Five-year results of Kaletra-based therapy in treatment-naïve HIV patients

Antiretroviral regimens have demonstrated potent virologic and CD4 responses, but longer-term data are needed to evaluate the durability of these responses.

One hundred antiretroviral-naïve patients received one of three doses of Kaletra (lopinavir/ritonavir, LPV/r) with d4T and 3TC twice-daily. After 48 weeks, all patients received LPV/r 400/100 mg twice-daily with d4T and 3TC.

Median baseline HIV viral load and CD4 count were 4.9 log10 copies/mL and 338 cells/mm3 respectively. Prior to week 252, 32 patients discontinued study therapy due to adverse events (13%) or other reasons [loss to follow-up, nonadherence, personal reasons (19%)].

At year five (week 252), 67/68 (observed data, 99%) and 67/100 (intent-to-treat, 67%) had viral load <400 copies/mL. The only HIV RNA measurement >400 copies/mL at year five occurred during a lengthy treatment interruption.

Through five years, no PI-associated mutations have been observed in patients with virologic failure.

Median CD4 increase from baseline to week 252 was 505 cells/mm3 among patients continuing therapy. The most common drug-related moderate/severe side effects through week 252 were diarrhoea (28%), nausea (16%), abdominal pain (10%), and asthenia (9%).

Sixteen and 13 patients initiated lipid-lowering agents (LLA) with total cholesterol >240 mg/dL or triglycerides >400 mg/dL (measured without regard to fasting); from LLA initiation to the final value available through week 252, total cholesterol and triglycerides decreased by a median of 24% and 32%, respectively.

The statins used were pravastatin in 11 patients, atorvastatin in nine, and four received both; nine patients used a fibrate, eight of them fenofibrate. Three patients used both a statin and a fibrate. Initiation of lipid-lowering therapy was at the discretion of the investigator and was not study defined.

“Lipid elevations are relatively common with lopinavir/ritonavir,” commented Dr Hicks, “but the most important piece of information here is that standard lipid-lowering therapy can have a pretty good impact, at least in this small subset of patients.”

LPV/r-based therapy demonstrates sustained antiretroviral activity and is generally well tolerated in ARV-naïve patients through five years of therapy. Decreases in total cholesterol and triglycerides were observed in patients initiating lipid-lowering agents.


Hicks C, Da Silva B, King KR et al. 5-year results of lopinavir/ritonavir (lpv/r)-based therapy in antiretroviral-naive HIV-infected patients. 9th EACS, Warsaw. 25-29 October 2003. Abstract 7.3/16.

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