Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead - LARVOL DELTA

Comparative analysis of lipid profile changes in treatment-naïve people living with HIV on INSTI-based single-tablet regimens, BIC/FTC/TAF and DTG/3TC: real-world evidence from South Korea. (PubMed, J Antimicrob Chemother) - "DTG/3TC demonstrated more favourable lipid changes than BIC/FTC/TAF in treatment-naïve individuals, with significantly smaller LDL cholesterol increases and a trend towards an improved TC/HDL ratio over time. These findings may be informative during the ART selection especially for PLH with cardiovascular risk factors."

HEOR • Journal • Real-world evidence • Atherosclerosis • Cardiovascular • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Newly Diagnosed HIV in an Octogenarian Woman: A Case Report on Delayed Diagnosis in Vulnerable Populations. (PubMed, Clin Case Rep) - "Antiretroviral therapy was initiated with Biktarvy, resulting in gradual immunologic improvement and viral suppression. This case highlights the need to consider HIV testing in older adults with social vulnerability, even when classical risk factors are absent."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4

HIV Complicated with Talaromyces Marneffei Multisystem Infection: A Case Report and Literature Review. (PubMed, Infect Drug Resist) - "Post-discharge management included combination antiretroviral therapy (Bictegravir/Emtricitabine/Tenofovir alafenamide) with oral itraconazole prophylaxis. One-year follow-up imaging demonstrated near-complete resolution of systemic lesions. This report highlights characteristic radiological patterns and emphasizes the importance of considering disseminated TM infection in HIV patients with neurological involvement, particularly in endemic regions."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pain

An audit of antiretroviral regimens in people living with HIV attending a sexual health clinic in Sydney's Inner West in response to the REPRIEVE study (IAS-HIV 2025) - "The most common ARV regimen was bictegravir/tenofovir alafenamide/emtricitabine (n=167) followed by dolutegravir/lamivudine (n=115), dolutegravir and tenofovir alafenamide/emtricitabine (n=35), dolutegravir/abacavir/lamivudine (n=21) and long acting cabotegravir/rilpivirine (n=17). This audit demonstrates the need to track and systematically review ARV regimes of PLWH to modernize treatment regimens and proactively prevent co-morbidities, particularly MACE. Further study is required to examine why some PLWH are reluctant to change therapy and to explore patient focused strategies to ensure HIV treatment and co-morbidity prevention and care are optimized."

Cardiovascular • Human Immunodeficiency Virus • Infectious Disease

Research on the Psychological Status of Patients With HIV-1 Infection (clinicaltrials.gov) - P=N/A | N=500 | Not yet recruiting | Sponsor: Shanxi Bethune Hospital

New trial • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry

COATL: DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity (clinicaltrials.gov) - P3 | N=306 | Recruiting | Sponsor: Instituto Mexicano del Seguro Social

New P3 trial • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Characterizing treatment interruptions in the OPERA cohort and virologic outcomes after resumption with bictegravir/emtricitabine/tenofovir alafenamide. (PubMed, AIDS Res Ther) - "Treatment interruptions occurred in 11% of ART users in routine clinical care during the 26-month study period. Despite treatment interruption increasing the risk for viral rebound, most individuals who resumed treatment with B/F/TAF were able to achieve virologic suppression or avoid virologic failure."

Journal • Human Immunodeficiency Virus • Infectious Disease

Real-world effectiveness, safety, and health-related quality of life in people living with HIV receiving bictegravir/emtricitabine/tenofovir alafenamide-12-month results of the BICSTaR French cohort. (PubMed, IJID Reg) - "The number of bothersome symptoms decreased in the TN group, and treatment satisfaction significantly increased in the TE group. These French real-world data confirm the effectiveness, safety, and tolerability of B/F/TAF in TN and TE participants with a high prevalence of comorbidities."

HEOR • Journal • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

A double-blind, active-controlled, phase 2b study to evaluate the efficacy and safety of ulonivirine in combination with islatravir in virologically suppressed adults living with HIV-1 (IAS-HIV 2025) - P2 | "This double-blind, phase 2b trial evaluated the efficacy and safety of ISL+ULO QW in virologically suppressed adults living with HIV-1 (MK-8591-013; NCT04564547). Participants without known NNRTI resistance who were virologically suppressed for =6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), were randomized (1:1:1:1) to receive ISL 20 mg plus ULO (100, 200, or 400 mg) QW, or remain on BIC/FTC/TAF once-daily. ISL+ULO showed efficacy in maintaining viral suppression through Week 24. Consistent with previous studies of ISL, decreases in TLC and CD4+ counts were observed with ISL 20 mg + ULO QW followed by a trend to recovery after discontinuation. Development of ISL 2 mg + ULO QW is ongoing."

