AEGiS-10CROI: Adverse Drug Reactions Associated with Post-exposure Prophylaxis.

10th Conference on Retroviruses and Opportunistic Infections


Boston, MA USA - February 10 -14, 2003

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Adverse Drug Reactions Associated with Post-exposure Prophylaxis.

Conf Retroviruses Opportunistic Infect 2003 Feb 10-14;10th: abstract no. 711
Puro V, Carli GD, Soldani F, Lazarevic Z, Mattioli F, Ippolito G; Inst Natl per le Malattie Infettive L Spallanzani, Rome, Italy

BACKGROUND: Post-exposure prophylaxis (PEP) is widely used after exposures to HIV. PEP-associated side effects (SE) often occur, causing discontinuation (D).

METHODS: We reviewed data collected in the Italian PEP Registry (08/96-09/02). Cases were analyzed according to gender, initial regimen, and reasons for PEP. Outcomes were development of at least one SE and D (< 28 days). Drop-outs, unavailable data, D because HIV-negative source, and self-withdrawal without SE were excluded. AST/ALT changes were categorized according to the toxicity grading used by the ACTG, modified by Sulkowski et al. Statistical analysis was performed with SPSS or EPIINFO v6.

RESULTS: Enclosed in the analysis were 587 healthcare workers (HCW) and 52 safety/social workers (SSW) occupationally exposed, 87 persons exposed by sexual route, and 95 with other exposures. Regimens were AZT-3TC in 248 (30%) cases and AZT-3TC plus indinavir (426) or nelfinavir (64) in 490 (60%); 24 subjects received nevirapine (NVP). Rates of SE were higher among females (67% vs 61%), among PI-including PEP (67.5% vs 57.3%), and among HCW (70% vs 60% in SSW, 53% sex, 43% other). Similar results were observed in D rate (26.6% vs 22.6%; 26.1% vs 19.7%, and 28% vs 23%, 8%, and 17%, respectively). At multivariate analysis, PI-including PEP (OR 1.50, 95% CI, 1.09-2.06; p 0.01), and occupational exposures in HCW (OR 2.29, 95% CI, 1.65-3.18, p 0.001) were independently associated with an higher risk of SE, and of D (PI: OR 1.54, 95% CI, 1.06-2.24; p 0.02; HCW: OR 2.00, 95% CI, 1.32-3.04; p 0.001). Type and incidence of SE were similar to those reported in the literature. Grade 3 AST/ALT alteration was observed in 2 PI-including PEP (incidence: 0.5 per 100 person-month), while grade 4 was observed in 2 cases of 2-NRTI+NVP PEP (incidence: 17 per 100 person-month among those receiving NVP). In 2-NRTI PEP, 1 grade 3 AST/ALT alteration was observed associated with HCV-seroconversion.

CONCLUSIONS: A significantly higher risk of developing SE and D appears independently associated with PI-including PEP and with occupational exposures among HCWs and SSW in comparison to sexual and other exposures. Although on a limited sample, our data confirm a high frequency of severe liver toxicity associated with NVP. Drug-induced hepatotoxicity is rare, often mild-moderate, reversible, and slightly more frequent in the PI-containing PEP.

Keywords: AEGIS, Pharmaceutical Preparations, Drug Toxicity, Incidence, HIV Infections, Commonwealth of Independent States, Human, Female, toxicity, adverse effects, prevention & control, drug therapy, therapy, poisoningKWDaegis,pharmaceuticalpreparations,drugtoxicity,incidence,hivinfections,commonwealthofindependentstates,human,female,toxicity,adverseeffects,prevention&control,drugtherapy,therapy,poisoning

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Copyright © 2003 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.