[TuPe1.1C25] Effect Of Ritonavir-Boosted Atazanavir (Atv/R) In Experienced HIV-Infected Patients Regarding Chronic Hepatitis B/C Status

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

EFFECT OF RITONAVIR-BOOSTED ATAZANAVIR (ATV/R) IN EXPERIENCED HIV-INFECTED PATIENTS REGARDING CHRONIC HEPATITIS B/C STATUS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe1.1C25

Perez-Elias M.J.¹, Gatell J.M.², Flores J.³, Santos J.⁴, Vera F.J.⁵, Clotet B.⁶, Moreno A.¹, Vendrell B.⁷, Perez-Molina J.A.⁷, Alvarez C.⁷, Ledesma E.⁸, Serrano O.⁷
¹H Ramon y Cajal, Madrid, Spain, ²H Clinic i Provincial, Barcelona, Spain, ³H Arnau de Vilanova, Valencia, Spain, ⁴H Virgen de la Victoria, Malaga, Spain, ⁵H Nuestra Señora del Rosell, Murcia, Spain, ⁶H German Trias i Pujol, Barcelona, Spain, ⁷Bristol-Myers Squibb, Madrid, Spain, ⁸Bristol-Myers Squibb, Wallingford, United States of America

INTRODUCTION: Liver toxicity in HIV-HBV/HCV coinfected patients (Hep) may limit the use of some ARV regimens. Safety data from a prospective cohort of ATV/r-based HAART in co-infected patients are presented.

METHODS: Subjects receiving ATV/r-containing HAART (ATV/r plus NRTIs) were prospectively evaluated into the Spanish NESTED Studies of the Early Access Program. Thirty-three centers and 304 patients with available hepatitis-B/C status participated.

RESULTS: A total of 180 Hep and 124 non coinfected (noHep) were included in the analysis. Accumulated follow-up until study closure was 762 person-months (Hep, 120 patients (67%) reached 6m) and 551 person-months (noHep, 90 (73%) reached 6m). Baseline characteristics were similar for Hep and noHep, with 44% meeting AIDS definition and 27-33% being female subjects. Baseline HIV RNA <500 c/mL and CD4 (cells/mm³) were 40%/331 (Hep) and 32%/327 (noHep). Successful virological outcome (defined as maintaining/achieving viral load <500cp/mL or decreases >1Log) and CD4 change at 6m were 73.8%/+51 (Hep) and 74.4%/+53 (noHep).

	Hep Baseline	Hep month 6	Non Hep Baseline	Non Hep month 6
Median ALT (UI/L)	48	48	28	26
ALT >200 UI/L or ALT >3 times baseline abnormal levels, n (%)	2(1.1%)	2(1.9%)
Median total bilirubin (mg/dL)	0.6	1.9	0.4	1.8
% Total Bil >3 mg/dL		27.5%	0.8	24.7

Discontinuations due to adverse events were low in Hep (9.4%) and noHep (5.6%) with only 3 (1.7%) withdrawals due to elevated liver enzymes. Scleral icterus/jaundice rate leading to discontinuation was similar between groups, 4.4%(Hep) and 3.2%(NoHep). Only 3 subjects discontinued due to virological failure.

CONCLUSIONS: In this relatively large cohort, ATV/r-containing HAART in co-infected patients was not associated with worsening liver function tests (including transaminases and bilirubin) vs non-co-infected patients. Virologic failure was uncommon in both groups. Therefore, ATV/r was a generally safe and well tolerated treatment option in patients with HBV and/or HCV co-infection.

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050724
Clinical | TuPe1.1C25 | Maria Jesus Perez-Elias
Hepatitis viruses

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