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

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) - No abstract available

Clinical • P2 data • Human Immunodeficiency Virus • Infectious Disease

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

Efficacy of Switching to Ainuovirine-Based Antiretroviral Regimen in Virologically Suppressed PWH (CROI 2025) - "Background In the SPRINT study, switch to ainuovirine, a novel non-nucleoside reverse transcriptase inhibitor, combined with lamivudine and tenofovir DF (ANV/3TC/TDF), was non-inferior to that to cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF) for virologically suppressed (VS) people with HIV-1 (PWH) in 48-week virologic efficacy endpoint. Conclusions VS was well preserved in PWH with second- or third-line switch to ANV/3TC/TDF through 96 weeks. Immunologic outcomes might favor a "same-class" switch to ainuovirine-based regimen, and warranted further investigation into the changes in the viral reservoir and immune functionality of VS PWH switching antiretroviral regimen."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

No impact of the M184I/V mutation on the efficacy of tenofovir or abacavir+lamivudine+doravirine in HIV treatment‐experienced people (HIV-Glasgow 2024) - "Baseline characteristics of the participants on tri-therapy according to the presence or not of M184V/I at baseline among switch participants (10 imputed datasets) M184V/I at baseline M184V/I at baseline Characteristic No (n = 293) n/N (%) or median (IQR) Yes (n = 45) n/N (%) or median (IQR) p-value Gender 0.3138 Male 191/293 (65.2) 33/45 (73.3) Female 102/293 (34.8) 12/45 (26.7) Viral subtype 0.5998 B 158/293 (53.9) 28/45 (62.2) CRF02 59/293 (20.2) 8/45 (17.8) Other non-B 76/293 (25.9) 9/45 (20.0) Nadir CD4 count (cells/mm3) 257 (130−409) 157 (42−318) 0.0246 CD4 count at baseline (cells/mm3) 620 (467−846) 616 (421−910) 0.9044 Doravirine co-treatment 0.5539 3TC+TDF 268/293 (91.5) 43/45 (95.6) 3TC+ABC 25/293 (8.5) 2/45 (4.4) GSS with doravirine (Stanford) 3.0 (3.0−3.0) 1.5 (1.0−2.0) <.0001 GSS with doravirine (ANRS) 3.0 (3.0−3.0) 2.0 (1.5−2.0) <.0001 Number of NNRTI mutations at baseline 0 (0−1) 1 (0−2) <.0001 Log zenith plasma HIV-1 RNA (log10 copies/ml) 4.9..."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (clinicaltrials.gov) - P4 | N=147 | Completed | Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Active, not recruiting ➔ Completed | N=222 ➔ 147

Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease • EGFR

Salvage ART regimens based on a combination of an integrase inhibitor and doravirine in heavily antiretroviral‐treated people living with HIV (HIV-Glasgow 2024) - "The aim of this study was to assess epidemiological aspects and outcomes in PLWH under salvage ART regimens based on a combination of a non-nucleoside reverse transcriptase inhibitor (DOR) and an integrase inhibitor—dolutegravir (DTG) or bictegravir (BIC)... Out of 69 PLWH on salvage ART regimens, 40 (57.9%) males, with a median age 36 years (IQR 35–49), 50.0% were on BIC/FTC/TAF + DOR, 35.2% 3TC/TDF/DOR + DTG and 14.7% 3TC/DTG + DOR... The number of PLWH changed to salvage ART regimens significantly increased during last year, especially among PM with heavy ART history. Efficacy of salvage ART regimens was high in PLWH adherent to ART. P134: Figure 1Open in figure viewerPowerPoint Viral suppression rates after initiation of ART salvage regimen."

Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Psychiatry • CD4

Factors linked to virological failure in people on a dolutegravir-based regimen in Mamelodi. (PubMed, S Afr J Infect Dis) - "Since 2019, the World Health Organization has recommended dolutegravir-containing regimens for HIV in low- and middle-income countries because of its high genetic barriers to resistance, lower drug interactions, fewer side effects, higher viral load (VL) suppression rates and cost-effectiveness compared to efavirenz...The study highlights the importance of addressing adherence factors to improve VL suppression rates among people living with HIV on TLD. Tailored interventions targeting adherence, especially among newly initiated patients, and addressing the use of traditional or herbal and religious products are warranted to enhance treatment outcomes."

Journal • Human Immunodeficiency Virus • Infectious Disease

Profiles of cardiac, liver, renal, musculoskeletal, and pancreatic safety in virologically suppressed people with HIV‐1 switching to tenofovir DF‐containing, ainuovirine‐based antiretroviral regimen: the secondary analyses of 48‐week results of the SPRINT trial, a randomised, active‐controlled phase III study (HIV-Glasgow 2024) - "This FDC as switch therapy has shown noninferior virological efficacy but improved lipid profile compared to tenofovir alafenamide (TAF)-containing, boosted elvitegravir (EVG/c) regimen among virologically suppressed people with HIV-1 (PWHs). Switches to ANV/3TC/TDF and EVG/c/FTC/TAF were both well tolerated in virologically suppressed PWHs. Liver and renal function tests showed an improving trend with both regimens, without clinically significant changes in cardiac, musculoskeletal and pancreatic measures observed."

Clinical • P3 data • Cardiovascular • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Nephrology • Renal Disease

Favourable cholesterol profile in virologically suppressed people with HIV‐1 switching to tenofovir DF‐ containing, ainuovirine‐based compared to tenofovir alafenamide‐containing, boosted elvitegravir‐ based antiretroviral regimen: normocholesterolemic subgroup analyses of the SPRINT trial, a randomised, active‐controlled phase III study (HIV-Glasgow 2024) - "Background: In the SPRINT trial, virologically suppressed people with HIV-1 (PWHs) switched to tenofovir DF (TDF) containing, ainuovirine (ANV, ACC008) based or tenofovir alafenamide (TAF) containing, boosted elvitegravir (EVG/c) based antiretroviral (ARV) regimen (comparator) from an efavirenz-based regimen. In PWHs with baseline normocholesterolaemia, switching to a TDF-containing, ANV-based regimen resulted in less LDL-C increase and better lipidaemic control compared to a TAF-containing, EVG/c-based regimen."

Clinical • P3 data • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease

Virological suppression, viral blip, low‐level viraemia, and confirmed viraemia in virologically suppressed people with HIV‐1 switching to tenofovir DF‐containing, ainuovirine‐based antiretroviral regimen: secondary, and subgroup virological efficacy analyses of the SPRINT trial, a randomized, active‐ controlled phase III study (HIV-Glasgow 2024) - "ANV/3TC/TDF, ainuovirine/lamivudine/tenofovir disoproxil; E/C/F/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. High proportion of virological suppression was achieved in virologically suppressed PWHs switching to ANV/3TC/TDF non-inferior to EVG/c/FTC/TAF. Viral blip, LLV, and confirmed viraemia occasionally occurred, which normally did not require alteration of ART regimen."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

SARS‐CoV‐2 vaccination and coronaviral disease 2019 in virologically suppressed people with HIV‐1 previously on NNRTI‐based antiretroviral regimen during the pandemic: the secondary longitudinal analysis of the SPRINT study, a multi‐centre, randomised, active‐controlled phase III trial (HIV-Glasgow 2024) - "This study compared efficacy and safety of switch to ainuovirine plus lamivudine and tenofovir DF (ANV/3TC/TDF) and that to cobicistat-boosted elvitegravir plus emtricitabine and tenofovir alafenamide (E/C/F/TAF) in virologically suppressed PWH previously on NNRTI-based antiretroviral (ARV) regimen. The SPRINT study population, a representative subset of virologically suppressed PWH, was well vaccinated against SARS-CoV-2 during the pandemic. No severe or critical illness of COVID-19 occurred in this subpopulation, at a low incidence of testing positivity, and established or suspected diagnosis."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Improved uric acid metabolism in virologically suppressed people with HIV‐1 switching to tenofovir DF‐ containing, ainuovirine‐based compared to tenofovir alafenamide‐containing, boosted elvitegravir‐ based antiretroviral regimen: the secondary analyses of 48‐week results of the SPRINT trial, a randomised, active‐controlled phase III study (HIV-Glasgow 2024) - "ANV/3TC/TDF, ainuovirine/lamivudine/tenofovir disoproxil; E/C/F/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. Switching to tenofovir DF-containing, ANV-based regimen resulted in constant glucose but improved uric acid metabolism in virologically suppressed PWHs compared to that to TAF-containing, boosted EVG-based regimen. Glucose or uric acid dysmetabolism should be well addressed although diabetes or gout occasionally emerges in virologically suppressed PWHs."

