Cimduo (lamivudine/tenofovir disoproxil fumarate) / Cipla, Celltrion, Macleods, Viatris, Sun Pharma, Aurobindo, Hetero - LARVOL DELTA

The impact of long-term potent antiviral therapy on the natural course of disease in patients with hepatitis B virus-related cirrhosis. (PubMed, Hepatol Forum) - "Potent antiviral treatment effectively maintained VR in the long-term follow-up of patients with HBV-related cirrhosis. HCC may still develop, albeit at a lower rate in these patients."

Journal • Fibrosis • Hepatitis B • Hepatocellular Cancer • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Antiviral efficacy of doravirine-based regimens in patients with NNRTI resistance in Europe: a retrospective observational study (EACS 2025) - "Most received DOR with TDF/3TC (91.4%); 8.6% received DOR with TAF/FTC. One experienced patient (1.8%) with multiple baseline NRTI and NNRTI RAMs that collectively may impact sensitivity to DOR experienced virological failure. Conclusions : In this well-characterised multicentre European cohort of PLWH with NNRTI RAMs and preserved genotypic DOR susceptibility, DOR-based regimens achieved high virological success and excellent treatment retention at 48 weeks."

Late-breaking abstract • Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-term viral suppression, and cardiometabolic benefits of switch to ainuovirine coformulated with lamivudine, and tenofovir DF in virologically suppressed people with HIV-1: 144-week, open-label results from the SPRINT post-study (EACS 2025) - "Purpose : In the previous 96-week results of the SPRINT extensional study, switch to ainuovirine, a new-generation NNRTI, coformulated with lamivudine, and tenofovir DF (ANV/3TC/TDF) maintained viral suppression (VS), and improved cardiometabolic conditions among people with HIV-1 (PWH) switching from both classical NNRTI-based regimens, and E/C/F/TAF. The accompanied safety benefits included persistent improvement in LDL-C level, and ASCVD risk strata. Renal function remained stable among this population, and required general routine monitoring."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Severe disseminated cryptococcosis, with asymptomatic central nervous system involvement, in a very late presenter (EACS 2025) - "Due to a lack of Amphotericin B and 5-Flucytosine, he initially received high-dose intravenous Fluconazole (1600 mg/day) for 30 days, which was replaced by Voriconazole because of continued blood culture positivity; they turned negative after five weeks. A single dose of liposomal Amphotericin B (10 mg/kg) was administered at week 7th.ART (DOR-TDF-3TC) was also initiated at this moment... Our case highlights the diagnostic and therapeutic challenges of a severe disseminated cryptococcosis, particularly in the absence of neurological symptoms despite extensive CNS involvement, with the importance of maintaining a high index of suspicion for cryptococcal meningitis in all patients with a CD4 count of less than 100 cells/mm³, regardless of their clinical presentation. Additionally, the importance of carefully timing ART initiation to avoid IRIS. Figure:"

Human Immunodeficiency Virus • Infectious Disease • CD4

Preserved renal function in PWH on ainuovirine-based antiretroviral regimen: week 144 results from SPRINT study, a randomized phase 3 trial (EACS 2025) - "In the extensional study, PWH continued ANV/3TC/TDF or switched to ANV/3TC/TDF from cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF) through144 weeks. Slight reduction in eGFR through 144 weeks indicated a three-year increment in age as per the CKD-EPI equation. Routine renal function monitoring is generally recommended for this low-risk population."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Long-term Lipid Metabolism Benefits of Switching to Ainuovirine-based Regimen in People with HIV-1: 144-Week Results from the SPRINT Extensional Post-study (EACS 2025) - "Purpose : This post-hoc analysis of the SPRINT extensional post-study aimed to evaluate the 144-week lipid profile changes in virologically suppressed people with HIV-1 (PWH) who switched to ainuovirine/lamivudine/tenofovir DF (ANV/3TC/TDF) from either NNRTI- or boosted INSTI-based regimens, with particular focus on its potential to reverse INSTI-associated dyslipidemia. Method : In this open-label extensional post-study, 723 out of 762 originally randomized participants (364 continuing ANV/3TC/TDF; 359 switching from E/C/F/TAF) were followed up for through weeks...Similar significant improvements were observed for non-HDL-C (-0.62 mmol/L, -0.72 to -0.52), total cholesterol (-0.77 mmol/L, -0.87 to -0.67), and triglycerides (-0.63 mmol/L, -1.00 to -0.26) from week 48. Conclusions : ANV/3TC/TDF regimen improved lipid safety profile remarkably in virologically suppressed people with HIV-1, with a special beneficial potential for people previously exposed to INSTI-based..."

