Short-term adverse effects from and discontinuation of antiretroviral post-exposure prophylaxis

V. Puro, G. De Carli, N. Orchi, L. Palvarini, A. Chiodera, M. Fantoni, C. Del Borgo, E. Iemoli, F. Niero, M. Monti, G. Micheloni, L. Caggese, C. Lodesani, G. Raineri, M. Massari, D. Drenaggi, G. Ippolito

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Objective: To evaluate short-term toxicity from and discontinuation of antiretroviral combination prophylaxis in HIV-exposed individuals in Italy. Design: Longitudinal, open study conducted by prospective collection of data in the National Registry of PEP. Setting: All the Italian centres dedicated to HIV related care and licensed by the Ministry of Health to dispense anti-retroviral drugs. Study population: Health care workers and other persons consenting to be treated with post exposure prophylaxis (PEP) after exposures to HIV. Results: Until October, 2000, 207 individuals receiving two nucleoside reverse transcriptase inhibitors (NRTIs), and 354 receiving two NRTIs plus a protease inhibitor (PI) were enrolled. More individuals experienced side-effects in the 3-drug group (53% and 62%, respectively; OR 0.68, (95% CI 0.48-0.98), p <0.03). However, the proportion of individuals discontinuing prophylaxis because of side-effects did not differ significantly between the 2 groups (21% and 25% respectively; OR 0.82 (95% CI 0.53-1.26); p=0.4). The 43 individuals in the 2 NRTI group discontinued PEP after a mean of 10.4 days of treatment (median 8, range 1-27), similarly to the 88 discontinuations observed in the 3-drug group (mean duration 10.5 days, median 7.5, range 1-26). Type and incidence of specific adverse effects were similar to those reported in the literature. Conclusion: Our study indicates that the difference in the proportion of individuals developing side effects and discontinuing PEP is not significant. The rate of discontinuation because of protease inhibitor side-effects does not justify per se the initial use of a less potent PEP regimen. We suggest initiating PEP with a three-drug regimen and discontinuing the protease inhibitor in the case of adverse effects.

Original languageEnglish
Pages (from-to)238-242
Number of pages5
JournalJournal of Biological Regulators and Homeostatic Agents
Volume15
Issue number3
Publication statusPublished - 2001

Fingerprint

Post-Exposure Prophylaxis
disease control
adverse effects
Reverse Transcriptase Inhibitors
Protease Inhibitors
Nucleosides
RNA-directed DNA polymerase
nucleosides
proteinase inhibitors
HIV
Pharmaceutical Preparations
drugs
Italy
Longitudinal Studies
Registries
acute toxicity
health care workers
Delivery of Health Care
Incidence
Health

Keywords

  • Antiretroviral
  • HIV infection
  • Occupational exposures
  • Post exposure prophylaxis
  • Toxicity

ASJC Scopus subject areas

  • Immunology
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology
  • Physiology (medical)
  • Medicine (miscellaneous)
  • Physiology
  • Agricultural and Biological Sciences(all)

Cite this

Short-term adverse effects from and discontinuation of antiretroviral post-exposure prophylaxis. / Puro, V.; De Carli, G.; Orchi, N.; Palvarini, L.; Chiodera, A.; Fantoni, M.; Del Borgo, C.; Iemoli, E.; Niero, F.; Monti, M.; Micheloni, G.; Caggese, L.; Lodesani, C.; Raineri, G.; Massari, M.; Drenaggi, D.; Ippolito, G.

In: Journal of Biological Regulators and Homeostatic Agents, Vol. 15, No. 3, 2001, p. 238-242.

