Study suggests Kaletra/Combivir is better tolerated PEP than Combivir/nelfinavir

Lopinavir/ritonavir (LPV, Kaletra) and AZT/3TC (zidovudine and lamivudine, Combivir) is “significantly” better tolerated as a post-exposure prophylaxis (PEP) than AZT/3TC plus nelfinavir, according to French researchers.

Dr Christian Rabaud, of the Service des Maladies Infectieuses et Tropicales, Vandoeuvre-les-Nancy, France, presented the preliminary findings of a study at the 42nd ICAAC. Rabaud says the improved tolerance could be because the intrinsic gut tolerance of LPV is better than that of nelfinavir.

The researchers conducted a prospective study of patients seeking HIV prophylaxis at six hospitals in eastern France. Ninety-eight patients were prescribed LPV and AZT/3TC over a 12-month period. The patients were 21 healthcare workers, 56 people who were exposed through sexual contact, two intravenous drug users, and 19 who were exposed to HIV by other means.

The HIV serological status of the source person could be determined in 30 (28.5%) cases; the source person was recognised as seropositive in 16 (53.5%) of these cases. Three people had not begun the prescribed PEP. Nine people were lost to follow-up. Tolerability could be evaluated in 86 people.

In 17 cases, PEP was discontinued before Day Five because the source person was recognised as HIV-seronegative or because the injury was reassessed as “low-risk”. In three (18%) of these cases, side effects were noted before this discontinuation. In 17 other cases, PEP was discontinued for adverse effects (median treatment period = seven days). Fifty-two people completed the 28 days of AZT/3TC plus LPV PEP and 27 (52%) experienced at least one adverse effect: diarrhoea (78%), nausea (63%), asthenia (48%) and/or skin rash (15%). Finally, in the 69 people who should have completed PEP, 44 (64%) experienced at least one side effect.

The researchers conclude: “Tolerability of [AZT/3TC plus LPV] PEP appeared significantly better when compared with [AZT/3TC plus nelfinavir] PEP (side effects : 64% vs 85%; p < 0,003).

Comment

Although encouraging it has to be emphasised that this was a single arm study compared to an historical control.

C Rabaud, C Burty, F Truchetet et al. Tolerability of Post-Exposure Zidovudine/Lamivudine + Lopinavir/Ritonavir Prophylaxis of HIV Infection. Presentation Number: H-177. Poster Board Number: 177