Clinical • P3 data • Diabetes • Gout • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Rheumatology

Immunological efficacy and early response in virologically suppressed people with HIV‐1 switching to tenofovir DF‐containing, ainuovirine‐based compared to tenofovir alafenamide‐containing, boosted elvitegravir‐based antiretroviral regimen: secondary immunological efficacy analyses of the SPRINT trial, a randomized, active‐controlled phase III study (HIV-Glasgow 2024) - "ANV/3TC/TDF, ainuovirine/lamivudine/tenofovir disoproxil; E/C/F/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. Immunological efficacy was comparable between virologically suppressed PWHs, switching to ANV/3TC/TDF and those to EVG/c/FTC/TAF, few of whom were severely immunocompromised at baseline. However, switch to ANV/3TC/TDF resulted in a favourable early immunological response within the first 12 weeks of switch, compared to that to EVG/c/FTC/TAF."

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

Virological outcomes and resistance profile in people with HIV‐1 switching to ainuovirine‐ from NNRTI‐ based antiretroviral regimen containing two‐NRTI backbone: the integrated efficacy analysis of the RACER‐EXT and SPRINT studies, two multi‐centre, randomized, active‐controlled phase III trials (HIV-Glasgow 2024) - "Switch to ANV plus lamivudine and tenofovir DF (ANV/3TC/TDF) showed durable virological suppression in people with HIV-1 (PWH) in the RACER-EXT and SPRINT studies, two multi-centre, randomized, active-controlled phase III trials. High proportion of virological suppression was achieved in PWH switching to ANV/3TC/TDF from previous efavirenz- or other NNRTI-based ARV regimens. Virological failure, including premature withdrawal due to lack of efficacy, and documented resistance-associated mutations were very occasionally (<1%) reported in PWH switch to ANV/3TC/TDF."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Economic Evaluation of the Co-Formulated Antiretroviral Efavirenz 400mg/Lamivudine/Tenofovir Disoproxil Fumarate for the Treatment of HIV-1 Infection in Adult Patients From the Perspective of the Mexican Public Health System (ISPOR-EU 2024) - "The comparators included bictegravir+emtricitabine(FTC)+tenofovir alafenamide (TAF), dolutegravir(DTG)+abacavir+3TC, DTG+FTC+TAF, DTG+((FTC+TAF) or (FTC or 3TC [XTC]+tenofovir disoproxil [TDx]])), DTG+3TC, doravirine+TDx+3TC, efavirenz(EFV)+TDx, darunavir+cobicistat+ ((TAF+FTC) or (TDx+FTC or 3TC)), doravirine+((TAF+FTC) or (TDx+FTC or 3TC)), EFV+((TAF+FTC) or (TDx+XTC)), raltegravir+((TAF+FTC) o (TDx+FTC or 3TC)), darunavir+cobicistat+ 3TC. EFV400/3TC/TDF shows no statistically significant differences in viral suppression and safety. It is a cost-saving option with savings of up to 75.1% compared to some of its competitors, making it a valuable option for the National Health System in Mexico for treating HIV-1 infection in adult patients."

Clinical • HEOR • Human Immunodeficiency Virus • Infectious Disease