Symfi (efavirenz/lamivudine/tenofovir disoproxil fumarate) / Viatris - LARVOL DELTA

Antiretroviral Therapy in India (2025): Drugs, Indications, Contraindications, Mechanisms, and Prophylaxis (PEP/PrEP). (PubMed, J Assoc Physicians India) - "India's ART platform is strong and increasingly INSTI-based. Scaling PrEP, standardizing DTG-aligned PEP, fortifying viral load and resistance monitoring, and integrating long-acting prevention as it becomes available are the next priorities."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Efficacy and safety of doravirine/lamivudine/tenofovir as initial treatment for people living with HIV in China. (PubMed, Antimicrob Agents Chemother) - "A real-world retrospective study was conducted involving treatment-naïve PLWH who initiated DOR/TDF/3TC, EFV/TDF/3TC, DTG/TDF/3TC, or BIC/TAF/FTC. DOR/TDF/3TC demonstrated antiviral effectiveness comparable to DTG/TDF/3TC and BIC/TAF/FTC, with a favorable tolerability profile at week 48. Additionally, DOR/TDF/3TC was associated with more favorable lipid changes."

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

Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection (clinicaltrials.gov) - P4 | N=202 | Completed | Sponsor: Peking Union Medical College Hospital | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Metabolic impact of switching from EFV/TDF/FTC to two INSTI-Based regimens (B/F/TAF vs. DTG/3TC): a real-world study in virologically suppressed individuals. (PubMed, Front Pharmacol) - "To compare metabolic outcomes in virologically suppressed PLWH switching from EFV/TDF/3TC to either B/F/TAF or DTG/3TC. In virologically suppressed PLWH, switching to B/F/TAF or DTG/3TC provides comparable metabolic safety profiles. Clinical management should prioritize individualized regimen selection alongside proactive management of traditional metabolic risk factors."

Journal • Real-world evidence • Cardiovascular • Human Immunodeficiency Virus • Hypertension • Infectious Disease

Time to incidence of tuberculosis and its predictors among adult HIV/AIDS patients who initiated ART by the Universal Test and Treat approach in Silte Zone, Ethiopia, 2023. (PubMed, PLOS Glob Public Health) - "The predominant regimen was TDF-3TC-EFV...Although TB incidence declined under the UTT approach, risk remained elevated during the first year of ART. Targeted interventions promoting early diagnosis, adherence support, nutritional care, and safe disclosure are essential to reduce TB burden among people living with HIV."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4

Effectiveness and safety of ainuovirine plus lamivudine and tenofovir DF in virologically suppressed people living with HIV-1: the 48-week results of a multicenter, real-world study. (PubMed, Antimicrob Agents Chemother) - "Although efavirenz (EFV)-based regimens have been widely used, current guidelines recommend integrase strand transfer inhibitor (INSTI)-based therapy as first-line...Virologically suppressed adults on a tenofovir disoproxil fumarate (TDF)/3TC+EFV regimen were either switched to TDF/3TC+ANV (ANV group) based on the physician's discretion or continued on TDF/3TC+EFV (EFV group)...Switching from EFV- to an ANV-based regimen effectively maintained VS and led to improved metabolic parameters, including less weight gain and a more favorable lipid profile. As an alternative switch strategy, the ANV-based regimen may be a more beneficial option for people living with HIV (PLWH) who are at high risk of weight-related or dyslipidemia-associated comorbidities."

Journal • Real-world evidence • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4 • CD8

Geographical and temporal trends of HIV-1 subtypes and drug resistance in China: a nationwide study over two decades (2003-2024). (PubMed, J Gen Virol) - "Notably, the TDR rate exceeded 5% for several regimens freely provided in China, including AZT+3TC+NVP (6.8%), AZT+3TC+RPV (8.0%), AZT+3TC+EFV (6.4%), TDF+3TC+NVP (6.0%), TDF+3TC+RPV (7.2%) and TDF+3TC+EFV (5.7%).Conclusion. Continued surveillance of HIV-1 genotypes and CRFs is critical, particularly in regions where routine genotypic testing is not implemented. Personalized antiretroviral regimens are urgently needed in regions with high levels of TDR."

