doravirine
Sources réglementaires consultées
Indications approuvées
- Traitement des adultes et adolescents d’au moins 12 ans et 35 kg atteints du VIH-1 sans résistance passée ou actuelle aux INNTI, toujours en association.
Contre-indications
Absolues
- Hypersensibilité à la doravirine.
- Association à des inducteurs puissants du CYP3A tels que carbamazépine, rifampicine, phénytoïne ou millepertuis.
Mises en garde cliniques
- Mise en garde majeure · Ne pas utiliser en monothérapie ; vérifier les résistances antérieures et le risque de syndrome de restauration immunitaire. — CIMA/AEMPS, ficha técnica 1181332001
- Syndrome de Stevens-Johnson et nécrolyse épidermique toxique ont été rapportés ; arrêter immédiatement en cas de réaction cutanée sévère. — CIMA/AEMPS, ficha técnica 1181332001
Interactions médicamenteuses
- ModéréeInducteurs du CYP3A
Mécanisme: Ils réduisent la doravirine et peuvent entraîner une perte d’efficacité.
Recommandation: Ne pas associer aux inducteurs puissants ; avec rifabutine, utiliser le schéma deux fois par jour.
CIMA/AEMPS, ficha técnica 1181332001
Effets indésirables
Communs (≥1%)
Nausées et céphalées
Rares mais graves
Syndrome de Stevens-Johnson et nécrolyse épidermique toxique
Grossesse et allaitement
Les données pendant la grossesse sont limitées ; n’utiliser que si le bénéfice justifie le risque. Ne pas allaiter pendant le traitement du VIH.
Bibliographie récente (PubMed)
The European AIDS Clinical Society (EACS) guidelines were revised for the 21st time in 2025, with updates covering all aspects of HIV care. The structure of the guidelines has been reorganized into two parts: Part I focuses on the management and prevention of HIV and related infections, and Part II addresses comorbidities and other relevant topics. In Part I, Version 13.0 recommends the following first-line regimens for adults with HIV-1: tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) with either lamivudine or emtricitabine (XTC), in combination with dolutegravir (DTG), bictegravir (BIC), or doravirine (DOR); or a dual therapy option consisting of XTC plus DTG. Version 13.0 introduces a completely new section on HIV-2. The preferred first-line regimens for HIV-2 include triple therapy with a second-generation integrase inhibitor: either TAF/FTC/BIC or TDF/XTC + DTG. The PrEP section has been updated to include the use of long-acting injectable antiretrovirals. Drug-drug interaction (DDI) tables have been updated to include long-acting antiretrovirals and considerations related to substance use, including drugs used to enhance or prolong sexual activity (chemsex). Tables for preferred and alternative ART regimens in children and adolescents have been updated, with particular attention to neonates. A new section on transition to adult care has also been included. The co-infections section has undergone extensive revision, especially regarding HBV, sexually transmitted infections, opportunistic infections (particularly tuberculosis, leishmaniasis, and cryptococcosis) and mpox, incorporating recent clinical trial data on tecovirimat. In Part II, Version 13.0 introduces major updates to the comorbidities section. In the cancer section, screening recommendations for anal and breast cancer have been updated. Cardiovascular and metabolic health sections have been significantly modified, reflecting recent advances and the use of statins in people with HIV
Doravirine and islatravir is a two-drug regimen being investigated for the treatment of HIV-1. This study evaluated efficacy and safety of once daily doravirine and islatravir versus bictegravir, emtricitabine, and tenofovir alafenamide in adults with HIV-1 who were treatment-naive. MK-8591A-053 is a phase 3, randomised, double-blind, active-controlled, non-inferiority study being done at 116 research, community, and hospital-based clinics across 20 countries. Adults aged at least 18 years with HIV-1 RNA of 500 copies per mL or more never previously treated for HIV-1 were randomly assigned (1:1), stratified by screening HIV-1 RNA viral load and CD4-cell count, to received either doravirine (100 mg) and islatravir (0·25 mg) or bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) orally once daily. The primary endpoint was percentage of participants with HIV-1 RNA less than 50 copies per mL at week 48 (FDA snapshot; prespecified non-inferiority margin -10%). Participants who received at least one dose of study intervention were analysed for safety. This trial is ongoing and is registered with ClinicalTrials.govNCT05705349. We screened 756 participants for eligibility between March 8, 2023, and Oct 11, 2024. 