Pifeltro (doravirine) / Merck (MSD) - LARVOL DELTA

DORDOL: Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Chelsea and Westminster NHS Foundation Trust | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8 • NEFL

Doravirine: two vs three-drugs based regimens, a multi-centre observational study (ESCMID Global 2026) - No abstract available

Clinical • Observational data • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

A 48-week, Randomized Controlled Trial of Doravirine for Individuals with HIV and Obesity on Integrase Inhibitors and Tenofovir Alafenamide: The Do IT Study (ACTG A5391). (PubMed, Clin Infect Dis) - P4 | "In people with HIV and obesity, switching from an INSTI+TAF/FTC regimen to DOR/FTC with either TAF or TDF did not produce clinically meaningful differences in weight change or metabolic health after 48 weeks."

Journal • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Optimizing Salvage ART: Real-World Outcomes of Doravirine Plus DTG or BIC in Heavily Treatment-Experienced Persons Living with HIV. (PubMed, Microorganisms) - "We conducted an observational, real-world-data study on HTE-PWH in active care at the "Victor Babeș" Hospital, Bucharest, receiving doravirine (DOR)-based salvage regimens combined with dolutegravir (DTG) or bictegravir (BIC)...Salvage regimens included BIC/FTC/TAF + DOR (50.0%), 3TC/TDF/DOR + DTG (35.2%), and 3TC/DTG + DOR (14.7%)...Individuals with PM infection were younger and had longer ART exposure than those with heterosexual acquisition. DOR-based salvage regimens combined with DTG or BIC were effective in adherent HTE-PWH, particularly those with extensive ART histories."

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

Virological Failure on Long-Acting Injectable Cabotegravir and Rilpivirine: An Analysis of Subtypes, Drug Levels, Resistance, and Therapeutic Implications. (PubMed, Clin Infect Dis) - "Emergent resistance in VF cases often resulted in cross-resistance to other nonnucleoside reverse transcriptase inhibitors and integrase strand transfer inhibitors. Although most cases did not meet the high-risk profile as defined by registration trials, subtype A lineages were overrepresented. Low drug levels were not elevated versus treatment successes. These data suggest that subtype-specific factors beyond A6 may influence VF risk and merit further study."

Journal

Prioritization of adverse events related to integrase inhibitors and NNRTIs: a disproportionality analysis using data from the FAERS database. (PubMed, J Antimicrob Chemother) - "This study provides a systematic framework for evaluating post-marketing AEs of INSTIs and NNRTIs using a semi-quantitative scoring system. Our findings identified five high-priority AEs that require clinical validation and further investigation."

Adverse events • Journal • Eosinophilia • Hematological Disorders • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Liver Failure

Drug Resistance in HIV Following First-line ART Failure: Insights from a Cross-sectional Study in India. (PubMed, J Assoc Physicians India) - "Ensuring adequate drug exposure history in patients can prevent poor outcomes in PLH being treated with ART due to resistance. Resistance profiling is especially relevant following first-line ART failure."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Drug resistance characteristics of rilpivirine in HIV-1-infected patients before starting antiretroviral therapy in nine provinces of China (PubMed, Zhonghua Liu Xing Bing Xue Za Zhi) - "The cross-resistance rate between RPV and efaviren/nevirapine (EFV/NVP) in total HIV-1-infected patients before ART was 57.5% (92/160), which was significantly higher than that between RPV and doravirine (DOR) (25.0%, 40/160) and that between RPV and etravirine (ETR) (34.4%, 55/160) (all P<0.001). The RPV resistance rate of HIV-1-infected patients with a history of antiretroviral drug exposure was relatively higher. It is recommended to conduct HIV-1 resistance testing for them before starting ART and formulate individualized treatment plans."

Journal • Human Immunodeficiency Virus • Infectious Disease

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. (PubMed, AIDS) - "We found that switching to DOR/3TC/TDF was associated with more favorable changes in SCORE-2 and METS-IR compared to DTG/3TC and BIC/FTC/TAF."

Journal • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease

Fixed-dose daily doravirine (100 mg) with islatravir (0·25 mg) versus bictegravir, emtricitabine, and tenofovir alafenamide for initial HIV-1 therapy: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial. (PubMed, Lancet HIV) - "Doravirine (100 mg) and islatravir (0·25 mg) is a two-drug, once daily regimen with efficacy and safety similar to bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) for initial treatment of HIV-1, which could provide an option for treatment without an integrase strand transfer inhibitor."

Head-to-Head • Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • Pain • CD4

Randomized Multicentric Proof-of-Concept Phase 2 Trial Doravirine in the Early Outpatient Management of nWest Nile Virus Infection in Patients at Risk of Progression - DORICO Trial (clinicaltrialsregister.eu) - P1/2 | N=50 | Not yet recruiting | Sponsor: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

New P1/2 trial • Infectious Disease

DoraDO: Doravirine Dose Optimisation in Pregnancy (clinicaltrials.gov) - P4 | N=76 | Recruiting | Sponsor: University of Liverpool | Trial completion date: Feb 2026 ➔ Jul 2028 | Trial primary completion date: Nov 2025 ➔ Jul 2028

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

Treatment durability, satisfaction and quality of life in virologically suppressed HIV-1 people switching to doravirine: Results from the French study DoraVIH. (PubMed, HIV Med) - "Despite the absence of a control group and limited sample size, these real-world data support the effectiveness of switching to a doravirine-based regimen, with high durability and improved patient satisfaction."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066) (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Mar 2028 ➔ Nov 2028

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, randomised, open-label, non-inferiority trial. (PubMed, Lancet) - P3 | "Doravirine and islatravir is efficacious and well tolerated and would represent the first non-INSTI-based, two-drug regimen for HIV-1 treatment. With increasing concern over the potential development of widespread INSTI resistance, this once-daily, oral, single-tablet regimen could be a potential option for people living with HIV-1 requiring a change to their antiretroviral regimen. The safety and efficacy findings support the ongoing development of islatravir, a drug with long-acting potential."

