Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD) - LARVOL DELTA

RapiDO: Efficacy and Safety of Doravirine in the Rapid Initiation (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Fundación Huésped | Not yet recruiting ➔ Recruiting

Enrollment open • 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

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

Initial HIV Therapy for Adults and Treatment-Associated Weight Gain: The Opti-DOR Randomized Clinical Trial. (PubMed, JAMA) - P3 | "Antiretroviral therapy (ART), particularly regimens containing tenofovir alafenamide with dolutegravir or bictegravir, is associated with substantial weight gain, potentially exacerbating cardiometabolic risk in people with HIV. Among predominantly Black African adults initiating ART, a regimen with doravirine, lamivudine, and tenofovir disoproxil fumarate was noninferior to a regimen with dolutegravir, emtricitabine, and tenofovir alafenamide for 48-week viral suppression and was associated with less weight gain. ClinicalTrials.gov Identifier: NCT05924438."

Clinical • Journal • 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

Opti-DOR: 48 week data on DOR/3TC/TDF as an alternative first-line antiretroviral therapy (ART) regimen to integrase inhibitors for people with HIV and BMI>25kg/m2 in a randomised phase 3b non-inferiority study (AIDS 2026) - "DOR/3TC/TDF was non-inferior to DTG/TAF/FTC for Week 48 virologic efficacy, both regimens were well tolerated, with DOR/3TC/TDF associated with less weight gain. Individual agent contribution to weight gain cannot be isolated as this was a regimen-level comparison."

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

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

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

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

Real-world effectiveness of doravirine-containing antiretroviral therapy in Chinese adults living with HIV-1: a retrospective study. (PubMed, BMC Infect Dis) - "DOR-containing ART is an effective treatment for Chinese PWH in real-world settings, regardless of their VLs and treatment experience at baseline."

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

Efficacy and safety of doravirine/lamivudine/tenofovir as initial treatment for people living with HIV in China. (PubMed, Antimicrob Agents Chemother) - "A real-world retrospective study was conducted involving treatment-naïve PLWH who initiated DOR/TDF/3TC, EFV/TDF/3TC, DTG/TDF/3TC, or BIC/TAF/FTC. DOR/TDF/3TC demonstrated antiviral effectiveness comparable to DTG/TDF/3TC and BIC/TAF/FTC, with a favorable tolerability profile at week 48. Additionally, DOR/TDF/3TC was associated with more favorable lipid changes."

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

Impact of Doravirine in Liver Steatosis and Fibrosis in PLWH. A pilot, proof of concept study (DORALI Study) (clinicaltrialsregister.eu) - P4 | N=50 | Active, not recruiting | Sponsor: Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease

Can switching to doravirine/lamivudine/tenofovir DF halt or reverse INSTI-associated weight gain? (PubMed, J Assoc Med Microbiol Infect Dis Can) - "Adults with a ≥10% increase in body weight while on an INSTI (± tenofovir alafenamide) regimen and HIV RNA <50 copies/mL were switched to DOR/3TC/TDF for 12 months. All three participants experienced small improvements in waist circumference, body fat, and metabolism, and all reported improvements in body image/self-esteem. Pandemic challenges significantly impacted the ability to enrol participants."

Journal • Human Immunodeficiency Virus • Infectious Disease • Renal Disease

Comparable efficacy of bictegravir/emtricitabine/tenofovir alafenamide and doravirine/lamivudine/tenofovir disoproxil fumarate in therapy-naive Human Immunodeficiency Virus adults with very high baseline viraemia. (PubMed, J Med Microbiol) - "The median increase in CD4 T lymphocyte count was comparable between groups (+139 and +117 cells mm-3, respectively), such as incidence of adverse events, while median increase in low-density lipoprotein cholesterol and weight gain was significantly greater in the BIC/F/TAF group (weight change, +1.64 kg vs. +0.85 kg; P=0.013).Conclusion. In this real-life cohort, BIC/F/TAF and DOR/3TC/TDF showed high and comparable virological efficacy in naive patients with baseline HIV RNA above 500,000 copies ml-1."

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

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

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

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 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

RapiDO: Efficacy and Safety of Doravirine in the Rapid Initiation (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Fundación Huésped

New P4 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/ TDF) treatment in people living with HIV: A single-center real-world experience from Belgrade, Serbia. (PubMed, Germs) - "In routine care in Belgrade, once-daily DOR/3TC/TDF was well tolerated and effective: naïve patients achieved rapid suppression with CD4 gains, and switch patients maintained high rates of undetectable viral load without adverse lipid shifts. These findings support DOR/3TC/TDF as a practical option in the Serbian setting."

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

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

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 (EACS 2025) - "Finally, regarding METS-IR, after 48 weeks we observed a significant decrease in the DOR group (-0.9, p=0.024), while there were no significant changes with DTG and an increase of +0.3 with BIC (p=0.013). Conclusions : We found that switching to DOR/3TC/TDF was associated with more favorable changes in SCORE-2, METS-IR and BMI compared to DTG/3TC and BIC/FTC/TAF."

Clinical • Infectious Disease

Improved body weight, lipid and immune profile and adipose tissue gene expression after a 48-week switch from an INSTI regimen to DOR/3TC/TDF in persons with HIV with INSTI-associated weight gain: The ADDORE study (EACS 2025) - "Conclusions : Switching PWH with INSTI-associated body weight increase to DOR/3TC/TDF for 48 weeks improved weight, lipid profile, allowed a partial reversal of INSTI-induced altered adipose gene expression associated with fat hypertrophy and inhibition of beiging together with changes in lymphoid and myeloid immune responses favoring a less inflammatory profile. ADDORE was granted by MSD"

IO biomarker • Human Immunodeficiency Virus • Infectious Disease • B3GAT1 • CD8 • GDF15 • IL10 • IL18 • LEP • PD-1 • PD-L1 • PPARG • PRDM16

Two versus three-drug Doravirine based regimens in real life: a multicentric observational study (EACS 2025) - "Purpose : To evaluate reasons for switching, effectiveness and durability of a two-drug (2DR) doravirine (DOR)-based combination, DOR+3TC, versus a DOR-based three-drug regimen (3DR), DOR/3TC/TDF. Conclusions : DOR/3TC/TDF and DOR+3TC were comparable in effectiveness and durability. DOR+3TC may be viable for people with complex metabolic profiles and treatment intolerance histories, if full susceptibility is confirmed and adherence reinforced."

Clinical • Observational data • Human Immunodeficiency Virus • Infectious Disease

Effectiveness of switching to bictegravir/emtricitabine/tenofovir alafenamide from NNRTI-based ART in virologically suppressed people with HIV (PWH): a retrospective analysis (DRIVE-SWITCH study) (EACS 2025) - "Purpose : Large real-world data in people with HIV (PWH) switching from non-nucleoside reverse transcriptase inhibitors (NNRTIs), especially from rilpivirine (RPV)-based regimens to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) are lacking...Results : Overall, 250 PWH were included: median age 59 years (interquartile range, IQR 51-65); 65 (26%) females at birth, 213 (85%) Italian natives; 141 (56%) switched from RPV/FTC/TAF, 7 (2.8%) from RPV/FTC/TDF, 96 (38.4%) from EFV/FTC/TDF, 3 (1.2%) from NVP+TDF/FTC, 2 (0.8%) from DOR/3TC/TDF, 1 (0.4%) from NVP+TAF/FTC...Treatment discontinuations were rare events. No resistance mutations detected."

Retrospective data • Human Immunodeficiency Virus • Infectious Disease