darunavir/ritonavir / Generic mfg. - LARVOL DELTA

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

Tenofovir Alafenamide Fumarate-Associated Fanconi Syndrome (KIDNEY WEEK 2025) - "The patient had been stable on darunavir, ritonavir, and raltegravir, but this was changed to a combined bictegravir-emtricitabine-tenofovir alafenamide for simplicity just prior to his presentation. His development of acute and severe electrolyte disturbances after initiation of TAF is concerning for acute worsening of preexisting Fanconi syndrome. This case highlights that while TAF is generally considered safer, there is still risk of renal toxicity, particularly when renal tubular dysfunction is already present."

Chronic Kidney Disease • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Nephrology • Orthopedics • Renal Disease

Doravirine Resistance Patterns Identified through Week 192 in the DRIVE-FORWARD and DRIVE-AHEAD Phase 3 Clinical Trials. (PubMed, J Acquir Immune Defic Syndr) - P3 | "In DRIVE-FORWARD and DRIVE-AHEAD, the development of resistance to doravirine was uncommon (genotypic 1.3%; phenotypic 1.0%) and occurred mainly during the first 48 weeks of treatment. Overall, the RAMs observed with doravirine were distinct from those of other NNRTIs."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease

Comparable efficacy but greater discontinuations due to adverse events with dolutegravir-containing two-drug versus three-drug antiretroviral therapy: a systematic review and meta-analysis (EACS 2025) - "We assessed three prespecified subgroups: dolutegravir/lamivudine (DTG/3TC); dolutegravir/rilpivirine (DTG/RPV) and dolutegravir/ritonavir-boosted-darunavir (DTG/DRV/r). There were more discontinuations due to AEs with 2DR. However, the effect of switch studies may have contributed to this."

Adverse events • Retrospective data • Review • Human Immunodeficiency Virus • Infectious Disease • CD4

Cardiovascular Risk Assessment Using the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score Model After Continuing or Switching to a Doravirine-Based HIV Treatment Regimen. (PubMed, J Acquir Immune Defic Syndr) - P3 | "After ∼4 years, DOR-based regimens were not associated with changes in ASCVD risk scores in PLWH. Given the increased burden of HIV-associated ASCVD, DOR may represent a therapeutic option that does not increase ASCVD risk."

Journal • Atherosclerosis • Cardiovascular • Human Immunodeficiency Virus • Infectious 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

Effectiveness of simplifying antiretroviral therapy to maintain viral suppression and improve bone and renal health: comparing simplified and non-simplified therapy. (PubMed, Braz J Infect Dis) - "These findings suggest that simplified therapy is as effective as triple therapy and has the additional benefit of reducing tenofovir-related adverse events."

Journal • Human Immunodeficiency Virus • Infectious Disease • Osteoporosis • Rheumatology

Breastfeeding on ART and a closer look at drug transfer to HIV-exposed uninfected infants. (PubMed, Sci Rep) - "Maternal ART regimens included abacavir/lamivudine (n = 2), tenofovir alafenamide/emtricitabine (n = 1) or tenofovirdisoproxil/emtricitabine (n = 5) in combinations with rilpivirine (n = 3) (RPV), dolutegravir (n = 2) (DTG), raltegravir (n = 1), darunavir/ritonavir (n = 1), or nevirapine (n = 1). Given this variability and the potential for drug accumulation in individual cases, maternal therapeutic drug monitoring should be considered to identify elevated levels early on. In such situations, infant monitoring tailored to the individual may also be warranted."

Journal • Retrospective data • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Neutropenia

Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance (clinicaltrials.gov) - P3 | N=392 | Recruiting | Sponsor: University of Nairobi | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

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

Antiretroviral-specific associations between bone hormonal changes and treatment induced weight gain. (PubMed, AIDS) - "This study suggests links between bone-derived hormones and ART induced weight gain in PWH and demonstrates that this relationship is influenced by specific antiretrovirals."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4 • LCN2

UNIVERSAL2: Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: PENTA Foundation | N=50 ➔ 0 | Trial completion date: Oct 2026 ➔ Jul 2025 | Active, not recruiting ➔ Withdrawn | Trial primary completion date: Dec 2025 ➔ Jul 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

The clinical and economic impact of genotypic resistance testing for people diagnosed with persistent virological non-suppression on tenofovir-lamivudine-dolutegravir in South Africa: a modelling study. (PubMed, Lancet HIV) - "GRT could increase life expectancy for people with HIV and persistent virological non-suppression on TLD in South Africa and could be cost-effective, especially at lower test costs. At current effectiveness and costs of tenofovir-lamivudine plus ritonavir-boosted darunavir, an immediate switch would not be preferred."

