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

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Apr 2025 ➔ Jul 2025 | Completed ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Emergence of Bictegravir Resistance in a Treatment-Experienced PWH on Functional Monotherapy and Rapid Replacement by an Ancient Wild-Type Strain Following Transient Treatment Interruption. (PubMed, Viruses) - "This led to viral failure on a quadruple regimen including BIC and doravirine (DOR). During a two-month ART interruption, the resistant virus was rapidly replaced by an ancient wild-type strain. Despite resistance to all four ART classes, a genotype-adapted salvage regimen, including fostemsavir, achieved viral suppression within seven months."

Journal • Monotherapy • Human Immunodeficiency Virus • Infectious Disease

Prevalence of Doravirine Resistance Mutations in a Large-Scale HIV-1 Transmitted Drug Resistance Survey in Buenos Aires, Argentina. (PubMed, Viruses) - "Our study shows the persistence of moderate to high levels of resistance to first-generation NNRTIs. Despite this, prevalence was low for DOR. Surveillance of TDR remains critical for recommendations of ART initiation."

Journal • Human Immunodeficiency Virus • Infectious Disease

MODULO: Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully (clinicaltrials.gov) - P2 | N=408 | Recruiting | Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Apr 2025 | Trial primary completion date: Mar 2026 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Comparative Pharmacokinetics and Safety of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate when used among Women Living with HIV on Doravirine-Containing Antiretroviral Therapy (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

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

Pharmacokinetic and clinical associations between doravirine-containing ART and injectable and implantable hormonal contraceptive methods among women living with HIV in South Africa. (PubMed, J Infect Dis) - "We found no detrimental bidirectional drug-drug interactions and few adverse events between doravirine and hormonal contraceptives."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Long-acting Reversible Contraceptives

HIV-1 cross-resistance to second-generation non-nucleoside reverse transcriptase inhibitors among individuals failing antiretroviral therapy in Cameroon: implications for the use of long-acting treatment regimens in low- and middle-income countries. (PubMed, JAC Antimicrob Resist) - "HIV-1 Sanger sequencing was performed on plasma and resistance-associated mutations (RAMs) to etravirine, rilpivirine and doravirine were interpreted using HIVdb program v.9.5.0 (HIVdb penalty scores were,  ≥60, high resistance; 15-59, intermediate resistance and  <15, susceptible) and the IAS-USA 2022 list. Among patients failing treatment in Cameroon, there is a high-level of cross-resistance to 2ndGenNNRTI due to wide exposure to 1stGenNNRTI. Thus, in LMICs sharing similar programmatic features, the use of NNRTI-sparing regimens should be prioritized as a public health approach, while second-generation-NNRTI long-acting regimens should be guided by genotyping or for clients without previous exposure to NNRTIs."

Journal • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=325 ➔ 205

Enrollment change • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Optimising antiretroviral therapy through a proactive treatment algorithm: a cost-effective strategy in Dutch healthcare for people with HIV. (PubMed, J Antimicrob Chemother) - "Our ART algorithm demonstrated high acceptance by prescribers and people with HIV, leading to substantial cost savings. The algorithm can be easily implemented in other HIV clinics to offer even more significant cost savings to Dutch healthcare payers."

HEOR • Journal • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Molecular characterization and drug resistance pattern in pol gene of HIV-1 sub-subtypes circulating in Lahore, Pakistan. (PubMed, Virus Genes) - "Furthermore, the isolate QAU-AZ2 (OR086936) proposes variable degree of resistance to nevirapine (NVP), etravirine (ETR), rilpivirine (RPV), efavirenz (EFV), Doravirine (DOR); while no resistance against NNTRI and NTRI was observed in the remaining isolates. Further studies are required to (i) examine the function of identified amino acid substitutions through molecular docking, and (ii) sequence the complete pol gene of the viral isolates from Pakistani patients to determine possible drug resistance associated with amino acid substitutions."

