Session 105Poster Presentations HCV: Therapeutic Progress Session Day and Time: Wednesday 1:30 - 3:30 pm Room: Hall B
844 Serious Ophthalmologic Pathology with Visual Compromise in HIV/HCV Co-infected Patients Treated with Pegylated Interferon Alpha-2b and Ribavirin C. Farel*1, S. Kottilil1, M. McLaughlin1, C. Ternisky1, C. Koratich1, J. Kovacs2, J. Tavel1, R. Davey1, J. Falloon1, H. Masur2, J. Metcalf1, M. Robinson3, M. Polis1 1Natl Inst of Allergy and Infectious Diseases, NIH, Bethesda, MD; 2Clin Ctr, NIH, Bethesda, MD; and 3Natl Eye Inst, NIH, Bethesda, MD
Background: Ophthalmologic disorders are recognized side effects of interferon-alpha (IFN). While retinal vascular occlusions, retinal hemorrhages, and cotton wool spots (CWS) have been reported in patients (pts) treated with IFN, optic neuropathy is uncommon but sight threatening.
Methods: An open-label prospective trial treated HIV/HCV co-infected pts (CD4+ T-cell counts = 100 cells/mm3) with Peg-IFN alpha-2b 1.5 mug/kg sc qwk and RBV 600 mg po bid for 48 wks. Ophthalmologic evaluations including visual acuity, threshold visual field testing, color vision exam, and indirect ophthalmoscopy were performed at baseline and at least every 3 months.
Results: Nineteen (19) pts enrolled on study for a median of 26 wks (range, 1-46) with 16 followed for at least 12 wks. Subjects had a baseline median CD4+ T-cell count of 704 cells/mm3 (range, 108-1,273), median baseline HIV log VL of 1.69 copies/mL (range, 1.69-4.52) and median baseline HCV log VL of 6.61 copies/mL (range 5.80-7.35). Seven (7) of the 16 pts (44%) developed ophthalmologic pathology. Six (6) had CWS on 12 wk follow-up funduscopic examination. These lesions waxed and waned while therapy was continued. One (1) of these pts was found to have bilateral cataracts at 12 wks while another developed a unilateral cataract. One (1) pt exhibited a 50% decrease in color vision requiring cessation of interferon therapy. Color vision has improved over the 4 wks since peg-IFN was discontinued, but has not returned to normal.
Conclusions: The incidence of serious ocular pathology associated with treatment with anti-HCV therapy may be very high and is likely associated with peg-IFN. While HIV, hypertension, and diabetes mellitus are associated with these ocular lesions, incident cases of CWS and cataracts occurred in pts with high CD4+ T-cell counts and developed soon after beginning peg-IFN therapy. As with pts treated with ethambutol, medications toxic to retinal ganglion cells can cause lesions such as optic neuropathy and result in color blindness or loss of vision. Our findings suggest a need for increased vigilance in monitoring pts treated with peg-IFN for visual changes. Color vision testing should be a routine component of the standard examination, as loss of color vision may be a harbinger of serious optic neuropathy.