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Session 23 Oral Abstracts
HIV/HCV Co-Infection
Tuesday, 4 - 6:15 pm
Presentation Time: 4:30 pm
Room 3000


112
Final Results of APRICOT: A Randomized, Partially Blinded, International Trial Evaluating Peginterferon-alfa-2a + Ribavirin vs Interferon-alfa-2a + Ribavirin in the Treatment of HCV in HIV/HCV Co-infection
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 Dieterich*14
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-a-2a (IFN) 3-MIU 3 times a week plus 800 mg/day ribavirin (RBV), peginterferon-a-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)

PEGASYS/placebo (B)

PEGASYS/RBV (C)

 

(n = 285)

(n = 286)

(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)

p = 0.0078 vs A

116 (40)

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).

Keywords: Treatment; peginterferon; combination therapy