128 patients were screened for entry into the study, 123 underwent an eye examination and 114 patients enrolled and initiated treatment (59 PEG α2a +RV, 55 PEG α2a + Placebo). The number of children who remained on treatment and underwent ophthalmologic examinations was 110 after 24 weeks and 103 after 48 weeks of treatment.
No patient had ischemic retinopathy at the screening eye exam prior to initiation of treatment. During the course of treatment, one patient (1 %) developed ischemic retinopathy with cotton wool spots and one patient (1%) developed uveitis. One patient complained of transient unilateral blindness which resolved spontaneously. Case summaries are detailed below.
Patient 1: Nine year old male with chronic HCV acquired by vertical transmission. Baseline ophthalmologic exam was normal with 20/25 vision in each eye. The subject received PEG α2a and RV. At 24 weeks he was found to have 20/25 vision in each eye without visual complaints. He had developed a single cotton-wool spot in the papillomacular bundle of the retina in the right eye. Per protocol, treatment was discontinued. Repeat examination one week later demonstrated scattered cotton wool spots in both eyes without any visual symptoms. Follow up exam 6 weeks later demonstrated resolution of the cotton wool spots without sequelae.
Patient 2: Twelve year old male with HCV. At entry, his eye exam was normal. Exam at 24 weeks was normal. He developed conjunctivitis 40 weeks into treatment that persisted. He completed 48 weeks of treatment with PEG α2a and placebo. At 48 weeks, he was reported to have uveitis which was treated with topical prednisolone acetate 1% and cyclopentylate 1%. The patient was poorly compliant with his medications and returned 4 weeks later with continued bilateral anterior uveitis. More intensive treatment was prescribed, but compliance continued to be poor with persistent uveitis at 16 months post initiation of treatment (5 months off treatment). Visual acuity was 20/60 in the right eye and 20/80 in the left eye. Slit lamp exam demonstrated small keratic precipitates in both eyes, with 1+ cells in the right anterior chamber and 3+ cells in the left anterior chamber. There were extensive synechiae in the left eye. The retinas were normal. Topical prednisolone was again prescribed, but 3 weeks later there were no significant changes. Oral prednisone (40 mg/day) was added to the topical therapy. The uveitis was rapidly controlled and over the next two months the oral prednisone was tapered and then discontinued. Twenty months from the start of treatment for HCV (9 months off treatment), both eyes were completely quiet off of all topical and systemic medications. However, extensive posterior synechiae persisted in the left eye (). Final visual acuity was 20/25 in the right eye and 20/20 in the left. Throughout the course of his ocular inflammatory disease he was never noted to have involvement of the vitreous, retina, retinal vessels or choroid of either eye. He was also never noted to have elevated intraocular pressures. In the course of his treatment a systemic workup found no cause for his iritis. Testing included normal ACE, lysozyme, ANA, RF, RPR and urine beta 2 microglobulin and negative serologies for Treponema pallidum and T. gondii.
Patient 2: Left eye with extensive synechiae (arrows) secondary to uveitis
Patient 3: Nine year old female with chronic HCV. She was treated with PEG α2a and RV. Eye exams at entry and at 24 weeks were normal. 36 weeks after enrollment she awoke complaining of the inability to see from the right eye. Her family chose to observe and not contact the medical team and used prayer therapy and her vision returned in approximately 60 minutes. This possible complication was brought to the attention of the research team 7 weeks later and therapy was discontinued. An ophthalmologic exam conducted 1 week later was normal.