Research output: Contribution to journalArticle

Puro, V, De Carli, G, Orchi, N, Palvarini, L, Chiodera, A, Fantoni, M, Del Borgo, C, Iemoli, E, Niero, F, Monti, M, Micheloni, G, Caggese, L, Lodesani, C, Raineri, G, Massari, M, Drenaggi, D & Ippolito, G 2001, 'Short-term adverse effects from and discontinuation of antiretroviral post-exposure prophylaxis', Journal of Biological Regulators and Homeostatic Agents, vol. 15, no. 3, pp. 238-242.
Puro, V. ; De Carli, G. ; Orchi, N. ; Palvarini, L. ; Chiodera, A. ; Fantoni, M. ; Del Borgo, C. ; Iemoli, E. ; Niero, F. ; Monti, M. ; Micheloni, G. ; Caggese, L. ; Lodesani, C. ; Raineri, G. ; Massari, M. ; Drenaggi, D. ; Ippolito, G. / Short-term adverse effects from and discontinuation of antiretroviral post-exposure prophylaxis. In: Journal of Biological Regulators and Homeostatic Agents. 2001 ; Vol. 15, No. 3. pp. 238-242.
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abstract = "Objective: To evaluate short-term toxicity from and discontinuation of antiretroviral combination prophylaxis in HIV-exposed individuals in Italy. Design: Longitudinal, open study conducted by prospective collection of data in the National Registry of PEP. Setting: All the Italian centres dedicated to HIV related care and licensed by the Ministry of Health to dispense anti-retroviral drugs. Study population: Health care workers and other persons consenting to be treated with post exposure prophylaxis (PEP) after exposures to HIV. Results: Until October, 2000, 207 individuals receiving two nucleoside reverse transcriptase inhibitors (NRTIs), and 354 receiving two NRTIs plus a protease inhibitor (PI) were enrolled. More individuals experienced side-effects in the 3-drug group (53{\%} and 62{\%}, respectively; OR 0.68, (95{\%} CI 0.48-0.98), p <0.03). However, the proportion of individuals discontinuing prophylaxis because of side-effects did not differ significantly between the 2 groups (21{\%} and 25{\%} respectively; OR 0.82 (95{\%} CI 0.53-1.26); p=0.4). The 43 individuals in the 2 NRTI group discontinued PEP after a mean of 10.4 days of treatment (median 8, range 1-27), similarly to the 88 discontinuations observed in the 3-drug group (mean duration 10.5 days, median 7.5, range 1-26). Type and incidence of specific adverse effects were similar to those reported in the literature. Conclusion: Our study indicates that the difference in the proportion of individuals developing side effects and discontinuing PEP is not significant. The rate of discontinuation because of protease inhibitor side-effects does not justify per se the initial use of a less potent PEP regimen. We suggest initiating PEP with a three-drug regimen and discontinuing the protease inhibitor in the case of adverse effects.",
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AU - Puro, V.

AU - De Carli, G.

AU - Orchi, N.

AU - Palvarini, L.

AU - Chiodera, A.

AU - Fantoni, M.

AU - Del Borgo, C.

AU - Iemoli, E.

AU - Niero, F.

AU - Monti, M.

AU - Micheloni, G.

AU - Caggese, L.

AU - Lodesani, C.

AU - Raineri, G.

AU - Massari, M.

AU - Drenaggi, D.

AU - Ippolito, G.

PY - 2001

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N2 - Objective: To evaluate short-term toxicity from and discontinuation of antiretroviral combination prophylaxis in HIV-exposed individuals in Italy. Design: Longitudinal, open study conducted by prospective collection of data in the National Registry of PEP. Setting: All the Italian centres dedicated to HIV related care and licensed by the Ministry of Health to dispense anti-retroviral drugs. Study population: Health care workers and other persons consenting to be treated with post exposure prophylaxis (PEP) after exposures to HIV. Results: Until October, 2000, 207 individuals receiving two nucleoside reverse transcriptase inhibitors (NRTIs), and 354 receiving two NRTIs plus a protease inhibitor (PI) were enrolled. More individuals experienced side-effects in the 3-drug group (53% and 62%, respectively; OR 0.68, (95% CI 0.48-0.98), p <0.03). However, the proportion of individuals discontinuing prophylaxis because of side-effects did not differ significantly between the 2 groups (21% and 25% respectively; OR 0.82 (95% CI 0.53-1.26); p=0.4). The 43 individuals in the 2 NRTI group discontinued PEP after a mean of 10.4 days of treatment (median 8, range 1-27), similarly to the 88 discontinuations observed in the 3-drug group (mean duration 10.5 days, median 7.5, range 1-26). Type and incidence of specific adverse effects were similar to those reported in the literature. Conclusion: Our study indicates that the difference in the proportion of individuals developing side effects and discontinuing PEP is not significant. The rate of discontinuation because of protease inhibitor side-effects does not justify per se the initial use of a less potent PEP regimen. We suggest initiating PEP with a three-drug regimen and discontinuing the protease inhibitor in the case of adverse effects.

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