Juluca (dolutegravir/rilpivirine) / ViiV Healthcare, J&J - LARVOL DELTA

A Quality Improvement Pilot to Increase Hepatitis B Screening and Optimize Patient Selection for the Switch to Two-Drug Antiretroviral Regimens in People With HIV. (PubMed, Open Forum Infect Dis) - "An EHR best practice advisory was linked to 2DR orders (dolutegravir-lamivudine, dolutegravir-rilpivirine, cabotegravir-rilpivirine) reminding clinicians to check HBV serologies prior to the switch and providing guidance for prescribing 2DRs to reduce risk of HBV reactivation in people with HIV. In this study, an EHR-based intervention increased HBV screening rates and decreased switches in those at highest risk of HBV reactivation (positive HBsAg or isolated positive HBcAb). With the increasing uptake of 2DRs, optimizing patient selection is vital to prevent HBV reactivation."

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

A case series of acute hepatitis B among PLWH switched to long acting (LA) Cabotegravir (CAB)/ Rilpivirine (RPV) (EACS 2025) - "Method : In this retrospective study, we enrolled PLWH without HBV coinfection (negative AgHbs)(5 HIV French centers;n= 16,550) who initiated LA CAB/RPV between January2022 and December2024...ART regimens before LA switch included tenofovir(TDF) for all patients except for one who was on DTG/RPV during 3months after a previous withdrawal of TDF...Anti-HBV therapy was reintroduced for 6 patients (TDForTAF(5),entecavir(1)).All patients reached HBV pVL<10UI/mL in the six following months the HBV infection. Conclusions : We alert on the need to ensure HBV coverage (either with protective titers of anti-HBs Abs or with continuation of anti-HBV therapy),before withdrawal of TDF from ART strategies among PLWH."

Clinical • Hepatitis B • 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

Risk of virological rebound is similar in people with HIV switching to long-acting cabotegravir/rilpivirine or integrase inhibitor-based oral therapy (EACS 2025) - "Method : Observational study on PWH on virological suppression who switched to CAB/RPV enrolled in the SCohoLART study or to INSTI-based oral therapy (DGT/3TC, DTG/RPV, B/F/TAF) from July 2022 to April 2025. PWH with a longer viral suppression time [HR 0.703 (0.57-0.87) p=0.0012] were less likely to experience blips and VFs (Figure 1) (Table 2). Conclusions : Risk of virological rebound was comparable in PWH switching to CAB/RPV or an INSTI-based oral regimen; longer duration of virological suppression before switching is associated with a lower risk of viral rebound."

Human Immunodeficiency Virus • Infectious Disease • CD4

Risk of virological failure after switch to a tenofovir-sparing dual therapy in virologically suppressed people with HIV and past HBV infection (EACS 2025) - "PWH starting a TFV-sparing DT (3TC+bPI or DTG, DTG+RPV, DOR+DTG or long-acting CAB+RPV) were considered in the “treatment”-group only if they switched within a predefined “grace” period of 2 years...DT didn't predict VF (vs TT, aHR: 0.96, 95% CI 0.67-1.37; p=0.812), that was conversely associated with HBsAb+ serostatus (vs HBsAb-, aHR: 0.64, 95% CI 0.48-0.86; p=0.003). Conclusions : Switch to a TFV-sparing DT did not predict VF in PWH and prior HBV infection."

Hepatitis B • Human Immunodeficiency Virus • Infectious Disease

Patient-Reported Health and Virological Outcomes Among People with HIV Switching to Long-Acting Injectable Cabotegravir and Rilpivirine (LANTERN) (EACS 2025) - "Antiretroviral therpy regimens before switching included BIC/FTC/TAF (n=37, 27.1%), DTG/3TC (n=65, 47.4%), DTG/RPV (n=6, 4.4%), TAF/FTC/RPV (n=28, 20.4%) and DTG/3TC/ABC (n=1, 0.7%). Conclusions : Switching to CAB plus RPV LA was associated with improved treatment satisfaction and high acceptance, alongside high rates of virological suppression, with no individuals experiencing virological failure during the observation period. In conclusion, this study suggests that CAB plus RPV LA may be a beneficial treatment option in Taiwan."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Long-acting injectable cabotegravir and rilpivirine outcomes in HIV individuals with stable treatment with dolutegravir and rilpivirine (EACS 2025) - "The virological failure was very low in both groups (table 2) Conclusions : In real life settings, the switch from DTG+RPV to CAB+RPV is safe and well tolerated. It is not essential the genotype nor the subtype if the VL is undetectable."