Clinical • Combination therapy • P2b data • Human Immunodeficiency Virus • Infectious Disease • CD4

Changes in cardiovascular and metabolic risk scores after switching to DOR/3TC/TDF, DTG/3TC or BIC/FTC/TAF: results from a multicenter Italian cohort (EACS 2025) - No abstract available

Clinical • Infectious Disease

Switching to Doravirine/Islatravir (100 mg/0.25 mg) once daily maintained viral suppression in the presence of archived M184I/V resistance-associated mutations in proviral DNA (IAS-HIV 2025) - P3 | "BACKGROUND: In three Phase 3 studies (P051: NCT05631093; P052: NCT05630755; P054: NCT05766501) virologic suppression was maintained in people living with HIV who switched to doravirine/islatravir (DOR/ISL 100 mg/0.25 mg); 2 studies (P051 and P052) were comparative and demonstrated noninferiority to baseline antiretroviral therapy (bART) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Switching to DOR/ISL 100 mg/0.25 mg in Phase 3 clinical studies maintained viral suppression for at least 48 weeks in the presence of preexisting M184I/V in proviral DNA."

Human Immunodeficiency Virus • Infectious Disease

ISLEND-2: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Gilead Sciences | Trial primary completion date: Jun 2027 ➔ Apr 2026

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Weight and Body Composition After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily from BIC/FTC/TAF in Adults Living With HIV-1: Week 48 Results From a Randomized, Double-Blind Phase 3 Study (EACS 2025) - No abstract available

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Bictegravir/emtricitabine/tenofovir alafenamide after virologic failure to cabotegravir/rilpivirine: A case series (IAS-HIV 2025) - "Until the management of cabotegravir/rilpivirine failure is systematically studied, clinical judgement will guide therapeutic decision. Bictegravir/FTC/TAF may offer a viable option for achieving virologic suppression in this setting."

Clinical • Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease • CD4

Is exclusion of tenofovir from antiretroviral regimens safe in Africa: insights on hepatitis B from the switch to DTG/3TC (Sungura) study (IAS-HIV 2025) - P3 | "Reactivation of HBV remains a potential risk in those with previous exposure in whom tenofovir is withdrawn. The Sungura study (NCT06444620) is a phase 3 single arm clinical trial at multiple sites in Kenya enrolling participants aged =60 years, with VL <50 copies/ml on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). Prior hepatitis B exposure is common in older PWH, majority of whom have immunity and can be safely transitioned to a two-drug regimen that excludes tenofovir. However, HBV serology panels to identify people at risk of HBV reactivation are not routinely available across much of sub-Saharan Africa, and further work is needed to evaluate the necessity of such screening in view of our study findings."

Late-breaking abstract • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Orthopedics

Efficacy and safety of switching to dolutegravir/lamivudine dual therapy from bictegravir/emtricitabine/tenofovir alafenamide among virally suppressed older adults ≥60 years: week 24 results from the Sungura study (IAS-HIV 2025) - P3 | "At week 24, there were no incidences of virological failure and no withdrawals from the Sungura study. Comorbidities were common, highlighting additional considerations for selecting antiretroviral agents for older populations."

Clinical • Late-breaking abstract • Cardiovascular • Diabetes • Dyslipidemia • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders

Evaluating social support, psychological distress, and HIV-related stigma in a cohort of ART-experienced migrant adults living with HIV switched to B/F/TAF in Montreal, Canada – the ASAP-Switch Study (IAS-HIV 2025) - "Psychological distress and stigma were low in 17 MWH rapidly switched to B/F/TAF, despite limited reported social support. Monitoring these mental health indicators along the HIV care cascade and offering tailored mental health interventions could improve their care."

Clinical • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease

Modeling HIV-1 Clade C SHIV-C109 viral pathogenesis and antiretroviral therapeutic responses in humanized mice (IAS-HIV 2025) - "Infected mice were administered with a combinatorial ART consisting of bictegravir, emtricitabine, and tenofovir alafenamide via drug incorporated diet. Our results showed that hu-mice could be readily infected by SHIV-C109 with viremia seen within a week... The data from above on SHIV-C109 viral infection in the hu-HSC mouse model showed the potential for its use in pre-clinical in vivo research on understudied HIV-1 clade C viruses. Importantly, cure studies on both HIV and SIV including their variant strains can be performed in the same animal model for effective comparisons."

Preclinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Week 96 Results from Dolutegravir/lamivudine versus bictegravir/ emtricitabine/tenofovir alafenamide fumarate: Real-world Assessment of weight Gain in people with HIV of Asian OrigiN (DRAGON) (IAS-HIV 2025) - "Our study showed that DTG/3TC was comparable to BIC/FTC/TAF in achieving virologic suppression. Furthermore, low CD4 counts and BMI were associated with a higher likelihood of weight gain among treatment-naïve PWH in Asia."

Clinical • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-term persistence, effectiveness, safety, and metabolic impact of bictegravir/emtricitabine/tenofovir alafenamide fixed-dose combination in treatment-naïve and experienced people living with HIV in a large Latin American cohort (IAS-HIV 2025) - "In TN and TE PLWH from Argentina, B/F/TAF demonstrated high persistence and sustained VS, with low AE rates over 48 months. To our knowledge, these findings represent the first long-term real-world evidence from Latin America, supporting B/F/TAF in guidelines as an effective and well-tolerated treatment option."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Survey on the experiences of people with HIV around the world (IAS-HIV 2025) - "Participants reported high levels of ART satisfaction and identified treatment effectiveness, side effects, and long-term safety as top considerations for remaining on or switching HIV medication. The substantial proportion of participants reporting delayed treatment highlights opportunities to support/improve rapid initiation."

Human Immunodeficiency Virus • Infectious Disease • CD4

Co-morbidities in HIV positive and HIV negative individuals aged ≥60 years: a comparative analysis (IAS-HIV 2025) - "We report the prevalence of non-HIV co-morbidities in older PLWH (=60 years) and age- and gender-matched HIV negative (HN) individuals. Data from participants in the B/F/TAF Elderly Study (which enrolled virally suppressed PLWH =60 years on first line antiretroviral therapy and randomised them to continue their current regimen or switch to B/F/TAF) and an age- and gender-matched HN group were included... PLWH compared to HN had more co-morbidities, medication burden and kidney impairment and osteoporosis. These findings highlight the burden of co-morbidities among older PLWH."

Clinical • Cardiovascular • Diabetes • Hypertension • Infectious Disease • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Renal Disease • Rheumatology

Patient-reported outcomes among virally suppressed people living with HIV switching to dolutegravir/lamivudine vs. continuing bictegravir/emtricitabine/tenofovir alafenamide from the randomized DYAD study (IAS-HIV 2025) - "In DYAD, both switching to DTG/3TC and continuing B/F/TAF were associated with similar and small reductions in overall symptom and treatment satisfaction score at W48. These data are the first describing PRO outcomes from a randomized clinical trial of DTG/3TC and B/F/TAF and support DTG/3TC as a switch option with comparable symptom burden and treatment satisfaction to modern 3-drug integrase inhibitor-based regimens."

Clinical • Patient reported outcomes • Human Immunodeficiency Virus • Infectious Disease • Pain

Treatment persistence among treatment-experienced people with HIV switching to integrase strand transfer inhibitor-based antiretroviral regimens. (PubMed, J Med Econ) - "The majority of INSTI-based regimen initiations were for bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (61%;n = 17,917), followed by dolutegravir/lamivudine (27.4%; n = 8034) and cabotegravir + rilpivirine (7.4%; n = 2186). This study provides evidence for greater treatment persistence with B/F/TAF versus other INSTI-based regimens. Unlike prior studies that focused on treatment-naïve individuals, this analysis uniquely evaluates persistence among treatment-experienced PWH initiating newer INSTI-based regimens."

Journal • Human Immunodeficiency Virus • Infectious Disease

Successful viral suppression in a two-year-old child with human immunodeficiency virus infection treated with bictegravir/emtricitabine/tenofovir alafenamide. (PubMed, Turk J Pediatr) - "The mother received zidovudine prophylaxis during delivery, and the infant was started on zidovudine (AZT) prophylaxis on the first day of life. The patient's ART history included AZT monotherapy at birth, followed by combination therapy with lamivudine (3TC), lopinavir/ritonavir (LPV/r), and later tenofovir/emtricitabine (TDF/FTC) with dolutegravir (DTG)...Its high genetic barrier to resistance and favorable tolerability make it a promising option when standard therapies fail. Further research is needed to optimize pediatric ART strategies and expand access to STRs globally."

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