Descovy (emtricitabine/tenofovir alafenamide) / Gilead - LARVOL DELTA

PREDUAL: Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women (clinicaltrials.gov) - P4 | N=210 | Recruiting | Sponsor: Fundación Huésped | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jul 2028 ➔ Oct 2028

Enrollment open • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Evaluation of dried blood spots relative to peripheral blood mononuclear cells for intracellular tenofovir-diphosphate and emtricitabine-triphosphate assessment using liquid chromatography-tandem mass spectrometry. (PubMed, J Pharm Biomed Anal) - "Tenofovir alafenamide/emtricitabine (TAF/FTC) is widely used for HIV treatment and prevention. In conclusion, the observed moderate correlations between DBS and PBMC concentrations of TFV-DP and FTC-TP suggest that DBS may serve as a feasible sampling approach for population-level assessment of intracellular TFV-DP and FTC-TP exposure. The simplicity of DBS sample collection and handling may facilitate large-scale clinical studies and highlights its potential utility in future clinical research."

Journal • Human Immunodeficiency Virus • Infectious Disease

Viral Kinetics, Pharmacokinetics, And Exposure-Response Analysis of Monotherapy of Multiple Ascending Dose Asuptegravir, a New-Generation Integrase Strand Transfer Inhibitor, Followed by Combination with Emtricitabine And Tenofovir Alafenamide in Treatment-Naïve People Living with HIV-1: a Two-Period, Randomized, Placebo-Controlled Phase 1/2 Study. (IDWeek 2026) - No abstract available

Clinical • Monotherapy • P1/2 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

TEAK: Tenofovir Exposures in Advanced Kidney Disease Study (clinicaltrials.gov) - P=N/A | N=50 | Not yet recruiting | Sponsor: King's College Hospital NHS Trust

New trial • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease

DISCOVER: Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection (clinicaltrials.gov) - P3 | N=5399 | Terminated | Sponsor: Gilead Sciences | Active, not recruiting ➔ Terminated; Following review of accumulated safety data from DISCOVER and real-world use of F/TAF, the sponsor determined that the long-term safety of F/TAF had been demonstrated and no further safety monitoring within the study was required.

Trial termination • Human Immunodeficiency Virus • Infectious Disease • B2M

Predicting Oral HIV Pre-Exposure Prophylaxis Efficacy in Cisgender Women Across Pregnancy and Postpartum. (PubMed, J Clin Pharmacol) - "Oral pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate (F/TDF) is recommended in pregnancy despite limited published pharmacokinetic (PK) and efficacy data during pregnancy. At high adherence levels of five or more pills per week, predicted effectiveness remained high across pregnancy and postpartum and effectiveness exceeded 97% for both regimens, with maximum decreases in the second trimester of only 0.9 percent point for F/TDF and 0.3 percent point for F/TAF. These findings suggest that adherence is the primary determinant of PrEP effectiveness during pregnancy and postpartum, while pregnancy-related PK changes have a limited impact on efficacy."

Journal • Human Immunodeficiency Virus • Infectious Disease

SimpPrEP: Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France. (clinicaltrials.gov) - P3 | N=524 | Recruiting | Sponsor: ANRS, Emerging Infectious Diseases | Trial completion date: May 2027 ➔ May 2028 | Trial primary completion date: Oct 2026 ➔ Dec 2027

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

Same-day initiation of tenofovir alafenamide-based pre-exposure prophylaxis with drug-level feedback for transgender women in Uganda. (PubMed, AIDS) - P=N/A | "Oral F/TAF PrEP adherence among TGW in Uganda was low and not affected by drug-level feedback or tailored adherence counseling. Long-acting injectable PrEP formulations should be considered for this population."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

ADYY-ACC017-101: Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

Trial completion

Phase Ib/IIa Clinical Study of ACC017 Tablets (clinicaltrials.gov) - P1/2 | N=36 | Completed | Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

Monotherapy • Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

SONATAS: Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: National University Hospital, Singapore | Trial completion date: Apr 2026 ➔ Sep 2026 | Trial primary completion date: Mar 2026 ➔ Sep 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • CXCL8

Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

The impact of removing insurance pre-approval on access to HIV pre-exposure prophylaxis in California, U.S. (AIDS 2026) - "PA rejections for generic Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) spiked after approval, primarily due to Medicaid FFS formulary delays, so analyses were performed without Medicaid FFS g/TDF claims...However, newer medications introduced post-SB159 had higher rejection rates: Emtricitabine/Tenofovir Alafenamide (F/TAF)=6.8%, Cabotegravir=5.0%... SB159 was associated with an immediate, short-term reduction in prior authorization rejections of PrEP claims, but substantial barriers persist. Increased HIV diagnosis following claims rejections highlight ongoing structural gaps in PrEP access that may undermine prevention efforts despite policy reform. Continued support for regulatory efforts is critical to improving PrEP uptake."

