11th Conference on Retroviruses and Opportunistic Infections


San Francisco, California - February 8 - 11, 2004

Print this Article


Final Results of APRICOT: A Randomized, Partially Blinded, International Trial Evaluating Peginterferon-α-2a + Ribavirin vs Interferon-α-2a + Ribavirin in the Treatment of HCV in HIV/HCV Co-infection

Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th:Abstract No. 112

F J Torriani1, J Rockstroh2, M Rodriguez-Torres3, E Lissen4, J Gonzalez5, A Lazzarin6, G Carosi7, J Sasadeusz8, C Katlama9, J Montaner10, H Sette11, F Duff12, J DePamphilis12, U M Schrenk13, and D Dieterich14
1Univ. of California, San Diego, USA; 2Univ. of Bonn, Germany; 3Fndn. de Investigación de Diego, Santurce, PR, USA; 4Virgen del Rocío Univ. Hosp., Seville, Spain; 5Hosp. La Paz, Madrid, Spain; 6San Raffaele Vita-Salute Univ., Milan, Italy; 7Univ. of Brescia, Italy; 8Royal Melbourne Hosp., Australia; 9Hosp. Pitié-Salpêtrière, Paris, France; 10Univ. of British Columbia, Vancouver, Canada; 11Inst. de Infectologia Emilio Ribas, Sao Paulo, Brazil; 12Roche, Nutley, NJ, USA; 13Roche, Basel, Switzerland; and 14Mt Sinai Sch. of Med., New York, NY, USA

BACKGROUND: The AIDS Pegasys Ribavirin International Co-infection Trial (APRICOT) was designed to evaluate the safety and efficacy of HCV therapies approved for patients with HCV mono-infection in patients with HIV/HCV co-infection.

METHODS: We randomized 868 HIV/HCV co-infected subjects in 19 countries to 48 weeks of treatment with interferon-α-2a (IFN) 3-MIU 3 times a week plus 800 mg/day ribavirin (RBV), peginterferon-α-2a (40 kD) 180 mg weekly (PEGASYS) plus placebo, or PEGASYS 180 mg weekly plus 800 mg/day RBV. Eligible subjects were HCV RNA and HCV antibody positive, had compensated liver disease, a CD4+ count ≥100 cells/mL, and stable HIV disease, with or without antiretroviral therapy (ART). The primary endpoint, sustained virological response, was defined as HCV RNA <50 IU/mL at the end of 24 weeks of treatment-free follow-up (week 72), determined by the COBAS AMPLICOR HCV Test v 2.0. Sustained virological response rates were compared by Cochran-Mantel-Haenszel test stratified by geographical region, genotype and CD4+ count using a closed testing procedure.

RESULTS: A total of 860 subjects received study drugs. Final week-72 results are presented in the table:

  IFN/RBV (A)
(n = 285)		 PEGASYS/placebo (B)
(n = 286)		 PEGASYS/RBV (C)
(n = 289)
Baseline Characteristics
Male (%) 81 82 80
Caucasian (%) 78 79 80
Age (years)a 40±7.6 40±7.4 40±7.9
HCV RNA (103 IU/mL)a 5208±5954 6354±6429 5616±6434
ALT (IU/L)a 87±53 88±57 85±50
HCV genotypes 1, 2, 3, 4, other (%) 60, 5, 26, 8, <1 61, 6, 26, 7, 0 61, 4, 28, 6, 0
HIV RNA (copies/mL)b 50 50 50
CD4± (cells/mL)a 542±270 530±265 520±277
Receiving ART (%) 84 85 84
Cirrhosis/bridging fibrosis (%) 16 16 15
Safety Outcome (%)
Treatment discontinuations
Overall 111 (39) 90 (31) 72 (25)
Adverse effects or lab abnormalities 44 (15) 47 (16) 43 (15)
Serious adverse effects (treatment-related c) 15 (5) 28 (10) 24 (8)
Deaths (overall/treatment-related c) 3/1 5/0 4/1
Neutropenia (<0.5 x 109/L) 1 (<1) 37 (13) 31 (11)
HCV Virological Outcome (%)
End-of-treatment 41 (14) 95 (33) 143 (49)
Sustained virological response
Overall		 33 (12) 58 (20) 116 (40)
    p = 0.0078 vs A p < 0.0001 vs A and B
HCV genotype 1 12/171 (7) 24/175 (14) 51/176 (29)
HCV genotypes 2&3 18/89 (20) 32/90 (36) 59/95 (62)
aMean±SD bMedian cConsidered possibly/probably related

CONCLUSIONS: The combination of PEGASYS + RBV produced significantly higher sustained virological response rates than conventional IFN + RBV in HCV/HIV co-infection (40% vs 12%, p <0.0001).

040208
112

Copyright © 2004 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.