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RPV + DRV/r
RPV + DRV/r is a Antiretroviral combination (NNRTI + protease inhibitor) Small molecule drug developed by ASST Fatebenefratelli Sacco. It is currently in Phase 3 development for HIV-1 infection (treatment-experienced or treatment-naive patients). Also known as: RVP: rilpivirine; brand name: EdurantTM., DRV: darunavir; brand name: PrezistaTM..
RPV (rilpivirine) and DRV/r (darunavir/ritonavir) are antiretroviral agents that inhibit HIV reverse transcriptase and protease, respectively, blocking viral replication.
RPV (Rilpivirine) and DRV/r (Darunavir/Ritonavir) are antiretroviral medications used to treat HIV-1 infection, as indicated by ClinicalTrials.gov. However, the mechanism of action for RPV and DRV/r is unknown, according to ChEMBL.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | RPV + DRV/r |
|---|---|
| Also known as | RVP: rilpivirine; brand name: EdurantTM., DRV: darunavir; brand name: PrezistaTM. |
| Sponsor | ASST Fatebenefratelli Sacco |
| Drug class | Antiretroviral combination (NNRTI + protease inhibitor) |
| Target | HIV reverse transcriptase; HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds to and inhibits HIV reverse transcriptase, preventing conversion of viral RNA to DNA. Darunavir is a protease inhibitor that blocks HIV protease, preventing maturation of viral particles. Ritonavir is a pharmacokinetic booster that inhibits CYP3A4, increasing darunavir plasma concentrations. Together, this combination targets two critical steps in the HIV replication cycle.
Approved indications
- HIV-1 infection (treatment-experienced or treatment-naive patients)
Common side effects
- Diarrhea
- Nausea
- Rash
- Headache
- Elevated liver enzymes
- Lipid abnormalities
Key clinical trials
- Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine (PHASE3)
- Patients' Experiences and Perceptions of 3TC/DTG Dual Therapy (the PEDAL Study)
- Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I (PHASE3)
- DRV/r + RPV QD: Efficacy and Toxicity Reduction (PHASE3)
- Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF (PHASE3)
- Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years (PHASE3)
- Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC (PHASE3)
- Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- RPV + DRV/r CI brief — competitive landscape report
- RPV + DRV/r updates RSS · CI watch RSS
- ASST Fatebenefratelli Sacco portfolio CI
Frequently asked questions about RPV + DRV/r
What is RPV + DRV/r?
How does RPV + DRV/r work?
What is RPV + DRV/r used for?
Who makes RPV + DRV/r?
Is RPV + DRV/r also known as anything else?
What drug class is RPV + DRV/r in?
What development phase is RPV + DRV/r in?
What are the side effects of RPV + DRV/r?
What does RPV + DRV/r target?
Related
- Drug class: All Antiretroviral combination (NNRTI + protease inhibitor) drugs
- Target: All drugs targeting HIV reverse transcriptase; HIV protease
- Manufacturer: ASST Fatebenefratelli Sacco — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection (treatment-experienced or treatment-naive patients)
- Also known as: RVP: rilpivirine; brand name: EdurantTM., DRV: darunavir; brand name: PrezistaTM.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing