. Surveillance of pregnancies in women receiving once-daily DRV/r is needed to further support the use of this dosing during pregnancy."

Journal • Human Immunodeficiency Virus • Infectious Disease

Factors Associated With Weight Change After Continuing or Switching to a Doravirine-based Regimen. (PubMed, Open Forum Infect Dis) - P3 | "Participants were randomized to first-line therapy with doravirine or darunavir/ritonavir, each given with 2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) (DRIVE-FORWARD) and to doravirine/lamivudine/tenofovir disoproxil fumarate (TDF) or efavirenz/emtricitabine/TDF (DRIVE-AHEAD); after 96 weeks, participants continued (n = 466) or switched to (n = 423) doravirine for 96-week open-label extensions. More research in historically underrepresented groups may help explain these findings. NCT02275780, NCT02403674, NCT02397096."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease