Preference for buprenorphine/naloxone and buprenorphine among patients receiving buprenorphine maintenance therapy in France: a prospective, multicenter study.

Maintenance treatment with buprenorphine tablets (Subutex) has been associated with reductions in heroin use; however, concerns for intravenous misuse exist. A buprenorphine/naloxone formulation (Suboxone) was designed to reduce this misuse risk while retaining buprenorphine's efficacy and safety. This prospective, open-label, multicenter trial compared preferences for buprenorphine and buprenorphine/naloxone in 53 opioid-dependent patients stabilized on buprenorphine. Buprenorphine was first administered at the patient's current dose (Days 1-2), followed by a direct switch to buprenorphine/naloxone (Days 3-5). Global satisfaction rates were high and similar between buprenorphine and buprenorphine/naloxone; however, patients preferred the tablet taste, size, and sublingual dissolution time of buprenorphine/naloxone. At the end of the study, 54% of patients preferred buprenorphine/naloxone, 31% preferred buprenorphine, and 15% had no preference; most patients (71%) wished to continue treatment with buprenorphine/naloxone. This study did not identify any impediments to a direct buprenorphine-to-buprenorphine/naloxone switch and revealed some characteristics that may facilitate treatment with buprenorphine/naloxone.

Routine practice HCV infection screening with saliva samples: multicentric study in an intravenous drug user population.

OBJECTIVE: The purpose of this randomized multicentric study was to evaluate the diagnostic contribution of screening for HCV infection on saliva samples in day-to-day practice in the intravenous drug-user (IVDU) population. METHODS: Between January and May 2004, 274 presumably HCV-negative IVDU were screened for HCV infection in 15 centers in France (median age 29 years). After centralized randomization, screening tests were performed on blood samples (arm A) or saliva samples (arm B). Screening tests were performed in 78 subjects (28%) had never been screened before and in 196 subjects (72%) who had had a negative HCV screening test on average 12 months prior to the beginning of the study. In the event of a positive saliva test for anti-HCV Ab, a serum test for anti-HCV Ab was performed. In the event of a positive serum test for anti-HCV Ab, PCR was performed on serum to measure HCV-RNA. RESULTS: Fourteen individuals were positive for HCV RNA (7 in each arm). Six of these cases had not been detected before. In eight cases, the median time between the last negative screening test and study inclusion was 11 months (range 6-94 months). CONCLUSIONS: Viremia tests were positive in 5% percent of the target population, although one-third of the individuals in arm A (blood samples) were not tested. The saliva test may be a useful alternative in the event of refusal of a blood test or when poor venous conditions compromise venous puncture. A confirmatory blood test still remains difficult to obtain in nearly half of patients.

[An inter-laboratory study of anti-HCV antibody detection in saliva samples]. / Etude inter-laboratoires de la détection des anticorps anti-VHC sur prélèvements salivaires.

AIM: The purpose of this study was to evaluate the efficacy of anti-hepatitis C virus (HCV) antibody detection in the saliva samples of 108 drug users in an inter-laboratory study. METHODS: Between January and June 2001, 108 subjects in Lille, Metz and Lens received a test to detect anti-HCV antibodies in their saliva. Two consecutive saliva samples were taken in each subject (Salivette system, Sarstedt). An HCV serology (Axsym HCV 3.0, Abbott) was also performed and serum HCV RNA detection by Amplicor HCV 2.0 (Roche) was performed when HCV serology was positive. Sixty three patients had a negative HCV serology, 45 had a positive HCV serology, and 31 of these had positive HCV RNA as well. Tests for the detection of the anti HCV antibody in saliva samples were performed as a blind study in both the Lille and the Thionville laboratories. RESULTS: The sensitivity of saliva anti-HCV antibody tests was respectively 71% (32/45) and 78% (35/45) in Lille and Thionville. In the event of positive HCV viremia, the sensitivity was respectively 90% (28/31) and 93% (29/31). The specificity was respectively 97% (61/63) and 98.5% (62/63). Results from the two laboratories agreed for 101 saliva tests while discrepancies were found in 7 (Kappa Concordance Coefficient: 0.85). CONCLUSIONS: This study confirms, in a large, unselected population sample, that anti-HCV antibody detection tests in saliva allow the detection of 90% of viremic HCV-antibody-positive patients with excellent specificity. The simplicity and reproductibility of this technique makes it a precious tool for epidemiological studies.