Table 2.
Subject Pre- and Post-vector Co-morbidities, All Deemed Unrelated to Vector Administration
| Study ID (and Vector Dose in vg/kg) | Age at Vector Infusion/Follow-Up Duration (Years) | Previously Described Co-morbidities Prior to Vector Infusion5 | Co-morbidities Post-vector |
|---|---|---|---|
| Subject B (8 × 1010) | 48/14 | HCV | atrial fibrillation |
| HIV | cataracts | ||
| hemophilic arthropathya | HIV | ||
| liver fibrosis (F1)b | hypertension | ||
| non-Hodgkin’s lymphomac | kidney disease, stage 4 | ||
| NIDDM | |||
| hemophilic arthropathy, progressivea | |||
| Subject D (4 × 1011) | 20/13 | F1 liver fibrosisb | carpal tunnel, bilaterala |
| Gilbert’s disease | HCV | ||
| HCV | headaches, migraine with dizziness | ||
| headaches, migraine | HIV | ||
| hemophilic arthropathya | Gilbert’s disease | ||
| HIV | hemophilic arthropathy, progressivea | ||
| lipodystrophy | |||
| Subject G (4 × 1011) | 27/12.5 | hemophilic arthropathya | hemophilic arthropathy, progressivea |
| Subject E (2 × 1012) | 31/15 | hemophilic arthropathya | hemophilic arthropathy, progressivea |
| fatty liver infiltration |
vg, vector genomes; HCV, hepatitis C virus; HIV, human immunodeficiency virus; F1, fibrosis stage 1; NIDDM, non-insulin-dependent diabetes mellitus.
a
Co-morbidity deemed related to underlying hemophilia.
b
Metavir score determined by liver biopsy, repeat liver biopsies post-vector were not completed due to ethical concerns of performing a procedure in severe hemophilia B subjects with attendent hemorrhagic risk and no direct benefit.
c
Subject B was diagnosed with non-Hodgkin’s lymphoma and treated with chemotherapy and radiation prior to vector infusion and remained in remission throughout the duration of follow-up.