THE SAFETY AND EFFICACY OF PROTEASE INHIBITORS (PIs) IN HEPATITIS C (HCV) CO-INFECTED PATIENTS

D Dieterich¹, M Fischl², D Rimland³, G Sepulveda^4
1Liberty Medical, LLP, New York, New York; ²University of Miami, Miami, Florida; ³Atlanta VA Medical Center, Atlanta, Georgia; ⁴Programa SIDA, Ponce, Puerta Rico

Background: With the prevalence of HCV/HIV co-infection ranging from 30%-50%+ depending on geographic location and mode of HIV transmission, the management of patients co-infected with HCV/HIV is a challenging issue. To profile immunologic and virologic outcomes in HCV co-infected patients (pts) receiving PI therapy for their HIV, we undertook a retrospective chart review of 1168 HCV/HIV co-infected patients who received >3 months of PI therapy.
Methods: This retrospective study collected safety data, viral load (VL), CD4 cell count (CD4) and treatment history (both HIV and HCV) from HCV/HIV co-infected patients while receiving a PI therapy for at least three months.
Results: To date, 877 case report forms have been reviewed (80% male, 20% female). Average age was 44.4 years. Mean yrs from HIV diagnosis was 8.84. Median baseline CD4 cell count (CD4) was 250 (range 0-1249) and median HIV-RNA (VL) was 4.11 log₁₀ (range <25-5,000,000 copies/mL). Mean time spent on PI-inclusive HAART was 29.7 months. 358 pts were on NFV, 300 pts were on IDV, 149 pts were on SQV, 127 were on RTV and 7 were on APV at some time during treatment. 87 patients were on dual PIs. Patients had a mean increase in CD4 of +145 cells, decrease in VL of –1.11 log₁₀ with 57% having a most recent VL<400 copies. For patients with baseline CD4<50 (n=133 (15%)), 50-200 (n=234 (27%)), and >200 (n=510 (58%)) mean CD4 changes were +176, +158, +131, and mean VL changes were –1.48log₁₀ (45%with VL<400), –1.21 log₁₀ (56% with VL<400), and –0.97log₁₀ (61%<400). 5% had a grade 3 or 4 elevation in AST (most recent), 6% had a grade 3 or 4 elevation in ALT (most recent). In comparison, those patients receiving NFV with baseline CD4<50 (n=62 (17%)), 50-200 (n=84 (24%)), and >200 (n=212 (59%)) mean CD4 changes were +179, +126, +97, and mean VL changes were –1.76 log₁₀ (45% with VL<400), –1.45log₁₀ (49% with VL<400), and –1.09log₁₀ (62% <400). 4% had a grade 3 or 4 elevation in AST (most recent), 3% had a grade 3 or 4 elevation in ALT (most recent).
Conclusions: NFV appears to be safe and efficacious in HCV/HIV co-infected pts. Among the PIs, it appears that NFV may be a safer agent to use based on comparisons of grade 3 and 4 elevations in AST and ALT.