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ATV/r plus ABC/3TC
ATV/r plus ABC/3TC is a Antiretroviral combination therapy (protease inhibitor + nucleoside reverse transcriptase inhibitors) Small molecule drug developed by Juan A. Arnaiz. It is currently in Phase 3 development for HIV-1 infection. Also known as: PI-Based Regimen.
This combination uses atazanavir/ritonavir (protease inhibitors) plus abacavir/lamivudine (nucleoside reverse transcriptase inhibitors) to suppress HIV replication by blocking viral protease and reverse transcriptase enzymes.
Atazanavir (ATV)/ritonavir (/r) plus Abacavir (ABC)/lamivudine (3TC) is used to treat HIV-1 infection. This combination was studied in a clinical trial (NCT00440947) for its effectiveness in treating HIV-1 infection.
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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 | ATV/r plus ABC/3TC |
|---|---|
| Also known as | PI-Based Regimen |
| Sponsor | Juan A. Arnaiz |
| Drug class | Antiretroviral combination therapy (protease inhibitor + nucleoside reverse transcriptase inhibitors) |
| Target | HIV protease, HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Atazanavir is a protease inhibitor that prevents HIV protease from cleaving viral polyproteins, while ritonavir acts as a pharmacokinetic booster to increase atazanavir levels. Abacavir and lamivudine are nucleoside reverse transcriptase inhibitors that block the reverse transcriptase enzyme, preventing conversion of viral RNA to DNA. Together, this triple-drug regimen targets multiple steps of the HIV replication cycle.
Approved indications
- HIV-1 infection
Common side effects
- Nausea
- Diarrhea
- Headache
- Hyperbilirubinemia
- Abacavir hypersensitivity reaction
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine (PHASE3)
- 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)
- 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)
- Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir (PHASE3)
- Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection (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:
- ATV/r plus ABC/3TC CI brief — competitive landscape report
- ATV/r plus ABC/3TC updates RSS · CI watch RSS
- Juan A. Arnaiz portfolio CI
Frequently asked questions about ATV/r plus ABC/3TC
What is ATV/r plus ABC/3TC?
How does ATV/r plus ABC/3TC work?
What is ATV/r plus ABC/3TC used for?
Who makes ATV/r plus ABC/3TC?
Is ATV/r plus ABC/3TC also known as anything else?
What drug class is ATV/r plus ABC/3TC in?
What development phase is ATV/r plus ABC/3TC in?
What are the side effects of ATV/r plus ABC/3TC?
What does ATV/r plus ABC/3TC target?
Related
- Drug class: All Antiretroviral combination therapy (protease inhibitor + nucleoside reverse transcriptase inhibitors) drugs
- Target: All drugs targeting HIV protease, HIV reverse transcriptase
- Manufacturer: Juan A. Arnaiz — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection
- Also known as: PI-Based Regimen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing