11th International AIDS Conference


Vancouver, British Columbia — July 7-12, 1996

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Saquinavir in the treatment of HIV infection: patterns of use in the French Compassionate use programme, 1996.

Int Conf AIDS 1996 Jul 7-12; 11:32 (abstract no. LB.C.6050)
Rousselle B, Dohin E, Pichon F, Andriamanamihaja M, Goehrs JM; Produits Roche, Medical Department, Neuilly-sur-Seine, France. Fax: 33 1 46.40.53.31.

OBJECTIVE: To describe patterns of use for the Roche HIV Protease Inhibitor (PI), Saquinavir during the French Compassionate use programme (see below for clarification of ATU) since February 1996.

METHODS: Saquinavir (SQV) was the first HIV PI to be made available to the French AIDS patients (pts). Access was through the French ATU system. Criteria for use included CD4 cells count of less than 200 cells/mm3 and prior intolerance or failure to at least 3 nucleoside analogues (AN). SQV was given at recommended dose of 600 mg TID.

RESULTS: First pts were enrolled in the French compassionate use programme for SQV in February 1996. 1200 pts were included during the first 3.5 months. SQV was provided widely and free of charge (through 250 physicians in more than 100 hospitals). Pts baseline characteristic data were: 78% male, mean age: 38.8 years, mean weight: 64 kg, mean CD4 cells count: 67/mm3. 50% out of the pts were classified as C3 of the CDC 1993 classification system. Mean prior antiretroviral therapy duration was 3.6 years. SQV was given as a monotherapy to 17 patients (1.4%) because of intolerance to all available ANs and in combination (98%) to all remaining participants. 60% were tri-therapy (SQV+ 2AN) and 38.6% were bitherapy (SQV+1 AN). The most common combination therapies (80.2%) observed are listed below: (Table: see text) The safety profile of SQV in French compassionate use programme was favorable. Only 10 out of the 1200 pts presented an adverse event (4 related to the HIV disease, 1 neuropathia, 1 hematotoxicity in association with 3TC and ZDV, 1 seizure, 3 cutaneous rash).

CONCLUSION: As the first of a new class of antiretrovirals, the PI, to be made available in France for the treatment of pts with advanced HIV disease, SQV was administered in predominantly combination with AN (98%) and as a triple therapy in 60% of cases. In this very advanced and very longly pretreated population, SQV demonstrated excellent safety and tolerability. These results indicate that SQV is well tolerated in combination with a variety of AN. (An ATU (Temporary Authorisation of Use) is a French legal way to provide patients with an experimental drug before registration).

Keywords: AEGIS, Saquinavir, HIV Infections, HIV Protease Inhibitors, CD4 Lymphocyte Count, Zidovudine, Reverse Transcriptase Inhibitors, Lamivudine, Exanthema, France, Male, Human, therapy, drug therapy, ICA11KWDaegis,saquinavir,hivinfections,hivproteaseinhibitors,cd4lymphocytecount,zidovudine,reversetranscriptaseinhibitors,lamivudine,exanthema,france,male,human,therapy,drugtherapy,ica11

960707
LBC6050

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