Ocular Surface Changes With Sofosbuvir in Egyptian Patients With Hepatitis C Virus Infection.

Purpose: To evaluate the effect of oral sofosbuvir on the ocular surface of Egyptian patients with chronic hepatitis C virus infection.

Methods: This prospective randomized comparative study was performed on 300 eyes undergoing sofosbuvir therapy with peginterferon and ribavirin and on 300 eyes undergoing treatment with only peginterferon and ribavirin. Patients were evaluated for dry eye subjectively (Ocular Surface Disease Index questionnaire) and objectively, Schirmer test, tear film breakup time, and conjunctival nucleus/cytoplasm ratio by impression cytology.

Results: The Ocular Surface Disease Index score significantly changed from 3.1 ± 2.8 at baseline to 11.9 ± 4.1 and 15.2 ± 3.8 after 1 and 3 months of therapy, respectively, in the sofosbuvir group but had decreased to 7.6 ± 6.2 by 3 months after cessation of therapy. Mean Schirmer test values showed a significant change in the sofosbuvir group from 17.5 ± 2.7 mm at baseline to 10.8 ± 1.4 and 7.0 ± 2.5 mm after 1 and 3 months, respectively, and started returning to normal (11.0 ± 3.3 mm) after 1 month of treatment and mean tear film breakup time varied from 11.0 ± 5.2 seconds at baseline to 9.2 ± 2.6 and 6.1 ± 1.2 seconds at 1 and 3 months, respectively (P < 0.001). The mean nucleus/cytoplasm ratio was significantly different from 1/1.5 at baseline to 1/1.9 and 1/2.4 at 1 and 3 months, respectively, and persisted 3 months after discontinuation of therapy (nucleus/cytoplasm ratio 1/2.0). These changes were not the same in the non-sofosbuvir group.

Conclusions: Impairment of tear function and squamous metaplastic changes in the ocular surface occurred in patients with chronic hepatitis C treated with sofosbuvir combined with other antivirals.