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Post-exposure prophylaxis for HIV infection: a clinical trial comparing lopinavir/ritonavir versus atazanavir each with zidovudine/lamivudine.
Antivir Ther. 2012; 17(2):337-46.AT

Abstract

BACKGROUND

A clinical trial comparing the rate of discontinuation and tolerability of two post-exposure prophylaxis (PEP) regimens was performed.

METHODS

A total of 255 individuals attending the emergency rooms of six hospitals for exposure to HIV and criteria to receive PEP were randomized to receive zidovudine/lamivudine plus either lopinavir/ritonavir (n=131) or atazanavir (n=124; day 0). The primary end point was the rate of PEP discontinuation before day 28 of follow-up. Secondary end points were incidence of side effects, follow-up at days 90 and 180 and rate of seroconversions.

RESULTS

A total of 55 patients (29 in lopinavir/ritonavir and 26 in atazanavir arms) did not attend the first scheduled appointment (day 1) and were excluded from the analysis. The rate of discontinuation before day 28 owing to any cause was similar between groups (37/102 [36%] in lopinavir/ritonavir and 35/98 [36%] in atazanavir arms, P=0.82). Adverse events were the reason for discontinuation or switching of PEP in 33 individuals (16/102 [16%] in the lopinavir/ritonavir arm and 17/98 [17%] in the atazanavir arm, P=0.84). Adverse events were reported in 92/200 (46%) of individuals on PEP who attend at least the day 1 appointment (50/102 [49%] in the lopinavir/ritonavir arm and 42/98 [43%] in the atazanavir arm, P=0.38). There were no seroconversions.

CONCLUSIONS

The rate of discontinuation of PEP before day 28 was similar with zidovudine/lamivudine plus either lopinavir/ritonavir or atazanavir. The rate of discontinuation of PEP because of adverse events was low in both arms. Almost 50% of the patients of both arms suffered side effects. New strategies are needed to improve the tolerance.

Authors+Show Affiliations

Hospital Clinic, University of Barcelona, Barcelona, Spain.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22293542

Citation

Diaz-Brito, Vicens, et al. "Post-exposure Prophylaxis for HIV Infection: a Clinical Trial Comparing Lopinavir/ritonavir Versus Atazanavir Each With Zidovudine/lamivudine." Antiviral Therapy, vol. 17, no. 2, 2012, pp. 337-46.
Diaz-Brito V, León A, Knobel H, et al. Post-exposure prophylaxis for HIV infection: a clinical trial comparing lopinavir/ritonavir versus atazanavir each with zidovudine/lamivudine. Antivir Ther. 2012;17(2):337-46.
Diaz-Brito, V., León, A., Knobel, H., Peraire, J., Domingo, P., Clotet, B., Dalmau, D., Cruceta, A., Arnaiz, J. A., Gatell, J. M., & García, F. (2012). Post-exposure prophylaxis for HIV infection: a clinical trial comparing lopinavir/ritonavir versus atazanavir each with zidovudine/lamivudine. Antiviral Therapy, 17(2), 337-46. https://doi.org/10.3851/IMP1955
Diaz-Brito V, et al. Post-exposure Prophylaxis for HIV Infection: a Clinical Trial Comparing Lopinavir/ritonavir Versus Atazanavir Each With Zidovudine/lamivudine. Antivir Ther. 2012;17(2):337-46. PubMed PMID: 22293542.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-exposure prophylaxis for HIV infection: a clinical trial comparing lopinavir/ritonavir versus atazanavir each with zidovudine/lamivudine. AU - Diaz-Brito,Vicens, AU - León,Agathe, AU - Knobel,Hernando, AU - Peraire,Joaquim, AU - Domingo,Pere, AU - Clotet,Bonaventura, AU - Dalmau,David, AU - Cruceta,Anna, AU - Arnaiz,Joan Albert, AU - Gatell,Josep M, AU - García,Felipe, AU - ,, Y1 - 2011/11/25/ PY - 2011/06/11/accepted PY - 2012/2/2/entrez PY - 2012/2/2/pubmed PY - 2012/7/24/medline SP - 337 EP - 46 JF - Antiviral therapy JO - Antivir Ther VL - 17 IS - 2 N2 - BACKGROUND: A clinical trial comparing the rate of discontinuation and tolerability of two post-exposure prophylaxis (PEP) regimens was performed. METHODS: A total of 255 individuals attending the emergency rooms of six hospitals for exposure to HIV and criteria to receive PEP were randomized to receive zidovudine/lamivudine plus either lopinavir/ritonavir (n=131) or atazanavir (n=124; day 0). The primary end point was the rate of PEP discontinuation before day 28 of follow-up. Secondary end points were incidence of side effects, follow-up at days 90 and 180 and rate of seroconversions. RESULTS: A total of 55 patients (29 in lopinavir/ritonavir and 26 in atazanavir arms) did not attend the first scheduled appointment (day 1) and were excluded from the analysis. The rate of discontinuation before day 28 owing to any cause was similar between groups (37/102 [36%] in lopinavir/ritonavir and 35/98 [36%] in atazanavir arms, P=0.82). Adverse events were the reason for discontinuation or switching of PEP in 33 individuals (16/102 [16%] in the lopinavir/ritonavir arm and 17/98 [17%] in the atazanavir arm, P=0.84). Adverse events were reported in 92/200 (46%) of individuals on PEP who attend at least the day 1 appointment (50/102 [49%] in the lopinavir/ritonavir arm and 42/98 [43%] in the atazanavir arm, P=0.38). There were no seroconversions. CONCLUSIONS: The rate of discontinuation of PEP before day 28 was similar with zidovudine/lamivudine plus either lopinavir/ritonavir or atazanavir. The rate of discontinuation of PEP because of adverse events was low in both arms. Almost 50% of the patients of both arms suffered side effects. New strategies are needed to improve the tolerance. SN - 2040-2058 UR - https://www.unboundmedicine.com/medline/citation/22293542/Post_exposure_prophylaxis_for_HIV_infection:_a_clinical_trial_comparing_lopinavir/ritonavir_versus_atazanavir_each_with_zidovudine/lamivudine_ L2 - https://ClinicalTrials.gov/search/term=22293542 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -