Wake Forest University School of Medicine Winston-Salem, NC
Herbert Bonkovsky, MD1, Sean Rudnick, MD1, Denise Faust, CCRC1, Michelle Moore, PA-C2, Christopher Ma, BS1, Kelly Wang, MPH3, Csilla Kormos-Hallberg, MD4, Karli Hedstrom, BS5, Hetanshi Naik, PhD5, Karl E. Anderson, MD6 1Wake Forest University School of Medicine, Winston-Salem, NC; 2Wake Forest Baptist Medical Center, Winston-Salem, NC; 3Mount Sinai Health System, New York, NY; 4University of Texas Medical Branch at Galveston, Galveston, TX; 5Icahn School of Medicine, New York, NY; 6University of Texas Medical Branch, Galveston, TX
Introduction: CHC is a risk factor for PCT. DAA alone can both cure CHC and lead to remission of PCT. We treated patients with CHC+PCT with ledipasvir/sofosbuvir [Harvoni] and followed them for >1 y to assess cure of CHC and remission of PCT.
Methods: We enrolled 15 previously untreated patients, 13 M, all with HCV genotype 1. 14 were White; 1 was Black. Mean age was 58.9 y. At baseline, HCV RNA in serum ranged from 0.26-4.32 x 106 IU/mL; and Metavir fibrosis scores, by Fibroscan or Fibrometer, were F1 [2], F2 [5], F3 [3], and F4 [2], not done in 3. At baseline, 7/15 had elevated serum ferritin suggesting iron overload; 10 regular alcohol use; 15 current or prior tobacco use. 1 had a genetic defect in UROD [familial PCT type 2]. We measured plasma and urinary porphyrins at baseline and monthly for the first 12 months and, whenever possible, at 16, 20, and 24 mos. We measured HCV RNA in serum at baseline, end-of-treatment, 8-12, and 20-24 mos. Cure of HCV was defined as no detectable HCV RNA in serum > 3 months after end-of-treatment [EOT]. Clinical improvement in PCT was assessed by skin exams for new PCT lesions. Remission of PCT was defined as normalization of plasma and urinary total porphyrins [< 0.9 mcg/dL and < 226 mcg/g creatinine, respectively] and normalization of porphyrin profile [< 41% uro-+ heptacarboxyl-porphyrins] by HPLC.
Results: 13/15 completed the study; 2 failed to return and were lost to follow-up. 11/13 who completed the study were cured of CHC and achieved clinical remission & biochemical improvement of PCT [no new blisters or bullae; decreased plasma & urinary total porphyrins]. 1 man had a complete virological response at EOT, followed by a low level of virological relapse. We treated him with Epclusa for 12 weeks with permanent cure of HCV. He continues to show clinical remission of PCT, albeit with an abnormal PCT-like pattern of urinary porphyrins. The other man, not cured after Harvoni, has active PCT & HCV; he has not yet been re-treated. Both continued alcohol and tobacco use. The other subjects who completed treatment and follow-up all achieved cure of CHC and are in clinical remission and biochemical amelioration of PCT.
Discussion: DAA are effective treatment of both HCV and PCT. We recommend initial treatment of HCV + PCT only with DAA. PCT does not decrease DAA efficacy to cure HCV.
Herbert Bonkovsky, MD1, Sean Rudnick, MD1, Denise Faust, CCRC1, Michelle Moore, PA-C2, Christopher Ma, BS1, Kelly Wang, MPH3, Csilla Kormos-Hallberg, MD4, Karli Hedstrom, BS5, Hetanshi Naik, PhD5, Karl E. Anderson, MD6. D0490 - Direct-Acting Antivirals [DAA] Are Effective as Sole Treatment of Porphyria Cutanea Tarda (PCT) With Chronic Hepatitis C [CHC], ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.