Idvynso (doravirine/islatravir) / Merck (MSD) - LARVOL DELTA

Comparative efficacy and safety of Islatravir–Doravirine versus integrase inhibitor–based triple antiretroviral therapy in HIV-1 infection: a systematic review (IDWeek 2026) - No abstract available

Clinical • Review • Human Immunodeficiency Virus • Infectious Disease

Changes in Fasting Lipids and Insulin Resistance After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 96 Results From Two Phase 3 Studies in Adults Living With HIV-1 (IDWeek 2026) - No abstract available

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Patient-Reported Outcomes With Doravirine/Islatravir (100/0.25 mg) Once Daily Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Previously Untreated Adults Living With HIV-1: Phase 3 Week 48 Results (IDWeek 2026) - No abstract available

Clinical • P3 data • Patient reported outcomes • Human Immunodeficiency Virus • Infectious Disease

Week 48 Efficacy and Safety of Doravirine/Islatravir (100/0.25 mg) vs Bictegravir/Emtricitabine/Tenofovir Alafenamide in Previously Untreated Adults Living with HIV-1 with Renal Impairment (IDWeek 2026) - No abstract available

Clinical • Human Immunodeficiency Virus • Infectious Disease

Efficacy and Safety by Demographic Subgroup After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 96 Results From Two Randomized, Active-Controlled Phase 3 Studies in Adults Living With HIV-1 (IDWeek 2026) - No abstract available

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Doravirine/Islatravir: First Approval. (PubMed, Drugs) - "Clinical development is underway in several other countries worldwide. This article summarizes the milestones in the development of doravirine/islatravir leading to these first approvals."

Journal • Human Immunodeficiency Virus • Infectious Disease

Allosteric Crosstalk between Inhibitor Binding Sites Drives Enhanced Islatravir Susceptibility in F227C HIV-1 Reverse Transcriptase. (PubMed, ACS Infect Dis) - "Doravirine (DOR) and islatravir (ISL) are inhibitors of human immunodeficiency virus type 1 (HIV-1) replication that block the viral reverse transcriptase (RT) by distinct mechanisms...Here, we report cryoEM structures of islatravir triphosphate (ISL-TP) bound to wild-type (WT) RT and F227C RT. Comparison with the corresponding ISL-TP and dATP-bound WT RT structures reveals that the F227C mutation induces an unexpected conformational change in a loop of the palm domain that is positioned to gate substrate access, providing a structural basis for ISL hypersusceptibility."

Journal • Human Immunodeficiency Virus • Infectious Disease

Doravirine and islatravir for HIV-1 treatment: A systematic review and meta-analysis with GRADE assessment. (PubMed, Ther Adv Infect Dis) - "The 0.25 mg Islatravir dose maintains antiviral efficacy while avoiding the immunologic declines observed with 0.75 mg dose, supporting its suitability as a simplified two-drug regimen. This review protocol was prospectively registered with PROSPERO (CRD420261321479)."

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

Doravirine/islatravir (Idvynso) for HIV. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Doravirine/Islatravir: A 2-Drug Regimen for the Treatment of HIV-1 Infection. (PubMed, Ann Pharmacother) - "Doravirine/islatravir is safe and effective as a 2-drug regimen for the treatment of HIV-1 infection."

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

IDVYNSOTM (doravirine and islatravir). (PubMed, Clin Ther) - No abstract available

Journal

Switching to doravirine/Islatravir (100/0.25mg) once daily maintained viral suppression at week 96 in the presence of baseline NNRTI resistance-associated mutations and/or M184I/V in proviral DNA (AIDS 2026) - P3 | " Participants with HIV-1 RNA <50 copies/mL and no history of virologic failure or documented DOR resistance at baseline were randomized (2:1) to switch to DOR/ISL 100/0.25mg once-daily or to continue baseline ART (bART; P051) or BIC/FTC/TAF (P052). Switching to DOR/ISL 100/0.25mg in Phase 3 clinical studies maintained viral suppression at W96 despite the presence of baseline NNRTI RAMs or M184I/V in proviral DNA."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

Simplification to single-tablet doravirine/islatravir from complex antiretroviral regimens: subgroup analysis from a randomized, open-label, phase 3 clinical study (AIDS 2026) - P3 | "Among virologically suppressed adults with HIV-1 receiving complex ART regimens, simplification to single-tablet DOR/ISL (100/0.25mg) maintained virologic suppression in >96% of participants and was generally well-tolerated through W48."

Clinical • Late-breaking abstract • P3 data • Human Immunodeficiency Virus • Infectious Disease

Community-led patent opposition case-study for HIV treatment access in Georgia (AIDS 2026) - " TBpeople Georgia submitted patent opposition filings against key antiretroviral drug patents (e.g., lopinavir/ritonavir, Islatravir and Doravirine), prepared proposal on legislative amendments on restricting of subject matter of protection of utility model patents that could limit competition and inflate treatment costs. The Georgian experience demonstrates that practice of a request to re-examine the Georgian ever greening patent for lopinavir/ritonavir opens a door for future similar actions on medicine access and affordability, initiated by community based organizations."