Clinical • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease

High Uptake of Intermittent Drug-Reduced ART Strategies Among Virally Suppressed People Living with HIV (PWH) at an HIV Clinic in Paris, France (EACS 2025) - "The main intermittent ART regimens were TAF/FTC/RPV (18.6%) and TAF/FTC/BIC (11.7%) for 3-DR-I, and DTG/RPV (4.8%) and DTG/3TC (3.1%) for 2-DR-I. Conclusions : Over 8 years, intermittent therapy was selected in 25% of PWH with suppressed viremia. This highly effective and cost-saving approach should be considered in Europe."

Human Immunodeficiency Virus • Infectious Disease

Durability and reasons for treatment discontinuation of BIC/FTC/TAF in real life: data from 927 Persons With HIV in charge to “D. Cotugno” hospital, Naples, Southern Italy (EACS 2025) - "Most common post-TD treatments were LA-Cabotegravir+LA-Rilpivirine and Dolutegravir/Lamivudine...Post-TD regimens varied significantly by discontinuation reason: DTG/3TC, LA RPV+LA CAB, DRV/c/FTC/TAF, FTC/TDF+RAL 1200mg, and DRV/c/FTC/TAF again were the regimens most used in case of switch for Simplification/proactive switch, Patients’ choice, Toxicity, Pregnancy, and Virologic failure, respectively. Conclusions : B/F/T shows excellent real-life durability, with a low TD rate. When discontinuation occurs, it is mostly due to physician-driven proactive strategies or PWH-driven decisions rather than efficacy or tolerability issues."

Clinical • Human Immunodeficiency Virus • Infectious Disease

A combined dolutegravir–rilpivirine oral regimen as lead-in therapy for long-acting injectable antiretroviral treatment in people living with HIV (EACS 2025) - "Purpose : Long-acting injectable cabotegravir and rilpivirine (LA CAB/RPV) simplifies HIV-1 maintenance therapy. No systemic toxicity including neurologic effects, was reported. Conclusions : Oral DTG/RPV appears to be a suitable alternative to standard oral CAB/RPV lead-in, before initiation of long-acting injectable therapy."

Human Immunodeficiency Virus • Infectious Disease • CD4

Differential expression of ER-TR7 following challenge with more recent antiretroviral drugs: an in vitro model (EACS 2025) - "Results : Cells expressed ER-TR7 with a different degree of expression, being CAB, DOR and the associations CAB/RPV and DTG/RPV able to express higher levels of ER-TR7 compared to RPV and to the association DTG/DOR that displayed moderate expression levels and to the containing TAF and TDF regimens that expressed this marker at a level comparable to control...Conclusions : This data highlights that in vitro challenge of 3T3-L1 cells with newer INSTIs and NNRTIs differently modulated ER-TR7 expression levels driving a number of these cells toward the expression of some morphological changes. This result, considering the potential role of this phenomenon on metabolic pathways, needs further studies to explore potential clinical implications."

Preclinical • Infectious Disease • ER

Clinical outcomes on B/F/TAF and dolutegravir-based regimens at 12 months following regimen switch: an observational cohort study. (PubMed, AIDS Res Ther) - "Despite differences in baseline characteristics and regimen adherence between individuals switched to B/F/TAF, DTG STRs, and MTRs, both B/F/TAF and DTG-based regimens were associated with high rates of virologic suppression. This data strongly supports the inclusion of these simple and safe regimens as switch options in virologically suppressed PWH. Baseline differences in patient demographics and characteristics may have impacted the adherence on B/F/TAF compared to DTG STR, however virologic outcomes were preserved, demonstrating the forgiveness of B/F/TAF in populations potentially facing adherence challenges."