Journal • Human Immunodeficiency Virus • Infectious Disease

HIV-1 drug resistance and genetic clustering among ART-treated individuals with virologic failure in Aksu, China. (PubMed, Front Microbiol) - "The most common DRMs were K103N/S (60.7%), M184V/I (27.3%), G190A/E/S (11.3%), and E138A/K/Q/G (10.8%), conferring high-level resistance mainly to lamivudine (3TC), efavirenz (EFV), and nevirapine (NVP)...The clustering of DRMs underscores the importance of molecular surveillance for guiding targeted interventions. These findings support accelerating access to effective second-line regimens, strengthening pretreatment resistance surveillance, and prioritizing adherence support among central individuals with high viral loads."

Journal • Human Immunodeficiency Virus • Infectious Disease

Longitudinal analysis of metabolic changes in people with HIV on integrase inhibitor-based versus efavirenz-based therapy: a prospective real-world cohort study in China. (PubMed, BMC Infect Dis) - "INSTI-based ART was associated with sustained weight gain but did not worsen long-term dyslipidemia compared to an EFV-based regimen in a real-world setting. Hepatic steatosis correlated with metabolic parameters rather than INSTI exposure."

Journal • Real-world evidence • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Incidence of antiretroviral therapy regimen modification and associated factors among People Living with HIV in Beijing, China. (PubMed, PLOS Glob Public Health) - "TDF + 3TC + EFV was the predominant initially prescribed regimen with the highest durability, while LPV/r + 3TC + AZT had the highest modification rate. These findings underscore the need for early ART initiation, comprehensive pretreatment screening, and enhanced early monitoring-especially during the first six months-to optimize regimen selection and minimize unnecessary modification."

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

Efficacy, and safety of ainuovirine-based antiretroviral regimen in women with HIV-1: the pooled analysis of the RACER, and SPRINT studies, two multicenter, randomized, active controlled phase 3 trials (EACS 2025) - "Method : In the RACER study (N=34), 18, and 16 treatment-naïve WWH were medicated with ANV/3TC/TDF, and EFV/3TC/TDF, respectively. In the SPRINT study (N=22), 11, and 11 virologically suppressed WWH were medicated with ANV/3TC/TDF, and E/C/F/TAF, respectively...Conclusions : At a small sample size, ANV/3TC/TDF regimen showed high viral suppression comparable to the comparators in women. Accompanied benefits included less neuropsychiatric symptoms for treatment-naïve women, and improved lipid metabolism for both subpopulations."

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

Efficacy, and safety of ainuovirine plus lamivudine, and tenofovir DF in young people with HIV-1: pooled analyses of RACER, and SPRINT studies, two randomized, active-controlled phase 3 trials (EACS 2025) - "This study evaluated ainuovirine (ANV), a next-generation NNRTI with demonstrated non-inferior efficacy to efavirenz (EFV) and elvitegravir/cobicistat (E/C) in phase 3 trials, focusing on young people with HIV-1 (YPWH) across treatment-naïve (TN), and virologically suppressed (VS) populations. Method : We pooled data from two randomized trials: RACER (TN, N=219; ANV/3TC/TDF vs EFV/3TC/TDF) and SPRINT (VS, N=107; ANV/3TC/TDF vs E/C/F/TAF)...The combination of maintained viral suppression, improved CD4 cell recovery, attenuated weight gain, better lipid control, and preserved renal function positions ANV/3TC/TDF as an optimized treatment option for YPWH, particularly in Asia-Pacific regions where metabolic complications are of growing concern. These findings support ANV's role as a valuable alternative to the antiretroviral armamentarium for this vulnerable population."

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

Machine Learning Algorithms for Adverse Drug Reactions Prediction and Identifying Its Determinants Among HIV Patients on Antiretroviral Therapy in the University of Gondar Comprehensive and Specialized Hospital, in Amhara Region, Ethiopia. (PubMed, Health Sci Rep) - "The top eight predictors of ADRs were identified by random forest feature importance and association rules as follows: Male, younger age, longer duration on ART, not taking Co-trimoxazole preventive therapy (CPT), not taking TB (Tuberculosis) preventive therapy (TPT), secondary educational status, TDF-3TC-EFV, and low CD4 counts. Our research shows that HIV patients who are at a high risk of adverse drug reactions and those who can recognize the predictive traits associated with the ADRs can be categorized according to how effectively their ART treatment is working. However, our research may help address the pressing public health issue of diagnosing and treating HIV-positive individuals."

