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

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

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

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

WHEN FUNGI ATTACK THE BRAIN: DISSEMINATED HISTOPLASMOSIS WITH CNS INVOLVEMENT IN AN HIV PATIENT (CHEST 2025) - "He was intubated and given Keppra for seizure prophylaxis. Review of his chart revealed that he had been recently hospitalized and was on Biktarvy and doravirine for HIV. His CD4 count was below 200, and he had been started on opportunistic infection prophylaxis with Azithromycin and Atovaquone...Neurosurgery was consulted, but no surgical intervention was necessary.The patient continued antiretroviral therapy for HIV and was started on posaconazole for histoplasmosis per ID recommendations... A high index of suspicion in endemic areas is important in immunosuppressed patients, particularly in HIV patients. This case highlights the importance of early treatment of histoplasmosis to prevent further dissemination and controlling HIV infection to prevent progression. Early diagnosis of histoplasmosis CNS involvement is important to avoid fatal outcomes."

Clinical • Chronic Lymphocytic Leukemia • CNS Disorders • Dermatology • Epilepsy • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Lymphoma • Solid Organ Transplantation • Substance Abuse • CD4

Doravirine Resistance Patterns Identified through Week 192 in the DRIVE-FORWARD and DRIVE-AHEAD Phase 3 Clinical Trials. (PubMed, J Acquir Immune Defic Syndr) - P3 | "In DRIVE-FORWARD and DRIVE-AHEAD, the development of resistance to doravirine was uncommon (genotypic 1.3%; phenotypic 1.0%) and occurred mainly during the first 48 weeks of treatment. Overall, the RAMs observed with doravirine were distinct from those of other NNRTIs."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease

Antiviral efficacy of doravirine-based regimens in patients with NNRTI resistance in Europe: a retrospective observational study (EACS 2025) - "Most received DOR with TDF/3TC (91.4%); 8.6% received DOR with TAF/FTC. One experienced patient (1.8%) with multiple baseline NRTI and NNRTI RAMs that collectively may impact sensitivity to DOR experienced virological failure. Conclusions : In this well-characterised multicentre European cohort of PLWH with NNRTI RAMs and preserved genotypic DOR susceptibility, DOR-based regimens achieved high virological success and excellent treatment retention at 48 weeks."

Late-breaking abstract • Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

Evaluation of the completion rate and associated factors in HIV-Post-Exposure Prophylaxis regimen containing Doravirine (DORASPEP): a prospective observational cohort (EACS 2025) - "No HIV-acquisition occurred. Conclusions : Doravirine-based PEP appears effective with a satisfactory completion rates but perceived severe adverse events may reduce adherence."

Clinical • Observational data • Human Immunodeficiency Virus • Infectious Disease

Metabolic and Body Composition Outcomes at 48 Weeks among People with HIV and Obesity on Integrase Inhibitors and Tenofovir Alafenamide Switching to Doravirine with or without Tenofovir Disoproxil Fumarate: ACTG A5391 (the DO-IT Trial) (EACS 2025) - "Changes at 48 weeks in triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and HOMA-IR were not different between DOR+TAF/FTC or DOR+TDF/FTC versus INSTI+TAF/FTC ( Figure ). Conclusions : Among PWH with obesity and insulin resistance, switching from an INSTI+TAF regimen to regimens containing DOR with either TAF or TDF did not meaningfully alter lipids, HOMA-IR, or body composition at 48 weeks. Other interventions are needed to improve metabolic health or reduce adiposity in people who have gained excessive weight or are obese following ART initiation."

Human Immunodeficiency Virus • Infectious Disease

Potential treatment options following virological failure with long-acting injectable cabotegravir and rilpivirine: an analysis based on reported cases (EACS 2025) - "Purpose : Virological failure (VF) with long-acting injectable cabotegravir and rilpivirine (LAI-CAB/RPV) is rare but may lead to selection of resistance-associated mutations (RAMs) that limit future treatment options. Resistance to CAB/RPV was common, being more prevalent among people with A compared to non-A subtypes. Reduced susceptibility to alternative treatment options was more pronounced for INI (dolutegravir/bictegravir) than for NNRTI (doravirine/etravirine)."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Integrating HIV and Mental Health Care in Prison: A Complex but Achievable Goal (EACS 2025) - "ART regimens were predominantly INSTI-based (67%, mainly dolutegravir and bictegravir), with 15% on NNRTI-based regimens (doravirine, rilpivirine), 9% on PI-based (DRV/b), and 9% on mixed regimens. However, the high burden of psychiatric disorders, substance use, and comorbidities necessitates integrated, multidisciplinary management. Special attention to drug interactions and post-release continuity of care is essential to maintain long-term health outcomes."

