[LbPeB9017] QD multicenter study: simplification therapy with once-daily NVP+DDI+TDF (Tenofovir)

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] QD multicenter study: simplification therapy with once-daily NVP+DDI+TDF (Tenofovir)

[AUTHOR(S):] Eugenia Negredo, Jordi Puig, Silvia Gel, Eva R Arisa, Carmina R Fumaz, Guillem Sirera, Sebastià Videla, Bonaventura Clotet¹, Esteve Ribera², Pompeyo Viciana³, Enric Pedrol⁴, Celia Miralles⁵, M José Galindo⁶, Guadalupe Gómez⁷

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. LbPeB9017

[ABSTRACT:]

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 once-daily (QD) administered NVP+DDI+TDF in antiretroviral-experienced 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<80 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<80 copies/ml. 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/l 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.

Presenting author: Eugenia Negredo

1 Lluita contra la SIDA Foundation. Germans Trias i Pujol Hospital, Barcelona, Spain.

2 Vall d’Hebron Hospital. , Barcelona, Spain.

3 Virgen del Rocio Hospital. , Sevilla, Spain.

4 Hospital, Barcelona, Spain.

5 Xeral de vigo Hospital, Vigo, Spain.

6 Clínico de valencia Hospital, Valencia, Spain.

7 Statystical Department. Politechnic University of Catalonia, Barcelona, Spain.

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