Clinical data • Journal • Observational data • Retrospective data • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • CD4

Risk of clinical events in virologically suppressed people with HIV switching to a two-drug regimen vs. remaining on a three-drug regimen: a target trial emulation. (PubMed, EClinicalMedicine) - "PWH were classified according to therapeutic strategies: switching to 2DR (protease inhibitors or dolutegravir plus lamivudine or dolutegravir plus rilpivirine) or remaining on 3DR (any combination). This study provides evidence that virologically suppressed PWH can be safely switched to 2DR, and may slightly reduce the 3-year risk of a composite clinical outcome. The Icona Foundation Study is supported by unrestricted grants from Gilead Sciences, ViiV Healthcare, Merck Sharpe & Dohme."

Clinical • Journal • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Oncology

Risk of developing low-level viremia (LLV) among people with HIV (PWH) with current HIV-RNA≤50 copies/mL receiving 2DR vs 3DR: a case control study (IAS-HIV 2025) - "The main exposure of interest was the type of regimen at the index date [2DR(DTG/3TC, DTG/RPV, DTG/DOR, CAB/RPV) vs. 3DR(DTG/BIC or RPV/DOR or boosted DRV or ATV + TXF/XTC)]. On modern ART era, the use of DTG-based 2DR is not associated with a higher risk of developing LLV after achieving suppression compared to TXF-based 3DR."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Safety and effectiveness of switch to bictegravir/emtricitabine/tenofovir alafenamide following dual regimen therapy in people with HIV: Insights from the Icona cohort. (PubMed, HIV Med) - "Switching from 2DR-INSTI to B/F/TAF is infrequent; this switch results in a low rate of toxicity and failure, along with a favourable immunovirological and lipid profile. CD4/CD8 gain is observed in those switching with detectable HIV-RNA."

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

Long-Acting Cabotegravir and Rilpivirine in Older People With HIV in the GEPPO Cohort (CROI 2025) - "Background The association of intramuscularly administered Long-acting cabotegravir and rilpivirine (LA CAB+RPV) has been proven to be effective and safe in the maintenance treatment of people with HIV (PWH)...The pre-switch regimen was mainly based on a three-drug combination in 53.5% of study participants (mostly bictegravir or rilpivirine-based) or two-drug combinations by 45.1% (mostly dolutegravir/rilpivirine and dolutegravir/lamivudine)...Conclusions Our results suggest that the LA CAB+RPV combination is effective and safe in OPWH despite a long history of ART and a high prevalence of multimorbidity and polypharmacy. Older age should not be a barrier to the LA regimen: this study paves the way to evaluate the risk of an ageism attitude when clinicians consider ART choices in older PWH."

Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Pain • CD4

Hepatitis B Reactivation in PWH With Isolated Anti-Core Pattern on Therapies Excluding Tenofovir (CROI 2025) - "The aim of this study was to evaluate the incidence of HBV reactivation in PWH with isolated anti-core pattern who are treated with dual ART regimens lacking TXF: DTG+3TC, DTG+RPV, or CAB+RPV-LA. Conclusions Our findings suggest that the risk of HBV reactivation in PLHIV with isolated anti-core patterns who are treated with TXF-free dual ART regimens is extremely low after more than 3 years of follow-up. This holds true even for regimens that do not have direct anti-HBV activity, such as DTG+RPV and CAB+RPV-LA."

Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

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

Dolutegravir With Either Doravirine or Rilpivirine: Two-Drug Antiretroviral Therapy Outcomes (CROI 2025) - "We aimed to compare virologic suppression (VS) in treatment-experienced persons with HIV following switch to DTG+DOR versus DTG+RPV. Conclusions Observed differences in VS following switch to DRG+RPV and DTG+DOR may be due to differences in participant characteristics, adherence, viral resistance patterns, and the dual regimens. Further studies are needed to evaluate efficacy of dual NRTI-free regimens in real-world settings."

Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease • CD4

Immediate virological failure with intramuscular cabotegravir-rilpivirine in a patient long suppressed with dolutegravir-rilpivirine. (PubMed, AIDS) - No abstract available

Journal

Change in weight and BMI associated with switching to bictegravir/emtricitabine/tenofovir alafenamide versus a dolutegravir-based regimen among virologically suppressed adults living with HIV through 144 weeks. (PubMed, Medicine (Baltimore)) - "This observational study collected demographics, clinical characteristics, weight, and BMI from virologically suppressed adults switched to BIC/emtricitabine/tenofovir alafenamide (TAF), emtricitabine/TAF plus DTG, DTG/abacavir/lamivudine, DTG/rilpivirine (RPV), and DTG/lamivudine 2 years prior to switch through 144 weeks post-switch...DTG plus emtricitabine/TAF switches had the highest annualized weight gain (0.68 kg/year, 95% confidence interval: -0.32, 1.65) whereas, DTG/RPV switches had the lowest annualized weight gain (-2.22 kg/year, 95% confidence interval: -3.69, -0.62) post-switch...Baseline BMI < 18.5 kg/m2 was associated with the highest annualized weight gain post-switch, whereas switching from protease inhibitors and self-report of dieting were associated with the lowest annualized weight gain post-switch. At week 144, switching to a BIC versus DBR were both associated with lower annualized weight gain post-switch among a large and diverse cohort of..."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Doravirine associated with greater LDL cholesterol reduction in people with HIV switching antiretroviral regimens. (PubMed, AIDS) - "In this observational cohort study, the objective was to compare low-density lipoprotein (LDL) cholesterol dynamics in people with HIV (PWH) who switched to a regimen containing doravirine (DOR), rilpivirine, dolutegravir, or bictegravir and were naïve to the studied drugs. Generalized additive mixed models were used to examine LDL cholesterol dynamics. LDL cholesterol was measured in 2381 PWH: during the first two years, DOR had the greatest lowering effect and showed the most favorable lipid outcome."

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

The steady-state pharmacokinetics of fixed-dose combination dolutegravir+rilpivirine in hemodialysis. (PubMed, AIDS) - "Hemodialysis did not lead to clinically appreciable differential exposures to DTG and RPV. Exposures throughout the dosing interval were greater than the reported protein-binding-adjusted IC90 efficacy values for DTG (64 ng/ml) and RPV (12 ng/ml) in all participants. These data suggest no dosing modifications are needed for the FDC DTG+RPV regimen in hemodialysis."

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

Antiretroviral therapy in people with HIV and end-stage kidney disease. (PubMed, AIDS) - "Dual/unboosted ART regimens such as dolutegravir/lamivudine provide robust viral efficacy in the setting of ESKD, and higher than recommended, including full-dose, lamivudine was well tolerated. The dolutegravir/lamivudine (300 mg) fixed-dose combination provides a single-tablet regimen for use across the eGFR spectrum, avoids under-exposure to lamivudine, and merits further evaluation in this population."

Journal • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease • Transplantation • CD4

Use of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in kidney transplant recipients living with HIV‐1 receiving calcineurin and mTOR inhibitors: a pilot switch study (HIV-Glasgow 2024) - " Five HIV-KTR were enrolled and were receiving 3TC/ABC+RAL (n = 4) or RPV+DTG (n = 1) before switching to B/F/TAF: two women, median (IQR) age 58 (48–66) years and BMI 25.0 kg/m2 (20.6–26.), two with AIDS...In addition to corticosteroids, the immunosuppressant regimen included calcineurin inhibitors (cyclosporine n = 1, mycophenolate mofetil n = 3, tacrolimus n = 1) and mTOR inhibitors (everolimus n = 2)... This pilot study shows that B/F/TAF appears to be safe and effective in HIV-KTR receiving calcineurin and mTOR inhibitors."

Clinical • Cerebral Hemorrhage • Chronic Kidney Disease • CNS Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Nephrology • Renal Disease • Transplantation • CD4 • CD8