Treating patients with both hepatitis C and severe kidney disease has always been one of our greatest challenges. Last month at the AASLD Liver Meeting in Boston, I witnessed what could be a game-changing moment: the presentation of the EXPEDITION-4 trial results for glecaprevir/pibrentasvir.
Understanding the Patient Population
Let me paint a picture of the challenges these patients face. Every week in my clinic, I see how hepatitis C accelerates kidney damage. Just yesterday, I met with a 60-year-old patient whose kidney function declined so rapidly he started dialysis within a year of his HCV diagnosis. This trial specifically targeted people like him – patients with stage 4 or 5 kidney disease, most (82%) already on dialysis.
The Treatment Breakthrough
The beauty of this new combination lies in its simplicity – one daily dose of glecaprevir/pibrentasvir (300/120mg), with no need for ribavirin. What excites me most is that neither drug depends on kidney excretion. After years of carefully adjusting doses for kidney function, having a treatment that bypasses this concern feels revolutionary.
The Numbers That Matter
The results exceeded my expectations: 98% cure rate across all genotypes. In twenty years of treating HCV, I’ve never seen such consistent success in kidney patients. Think about it – whether you had genotype 1 or the traditionally harder-to-treat genotype 3, the treatment worked. I had a patient last week who’d failed three previous treatments due to kidney complications; this kind of option would transform his prospects.
Safety Profile in Practice
The side effect profile particularly impressed me. Yes, about a quarter experienced serious adverse events, but none were treatment-related. Compare this to my experience with older regimens, where I often had to stop treatment due to complications. The most common complaints – itching (20%), fatigue (14%), and nausea (12%) – are manageable. One of my dialysis patients recently asked me, “Doctor, how bad will the side effects be?” Now I can offer reassuring, evidence-based answers.
Current Treatment Landscape
Until now, we’ve been working with limited options. For genotype 1, we have the ‘3D’ regimen or grazoprevir/elbasvir, but what about my patients with other genotypes? Sofosbuvir-based treatments require such careful kidney monitoring that many of us avoid them entirely in severe kidney disease. Just last month, I had to decline treatment for a genotype 3 patient because our current options were too risky.
Real-World Applications
Looking at the study population – 80% male, 25% black, median age 57 – I see my kidney clinic patients reflected accurately. The inclusion of treatment-experienced patients (40%) and those with cirrhosis (20%) makes these results particularly relevant. These aren’t cherry-picked easy cases; they represent our challenging daily practice.
Implementation Challenges
While we await approval, I’m already planning implementation strategies. We’ll need coordinated care between hepatology and nephrology, careful monitoring protocols, and clear communication channels. I’m developing a checklist for my dialysis unit staff to monitor these patients effectively.
Looking Forward
This treatment could fundamentally change our approach to HCV in kidney disease. No more watching helplessly as patients’ conditions deteriorate while we wait for safer treatment options. The pangenotypic efficacy means we can treat immediately, without the delays of genotype testing.
Practical Implications
This morning, I reviewed my patient list and identified fifteen people who could benefit from this treatment once approved. For each one, it represents not just a cure for HCV, but potentially improved kidney transplant candidacy, better dialysis outcomes, and enhanced quality of life. That’s the real impact of these clinical trial results – transformed lives, one patient at a time.