Hepatitis B • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease • CD4

CSF PHARMACOKINETICS AND ANTIVIRAL ACTIVITY OF DORAVIRINE: IMPLICATIONS IN NEUROCOGNITIVE IMPAIRMENT (EACS 2025) - "No concentrations correlated with NC performance. Conclusions : Stable DOR concentrations in CSF were achieved after 12-week treatment that significantly exceeded the 90% inhibitory concentration for wild-type HIV-1, suggesting therapeutic effectiveness of DOR in the CNS."

PK/PD data • Human Immunodeficiency Virus • Infectious Disease • CD4

The role of doravirine in the treatment of multidrug-resistant HIV: data from the PRESTIGIO Registry (EACS 2025) - "Three PWH viremic at baseline selected new resistance-associated mutations: all to doravirine, 2 also to accompanying drugs. Conclusions : In our cohort of 4DR-PWH, doravirine-containing regimens showed good durability and virological effectiveness, supporting a role for doravirine in heavily treatment-experienced individuals, particularly as a switch strategy in the context of virological suppression."

Human Immunodeficiency Virus • Infectious Disease

Potential for replacing the boosted-PI with doravirine in ART-experienced subjects successfully treated with darunavir-cobicistat plus dolutegravir dual regimen (EACS 2025) - "In 31/219 (14%), DTG bid may be used if DRV/c removal is necessary. Conclusions : According to our results, most people in our cohort were eligible to be switched to DOR+DTG regimen, with potential benefits in lipid profile, cardiovascular risk, drug-drug interactions, and overall costs."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Switch to DOR/TDF/3TC in People With Controlled HIV and history of RNA genotype M184V/I mutation: Interim Results of the DRIVE OFF-ROAD Multicenter Single-Arm Phase II trial (EACS 2025) - P2 | "Purpose : Doravirine (DOR), tenofovir disoproxil fumarate (TDF), and lamivudine (3TC) fixed-dose combination is approved for people with HIV-1 (PWH) with no prior or current resistance to the NNRTI class, TDF, or 3TC. Enrollment is currently paused, pending the Week 24 follow-up of the #13 participant, expected in July 2025. Conclusions : These interim findings suggest efficacy of DOR/TDF/3TC in individuals with historical M184V/I lamivudine resistance, supporting to move the DRIVE OFF-ROAD trial forward."

Clinical • P2 data • Human Immunodeficiency Virus • Infectious Disease • CD4

Virological Failure on Long-Acting Cabotegravir + Rilpivirine: Associated Factors and Remaining Options in the Real-World Dat’AIDS Cohort (EACS 2025) - "Regarding NNRTI, 9/26 participants had RAMs, including 2 with no remaining NNRTI options, and doravirine remained active in 24/26. Regarding INSTI, 12/26 participants had RAMs, including 3 with no available INSTI options, and 9/26 retained only twice-daily dolutegravir option...Although VF was rare, RAM emergence was frequent and had a severe impact on remaining available NNRTI and INSTI options. Higher BMI, low nadir CD4, and short prior viral suppression duration were independently associated with VF."

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

Unconventional DORAVIRINE antiretroviral regime: a single-center experience (EACS 2025) - "1,2 Available in a once-daily combination with tenofovir-disoproxil/lamivudine (TDF/3TC), DOR showed versatility in more unconventional combinations, especially in dual-therapy with dolutegravir (DTG) 1,3 or 3TC...Twenty-two were dual-therapy with DOR+darunavir/cobicistat (DRV/c) (9/30; 30%) and DOR+DTG (7/30; 23%) being the most common...DOR+ARV ensured good immunovirological control and neutral impact on cholesterol and BMI as already reported 1,3,4 with high tolerability, having only one person/30 discontinuing DOR. Conclusions : Unconventional DOR combinations in dual-therapy including those with DRV/c or raltegravir are effective and well-tolerated options among others for multi-treated PLWH experiencing aging and comorbidities."

Clinical • Human Immunodeficiency Virus • Infectious Disease