Reimbursement • US reimbursement • Human Immunodeficiency Virus • Infectious Disease

Decoding HIV pre-exposure prophylaxis discourse on X platform: topic modeling and trend analysis (AIDS 2026) - "Topic modeling of personal discussion tweets revealed 15 interpretable themes, including Truvada use and testing, Descovy and insurance, long-acting HIV medicine for PrEP and women’s health, condom and medication use, HIV prevention and advocacy, testing and prescription practices, stigma and misinformation, patent activism (#BreakThePatent), and kidney side effects. The shifting from promotional activity to personal discussions reflects growing community engagement with PrEP beyond promotional efforts. Despite enthusiasm for different PrEP modalities, persistent concerns remain around affordability, insurance coverage, side effects, and social stigma. These findings further underscore the value of monitoring social media discourse to understand evolving perspectives and inform strategies to address barriers for PrEP uptake."

Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Women's Health

Features of HIV-1 acquisition in adults receiving pre-exposure prophylaxis as part of the IMPOWER-22 and IMPOWER-24 open-label phase (AIDS 2026) - P3 | " Islatravir 60 mg oral once-monthly, compared with daily FTC/TDF or FTC/TAF as PrEP, was evaluated in cisgender women (randomized 1:1; IMPOWER-22, NCT04644029) and transgender women and men who have sex with men (randomized 2:1; IMPOWER-24, NCT04652700). No clear evidence of LEVI was found; delays between viremia detection and seroconversion generally followed expected patterns of natural infection, with no evidence of antibody-antecedent low-level viremia characteristic of LEVI."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Development of targeted HIV-PrEP support systems for real world needs through social media analytics (AIDS 2026) - "Using the Python Reddit API Wrapper (PRAW), we extracted posts mentioning four PrEP therapies: Truvada (TDF/FTC), Descovy (TAF/FTC), Apretude (cabotegravir), and Yeztugo (lenacapavir). Reddit users frequently seek peer-to-peer advice on practical and safety-related PrEP topics, bridging gaps left by traditional healthcare providers. The prevalence of queries regarding side effects and drug interactions highlights the need for accessible, reliable digital tools. These findings are directly informing the development of an AI chatbot trained exclusively on authoritative UK sources (e.g., BHIVA guidelines, NHS resources) to provide accurate, stigma-free support at the point of need."

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

Evolution of PrEP efficacy: a Bayesian sequential meta-analysis of global trials highlighting the superiority of long-acting injectables (AIDS 2026) - "Included 33 RCTs/non-randomised interventions (N=54,258) comparing oral (TDF/FTC, TAF/FTC, TDF) and long-acting injectable (CAB-LA, LENA) PrEP against placebo/no PrEP. The dynamic evidence synthesized through BSMA confirms a major shift in the HIV prevention landscape. Long-acting injectables have fundamentally raised the bar for PrEP efficacy, largely by circumventing the adherence challenges inherent in daily oral regimens. These findings underscore the urgency of transitioning to injectable options for populations where adherence remains a structural barrier, ensuring that the next decade of prevention is both equitable and highly effective."

Head-to-Head • Retrospective data • Human Immunodeficiency Virus • Infectious Disease

Early cardiometabolic safety of bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) among antiretroviral therapy–naïve people living with HIV in Chile (AIDS 2026) - "BIC/TAF/FTC achieved sustained viral suppression, immune recovery, modest weight gain without metabolic deterioration, and significant improvement in liver health, supporting its cardiometabolic and hepatic safety in routine HIV care."

Clinical • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Obesity • CD4

Renal outcomes of tenofovir alafenamide versus tenofovir-free regimens in antiretroviral-naïve people with HIV (AIDS 2026) - "We included adult antiretroviral-naïve PWH initiating TAF/emtricitabine-based regimens combined with bictegravir or dolutegravir, or DTG/3T. In antiretroviral-naïve PWH with preserved baseline renal function, TAF-based regimens were not associated with worse renal outcomes compared with DTG/3TC. These findings support the renal safety of TAF as comparable to tenofovir-free regimens in routine clinical practice."

Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • CD4

Baseline and week 48 resistance analyses in the phase 3 ARTISTRY-1 study evaluating the bictegravir/lenacapavir single-tablet regimen (AIDS 2026) - "Three of these 4 participants resuppressed HIV-1 RNA <50 copies/mL later in the study while remaining on the same regimen, while the 4th participant resuppressed after a switch from SBR to BIC/emtricitabine/tenofovir alafenamide + subcutaneous LEN. BIC/LEN STR maintained high levels of virologic suppression despite high frequency of baseline RAMs at enrollment. No resistance to BIC/LEN was detected in 2 participants with virologic rebound. These data underscore the potential for BIC/LEN STR as an option for treatment optimization in people with HIV who are virologically suppressed on complex regimens."

P3 data • Human Immunodeficiency Virus • Infectious Disease

Real-world outcomes of long-acting cabotegravir plus rilpivirine in virally suppressed people with HIV in south China (AIDS 2026) - "Prior regimens mainly included BIC/TAF/FTC (57.6%) and DTG/3TC (28.8%). In this multicenter real-world cohort from South China, CAB+RPV LA demonstrated excellent short-term effectiveness, safety, and high patient acceptance, providing important Asian real-world evidence supporting direct-to-injection long-acting ART."

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

Switching INSTI-based to doravirine-based ART with TAF/FTC reduces ex vivo molecular signatures of atherogenesis in people with HIV (AIDS 2026) - P1 | "BACKGROUND: Antiretroviral therapy (ART), such as bictegravir and tenofovir alafenamide (B/F/TAF), containing the combination of Integrase Inhibitors (INSTI) and TAF, are linked to weight gain and lipid abnormalities that increase the risk for future atherosclerotic cardiovascular disease (CVD). Switching from INSTI-based B/F/TAF to DOR-based DOR/F/TAF in PLWH with weight gain and dyslipidemia resulted in at least a 35% relative decrease in key early atherogenesis mechanisms (TEM and MDFCF) in a mechanistic ex vivo assay of atherogenesis. These changes within each individual could be attributed solely to DOR, as the backbone of ART (F/TAF) remained unchanged. Larger studies in PLWH using DOR-based ART, such as DOR/islatravir compared to Dolutegravir (DTG) + Lamivudine (3TC) and B/F/TAF, are needed to determine whether INSTI-TAF-induced cardiometabolic toxicity can be reversed by switching to DOR."

Preclinical • Atherosclerosis • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • ITGAM

Pharmacokinetics, predicted antiviral activity, and safety of single-ascending-dose asuptegravir, a new-generation integrase strand transfer inhibitor, in healthy adults: a two-period, randomized, placebo-controlled phase 1 study (AIDS 2026) - "BACKGROUND: Asuptegravir (ASU), a new HIV integrase strand transfer inhibitor metabolized by UGT1A1, was evaluated in healthy subjects through a single ascending dose (SAD) study, a food effect (FE) assessment, and a drug-drug interaction (DDI) study with emtricitabine/tenofovir alafenamide (FTC/TAF)... ASU was well tolerated, showed a dose-dependent, nonlinear pharmacokinetics, eliciting no dose-limiting toxicity and demonstrates promising potent anti-HIV activity predicted by PBPK modeling. Food significantly increased the exposure of ASU."

Clinical • P1 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Viral kinetics, pharmacokinetics, and exposure-response analysis of asuptegravir monotherapy, followed by combination with emtricitabine and tenofovir alafenamide in treatment-naïve people living with HIV-1: a two-period, randomized, placebo-controlled phase 1/2 study (AIDS 2026) - "ASU demonstrated potent antiviral activity, favorable PK and exposure-response characteristics, and good short-term tolerability in treatment-naïve PLWH. Based on integrated efficacy, PK/PD, and safety assessments, ASU 40 mg once daily is recommended for pivotal clinical trials."

Clinical • Monotherapy • P1/2 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Zero HIV acquisitions with twice-yearly subcutaneous lenacapavir for PrEP during 52 weeks of open-label extension in PURPOSE 1 (AIDS 2026) - P3 | "BACKGROUND: Twice-yearly subcutaneous lenacapavir for HIV pre-exposure prophylaxis (PrEP) showed superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (F/TDF) in cisgender women in PURPOSE 1 (NCT04994509)...HIV incidence among participants on F/TDF or emtricitabine/tenofovir alafenamide (F/TAF) in the RBP was 1.94/100 PY and 1.98/100 PY, respectively; in those who switched to lenacapavir in OLE, HIV incidence was 0/100 PY through the OLE Week 52 visit... Twice-yearly lenacapavir demonstrated high efficacy with zero HIV acquisitions through Week 52 of the OLE; this, in combination with high adherence and a consistent safety profile, reinforces lenacapavir as a transformative PrEP option for cisgender women."

Clinical • Human Immunodeficiency Virus • Infectious Disease