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An Italian Approach to Postmarketing Monitoring: Preliminary Results From the SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals) Project on the Safety of Lopinavir/Ritonavir

Bonfanti, Paolo MD*; Martinelli, Canio MD; Ricci, Elena MD*; Carradori, Silvia MD; Parruti, Giustino MD§; Armignacco, Orlando MD; Magnani, Carlo MD#; Quirino, Tiziana MD**for the CISAI Group (Italian Coordinators for the Study of Allergies HIV Infection)

JAIDS Journal of Acquired Immune Deficiency Syndromes: July 1st, 2005 - Volume 39 - Issue 3 - p 317-320
doi: 10.1097/01.qai.0000164248.56722.3c
Brief Report: Clinical Science

The SCOLTA project (Surveillance Cohort Long-term Toxicity Antiretrovirals) is a system for online surveying of adverse reactions to recently commercialized antiretroviral drugs and a “sentinel” for unexpected and late adverse reactions arising during any antiretroviral treatment (available at: http://www.cisai.info). To date, 25 Italian departments of infectious diseases have participated at the project. The New Drugs Project is a prospective, multicenter, observational pharmacovigilance study involving 1 cohort of patients for each new drug. All patients who were consecutively started on lopinavir (LPV), tenofovir (TDF), peginterferon (IFN), atazanavir (ATZ), enfuvirtide (T-20), and tipranavir (TPV) were enrolled. All grade III or IV adverse events (according to the AIDS Clinical Trials Group definitions) are reported on the web site. The Unexpected Events Project identifies unexpected adverse reactions during treatment and reports them. This paper presents the preliminary findings for the New Drugs Project. Between October 1, 2002, and March 30, 2004, 1184 patients were enrolled. The lopinavir/ritonavir (LPV/r) cohort comprises 703 patients, the TDF cohort 585, IFN 35, ATZ 95, T-20 10, and TPV 8. So far 100 grades III and IV adverse events have been reported, 73 in the LPV/r group. In this cohort the rate of adverse events per 100 person-years was 14.2 on the basis of all patients treated, 9.8 for treatment-naive patients, and 15 for treatment-experienced patients. These findings, though preliminary, show that this data collection method gives timely real-life information from which to assess the impact of short- and long-term toxicity of new antiretroviral drugs.

From the Department of Infectious Diseases, Luigi Sacco Hospital, Milan, Italy; †Department of Infectious Diseases, Careggi Hospital, Florence, Italy; ‡Department of Infectious Diseases, Sant'Anna Hospital, Ferrara, Italy; §Department of Infectious Diseases, Pescara Hospital, Pescara, Italy; ¶Department of Infectious Diseases, Viterbo General Hospital, Viterbo, Italy; #Department of Infectious Diseases, Legnano General Hospital, Milan, Italy; and Department of Infectious Diseases, Busto Arsizio Hospital, Busto Arsizio, Italy.

Received for publication July 17, 2004; accepted March 21, 2005.

Supported by an ISS grant (project no. 30F.43) from Ministry of Health, Rome, Italy.

Reprints: Tiziana Quirino, Department of Infectious Diseases, Busto Arsizio Hospital, Piazza Solaro 3, 21052 Busto Arsizio, Italy (e-mail: t.quirino@virgilio.it).

© 2005 Lippincott Williams & Wilkins, Inc.