Adverse drug reaction • Journal • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4

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

Current status of antiretroviral treatment for people living with human immunodeficiency virus in Burkina Faso in the era of the World Health Organization's "test and treat" strategy (PubMed, Med Trop Sante Int) - "The main treatment combination used in adults was TDF/FTC/EFV, accounting for 42% in 2018, 50% in 2019, and 38% in 2020. The TDF/3TC/EFV combination was dominant in 2021, accounting for 46%. In 2022 and 2023, the TDF/3TC/DTG combination was the most common, at 76% in 2022 and 91% in 2023...The proportion of people on ART has gradually increased since the WHO's "test and treat" recommendations. These results bring Burkina Faso closer to achieving the UNAIDS targets."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

Efficacy, and safety of ainuovirine-based antiretroviral regimen in women with HIV-1: the pooled analysis of the RACER, and SPRINT studies, two multicenter, randomized, active controlled phase 3 trials (IAS-HIV 2025) - "This integrated analysis aimed to evaluate the virological outcomes, and safety profile of ANV/3TC/TDF in women with HIV-1 (WWH) at week 48. In the RACER study (N=34), 18, and 16 treatment-naïve WWH were randomized, and medicated with ANV/3TC/TDF, and EFV/3TC/TDF, respectively. In the SPRINT study (N=22), 11, and 11 virologically suppressed WWH were randomized, and medicated with ANV/3TC/TDF, and E/C/F/TAF, respectively... Although at a small sample size, ANV/3TC/TDF regimen showed high viral suppression comparable to the comparators in both treatment-naïve, and virologically suppressed women."

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

Metabolic Health Consequences of Switching to the Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir Plus Lamivudine Regimens in Virologically Suppressed People Living with HIV Aged > 40 Years: A Retrospective Real-World Study. (PubMed, Infect Drug Resist) - "This study aimed to evaluate the safety and metabolic health consequences of two switched regimens in a real-world setting among virologically suppressed PLWH previously treated with EFV/TDF/3TC. In this study, the B/F/TAF or DTG/3TC regimens are safe for virologically suppressed PLWH aged > 40 years. The transition to B/F/TAF demonstrated dual clinical benefits, significantly reducing hyperglycemia incidence while preserving renal function."

Journal • Real-world evidence • Retrospective data • Diabetes • Human Immunodeficiency Virus • Infectious Disease

The cost-effectiveness analysis of single-tablet efavirenz-based regimen among HIV-1 infected adults in China. (PubMed, Front Public Health) - "In 2018, the Chinese Guidelines for Diagnosis and Treatment of HIV/AIDS recommended the adoption of the efavirenz 400 mg-based TLE (tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV)) regimen as the primary first-line treatment for ART-naive HIV-1 infected adults in China. In probabilistic sensitivity analysis, TLE400 STR demonstrated a 71.4% probability of being highly cost-effective nationwide, based on the one-time national-level GDP per capita. In the context of treating HIV-1 infected adults in China, the STR of TLE400 demonstrated cost-effectiveness when compared to both the MTR of TLE400 and the MTR of TLE600."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

INSTIs-centered antiviral regimens for first-line treatment of HIV/AIDS: a network meta-analysis and cost-effectiveness analysis. (PubMed, BMC Infect Dis) - "INSTI-based regimens are as effective and safe as the national standard but offer additional benefits in drug resistance and patient compliance. B/F/TAF is economically viable from the patient perspective but does not present a cost-utility advantage from the healthcare system perspective. This study underscores the need for considering both clinical and economic factors in selecting first-line HIV/AIDS treatments in China."

Clinical • HEOR • Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

Transitioning Adolescents With HIV to TDF/3TC+DTG Improves Virologic Outcome: CIPHER-ADOLA Study (CROI 2025) - "Background WHO recommends transitioning to tenofovir/lamivudine/dolutegravir (TLD)-regimen to improve virological success (VS), considering vulnerable populations like adolescents living with HIV/AIDS (ADLHIV). However, VR occurs in some cases, especially when switching from a DTG-based regimens. Thus, scaling-up the transition of ADLHIV to TLD, regardless of previous exposure to TDF/3TC/EFV and baseline VL, would contribute to markedly decreasing, down toward eliminating paediatric AIDS."

Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Efficacy and safety of an Albuvirtide-based regimen for preventing mother-to-child transmission of multidrug-resistant HIV: a case report. (PubMed, BMC Pregnancy Childbirth) - "In our case, ABT-based antiretroviral regimen was effective in suppressing viral load (VL) in pregnancy, and there is no reported safety issues for the mother or the baby. Albuvirtide use in pregnancy might represent a strategy to avoid in utero transmission of MDR-HIV, but further investigation is warranted."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Impact of different antiretroviral therapy regimens on bone mineral density in people living with HIV: a retrospective and longitudinal study in China. (PubMed, BMC Infect Dis) - "TAF-containing and DTG-containing regimens caused less bone loss than TDF + 3TC + EFV, offering safer options for preserving bone health in Chinese PLWH."

