By Counterforce Health Team —

Tavneos (Avacopan): A New Oral Option for ANCA-Associated Vasculitis

ANCA-associated vasculitis (AAV) is a rare autoimmune disease in which the body’s immune system mistakenly attacks small blood vessels, causing inflammation and damage in organs such as the kidneys, lungs, nerves, and sinuses.

For years, the standard treatments for AAV—such as high-dose corticosteroids (like prednisone) combined with medications such as rituximab or cyclophosphamide—were effective but came with serious side effects.

In October 2021, the U.S. Food and Drug Administration (FDA) approved Tavneos® (avacopan), the first oral complement inhibitor developed specifically for adults with severe active ANCA-associated vasculitis. Tavneos offers a way to control inflammation while helping reduce dependence on long-term steroids.

What Is Tavneos?

Tavneos (avacopan) is a prescription oral medication used in combination with standard immunosuppressive therapy (such as rituximab or cyclophosphamide) to treat:

Adults with severe active ANCA-associated vasculitis (granulomatosis with polyangiitis or microscopic polyangiitis).

These conditions are both forms of AAV, autoimmune diseases caused by anti-neutrophil cytoplasmic antibodies (ANCAs) that trigger damaging inflammation in blood vessels.

Tavneos works differently from traditional treatments by targeting the complement system, a part of the immune response that drives inflammation in AAV.

Understanding ANCA-Associated Vasculitis

In AAV, the immune system produces ANCA antibodies that mistakenly activate neutrophils, a type of white blood cell.

When these neutrophils become overactive, they release harmful enzymes and inflammatory molecules that damage small blood vessels (capillaries), leading to:

  • Kidney inflammation (glomerulonephritis)
  • Lung inflammation (alveolitis or hemorrhage)
  • Sinus, nerve, or skin damage

Without treatment, AAV can cause organ failure or become life-threatening.

Traditional treatments suppress the immune system broadly, but they can also cause serious side effects, such as infections, high blood sugar, and osteoporosis from prolonged steroid use.

Tavneos offers a more targeted approach by blocking a key molecule that drives this immune overreaction.

How Tavneos Works

Tavneos is a complement C5a receptor antagonist — meaning it blocks the action of C5a, a powerful inflammatory signal in the complement cascade (part of the body’s immune defense system).

Here’s what that means:

  1. C5a binds to C5a receptors (C5aR1) on immune cells like neutrophils.
  2. This triggers inflammation and vessel damage in AAV.
  3. Tavneos blocks C5aR1, preventing C5a from activating these immune cells.
  4. As a result, inflammation decreases, helping protect organs and reduce symptoms.

By blocking this single pathway, Tavneos helps control the disease without broadly suppressing the immune system, potentially reducing some side effects of steroid-heavy regimens.

How Tavneos Is Taken

  • Form: Oral capsule
  • Dose: 30 mg (three 10 mg capsules) taken twice daily with food
  • Used with: Rituximab or cyclophosphamide as part of a combination regimen

Tavneos does not replace standard immunosuppressants—it works alongside them to help reduce the need for long-term corticosteroids.

Clinical Evidence and FDA Approval

Tavneos was approved based on results from the ADVOCATE Phase 3 clinical trial, which compared Tavneos + standard therapy to high-dose steroids + standard therapy in adults with severe AAV.

Key findings:

  • Tavneos was as effective as prednisone at controlling disease activity at 26 weeks.
  • At 52 weeks, Tavneos showed superior sustained remission (66% vs. 55% with prednisone).
  • Patients receiving Tavneos had fewer corticosteroid-related side effects such as weight gain, diabetes, and bone loss.
  • Kidney function improved significantly in many participants, a crucial outcome for AAV patients.

These results established Tavneos as an effective and safer long-term option for managing ANCA-associated vasculitis.

Benefits of Tavneos

Tavneos offers several key advantages for eligible patients:

  • Effective control of inflammation and vasculitis symptoms
  • Reduced reliance on long-term corticosteroids
  • Improved kidney outcomes in patients with renal involvement
  • Convenient oral dosing (no infusions or injections)
  • Sustained remission over time with fewer steroid-related complications

For many people with AAV, Tavneos represents a step toward better disease control and quality of life.

Possible Side Effects

Like all medications, Tavneos can cause side effects. Most are mild to moderate, but some can be serious.

Common side effects:

  • Nausea
  • Headache
  • Diarrhea
  • Fatigue
  • High blood pressure
  • Rash

Serious but less common side effects:

  • Liver problems (elevated liver enzymes or jaundice)
  • Infections (such as urinary tract or respiratory infections)
  • Allergic reactions (swelling, rash, difficulty breathing)

Because Tavneos affects the immune system, liver function and infection risk should be monitored regularly through blood tests.

Who Can Receive Tavneos

Tavneos is approved for adults with severe, active ANCA-associated vasculitis, including:

  • Granulomatosis with polyangiitis (GPA)
  • Microscopic polyangiitis (MPA)

It is not approved for use as monotherapy or for patients with milder disease that can be managed with standard treatment alone.

Before starting Tavneos, doctors typically check:

  • Liver function
  • Infection history
  • Concomitant medications (to avoid interactions)

Monitoring and Follow-Up

Patients on Tavneos should have regular check-ups and lab monitoring, including:

  • Liver function tests (ALT, AST, bilirubin)
  • Signs of infection
  • Kidney function (especially in those with renal disease)
  • Blood pressure checks

If serious infection or liver problems develop, Tavneos may be paused or discontinued.

Practical Considerations

  • Storage: Store at room temperature in the original container.
  • Missed dose: Take as soon as remembered, unless it’s close to the next dose (never double up).
  • Lifestyle: Continue following medical and dietary advice for managing AAV and overall health.
  • Combination therapy: Tavneos is used with other AAV treatments, not as a replacement.

The Bottom Line

Tavneos (avacopan) represents a major step forward in the treatment of ANCA-associated vasculitis. By targeting the complement pathway, it provides effective disease control with the potential to reduce dependence on steroids — and with it, many of the complications that long-term steroid use can bring.

For patients living with this rare and challenging condition, Tavneos offers a new, more precise way to calm inflammation, protect vital organs, and sustain remission.