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

Exposure-Response Analysis of Islatravir 0.25 mg With Doravirine 100 mg Once Daily in Treatment-Naive and Virologically Suppressed People Living With HIV-1 at Week 48 (IDWeek 2026) - No abstract available

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

Switching from etravirine to doravirine in people with HIV harbouring NNRTI resistance-associated mutations: the DorSwitch pilot study. (PubMed, J Antimicrob Chemother) - "In this small, highly selected pilot cohort, switching from etravirine to doravirine as part of an otherwise suppressive regimen was associated with maintenance of virological suppression through Week 48 and a more favourable predicted NNRTI resistance profile in most participants. The favourable resistance profile, safety, metabolic effects and PK findings consistent with expected exposure-particularly in combination with darunavir/cobicistat- support further evaluation of doravirine as a switch option in carefully selected individuals with prior NNRTI failure."

Journal • Human Immunodeficiency Virus • Infectious Disease

An optimized product-enhanced reverse transcriptase assay for sensitive and quantitative detection of HIV viral load and phenotypic drug resistance. (PubMed, J Clin Microbiol) - "We demonstrated the assay's feasibility for phenotypic DRT using lamivudine-5'-triphosphate (3TC-TP)-to which the M184V mutation confers high-level resistance-and quantified 3TC-TP inhibition using the difference in cDNA produced between drug and no-drug conditions...Finally, we showed that PERT could detect resistance to existing and emerging RT inhibitors, including tenofovir-diphosphate (TFV-DP), doravirine (DOR), and islatravir (ISL)-TP.IMPORTANCEAlthough antiretroviral therapy can effectively treat and prevent HIV infection, treatment efficacy and global control of the HIV epidemic are threatened by rising rates of HIV drug resistance...Our optimized product-enhanced reverse transcriptase (PERT) assay for simultaneous viral load and phenotypic drug resistance quantification is fast (~2 h), sensitive, and accurate. We can also leverage existing RT-qPCR instruments used for viral load measurement to significantly improve access to HIV drug resistance..."

Journal • Human Immunodeficiency Virus • Infectious Disease

Profile of People Living with HIV Switching Prior Antiretroviral Treatment to a Doravirine-Based Regimen in the Real-World Clinical Setting in Greece: The Retrospective DORAVITO Study. (PubMed, Biomedicines) - "Most PLWH (98.2%) were prescribed DOR plus two nucleoside reverse transcriptase inhibitors; 87.3% were prescribed DOR/Lamivudine/Tenofovir Disoproxil Fumarate fixed-dose combination. This study highlights the patterns of DOR use in real-life clinical practice in Greece among treatment-experienced PLWH. Physicians switch HIV-1-infected individuals from prior ART to DOR-based regimens to offer a simplified regimen or to avoid or prevent toxicity."

Journal • Real-world evidence • Retrospective data • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Terminated | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Completed ➔ Terminated; The study was closed to accrual early based on Study Monitoring Committee review indicating that the study objectives had either been achieved or could not be met within a reasonable timeframe for the then-open arms.

Trial termination • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Synthesis of precursors for novel doravirine regulated induced proximity targeting chimeras to promote HIV cell death | Poster Board #1375 (ACS-Fall 2026) - "To circumvent undesired reactivity, O-alkylation is completed prior to the final coupling of the doravirine with various linker chains. The ability to synthesize the O-alkylated doravirine derivatives is the first key step to developing a library of novel HIV-RIPTAC analogs, of which is ongoing."

Human Immunodeficiency Virus • Infectious Disease

Long‑Term Effectiveness and Safety of Doravirine‑Based Antiretroviral Regimens in Virologically Suppressed People with HIV: The French Dat'AIDS Cohort. (PubMed, Infect Dis Ther) - P | "In this study, reporting the largest cohort of people receiving DOR-based regimens to date, DOR-based regimens demonstrated durable virologic effectiveness and a very favorable safety profile in treatment-experienced people with HIV and multiple comorbidities."

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

In-silico molecular design approach of some phytoconstituents from Nardostachys jatamansi as HIV/AIDS agents. (PubMed, 3 Biotech) - "Fifteen ligands from N. jatamansi and the standard drug Doravirine were evaluated for biological activity, ATC classification, ADMET properties, HIV-1 RT inhibition, and docking performance...Among these, compound 10 showed the highest therapeutic potential, exhibiting a therapeutic index value of 36.32. These findings support the therapeutic relevance of N. jatamansi-derived compounds and warrant further in-vitro and in-vivo studies to explore their role as novel antiretroviral agents."

