Table 13.
Four Pivotal Studies of Treatment of Chronic Hepatitis C in HIV-Infected Persons
| Number enrolled | 868 | 133 | 412 | 95 |
| Peginterferon | 2a | 2a | 2b | 2b |
| Ribavirin | 800 mg | 600 up to 1g | 800 mg | 0.8 g, 1 g, 1.2 g1 |
| HIV and CD4+ status | >200/mm3 or 100–200/mm3 and HIV RNA < 5000 c/mL | >100/mm3 and HIV RNA <10,000 c/mL | >200/mm3 | >250/mm3 and HIV RNA < 10,000 c/mL |
| ALT | “Elevated” twice | NA | NA | 1.5 ULN |
| % Genotype 12 | 60 | 77 | 48 | 55 |
| % bridging fibrosis or cirrhosis2 | 12 | 11 (cirrhosis) | 39 | 29 |
| Genotype 1 peg-RBV SVR rate3 | 29% | 14% | 17% | 38% |
Abbreviations: ALT, alanine aminotransferase; ULN, upper limit of normal; c/mL, copies/mL; NA, not applicable. Table adapted from Thomas, HEPATOLOGY 2006;43:S221–S229.
1
Based on body weight <65, 65–75, >75 kg.
2
Taken from peginterferon and ribavirin arm; cirrhosis defined as F4–6 MHAI or F3–4 Metavir and Scheurer.
3
Refers to the sustained virologic response (SVR) rate for HIV-infected persons taking peginterferon and ribavirin. Rates are for patients with genotype 1 hcv infection except for the RIBAVIC and Barcelona studies that grouped genotypes 1 and 4.