Tag Archives: voxilaprevir

What Can Be Done for Patients with Hepatitis C Who Do Not Respond to the Newest Medications

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While the emergence of multiple highly-active agents for Hepatitis C has been a terrific advance, there are a small subset of patients who have not responded to them in almost all clinical trials.  A recent study (M Bourliere et al. NEJM 2017; 376: 2134-46) has identified a highly-effective combination regimen for this population: sofosbuvir/velpatasvir/voxilaprevir x 12 weeks

The authors conducted two phase 3 trials in patients who had not responded to a direct-acting antiviral (DAA) regimen previously.  POLARIS-1 and POLARIS-4. 46% of patients had compensated cirrhosis Key findings:

  • POLARIS-1: 96% of combination group had a sustained virologic response (SVR) compared with 0% of patients receiving placebo
  • POLARIS-4: the triple combination had a SVR of 98%, whereas 90% had SVR with dual therapy (sofosbuvir-velpatasvir)
  • Among patients receiving active treatment, less than 1% discontinue treatment due to advers events.

My take: This triple therapy is highly effective in patients who were  previously-treated with DAA for HCV.

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HCV Treatment: Nearing 100% Effectiveness

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While access to HCV treatment remains the biggest obstacle, recent studies show that the rates of HCV eradication, even in the toughest cases, now approaches 100%.

  • E Lawitz et al. Gastroenterol 2016; 151: 893-901.
  • EJ Gane et al. Gastroenterol 2016; 151: 902-9.
  • Editorial: M Buti pgs 795-8.

Most prior studies examined the use of two direct-acting antivirals (DAAs) with or without ribavirin.  These DAAs targeted nonstructural (NS) proteins necessary for HCV replication: NS3 protease, NS5B polymerase, and NS5A protein.

These two new studies examined whether treatment with a DAA targeting all 3 NS proteins would be effective and possibly allow shorter treatments.  It is noted that currently only treatment-naive genotype 1 (w/o cirrhosis) patients have a regimen that is recommended for only 8 weeks; these patients also should have HCV-RNA<6,000,000 IU/mL.

Lawitz et al studied the combination of sofosbuvir-velpatasvir and GS-9857 (voxilaprevir) for 6-8 weeks (one treatment group received ribavirin); n=197. Among treatment-naive patients w/o cirrhosis, SVR12 was 100% after 8 weeks of treatment and 94% of treatment-naive patients with cirrhosis.  Among treatment-experienced patients treated for 12 weeks, 100% of all patients (w and w/o cirrhosis) achieved SVR12.

Gane et al studied the effectiveness of the combination of sofosbuvir-velpatasvir and GS-9857 in HCV genotypes 2, 3, 4, and 6 (as well as 1 with 1b); n=128. After 8 weeks of treatment, SVR12s were achieved in 93% of treatment-naive patients with cirrhosis.  After 12 weeks, treatment-experienced patients with and without cirrhosis had SVR12s of 97% and 100% respectively.

My take: This combination of therapies should allow shorter treatment regimens in treatment-naive patients and effective rescue therapy for previous DAA failures. Now that we can cure almost everyone with HCV, how do make therapies affordable and accessible?

Glacier Nat'l Park

Glacier Nat’l Park