Human Immunodeficiency Virus • Infectious Disease

Long-term changes in triglyceride-glucose index and insulin resistance in virologically suppressed people with HIV-1 switching to ainuovirine coformulated with lamivudine, and tenofovir DF: 144-week, open-label results from the SPRINT post-study (EACS 2025) - "Purpose : In the SPRINT study, switch to ainuovirine, a novel NNRTI, combined with lamivudine and tenofovir DF (ANV/3TC/TDF), resulted in noninferior virological efficacy and improved cardiometabolic conditions, compared to that to cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF), in virologically suppressed (VS) people with HIV-1 (PWH) previously on classical NNRTI-based antiretroviral (ARV) regimen. This increase was reverted in E/C/F/TAF arm through 144 weeks following re-switch to ANV/3TC/TDF. Conclusions : Switch to ANV/3TC/TDF from preceding classical NNRTI-, and boosted integrase transfer inhibitor-based ARV regimens resulted in a favorable change in TyG index and IR among virologically suppressed PWH through 144 weeks."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Improved atherosclerotic cardiovascular disease risk-associated dyslipidemia strata in people with HIV-1 switching to ainuovirine-based antiretroviral regimen: week 144 results from SPRINT, a randomized phase 3 trial (EACS 2025) - "Purpose : In the SPRINT study, switch to ainuovirine, a novel NNRTI, combined with lamivudine and tenofovir DF (ANV/3TC/TDF), resulted in favorable changes in body weight and serum lipids, compared to that to cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF), in virologically suppressed people with HIV-1 (PWH). Non-HDL-C, TC, and TG demonstrated similar trends in proportions of people with normal, borderline high, and high strata through 144 weeks (Figure 1). Conclusions : Switch to ANV/3TC/TDF favored ASCVD risk-associated with dyslipidemia strata in virologically suppressed PWH previously on classical NNRTI- or boosted integrase strand transferase inhibitor-based antiretroviral regimen as per the primary prevention target."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Switch to DOR/TDF/3TC in People With Controlled HIV and history of RNA genotype M184V/I mutation: Interim Results of the DRIVE OFF-ROAD Multicenter Single-Arm Phase II trial (EACS 2025) - P2 | "Purpose : Doravirine (DOR), tenofovir disoproxil fumarate (TDF), and lamivudine (3TC) fixed-dose combination is approved for people with HIV-1 (PWH) with no prior or current resistance to the NNRTI class, TDF, or 3TC. Enrollment is currently paused, pending the Week 24 follow-up of the #13 participant, expected in July 2025. Conclusions : These interim findings suggest efficacy of DOR/TDF/3TC in individuals with historical M184V/I lamivudine resistance, supporting to move the DRIVE OFF-ROAD trial forward."