Case study • Clinical • Human Immunodeficiency Virus • Infectious Disease

Efficacy and safety by subgroup of doravirine/islatravir (100 mg/0.25 mg) once daily as initial HIV-1 therapy: week 48 results from a randomized, active-controlled phase 3 study (AIDS 2026) - P3 | "At Week 48, DOR/ISL (100 mg/0.25 mg) demonstrated comparable efficacy and safety to BIC/FTC/TAF across demographic subgroups based on age, sex, race, ethnicity, and region. Table 1. P053 efficacy (HIV RNA <50 copies/mL) at Week 48 (FDA snapshot approach) by subgroup Subgroup DOR/ISL n/N (%) BIC/FTC/TAF n/N (%) Difference in Percent Response (95% CI) All participants 247/269 (91.8) 242/267 (90.6) 1.2 (-3.7 to 6.1) Age 18 to 49 years =50 years 225/242 (93.0) 22/27 (81.5) 224/247 (90.7) 18/20 (90.0) 2.3 (-2.7 to 7.3) -8.5 (-29.2 to 14.6) Sex Male Female 189/204 (92.6) 58/65 (89.2) 180/198 (90.9) 62/69 (89.9) 1.7 (-3.8 to 7.4) -0.6 (-11.9 to 10.4) Race White Black or African American Asian Other a 103/110 (93.6) 78/89 (87.6) 27/29 (93.1) 36/38 (94.7) 106/115 (92.2) 73/82 (89.0) 28/29 (96.6) 33/38 (86.8) 1.5 (-5.8 to 8.7) -1.4 (-11.4 to 8.8) -3.4 (-19.2 to 11.4) 7.9 (-6.2 to 23.1) Ethnicity Hispanic or Latino/a Not Hispanic or Latino/a 98/104 (94.2) 146/162 (90.1)..."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Open-label Phase 1 study to evaluate relative bioavailability and food effect on the pharmacokinetics of the fixed-dose combination of doravirine/islatravir (100 mg/0.25 mg) in adults without HIV (AIDS 2026) - P1 | "There is no clinically meaningful difference in the bioavailability of DOR/ISL administered as an FDC versus single entities. Administration of DOR/ISL following a high-fat meal does not have a clinically meaningful effect on DOR or ISL PK, which supports its administration without regard to food. Table."

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

Current evidence on islatravir drug resistance and implications for future HIV treatment. (PubMed, Top Antivir Med) - "In late 2025, a fixed-dose combination of the nonnucleoside reverse transcriptase inhibitor (NNRTI) doravirine (DOR) and ISL (DOR/ISL 100/0.25 mg once daily) was filed with the US Food and Drug Administration for therapy in adults with HIV who are virologically suppressed on their antiretroviral (ARV) regimens and have no known resistance to either drug. In parallel, a once-weekly oral regimen combining ISL with the capsid inhibitor lenacapavir is currently undergoing phase III clinical investigation as maintenance therapy for people with HIV-1 who are virologically suppressed. People with HIV who are expected to be eligible for combinations with ISL may have been previously exposed to ARV therapy or preexposure prophylaxis, during which resistance mutations may have emerged. In addition, some individuals may have acquired virus containing resistance mutations through the transmission of a resistant strain."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Efficacy and safety of doravirine/islatravir for HIV-1: a GRADE-assessed systematic review and meta-analysis of randomized controlled trials. (PubMed, HIV Res Clin Pract) - "DOR/ISL was weight-neutral compared to bictegravir/emtricitabine/tenofovir alafenamide (MD -0.25 kg [-0.66 to 0.16]; low-certainty evidence). The immunological safety concerns observed in early trials were successfully resolved by dose optimization. These findings support the use of DOR/ISL (IDVYNSO) as a potential treatment option for both treatment-naïve and virologically suppressed adults while emphasizing long-term safety surveillance."

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

Efficacy and safety of doravirine/islatravir for the treatment of HIV-1: a systematic review and meta-analysis of randomized controlled trials with GRADE assessment. (PubMed, Eur J Clin Pharmacol) - "Doravirine/islatravir is an effective and generally well-tolerated two-drug regimen for HIV-1. The optimized 100/0.25 mg formulation maintained virological efficacy without significant short-term immunological differences versus standard triple option therapy; however, longer follow-up is needed to confirm its long-term immunological safety."

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

Switching to Daily Doravirine/Islatravir (100/0.25 mg) Maintains Viral Suppression Through Week 48 Despite Baseline Non-Nucleoside Reverse Transcriptase Inhibitor Resistance-Associated Mutations or M184I/V in Proviral DNA. (PubMed, J Infect Dis) - P3 | "Baseline NNRTI RAMs and M184I/V in proviral DNA did not impact virologic outcomes through 48 weeks after switching to DOR/ISL (100/0.25 mg)."

Journal • Human Immunodeficiency Virus • Infectious Disease

CROI 2026: Antiretroviral THerapy in Adult, Maternal, and Pediatric Populations With HIV. (PubMed, Top Antivir Med) - "Data on doravirine/islatravir showed that this regimen is an effective 2-drug regimen in those initiating antiretroviral therapy (ART) and in those switching from a suppressive regimen. Several abstracts on ART resistance were presented, focusing on the emergence of resistance to integrase strand transfer inhibitors and to lenacapavir. Recent data highlighted new strategies for the empiric treatment of severe pneumonia in infants with HIV, the potential for long-term ART-free remission using broadly neutralizing antibodies and very early initiation of ART, the evaluation of simplified and long-acting ART regimens, and optimizing transition services for adolescents with perinatally acquired HIV to adult care."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • Pneumonia • Respiratory Diseases

FDA Approves Merck’s Once-Daily IDVYNSO (doravirine/islatravir) (Businesswire) - "The efficacy and safety of IDVYNSO is supported by Week 48 data from two randomized, active-controlled, non-inferiority trials [Trial 052 (NCT05630755) and Trial 051 (NCT05631093)] in virologically-suppressed (HIV-1 RNA less than 50 copies per mL) adults living with HIV."

FDA approval • Human Immunodeficiency Virus

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

A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061) (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

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