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

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

Hepatitis B virus (HBV) viremia despite tenofovir disoproxil fumarate-containing antiretroviral therapy in persons with HBV/HIV coinfection. (PubMed, J Clin Virol) - "HBV viremia despite high adherence to TDF/3TC-based ART may be associated with the presence of TFV RAMs. These findings highlight the need for enhanced resistance monitoring and further research to examine the clinical significance of reported TFV RAMs. Individuals with HBV/HIV coinfection and TFV resistance on TDF-based ART may need alternative treatment strategies."

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

A MULTICENTER REAL WORLD STUDY OF SOFOSBUVIR/VELPATASVIR FOR HIV/HCV COINFECTED PATIENTS (AASLD 2024) - "sofosbuvir/velpatasvir(SOF/ VEL),either as monotherapy or in combination with ribavirin(RBV),exhibited robust virologic response and favorable safety outcomes in the treatment of HIV/HCV coinfected patients."

Clinical • Real-world • Real-world evidence • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • CD4

Safety and adherence to TDF-3TC or TDF-FTC as daily HIV Pre-exposure prophylaxis (PrEP) among Men who have Sex with Men, a phase II randomized clinical trial in Belo Horizonte, Brazil (HIVR4P 2024) - "This first prospective, randomized study comparing TDF-3TC and TDF-FTC for daily PrEP in MSM, showed similarities in safety and equally good adherence. Our findings can help Brazil and other developing countries decide on expanding oral PrEP options in their public health system."

Adherence • Clinical • P2 data • CNS Disorders • Depression • Herpes Simplex • Human Immunodeficiency Virus • Infectious Disease • Pain • Psychiatry

Evaluation of Viral Suppression in Paediatric Populations: Implications for the Transition to Dolutegravir-Based Regimens in Cameroon: The CIPHER-ADOLA Study. (PubMed, Biomedicines) - "VS was 85.1% on a DTG-based regimen versus 80.0% on efavirenz/nevirapine and 65.6% on lopinavir/ritonavir or atazanavir/ritonavir. Predictors of non-VS are younger age, non-TDF/3TC- and non-DTG-based regimens. Thus, efforts toward eliminating paediatric AIDS should prioritise the transition to a DTG-based regimen in this new ART era."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

A case series of intermittent nucleoside analogue-based (NA) regimen to maintain HBV virological suppression in coinfected HBV/HIV patients with suppressed viremia. (PubMed, Infect Dis Now) - "This case series shows the potential for intermittent NA-containing regimens to maintain long-term control of HBV replication among suppressed HBV/HIV-1 patients."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease

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

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • EGFR

Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients. (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Shanxi Kangbao Biological Product Co., Ltd. | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Switch to fixed-dose ainuovirine, lamivudine, and tenofovir DF versus elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed people living with HIV-1: the 48-week results of the SPRINT trial, a multi-centre, randomised, double-blind, active-controlled, phase 3, non-inferiority trial. (PubMed, Lancet Reg Health West Pac) - "We compared the efficacy and safety profiles of ainuovirine (ANV), a new-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), with boosted elvitegravir (EVG), both coformulated with two nucleoside reverse transcriptase inhibitors (NRTIs), in people living with HIV-1 (PLWH) who had achieved virological suppression on previous NNRTI-based antiretroviral (ARV) regimen. In virologically suppressed PLWH on previous NNRTI-based ARV regimen, switch to ANV/3TC/TDF resulted in less weight gain, and improved lipid metabolism while maintaining virological suppression non-inferior to that to EVG/Cobi/FTC/TAF. Jiangsu Aidea Pharmaceutical & the National "Thirteenth Five-year Period" Major Innovative Drugs Research and Development Key Project of the People's Republic of China Ministry of Science and Technology."

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

Pharmacogenetic determinants of tenofovir diphosphate and lamivudine triphosphate concentrations in people with HIV/HBV coinfection. (PubMed, Antimicrob Agents Chemother) - "Individuals with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) coinfection receiving TDF/3TC-containing antiretroviral therapy were enrolled...Our study identified ABCC2 SNP to be associated with 3TC-TP concentrations in PBMCs. Also, a combination of genetic variants of drug transporters and PDE was associated with HIV non-suppression."

Biomarker • Journal • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • ABCC2