Clinical • P2 data • Human Immunodeficiency Virus • Infectious Disease • CD4

Unconventional DORAVIRINE antiretroviral regime: a single-center experience (EACS 2025) - "1,2 Available in a once-daily combination with tenofovir-disoproxil/lamivudine (TDF/3TC), DOR showed versatility in more unconventional combinations, especially in dual-therapy with dolutegravir (DTG) 1,3 or 3TC...Twenty-two were dual-therapy with DOR+darunavir/cobicistat (DRV/c) (9/30; 30%) and DOR+DTG (7/30; 23%) being the most common...DOR+ARV ensured good immunovirological control and neutral impact on cholesterol and BMI as already reported 1,3,4 with high tolerability, having only one person/30 discontinuing DOR. Conclusions : Unconventional DOR combinations in dual-therapy including those with DRV/c or raltegravir are effective and well-tolerated options among others for multi-treated PLWH experiencing aging and comorbidities."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Lipids and Body Mass Index in Antiretroviral-Experienced People With HIV on Doravirine-Based Treatments: A Comparison Between Dual or Triple Regimen Versus Bictegravir-Based Triple Regimen. (PubMed, AIDS Res Treat) - "Objective: To evaluate the lipid profile and body mass index (BMI) in antiretroviral-experienced people living with HIV (PLWH) starting therapy with two doravirine (DOR)-based regimens (dolutegravir (DTG)/DOR or lamivudine (3TC)/tenofovir disoproxil fumarate (TDF)/DOR)...At baseline, 147 people treated with FTC/TAF/BIC had a better lipid profile and lower CD4 cell count than 147 people treated with 3TC/TDF/DOR; diabetes was less frequent in the latter group... The regimens were well tolerated in terms of lipid profile and BMI. Persons treated with 3TC/TDF/DOR triple regimen showed a better lipid profile, as expected, whereas those on DTG/DOR did not show any significant changes."

Journal • Diabetes • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4

Immediate and delayed switches to tenofovir DF-containing, ainuovirine-based antiretroviral regimen: the SPRINT extensional study. (PubMed, BMC Med) - P3 | "Both ISG and DSG maintained high viral Suppression in PLWH through 96 weeks. DSG could offset weight gain and dyslipidemia associated with previous exposure to E/C/F/TAF."

Clinical • Journal • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Psychiatry

DOVETAIL: Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Johns Hopkins University | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Human Embryoid Body-Based Assays for Preclinical Screening of Potential Teratogenic Drugs: Antiviral Drugs for Hepatitis B Virus as Examples. (PubMed, Stem Cells Dev) - "Animal tests are not always reliable for accurately identifying human teratogens, as evidenced by the infamous thalidomide case...Additionally, we subjected our hEB systems to Cmax doses of four nucleoside/nucleotide analogs (adefovir dipivoxil [ADV], entecavir [ETV], lamivudine [LAM], and tenofovir disoproxil fumarate [TDF]), which are used for anti-hepatitis B virus treatment and belong to different pregnancy-related risk categories...TDF and ADV appear to be safer options during the very early stages of embryonic development compared with LAM and ETV. Our findings indicate that EB transcriptomics-based analyses can accurately identify potent teratogens and aid in assessing the potential risk of commonly prescribed drugs during pregnancy."

Journal • Preclinical • Hepatitis B • Infectious Disease • Inflammation

Identifying care gaps along the HIV treatment failure cascade: A multistate analysis of viral load monitoring, re-suppression, and regimen switches in Zambia. (PubMed, PLoS Med) - "After treatment failure, we identified substantial delays in returning for adherence counseling, treatment interruptions, and missed opportunities in rechecking VL status or switching to second-line therapy in routine care in Zambia. Among those who did have VL tests rechecked, re-suppression rates were significantly higher among individuals on TLD compared to TLE. To optimize response and outcomes after treatment failure, strategies must prioritize and target both client and health systems behaviors to meet the care needs in the modern era of TLD."