HEOR • Journal • Allergy • Human Immunodeficiency Virus • Immunology • Infectious Disease

Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Federal University of São Paulo | Trial completion date: Aug 2025 ➔ Nov 2025

IO biomarker • Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance (clinicaltrials.gov) - P3 | N=392 | Not yet recruiting | Sponsor: University of Nairobi | Trial completion date: Feb 2027 ➔ Jun 2027 | Initiation date: Jun 2025 ➔ Sep 2025 | Trial primary completion date: Aug 2026 ➔ Nov 2026

Trial completion date • Trial initiation date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetic modeling to support WHO-weight band dosing of the new pediatric Darunavir/ritonavir (120/20 mg) fixed-dose combination tablet for children (IAS-HIV 2025) - "The model-based dosing of the new pediatric DRV/r FDC tablets supports once- and twice-daily dosing according to WHO weight bands in children aged =3 years and weighing 10 to <35 kg."

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

Evaluation of antiretroviral regimen switching options in adults with HIV with sustained viral load non-suppression on dolutegravir, lamivudine, and tenofovir in eastern, central, southern, and western Africa: a modelling study. (PubMed, Lancet HIV) - "Introduction of HIV drug resistance testing for people with sustained viral load non-suppression on dolutegravir-based antiretroviral therapy is likely to be cost-effective. We suggest that exploratory planning for increased access and scale-up of high-quality, low-cost drug resistance testing for the region is undertaken."

Journal • Human Immunodeficiency Virus • Infectious Disease

A randomised trial to compare dolutegravir plus boosted darunavir versus recommended standard of care antiretroviral regimens in people with HIV-1, whose first-line non-nucleoside reverse transcriptase inhibitor therapy has failed: Final 96-week results of the D2EFT study. (PubMed, Clin Infect Dis) - "After 96 weeks of follow-up, DTG+DRV/r and DTG+TDF/XTC demonstrated virological superiority over DRV/r+2NRTIs after first-line NNRTI-failure. However, emerging dolutegravir resistance, which was observed only in individuals taking DTG+TDF/XTC, requires ongoing global surveillance."

Journal • Human Immunodeficiency Virus • Infectious Disease

HIV-associated nephropathy in a patient with undetectable viral load: a case report (ERA 2025) - "He was on a regimen of Bictegravir/Emtricitabine/Tenofovir Alafenamide and had additional comorbidities, including chronic lung disease and active smoking...He was diagnosed with influenza A pneumonia and was hospitalized due to hypoxemia, initiating oseltamivir treatment...Two days after admission, the patient developed bacterial pneumonia, and Piperacillin-tazobactam was initiated...ART was subsequently changed to Ritonavir/Darunavir and Dolutegravir... Nephropathy in HIV patients presents a multifactorial challenge. This case highlights the complexity of diagnosing HIVAN, emphasizing the importance of maintaining a high index of suspicion even in patients with undetectable or low HIV RNA levels, particularly in the presence of a history of nonadherence to ART and CD4+ T-cell counts below 200 cells/µL. We may hypothesize if the respiratory infection was the trigger for developing the disease, although the patient had prior de novo proteinuria."

Case report • Clinical • Chronic Kidney Disease • Fibrosis • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Influenza • Metabolic Disorders • Monoclonal Gammopathy • Nephrology • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • CD4

HIV drug resistance, early treatment outcomes and impact of guidelines compliance after protease inhibitor-based second-line failure in a dedicated resistance clinic in western Kenya: a retrospective cohort study. (PubMed, J Int AIDS Soc) - "We found high levels of drug resistance and early VF following PI-based second-line failure in Kenya. Treatment guidelines compliance and switches to third-line, even within guidelines recommendations, improved early viral outcomes. Findings highlight the vulnerability of PLWH with advanced ART experience and resistance profiles, and the importance of following guidelines and improving access to third-line and drug resistance testing, particularly in the new ART era."

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

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Apr 2025 ➔ Jul 2025 | Completed ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

UNIVERSAL2: Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV (clinicaltrials.gov) - P1/2 | N=50 | Active, not recruiting | Sponsor: PENTA Foundation | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Precision medicine evaluation of heterogeneity of treatment effect for a time-to-event outcome with application in a trial of Initial treatment for people living with HIV. (PubMed, Clin Trials) - "We further explored the impact of covariates on heterogeneity of treatment effect and the choice between treatments.ResultsThe heterogeneity of treatment effect analysis showed that while there is a clear trend favoring raltegravir-based therapy over darunavir/ritonavir-based therapy for the vast majority of the target population, there were a small subset of patients, characterized by more advanced HIV disease status, for whom the choice between the two treatments might be equivocal.ConclusionsThrough this example, we illustrate how an exploratory heterogeneity of treatment effect analysis might provide further insights into the comparative efficacy of treatments evaluated in a randomized trial. We also highlight some of the issues in implementing and interpreting effect modeling analyses in randomized trials."

Clinical • Heterogeneity • Journal • Human Immunodeficiency Virus • Infectious Disease

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 date: Mar 2026 ➔ Apr 2025 | Trial primary completion date: Mar 2026 ➔ Apr 2025

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

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