Journal • Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Osteoporosis

Rapid start with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment in people with HIV‐1 (PWH): a systematic literature review (SLR) of clinical and patient‐reported outcomes (PROs) (HIV-Glasgow 2024) - "Efficacy and safety outcomes at key timepoints reported by included rapid start (RS) studies Characteristic/Endpoints BIC-NOW (Spain) [5] BIFAST (Spain) [6] FAST (France) [7] Rainbow (Italy) [8] Test&Treat (Spain) [9] Benidir 2022 (USA) [10] Study design Single arm Single arm Single arm Single arm Single arm Non-RCT (RS vs non-RS) Phase IV IV IV IV III NR Treatment arms B/F/TAF RS (n=208) B/F/TAF RS (n=59) B/F/TAF RS (n=112) B/F/TAF RS (n=30) B/F/TAF RS (n=100) B/F/TAF RS (n=65) B/F/TAF non-RS (n=42) Efficacy Outcomes Virologic suppression (Viral load <50 copies/mL) W24 (n=160), 88.8% W24 (n=59), 84.4% W24 (n=112), 80.4% W24 (n=30), 80%, p < 0.001 W4 (n=100), 52% Visit 5 (timepoint NR) (n=65), 100%, p ≥ 0.05 Visit 5 (timepoint NR) (n=42), 100% Engagement in care (Attendance at visits) W48 (n=30), 100% W4 (n=100), 100% Visit 4 (median 192.0 [IQR 185.0,238.0] days) (n = 16), 56.3%, p = 0.003 Visit 4 (median 243.5 [IQR 180.2, 306.8] days) (n = 22), 9.1% Safety..."

Clinical • Patient reported outcomes • Review • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry

BIC/FTC/TAF Benefits People Living With HIV After Omicron Breakthrough Infection in Shortening Duration of Symptoms, Enhancing Specific Immune Response and Increasing Total CD4 Cells. (PubMed, J Med Virol) - "In cellular immunity, the use of BIC/FTC/TAF was also found to increase not only BA.5-specific B lymphocytes and BA.5-specific CD4+T lymphocytes, but also total CD4+T cells. In conclusion, compared to TDF/3TC/EFV, BIC/FTC/TAF can help PLWH shorten the duration of COVID-19 symptoms, enhance SARS-CoV-2 specific humoral and cellular immune responses, help to expand the total CD4+T cells increase in PLWH after Omicron infection and may be more beneficial for PLWH with high risk of infection in the context of COVID-19 normalization."

Journal • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

High virological suppression in treatment‐naïve people with HIV‐1 on ainuovirine‐ versus efavirenz‐ based antiretroviral regimen as initial therapy: effect of pretreatment NNRTI resistance from RACER trial, a multi‐centre, randomized, active‐controlled study (HIV-Glasgow 2024) - "Virological outcomes of treatment-naïve people with HIV-1 on ANV- versus EFV-based antiretroviral regimen as initial therapy at week 48 (PDR to NNRTI subgroup, N = 71) n (%) ANV+3TC+TDF (N = 44) EFV+3TC+TDF (n = 27) Viral suppression (HIV RNA <50 copies/ml) 36 (81.8) 18 (66.7) Incomplete viral suppression (observed HIV RNA ≥50 copies/ml) 3 (6.8) 4 (14.8) HIV RNA ≥50∼<1000 copies/ml 2 (4.5) 3 (11.1) HIV RNA ≥1000 copies/ml 1 (2.3) 1 (3.7) No virological data 5 (11.4) 5 (18.5) Abbreviations: 3TC, lamivudine; ANV, ainuovirine; EFV, efavirenz; NNRTI, non-nucleoside reverse transcriptase inhibitor; PDR, pretreatment drug resistance; RNA, ribonucleic acid; TDF, tenofovir disoproxil fumarate. ANV-based antiretroviral regimen achieved a relatively high VS in treatment-naïve PWH although PDR to NNRTI prevailed in the study population. In consideration of additional safety benefits of ANV compared to EFV, ANV-based regimen is recommended as a first-line treatment..."

Clinical • Human Immunodeficiency Virus • Infectious Disease