Journal • Gastroenterology • Gastrointestinal Disorder • Human Immunodeficiency Virus • Infectious Disease

National cross-sectional survey on acquired HIV drug resistance in Haiti in 2023: warnings resistance to dolutegravir (AIDS 2026) - "3.77% of HIVs were resistant to dolutegravir and bictegravir, 4.4% to cabotegravir, 4.72% to raltegravir, and 5.03% to elvitegravir. Additionally, 15.19% of the viral strains were resistant to abacavir, 13.92% to lamivudine and emtricitabine, 6.65% to zidovudine, 8.23% to stavudine and didanosine, and 4.13% to tenofovir...Furthermore, some HIVs strains developed resistance against efavirenz (49.37%), nevirapine (50%), Rilpivirine (20.25%), Etravirine (12.66%), and doravirine (3.61%). Finally, HIV genome resistance was 0.63% against atazanavir/ritonavir and indinavir/ritonavir, 0.95% against lopinavir/ritonavir and 0.32% against darunavir/ritonavir. HIV acquired pharmacoresistance is moderate in Haiti and requires innovating adapted strategy for preventing its development, its transmission, and for protecting PLHIV health, while emphasizing on children and male individuals."

Human Immunodeficiency Virus • Infectious Disease • Respiratory Diseases

Incidence of mutational patterns affecting doravirine or/and rilpivirine in people living with HIV and previous failure with NNRTIs efavirenz or nevirapine (AIDS 2026) - "BACKGROUND: The growing use of new non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as doravirine (DOR) or long-acting rilpivirine (RPV) makes necessary to evaluate the impact of previous failure to NNRTIs. Our results confirm that doravirine resistance in NNRTI-failing PLWH is lower than resistance to other NNRTIs currently used. However, these data suggest considering carefully genotypic resistance test results before the use of RPV or DOR in the clinical setting in those PLWH with previous failure to NNRTIs."

Human Immunodeficiency Virus • Infectious Disease • CD4

Resistance to etravirine and doravine in experienced PLHIV in Mexico. Impact on salvage treatment (AIDS 2026) - "BACKGROUND: Doravirine (DOR) and Etravirine (ETV) are the only NNRTIs indicated in people living with HIV (PLHIV) after virologic failure (VF) to first-generation NNRTIs as Efavirenz and Nevirapine. In our study, resistance to ETR in adult PLHIV who experienced at least two treatment failures in Mexico, was lower than to DOR. HLR was uncommon specially with respect to total sample, but higher (almost double) to DOR. Resistance prevalence could be higher, as most of the genotypes were performed without the NNRTI drug pressure."

Human Immunodeficiency Virus • Infectious Disease

A rapid and inexpensive phenotypic assay for measuring resistance to existing and emerging HIV drugs (AIDS 2026) - "We measured inhibition of HIV-RT activity (viral load ~2500) by the nucleoside RT inhibitor lamivudine-5’-triphosphate (3TC-TP), nucleoside RT translocation inhibitor MK-8591-TP, and non-nucleoside RT inhibitors doravirine and rilpivirine. This PERT assay meets WHO analytical sensitivity requirements for DRT. With its high sensitivity, short duration (~2 hours), compatibility with existing and emerging RT inhibitors, and ability to leverage existing instruments in high- and low-resource settings, this enzymatic assay has the potential to significantly improve access to routine HIV DRT in point-of-care and clinical trial settings."

Human Immunodeficiency Virus • Infectious Disease

ELDORADO: DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-nave People Living With HIV-1 Infection (clinicaltrials.gov) - P3 | N=610 | Recruiting | Sponsor: ANRS, Emerging Infectious Diseases | Trial completion date: Nov 2027 ➔ Jan 2029 | Trial primary completion date: Nov 2026 ➔ Jan 2028

Head-to-Head • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CYP3A5

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

Real-world experience with doravirine-based regimens in Argentina: 12‑month follow-up from the multicenter DOLART study (AIDS 2026) - "Overall, 96% (493/511) received doravirine/lamivudine/tenofovir disoproxil fumarate and 3.5% (18/511) doravirine with another backbone. Prior ART was mainly first-generation NNRTI-based (XTC-TDF-EFV 65%, XTC-ABC-EFV 8.8%, XTC-TDF-NVP 7.1%); others included BIC/FTC/TAF (6.1%), DTG-based (3.2%), and DRV/r-based (2.2%) ART... In this large Argentinian cohort, switching to doravirine-based ART showed high 6- and 12-month persistence and sustained virological effectiveness, with low discontinuation rates due to AE or VF. These data support doravirine as an effective optimization and simplification option for PWH in Latin America."

