Title
Ledipasvir/Sofosbuvir Is Effective as Sole Treatment of Porphyria Cutanea Tarda with Chronic Hepatitis C
Authors
Herbert L. Bonkovsky1, Sean P. Rudnick1 , Christopher D. Ma1 , Jessica R. Overbey2 , Kelly Wang2 , Denise Faust1 , Csilla Hallberg3 , Karli Hedstrom4 ,
Hetanshi Naik4 , Akshata Moghe3 , Karl E. Anderson3
Journal
Digestive Diseases and Sciences
Abstract:
Background and Aims: and Aims Chronic hepatitis C [CHC] is a risk factor for porphyria cutanea tarda [PCT]. To assess whether ledipasvir/sofosbuvir is effective for treating both PCT and CHC, we treated patients with CHC + PCT solely with ledipasvir/sofosbuvir
and followed them for at least 1 year to assess cure of CHC and remission of PCT.
Methods: Between September 2017 and May 2020, 15 of 23 screened PCT + CHC patients were eligible and enrolled. All were treated with ledipasvir/sofosbuvir at recommended doses and durations, according to their stage of liver disease. We measured plasma
and urinary porphyrins at baseline and monthly for the first 12 months and at 16, 20, and 24 mos. We measured serum HCV RNA at baseline, 8–12, and 20–24 mos. Cure of HCV was defined as no detectable serum HCV RNA ≥ 12 weeks after the
end of treatment (EOT). Remission of PCT was defined clinically as no new blisters or bullae and biochemically as urinary uro- plus hepta-carboxyl porphyrins ≤ 100 mcg/g creatinine.
Results: All 15 patients, 13 of whom were men, were infected with HCV genotype 1. 2/15 withdrew or were lost to follow up. Of the remaining 13, 12 achieved cure of CHC; 1 had complete virological response, followed by relapse of HCV after ledipasvir/sofosbuvir
but was subsequently cured by treatment with sofosbuvir/velpatasvir. Of the 12 cured of CHC, all achieved sustained clinical remission of PCT.
Conclusions: Ledipasvir/sofosbuvir [and likely other direct-acting antivirals] is an effective treatment for HCV in the presence of PCT and leads to clinical remission of PCT without additional phlebotomy or low-dose hydroxychloroquine treatment. Trial
Registration ClinicalTrials.gov NCT03118674.