269 participants were treated with doravirine-islatravir and 267 with bictegravir-emtricitabine-tenofovir. The last study visit for this analysis occurred on Oct 13, 2025. Median age was 32 years (IQR 26-40), 134 (25%) participants were assigned female at birth, 225 (42%) were White, 92 (17%) had CD4 counts less than 200 cells per μL, 197 (37%) had an HIV-1 RNA greater than 100 000 copies per mL, and 314 (59%) had pre-existing resistance-associated mutations. At week 48, doravirine-islatravir was non-inferior to bictegravir-emtricitabine-tenofovir: 247 (91·8%) of 269 versus 242 (90·6%) of 267 had HIV-1 RNA less than 50 copies per mL (estimated difference 1·2%, 95% CI -3·7 to 6·2). Mean increase in CD4 count was 218 cells per μL in the dora
Doravirine and islatravir is an investigational, once-daily, single-tablet regimen containing two potent antiretrovirals with complementary mechanisms of action and resistance profiles. We aimed to evaluate the efficacy and safety of switching from stable, oral antiretroviral therapy (ART) to the fixed combination of doravirine (100 mg) and islatravir (0·25 mg) in virologically suppressed adults living with HIV-1. This phase 3, randomised, active-controlled, open-label, non-inferiority trial was conducted at 53 research, community, and hospital-based clinics in eight countries: Australia, Canada, Colombia, Japan, South Africa, Switzerland, the UK, and the USA. Adults (aged ≥18 years) with a viral load of fewer than 50 copies of HIV-1 RNA per mL on any oral, two-drug or three-drug ART regimen for at least 3 months, with no history of treatment failure, known resistance to doravirine, or active hepatitis B infection, were randomly assigned (2:1) according to a computer-generated randomisation schedule (block size three) to receive oral doravirine (100 mg) and islatravir (0·25 mg) once daily or to continue baseline ART for 48 weeks. Randomisation was stratified by the anchor antiretroviral drug class (integrase strand-transfer inhibitor [INSTI], non-nucleoside reverse transcriptase inhibitor, or protease inhibitor) in the baseline regimen. The primary endpoint (assessed in all treated participants) was the percentage of participants with a viral load of 50 copies per mL or higher at week 48 (analysed according to the US Food and Drug Administration snapshot approach); non-inferiority would be concluded if the upper bound of the multiplicity-adjusted 95% CI for the treatment difference was less than 4%. The safety analysis population included all randomly assigned participants who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov, NCT05631093, and is ongoing but closed to enrolment. Between Feb 20 and Oct 24, 2023, 614 individu
The combination of doravirine and islatravir is under investigation as a fixed-dose, single-tablet regimen for the treatment of HIV-1. We aimed to assess the efficacy and safety of switching to doravirine (100 mg) and islatravir (0·25 mg) from bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV-1. This phase 3, randomised, controlled, double-blind, non-inferiority trial was conducted at 49 research, community, and hospital-based clinics in six countries: Australia, Chile, Israel, Japan, the UK, and the USA. Adults aged 18 years or older with HIV-1, who were virologically suppressed (with a viral load of HIV-1 RNA <50 copies per mL) for at least 3 consecutive months on bictegravir, emtricitabine, and tenofovir alafenamide and had no history of treatment failure or known resistance to doravirine, were eligible for the study. Participants were randomly assigned, in a 2:1 ratio according to a computer-generated randomisation schedule with a block size of three, to switch to oral doravirine (100 mg) and islatravir (0·25 mg) or to continue bictegravir, emtricitabine, and tenofovir alafenamide, once daily. Participants, investigators, study staff, and sponsor personnel were masked to study treatment; sponsor personnel directly involved in this analysis were unmasked at week 48. The primary endpoint, which was assessed in all randomly assigned participants who received at least one dose of study treatment, was the percentage of participants with a viral load of 50 copies per mL or higher at week 48 according to the US Food and Drug Administration snapshot approach; non-inferiority would be concluded if the upper bound of the multiplicity-adjusted 95% CI for the treatment difference was less than 4%. The trial is registered at ClinicalTrials.gov, NCT05630755, and is ongoing but closed to enrolment. Between Feb 17 and Nov 17, 2023, 585 individuals were screened, of whom 514 were randomly assigned and 513 treated: 342 participants