Journal • Human Immunodeficiency Virus • Infectious Disease

Patterns of Reverse Transcriptase Inhibitor Resistance Mutations in People Living with Human Immunodeficiency Virus in Libreville, Gabon. (PubMed, Trop Med Infect Dis) - "Three of the most prescribed treatment regimens were associated to the appearance of both NRTIs and NNRTIs resistance mutations: TDF + 3TC + EFV (24.02%; 160/666); TDF + FTC + EFV) (17.2%; 114/666) and AZT + 3TC + EFV (14.6%; 97/666)...Also, treatment containing TDF-3TC + DTG is more protective against mutations. Drug resistance mutations are common in Gabon and compromise the efficacy of ART. Further study must search for other causes of therapeutic failure in Gabon in PWHIV."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Cardiac, liver, renal, and other safety profiles in PWH on ainuovirine-based antiretroviral regimen: week 96 results from SPRINT, a randomized phase 3 trial (IAS-HIV 2025) - "In the extensional study, PWH continued ANV/3TC/TDF or switched to ANV/3TC/TDF from cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF) until 96 weeks. Out of 762 randomized participants, 376 participants originally assigned to ANV/3TC/TDF (376/381, 98.7%), and 371 participants originally to E/C/F/TAF (371/381, 97.4%) completed the extensional study, respectively. Switch to ANV/3TC/TDF is well tolerated in VS PWHs, without clinically significant changes in organ-associated biochemical measures observed. Routine safety laboratory monitoring is generally recommended in PWHs on switching therapy."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Profiles of body weight, glucose, and uric acid in PWH on ainuovirine-based antiretroviral regimen: week 96 results from SPRINT, a randomized phase 3 trial (IAS-HIV 2025) - "Continuation of ANV/3TC/TDF treatment resulted in constant profiles of BW, FSG and SUA for VS PWH. However, switch from E/C/F/TAF favored profiles of BW and SUA in the SPRINT extensional period in contrast to that to E/C/F/TAF in the randomized study."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Favorable lipid profile in people with HIV-1 switching to ainuovirine-based antiretroviral regimen: week 96 results from SPRINT, a randomized phase 3 trial (IAS-HIV 2025) - "Switch to ANV/3TC/TDF from E/C/F/TAF is favored for improved serum lipid profile and ASCVD risk-associated dyslipidemia in VS PWH."

Clinical • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Safety and efficacy of ANV/3TC/TDF vs E/C/F/TAF for maintaining virologic suppression in adults living with HIV-1: week 96 results from the phase 3, noninferiority SPRINT randomized trial (IAS-HIV 2025) - "Both immediate and delayed switches to ANV/3TC/TDF maintained high viral suppression through 96 weeks. Delayed switch could offset weight gain, and lipid dysmetabolism associated with previous exposure to E/C/F/TAF."

Clinical • Head-to-Head • P3 data • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Kidney impairment in HIV: an insight into the burden and associated factors among adults on antiretroviral therapy in Zambia. A retrospective cross-sectional study. (PubMed, Ther Adv Infect Dis) - "After accounting for duration on ART, sex and blood pressure (systolic and diastolic), older age and being on a Dolutegravir (DTG) and tenofovir disoproxil fumarate/lamivudine (TDF/3TC) based regimen was positively associated with kidney impairment (adjusted odds ratio (aOR) 1.09; 95% CI: 1.05, 1.14, p < 0.001) and (aOR 2.44; 95% CI: 1.02, 5.79, p = 0.043), respectively. The prevalence of kidney impairment was common among adult PLWH and was significantly associated with older age and the use of a DTG and TDF/3TC-based regimen. There is a need to regularly monitor kidney function among people with HIV, especially older people who are on a DTG and TDF/3TC-based regimen."

Journal • Observational data • Retrospective data • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease

PPREPP-SA: Utilizing Private Pharmacies to Initiate High-risk Young Individuals on PrEP in South Africa (clinicaltrials.gov) - P4 | N=1900 | Active, not recruiting | Sponsor: Professor Francois Venter

New P4 trial • Human Immunodeficiency Virus • Infectious Disease

Optimising antiretroviral therapy through a proactive treatment algorithm: a cost-effective strategy in Dutch healthcare for people with HIV. (PubMed, J Antimicrob Chemother) - "Our ART algorithm demonstrated high acceptance by prescribers and people with HIV, leading to substantial cost savings. The algorithm can be easily implemented in other HIV clinics to offer even more significant cost savings to Dutch healthcare payers."

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

Effects of TDF/3TC/ANV on cardiovascular disease risk score and intestinal microecology in HIV-1 patients with dyslipidemia (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: First Affiliated Hospital of China Medical University; First Affiliated Hospital of China Medical University

New P4 trial • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

PrIMO: UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study (clinicaltrials.gov) - P4 | N=621 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Phase classification: P ➔ P4

Phase classification • Human Immunodeficiency Virus • Infectious Disease