Journal • Human Immunodeficiency Virus • Infectious Disease

ELDORADO: DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living with HIV-1 Infection (clinicaltrials.gov) - P3 | N=610 | Recruiting | Sponsor: ANRS, Emerging Infectious Diseases | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

Development of a 2-Drug Long-Acting Removable Formulation for HIV Suppression (CROI 2025) - "Methods First, an injectable LA formulation of the non-nucleoside reverse transcriptase inhibitor doravirine (DOR-ISFI) was developed. The second drug, an integrase strand transfer inhibitor dolutegravir (DTG), was incorporated into the same formulation using co-solvent optimization...Removal of the implant successfully stopped the delivery of both drugs. Conclusions DTGDOR-ISFI is an important advance in managing HIV suppression by reducing the number of injections and simplifying LA drug delivery."

Human Immunodeficiency Virus • Infectious Disease

Decreased Adipose Tissue Gene Expression After a 48-Week Switch From an InSTI Regimen to TDF/3TC/DOR (CROI 2025) - "Conclusions These results suggest that switch from INSTI to TDF/3TC/DOR allowed a partial reversal of the INSTI-induced gene expression profile associated with adipocyte hypertrophy and lipid accumulation. Larger clinical pathogenesis studies are needed to better understand the underlying mechanisms of INSTI-induced weight gain and its reversibility by doravirine."

Fibrosis • Immunology • ADIPOQ • FASN • LEP • PPARG • PPIA • SREBF1

In Vitro Modulation of Adipocyte Differentiation by TAF/TDF After Challenge With New ARV Regimens (CROI 2025) - "Background We previously demonstrated in a 3T3L1cells in vitro model of adipogenesis, that Integrase Strand Transfer Inhibitors (INSTI) increase adipogenesis, while, tenofovir alafenamide fumarate (TAF) and tenofovir disoproxil fumarate (TDF), displayed an inhibitory effect, counteracting increased adipogenesis caused by INSTIs [dolutegravir (DTG), bictegravir (BIC)]...Methods We used a 3T3-L1 cells in vitro model of adipogenesis to study the effects on adipocyte differentiation of the NNRTIs doravirine (DOR) and rilpivirine (RPV), alone or in combination with the previously evaluated DTG and the newer INSTI cabotegravir (CAB), or TDF or TAF...Furthermore, NNRTIs and CAB enhanced the expression levels of ER-TR7 compared to control, being the combination DTG+DOR less effective in this activity. Conclusions Our data support the evidence that in-vitro challenge of 3T3-L1 cells with INSTIs and NNRTIs is able to increase adipocytic differentiation and to drive a number of..."

Preclinical • Diabetes • Diabetic Nephropathy • Metabolic Disorders

Shifting Paradigms: Doravirine's Potential in Treating Non-Group M HIV-1, the DORAVI-O Study (CROI 2025) - "Conclusions The DORAVI-O study revealed a broad phenotypic sensitivities of non-M HIV-1 to DOR, despite the natural Y181C mutation. Phenotypic resistance was observed in 6O, 1P (25%) whereas only 1O isolate has resistance mutations to DOR, suggesting the potential existence of non-M virus specific genotypic pattern not covered by the french ANRS algorithm designed for M variants."

Human Immunodeficiency Virus • Infectious Disease

HIV-1 Drug Resistance Trends in the Era of Modern Antiretrovirals: 2018-2024 (CROI 2025) - "Doravirine and rilpivirine DRMs remained low, with respective 2024 prevalences of 2% (RNA) and 2.9% (DNA) and 6.3% (RNA) and 10.1% (DNA)...Cabotegravir DRM prevalence in 2024 was 3.8% (RNA) and 2.5% (DNA)...Conclusions Prevalence of NRTI and NNRTI resistance declined which is consistent with increased use of regimens with higher resistance barriers, improved tolerability, and more convenient dosing, resulting in better adherence. Prevalence of INSTI DRMs was low, supporting US guidelines for limiting INSTI resistance testing to cases of treatment failure, suspected transmitted resistance, or infection during INSTI-based PrEP."

Human Immunodeficiency Virus • Infectious Disease

No Virologic Failure in Patients Switched to Doravirine Treatment With Past Resistance Mutations (CROI 2025) - "Conclusions Our study provides the first large real-world data on the use of DOR-containing regimens with up to 96 weeks of follow-up. NNRTIs drugs are often compromised by cross-resistance within the class, but with the introduction of DOR, which offers protection even in the presence of some resistant variants in the past, there is still hope for the use of this molecule as an option in salvage regimens for patients with a history of specific NNRTIs-RAMS, provided they have been virologically suppressed for a long time."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Plasma CNS Tissue Markers in Heavily Treatment-Experienced PWH in the PRESTIGIO Registry (CROI 2025) - "In HTE, lower tau was associated with fostemsavir (p=.049) and doravirine use (p=.037) and lower GFAP with darunavir (p=.009). Conclusions Plasma CNS tissue marker levels do not support higher CNS injury risk in HTE-PWH. Several other variables seem independently and variably associated with higher levels of each marker."

CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Targeted Protein Degradation • CD4 • GFAP • NEFL • UBC

Effect of the Transition to Dolutegravir on Blood Pressure in People Living With HIV in West Africa (CROI 2025) - "Background Dolutegravir (DTG) has been increasingly linked to metabolic disorders including significant weight gain in people living with HIV (PLHIV) but to which extend these metabolic disorders translate into cardiovascular diseases is still debated. These findings support the integration of HTN screening and management into HIV care programs in West Africa and question the need of alternative first-line regimens such as Doravirine-based regimen in PLHIV at high-risk of cardiovascular diseases. Further analyses are needed to better understand the interplay between DTG, sex, prior ART regimen and BP."

Cardiovascular • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders

Dolutegravir With Either Doravirine or Rilpivirine: Two-Drug Antiretroviral Therapy Outcomes (CROI 2025) - "We aimed to compare virologic suppression (VS) in treatment-experienced persons with HIV following switch to DTG+DOR versus DTG+RPV. Conclusions Observed differences in VS following switch to DRG+RPV and DTG+DOR may be due to differences in participant characteristics, adherence, viral resistance patterns, and the dual regimens. Further studies are needed to evaluate efficacy of dual NRTI-free regimens in real-world settings."

Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease • CD4

Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: University of Texas Southwestern Medical Center | N=20 ➔ 30

Enrollment change • Atherosclerosis • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Drug resistance mutations to integrase inhibitors, proteinase, and reverse transcriptase inhibitors in newly diagnosed HIV-1 infections in Hebei province, China, 2018-2022. (PubMed, Front Cell Infect Microbiol) - "In the PR-RT gene coding region, E138EK/G was the most common (1.6%), followed by K103N (1.4%), G190GE/A/S (0.6%), K101E (0.5%), A98G (0.4%), and T215I/TS (0.3%), associated with the low- to high-level resistance to doravirine (DOR), efavirenz (EFV), etravirine (ETR), nevirapine (NVP), rilpivirine (RPV), and zidovudine (AZT)...G163GRS/EK, P145PS, Y143S, and T66A were associated with the resistance to elvitegravir (EVG) and raltegravir (RAL). S153SF and Q148QH were mainly related to the resistance to dolutegravir (DTG), bictegravir (BIC), and caboteravir (CAB)...The overall prevalence of HIV-1 PDR in Hebei is high, belonging to a moderate resistant level (5.0%-15.0%). It is necessary for us to strengthen the effective surveillance of PDR among treatment-naive patients, and we should adjust the treatment plan according to the results of PDR surveillance."

Journal • Human Immunodeficiency Virus • Infectious Disease

A United States HIV provider survey of antiretroviral therapy management in people living with HIV with co-occurring conditions. (PubMed, AIDS Res Ther) - "This study reveals varied ART approaches for people living with HIV and non-infectious conditions, often diverging from standard regimens. While guidelines provide a framework, providers adapt treatment based on patient needs. Further research is crucial to optimize ART management in these complex situations."

Journal • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease