What is Iqirvo and Why is 'Icarvo' a Misspelling?
Iqirvo is the brand name for elafibranor, a prescription medication approved for primary biliary cholangitis (PBC). The term 'Icarvo' is a common misspelling; the correct name is Iqirvo. This medication serves as an alternative for adults who do not respond well to or cannot tolerate the standard first-line treatment, ursodeoxycholic acid (UDCA).
What is Primary Biliary Cholangitis (PBC)?
Primary biliary cholangitis (PBC) is a rare, chronic autoimmune liver disease affecting the small bile ducts in the liver. The immune system attacks these ducts, leading to inflammation and bile buildup (cholestasis). This can cause scarring (cirrhosis) and liver failure over time.
Common symptoms of PBC include:
- Fatigue
- Persistent itching (pruritus)
- Jaundice (yellowing of the skin or eyes)
- Abdominal pain
- Dry eyes and mouth
- High cholesterol levels
The Role of Iqirvo in PBC Treatment
Iqirvo is for adult patients with PBC who have an inadequate response to or are intolerant of UDCA. It is not a cure but helps manage the disease by improving liver function markers.
How Iqirvo Works: The Mechanism of Elafibranor
Elafibranor, the active ingredient in Iqirvo, is a dual peroxisome proliferator-activated receptor (PPAR) agonist, targeting PPAR-α and PPAR-δ. These receptors regulate metabolism and liver health. By activating them, Iqirvo influences pathways involved in PBC.
This dual activation helps by:
- Reducing Bile Acid Synthesis: Inhibits excessive bile acid production, reducing liver cell damage.
- Providing Anti-inflammatory Effects: Reduces liver inflammation from the autoimmune attack.
- Improving Lipid Profile: Can lower triglycerides and improve cholesterol levels.
Clinical Trial Evidence (The ELATIVE Trial)
Accelerated FDA approval was based on the Phase 3 ELATIVE trial data. This study involved 161 adults with PBC. Results showed Iqirvo significantly reduced the liver enzyme alkaline phosphatase (ALP) compared to placebo.
At 52 weeks, the trial demonstrated:
- Biochemical Response: 51% on Iqirvo achieved a biochemical response versus 4% on placebo.
- ALP Normalization: 15% on Iqirvo reached normal ALP levels, none on placebo.
- Sustained Effect: ALP reduction was seen early and lasted throughout the trial.
Key Safety Information and Considerations
Iqirvo has potential risks and contraindications, including for patients with advanced liver disease like decompensated cirrhosis or complete biliary obstruction.
Common Side Effects (≥5% occurrence):
- Weight gain
- Diarrhea, nausea, and vomiting
- Abdominal pain
- Muscle or joint pain
- Constipation
- Bone fractures (6% of patients on Iqirvo vs 0% on placebo)
Serious Warnings and Precautions:
- Muscle Problems: Risk of myalgia, myopathy, and rare rhabdomyolysis, especially with statins. CPK levels should be monitored.
- Liver Injury: Abnormal liver tests can occur; liver function needs monitoring.
- Fetal Harm: May harm unborn babies. Women of reproductive age need non-hormonal contraception during and after treatment.
Comparison: Iqirvo vs. Other PBC Treatments
Below is a comparison of Iqirvo with other common primary biliary cholangitis treatments:
| Feature | Iqirvo (elafibranor) | Obeticholic Acid (OCA) | Ursodeoxycholic Acid (UDCA) |
|---|---|---|---|
| Drug Class | Dual PPAR-α/δ Agonist | Farnesoid X Receptor (FXR) Agonist | Bile Acid |
| First-Line Therapy | No, second-line or monotherapy for UDCA intolerance | No, second-line therapy | Yes, standard first-line therapy |
| Mechanism | Inhibits bile acid synthesis, anti-inflammatory effect | Increases bile acid excretion | Suppresses toxic bile acid levels |
| Common Side Effects | Weight gain, abdominal pain, diarrhea, nausea, muscle pain, fractures | Pruritus (often severe), fatigue, thyroid abnormalities, hyperlipidemia | Diarrhea, abdominal pain, constipation, hair loss |
| Pruritus Relief | Not clearly shown in studies | Can worsen itching | Not a primary effect |
| Contraindications | Decompensated cirrhosis, complete biliary obstruction, pregnancy | Decompensated cirrhosis, severe PBC, complete biliary obstruction | Complete biliary obstruction |
Conclusion
Iqirvo (elafibranor) is a significant new medication for primary biliary cholangitis (PBC). Despite the common misspelling 'Icarvo,' this dual PPAR-α/δ agonist is a valuable second-line option for adults not responding to or intolerant of UDCA. It improves liver function markers by reducing bile acid buildup and inflammation. Healthcare providers must manage potential side effects like muscle issues and bone fractures. For eligible patients, Iqirvo offers a positive step in managing this chronic liver disease.
For more detailed prescribing information, refer to the official package insert provided by the FDA.
