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

mutations were examined at baseline. Follow-up HBV-DNA
levels were measured every 12 weeks.
Results: One female and 8 males with a median age of 40
years-old were studied. They had received 3TC for a median of
84 weeks. 6/9 were HBeAg positive, and 3/12 were also
infected with hepatitis C virus. The median baseline HBV-DNA
levels was 4,970,00ooo copies/ml. 3TC-resistance mutations at
positions 552 plus/minus 528 were found in 6 subjects. In the
remaining 3, good adherence to the medication was
ascertained. The median time to follow-up was 24 weeks
(range, 12-48). No side effects related to TDF were reported. All
patients had a significant decrease in HBV DNA levels, with a
median (range) drop of 2.89 (0.71-4.70) loglo at 12-24 weeks.
One patient lost the HBsAg at 48 weeks, and has remained
with undetectable HBV-DNA thereafter.
Conclusions: TDF is very effective at reducing HBV DNA levels
in HIV/HBV coinfected patients carrying either wild type or
3TC-resistant viruses.
Corresponding author: Nhfiez, Marina, Hospital Carlos Ill,
c/ Sinesio Delgado, 10, 28029, Madrid, Spain,
Tel: [phone], Fax: [phone],
Email: [email protected]
LBPEB90o161
Lack of persistent drug-resistant mutations evaluated within
and between treatment interruptions (TI) in chronically HIV-1
infected patients
Papasavvas, Emmanouil, Grant, Robert, Sun,
Jun-wei, Mackiewicz, Agnes, Pistilli, Maxwell, Kostman, ay,
Mounzer, Karam, Montaner, Luis ] (United States)
Background: The effect of TIs on the evolution and persistence
of drug-resistant viruses in chronically HIV-1 infected
suppressed patients is undetermined.
Methods: The emergence of viral resistance to ART was
monitored in 11 suppressed chronically HIV-1 infected
patients (mean follow-up=326 days) undergoing from 1 up to
4 sequential TIs, by genotyping virus for known mutations in
the protease and RT gene (a total of 25 TIs). Resistance
assays were performed at the first viral rebound
> loo copies/mi.
Results: All subjects achieved re-suppression of HIV-1 under
the same ART, regardless of the number of TIs. 3/11 - who had
up to 3 sequential TIs - showed no development of resistance.
In the remaining 8, 7 mutations associated with viral
resistance were detected during the 1st TI (pre-existence of
these mutations is unknown). Three of these mutations were
persistent (L63P, 164V, K7oR) in 7 of these 8 subjects. However,
intermittent presence or loss of 6 mutations (M361, 164V, L63P,
M184V, N88N/D, L9oM) was found in 3/8 patients following
extended TIs, treatment re-initiation and/or during subsequent
TIs. Interestingly, 2 subjects showed evidence of evolution of a
mutation against 3TC (M184V) or d4T (K219E) not present
during the 1st TI, which subsequently disappeared following
therapy re-initiation or during next TIs.
Conclusions; Detection of drug-resistance during treatment
interruption does not predict failure to re-suppress after ART
re-initiation nor persistence of a resistant viral population
during interruptions or subsequent TIs.
Corresponding author: Montaner, Luis, Wistar Institute, 3601
Spruce Street, Philadelphia, PA, United States,
Tel: [phone], Fax: +i 215 573 7008,
Email: [email protected]

[LBPEB9017
QD multicenter study: simplification therapy with once-daily
NVP+DDI+TDF (Tenofovir)
Negredo, Eugenia, Ribera, Esteve, Viciana, Pompeyo, Pedrol,
Enric, Miralles, Celia, Galindo, M Josd, Puig, Jordi, Gel,
Silvia, Arisa, Eva R, Fumaz, Carmina R, Sirera, Guillem, Gdmez,
Guadalupe, Videla, Sebastid, Clotet, Bonaventura (Spain)
Background: Antiretroviral therapy is not able to eradicate HIV
infection. Simplified strategies are required in order to assure
prolonged adherence.
Objective: To demonstrate the safety and the efficacy of oncedaily (QD) administered NVP+DDI+TDF in antiretroviralexperienced patients (pt), as well as to study the
pharmacokinetic interactions between DDI and TDF.
Patients and Methods: This is a multicenter study where pts
receiving HAART>9 months and with a VL<8o copies/ml >6 months
were randomised to NVP+DDI+TDF, 4 pills at breakfast time (QD
arm), or to maintain their current BID regimen (Control arm). HIV
RNA, CD4+ and fasting routine blood tests were performed every
12 weeks (wk), as well as clinical events, quality of life (QOL) and
adherence. TDF and DDI intracellular levels are being analized.
Due to ethical reasons, it was planned to performe an interin
analysis when at least 1/3 of pts per arm reached 24 wks.
Results: Sixty five out of 159 pts (41%) have reached wk24.
All but 2 pts, one of each arm, maintained VL<8o copies/mi.
No significant changes were seen in CD4+. A mean decrease of 61
mg/dl in triglyceride levels (from 224 mg/dl to 134 mg/dl) and a
mean increase of 134 U/1 in GGT (from 54 to 182 U/L) were seen
only in QD arm. Ten pts in QD regimen stopped treatment: 3
cases of hepatitis, 2 rash, 1 neuropathy and 1 severe dry mouth
and 3 pts did not continue scheduled visits. Five pts in control
arm were lost of follow-up, 2 of them for toxicity. Adherence was
similar between both arms but QOL improved in QD arm.
Conclusions: NVP, DDI and TDF, once daily at breakfast time,
seems to be equally active at wk24 than the standart of care
approches (BID regimens) in ARV-experienced pts with long-term
viral suppression. However, QD regimen improved triglyceride
levels and QOL. Minimal NVP-associated hepatoxicity was
observed in these pts while increase of DDI-related toxicity was
not found.
Corresponding author: Negredo, Eugenia, Lluita contra la SIDA
Foundation. Germans Trias i Pujol Hospital. C/ Canyet S/N,
Badalona 08916, Barcelona, Spain,
Email: [email protected]
[LBPEB90181
A prospective, multicenter, randomized trial comparing the
efficacy and safety of fenofibrate versus pravastatin in HIVinfected subjects with lipid abnormalities: ACTG 5087
Aberg, Judith, Zackin, Robert, Evans, Scott, Yang, Yijun, Alston,
Beverly, Henry, W.Keith, Glesby, Marshall, Brobst,
Susan, Owens, Susan, Fichtenbaum, Carl (United States)
Objective: To determine whether fenofibrate (F) and pravastain
(P) are equivalent and the safety of these agents in the
treatment of HIV-related dyslipidemia at week 12
Methods: HIV- infected persons with dyslipidemia (LDL _ 130
mg/dL and TG _ 2oo mg/dL) on ART for > 6 months were
randomized to receive either P 40 mg or F 2oo mg (F) daily.
Subjects who had failed to reach the National Cholesterol
Education Program (NCEP) goal (a composite of LDL, HDL, and
TG levels, and pre-existing CV risk factors) by week 12 received
both P and F and were followed for a total of 48 weeks.

XIV International AIDS Conference BARCELONA - JULY 7-12

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