Program Supplement [International Conference on AIDS (14th: 2002: Barcelona, Spain)]

LBOR16-1
RIBAVIC trial (ANRS HCo2): a controlled randomized trial of
pegylated-interferon alfa-2b plus ribavirin vs interferon alfa2b plus ribavirin for the initial treatment of chronic hepatitis
C in HIV co-infected patients: preliminary results
Perronne, Christian, Carrat, Fabrice, Bani Sadr, Firouze, Hor,
Thidaravy, Morand, Patrice, Lunel, Francoise, Rosenthal,
Eric, Pol, Stanislas, Cacoub, Patrice, Study group,
For the ANRS HCO2 (France)
Background: HCV morbidity and mortality is increasing in HIVinfected patients. We compared the safety, tolerability, and
efficacy of a 48 week-course of the standard (lFNa2b: 3 MIU x3/w,
n=210) to the pegylated (PEG-IFNa2b: 1.5 pg/kg xi/w, n=2o6)
interferon + ribavirin combination (8oo00mg/d, = 12 mg/kg/d).
Methods: A randomized, multicenter, parallel-group, open-label
trial. Inclusion criteria were: HCV-RNA positive and abnormal liver
histology, CD4 > 200/ml, stable HIV-RNA, stable HAART or off
HAART. Primary endpoint was the virologic response rate (loss of
detectable serum HCV RNA) at week 72.
Results: The 416 patients (40 y, 73% male, 79% IVDU) were given
HAART in 80%; they had a mean CD4 cell count of 515 ~ 228/ml,
HIV RNA< 200 cp in 60% (mean viral load in others: 3.48 ~ 0.8
logs) and belonged to the CDC class A, B & C in 56, 28 & 16%
respectively. The mean pre-treatment Metavir score was A 1.8 ~
0.7, F 2.3 ~ 1.0, 39% of pts had F3-F4 of which 16% had sustained
normal ALT. Baseline variables at entry were not different
between groups. In tested serum samples, a virologic response
at W48 was observed in 27% of IFN group pts (n=118) and 44%
of PEG group pts (n=11o)- p=o.oo9. The response rate varied
with genotypes 1 and 4 (19%/) vs 2 and 3 (57%/), but not with the
Metavir score or the adjusted ribavirin dose for bodyweight.
Treatment discontinuation have been reported in 124 pts (30%)
and severe adverse events in 99 (24/%))(42 IFN & 57 PEG). A
significant decrease (p<o.ool) was observed at the early stage of
treatment (W12) in Hb (IFN: -1.5g/dl; PEG:-1.8g/dl; p=o.o4),
neutrophils (IFN: -693;PEG: -1298; p=o.oo35), lymphocytes (IFN:
-317; PEG: -542; p=o.12; including -44 CD4 and -69 CD4, p=0.21)
and platelets (IFN: -16.ooo; PEG: -33 00ooo0; p=0.02).
Conclusion: PEG-lFNa2b + ribavirin is associated with a
superior HCV virologic response and a quite similar adverseevent profile at the end of treatment. Long term response will
be further evaluated.
Corresponding author: Carrat, Fabrice, INSERM U444, 27,
rue Chaligny, Paris, France, Tel: + 33 1 44 73 84 58,
Fax: + 33 1 44 76 84 62, Email: [email protected]
[ LBOR17I
Efficacy and safety of tenofovir disoproxil fumarate (TDF)
versus stavudine (d4T) when used in combination with
lamivudine (3TC) and efavirenz (EFV) in HIV-1 infected
patients nalive to antiretroviral therapy (ART): 48-week
interim results
Staszewsk, 51, Gallant, J2, Pozniak, A3, Suleiman,
]MAH4, DeJesus, E2, Koenig, Es, Coleman, 52, Lu, B2, Cheng,
AK2, Coakley, DP, for the 903 Study Team,2
(Germany; 2United States; 3United Kingdom; 4Brazil;
5Dominican Republic)
Background: TDF is a single tablet, once daily nucleotide
analog reverse transcriptase inhibitor with potent activity
against wild-type and nucleoside resistant HIV. Prior studies
have demonstrated significant anti-HIV activity when TDF was
added to stable background ART in treatment-experienced

patients. Study 903 was designed to evaluate the efficacy and
safety of TDF as part of a fixed ART regimen in antiretroviral
naive patients over a 3-year period.
Methods: Phase III, multicenter, randomized, double-blind,
active-controlled trial in patients with HIV-1 RNA > 5,000
copies/mL with no requirement for entry CD4+ lymphocyte cell
count. Patients were randomized to receive either TDF (300oomg
qd) or d4T (40mg bid or 30mg bid if weight < 6okg) plus 3TC
(150omg bid) and EFV (6oomg qd). Patients randomized to TDF
received d4T placebo bid while those randomized to d4T
received TDF placebo once daily.
Results: The intent-to-treat (ITT) population included 600
patients with the following baseline characteristics: mean age
36 years, 76% male, 64% Caucasian, mean HIV-1 RNA 4.9
loglo c/mL; mean CD4 count 279 cells/mm3. Data from a week
48 interim analysis are shown below.
TDF/3TC/EFV d4T/3TC/EFV
(n=299) (n=3ol) 95% CI*

HIV RNA<4ooc/mL (ITT)
missing equals failure
missing values excluded
HIV RNA<5oc/mL (ITT)
missing equals failure
missing values excluded
Mean change in HIV RNA
(loglo c/mL)
Mean change CD4 cell count
(cell/mm3)
Study discontinuation (d/c)
Drug regimen d/c
for adverse events
_ Grade 3 adverse events
2 Grade 3 laboratory
abnormality

87%
95%
82%
90%
-3.o9
+169
9%
7%
19%
29%

87% -6,+5
96% -4, +2
81% -6, +6
89% -4, +5
-3.o9
+167
9%
6%
17%
32%

*For difference in TDF arm - d4t arm.
Conclusions: Through 48 weeks, combination therapy with TDF
was highly effective and comparable to d4T for safety and
efficacy in ART-nalve patients.
Corresponding author: Coakley, Dion, Gilead Sciences, 333
Lakeside Dr, Foster city, CA 94404, United States,
Tel: [phone], Fax: +i 6505225801,
Email: [email protected]
LBOR18
Growth hormone (Serostim~) effectively reduces viceral
adipose tissue (VAT) accumulation and non-HDL cholesterol
Kotler, Donald P, Thompson, Melanie, Grunfeld, Carl, Testa,
Macia, Turner, Ralph, Gertner, Joseph, Muurahainen,
Norma, Investigator Group, Hars (United States)
Background: This placebo-controlled, multi-center trial
evaluated recombinant human growth hormone (r-hGH,
Serostim~) in HIV-associated adipose redistribution syndrome
(HARS). HARS patients (pts) have pathological accumulation of
visceral adipose tissue (VAT), often with metabolic
abnormalities.
Methods: To be eligbile, men (M) needed a waist
circumference (WC) >88.2 cm and wasit/hip ratio (WHR)
>.95 and women (W) a WC >75.3 cm and WHR >.o9. Pts were
randomized (1:1:1) to placebo (P) or GH 4mg dosed daily (DD)
or on alternate days (AD) for 12 weeks (wks). VAT was
assessed by CT scan, body composition by DXA, and quality of
XIV International AIDS Conference BARCELONA - JULY 7-12

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