Clinical • Head-to-Head • Journal • P3 data • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial. (PubMed, Lancet) - P3 | "The combination of doravirine (100 mg) and islatravir (0·25 mg) has similar efficacy and safety profiles to bictegravir, emtricitabine, and tenofovir alafenamide, and could provide a two-drug, once daily, oral single-tablet option without an integrase strand-transfer inhibitor for adults who are virologically suppressed and want to switch to a different ART regimen."

Clinical • Head-to-Head • Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease

Doravirine versus dolutegravir-based regimen in antiretroviral treatment-naive people living with HIV-1 (ANRS0392s ELDORADO): protocol for an international, open-label, randomised, non-inferiority, phase III trial. (PubMed, BMJ Open) - P3 | "Participants will be randomised in a 1:1 ratio to receive either DOR 100 mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300 mg daily) plus lamivudine (3TC) (300 mg daily) or DTG (50 mg daily) in combination with TDF (300 mg once daily) plus either emtricitabine (FTC) (200 mg daily) or 3TC (300 mg daily). Results will also be communicated to policymakers, healthcare professionals, community stakeholders and study participants through appropriate dissemination activities, including policy briefs, stakeholder meetings and lay summaries on dedicated and easily accessible platforms. NCT06203132; EU-CT, 2023-508626-10-00."

Clinical protocol • Head-to-Head • Journal • P3 data • Cardiovascular • Diabetes • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders

Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: University of Texas Southwestern Medical Center | Active, not recruiting ➔ Completed | Trial completion date: Aug 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2025 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Switch to Fixed Dose of Doravirine, Lamivudine, Tenofovir Disoproxil Fumarate Versus Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate in Virologically Suppressed Adults on Efavirenz-Based Regimens: 48-Week Results of a Real-world, Prospective, Observational Cohort Study. (PubMed, Open Forum Infect Dis) - "The change in body weight from baseline to week 48 in the DOR group was 1.8 kg lower than that in the BIC group (95% CI, -2.474 to -1.114; P < .001). In previously virologically suppressed PWH on an EFV-based regimen, the switch to DOR/3TC/TDF maintained virological suppression noninferior to that of BIC/FTC/TAF, with favorable metabolic profiles."

Clinical • Journal • Observational data • Real-world evidence • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • CD4

Pharmacokinetic evaluation of doravirine and dolutegravir during paclitaxel-based chemotherapy: a case report in an HIV-positive woman with metastatic pancreatic cancer. (PubMed, Eur J Clin Pharmacol) - No abstract available

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Oncology • Pancreatic Cancer • Solid Tumor

DrEW: A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/ (clinicaltrials.gov) - P=N/A | N=500 | Active, not recruiting | Sponsor: NEAT ID Foundation | Completed ➔ Active, not recruiting | Trial completion date: Aug 2023 ➔ May 2026 | Trial primary completion date: Feb 2023 ➔ Mar 2026

Enrollment closed • Real-world evidence • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Detailed in silico Evaluation of WNV Proteins: Dynamic and Thermodynamic Insights into Doravirine as a Potential Multitarget Agent. (PubMed, Drug Des Devel Ther) - "This study aimed to identify potential druggable targets for WNV and assess the repurposing of three FDA-approved antivirals - remdesivir, rilpivirine, and doravirine - through comprehensive in silico evaluations. Triplicate MD simulations and residue-level fluctuation analyses further confirm doravirine's stability and consistent interaction patterns in all binding sites, highlighting its potential as a promising candidate for WNV inhibition with multitarget activity. These findings provide in silico evidence supporting doravirine as a promising multitarget inhibitor of WNV, warranting further investigation for its repurposing for WNV treatment."

Journal • Infectious Disease

Factors Associated With Weight Change After Continuing or Switching to a Doravirine-based Regimen. (PubMed, Open Forum Infect Dis) - P3 | "Participants were randomized to first-line therapy with doravirine or darunavir/ritonavir, each given with 2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) (DRIVE-FORWARD) and to doravirine/lamivudine/tenofovir disoproxil fumarate (TDF) or efavirenz/emtricitabine/TDF (DRIVE-AHEAD); after 96 weeks, participants continued (n = 466) or switched to (n = 423) doravirine for 96-week open-label extensions. More research in historically underrepresented groups may help explain these findings. NCT02275780, NCT02403674, NCT02397096."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk. (PubMed, Br J Clin Pharmacol) - "We present in silico and clinical evidence of the transfer of doravirine into breastmilk. However, based on these data, the infant's exposure to doravirine through breastmilk is not expected to be hazardous."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Switching from etravirine to doravirine in virologically suppressed people with HIV: results from the French multicentre SWEED observational study. (PubMed, J Antimicrob Chemother) - "Doravirine-based ART maintained virological suppression in PWH switching from etravirine-based ART, even in presence of prior NNRTI resistance. Its once-daily dosing, favourable safety profile, and minimal drug interactions support its use in long-term ART strategies."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease • CD4