Clinical • Real-world • Real-world evidence • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Sleep Disorder

Decision-making factors when tensions exist between antiretroviral therapy and contraception options: qualitative insights from a pharmacokinetic study among women living with HIV in South Africa (AIDS 2026) - " We analyzed qualitative data from participants in a pharmacokinetic study, named EPIC, that examined drug-drug interactions between hormonal and non-hormonal contraceptives and a newer ART regimen containing doravirine from November 2021 to February 2024... Women living with HIV encounter several complexities when tensions exist between ART and contraceptive options; greater emphasis needs to be placed on bolstering their agency and awareness of risks and benefits through provider counseling, information sharing, and adaptive clinical practices to support informed decision-making."

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

Cracking the code to remove patent barriers (AIDS 2026) - "Overall, 25 of these PO templates were used to file 59 POs, including six oppositions using the nirmatrelvir/ritonavir template; and five oppositions each, on lenacapavir, doravirine and molnupiravir templates. The MMA experience demonstrates that, despite the complex technical aspect of POs, local CS and CBOs are able to file successful cases; 38% of POs filed by MMA members were successful, while 43% are in process. PO templates enabled the filing of additional patent oppositions on prioritized medicines across multiple countries."

Human Immunodeficiency Virus • Infectious Disease

Archived M184V/I Mutation and Risk of Virological Failure After Switching to Doravirine, Lamivudine, Tenofovir Disoproxil Fumarate: A National Observational Study (Dat'AIDS Cohort). (PubMed, Open Forum Infect Dis) - "Among 1282 virally suppressed people with HIV switching to doravirine/lamivudine/tenofovir disoproxil fumarate, 40 (3.1%) experienced virological failure (VF) during follow-up (median 81 weeks). Archived M184V/I mutation (7.4% of study population) was not significantly associated with VF after adjustment (adjusted hazard ratio 1.36; 95%CI 0.51-3.66)."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Single-Dose Longitudinal Pharmacokinetic Evaluation of Doravirine in Pregnant Women Living With HIV: Protocol for a Phase 1 Study. (PubMed, JMIR Res Protoc) - "In total, 7 participants were enrolled in the study, and 5 were evaluable. The data collected with this novel single-dose pharmacokinetic study design will provide important insights into the clinical management of patients on doravirine during pregnancy and provide an effective model for obtaining early pharmacokinetic and dosing information for new drugs that can be used in pregnant women."

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

SOMNART: Sleep Outcomes and Multidimensional Assessment With Antiretroviral Therapy in People Living With HIV on Dolutegravir- vs Doravirine-Based Regimens (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: University of Witwatersrand, South Africa

New P4 trial • Human Immunodeficiency Virus • Infectious Disease

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

Add-on efficacy of doravirine in PLWHIV with virological failure and low-level viremia. (PubMed, J Antimicrob Chemother) - "These findings support the use of doravirine add-on strategies to rescue virological control without changing the full regimen, particularly when a full regimen change is not feasible and when GSS is favourable. The study highlights the potential of doravirine in tailored salvage therapy strategies."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Structural and Mechanistic Basis of F227C-Mediated Hypersusceptibility to Islatravir in HIV-1 Reverse Transcriptase. (PubMed, bioRxiv) - "Islatravir (ISL; 4'-ethynyl-2-fluoro-2'-deoxyadenosine (EFdA)), a first-in-class nucleoside reverse transcriptase (RT) translocation inhibitor (NRTTI), was recently approved by the FDA for the treatment of HIV-1 infection in combination with the non-nucleoside RT inhibitor (NNRTI), doravirine (DOR). Complementary biochemical assays showed that although F227C does not significantly affect ISL incorporation, it alters RT translocation and impairs ATP-dependent phosphorolytic excision of ISL-terminated primers, thereby enhancing ISL susceptibility. These findings establish direct structural and mechanistic links between NNRTI resistance and ISL hypersusceptibility, providing a structural foundation for rationally designed, resistance-informed combination regimens that exploit this unique collateral sensitivity."

Journal • Human Immunodeficiency Virus • Infectious Disease

Analysis of Viral Blips Through Week 192 of the DRIVE-FORWARD and DRIVE-AHEAD Phase 3 Studies of Doravirine-Based Regimens in Adults Living With Previously Untreated HIV-1. (PubMed, Open Forum Infect Dis) - P3 | "Adults living with untreated HIV-1 were randomized (1:1) to a DOR-containing regimen or comparator (darunavir/ritonavir- or efavirenz-containing), each with 2 nucleos(t)ide reverse transcriptase inhibitors, for 96 weeks (double-blind base), followed by 96 weeks of a DOR-containing regimen (open-label extension). Clinical Trials Registration.  ClinicalTrials.gov NCT02275780, NCT02403674."

Clinical • Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • CD4