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Maviret for people with HCV and chronic kidney disease

In a study called Expedition-5, researchers enrolled 110 participants who had moderate to severe kidney injury and chronic HCV infection. Participants were assigned to receive one of the following regimens:

  • 8 weeks of Maviret – 84 people
  • 12 weeks of Maviret – 13 people
  • 16 weeks of Maviret – four people

The average profile of participants upon entering the study was as follows:

  • age – 60 years
  • most participants had HCV genotypes 1 to 4
  • viral load – 1 million IU/mL
  • most participants had a moderate degree of liver injury
  • no participant was co-infected with hepatitis B virus

Staging of kidney disease

The researchers used the estimated glomerular filtration rate (eGFR) to assess participants’ degree of kidney injury. Participants fell into the following categories based on eGFR results:

  • stage three – an eGFR between 30 and 44
  • stage four – an eGFR between 15 and 29
  • stage five – an eGFR less than 15 or being dependent on dialysis (about 60% of participants required dialysis)

Results

Results were made available for 101 (of 110) participants, as the remainder were still being monitored to assess if they were cured from HCV.

Of the 84 people who were taking the 8-week regimen, 81 were cured. Two participants left the study prematurely because of itchy skin, and in one case, intestinal obstruction. The third person stopped attending the study clinic.

Among the 13 people who took the 12-week regimen, all were cured.

Among four people who took the 16-week regimen, all were cured.

Adverse events

The most common adverse event was itchy skin, reported in 6% of participants.

Lab tests did not detect any serious abnormalities.

Most participants with stage 3 or 4 chronic kidney disease did not have their eGFRs change after being cured. However, two participants had their eGFR improve after being cured and two others had their eGFR decline after being cured.

Bear in mind

  • All participants who completed treatment were cured.
  • Maviret was generally well tolerated, with the most common side effect being itchy skin in a minority of participants.
  • Maviret did not affect the health of the kidneys.

—Sean R. Hosein

REFERENCE:

Persico M, Aglitti A, Bruchfeld A, et al. Efficacy and safety of glecaprevir/pibrentasvir in renally-impaired patients with chronic hepatitis C virus genotype 1-6 infection. International Liver Congress, 11-15 April 2018, Paris, France. Poster THU-363.