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Abstract
Tolerability of fosamprenavir/ritonavir associated with zidovudine/lamivudine in HIV post exposure prophylaxis (PEP)
Burty C.1, Pavel S.2, Ghomari K.3, Vermersch A.4, Christian B.5, Pouaha J.6, Yasdanpanah Y.2, May T.1, Rabaud C.1
Background: Since 1998, we successively evaluated tolerance of different PEP regimens: zidovudine/lamivudine (Z/L) + nelfinavir, Z/L + lopinavir/ritonavir (Z/L+L/r), Z/L + tenofovir and tenofovir + lamivudine + atazanavir/ritonavir. We finally recommended to use Z/L+L/r as PEP considering tolerance, cost and efficiency. But the rate of adverse events (AE) and treatment interruption with Z/L+L/r remained important; then we decided to test a new association: Z/L + fosamprenavir/ritonavir BID (Z/L+F/r), choice based on multiple arguments: using a protease inhibitor as recommanded by French 2003 guidelines, reducing the pill burden to improve patient adherence.
Methods: Multicentric prospective study with standardized forms.
Results: Between November 2005 and April 2006, 54 persons were included in 6 French hospitals. Consultants were 57.5% women; mean age was 29.8±9 years; 67% were sexual exposure, 29% professional exposure. Only 3 persons were lost to follow-up. No grade 3 or 4 AE, neither clinical nor biological, was observed. But grade 1 or 2 AE were reported by 64.3% of treated subjects: mostly nausea and/or vomiting (73%), asthenia (61.5%), diarrhea (57.5%), rash (11.5%). 18 persons stopped treatment for another reason than AE (source patient known HIV seronegative or revaluation of risk). Among 28 others patients, 12 (54.5%) reported at least one AE, which leaded to premature treatment interruption in 6 cases (21.4%). No HIV, HBV nor HCV seroconversion occurred during the study.
Conclusion: When comparing tolerability of Z/L+F/r with others previously tested in the same conditions, specially Z/L+L/r, we did not observe statistically significant difference. But, we prematurely stopped the study because report of occurrence of two grade 4 liver toxicity and one grade 2 cutaneous toxicity in 2 patients not included in the study but receiving Z/L+F/r as PEP. Then, considering these severe AE observed by others, we stop our study and do not recommend to further use Z/L+F/r as PEP.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
CDC021
Suggested Citation
"BurtyC., et al.
Tolerability of fosamprenavir/ritonavir associated with zidovudine/lamivudine in HIV post exposure prophylaxis (PEP).
:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
CDC021"
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