Important note: Information in this article was accurate in December 2003. The state of the art may have changed since the publication date.
 |
HIV Treatment Bulletin - December 2003 / January 2004
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.
Ref: Hicks C, Da Silva B, King KR et al. 5-year results of lopinavir/ritonavir (lpv/r)-based therapy in antiretroviral-naïve HIV-infected patients. European AIDS Conf 2003 Oct 25-29;9:7.3/16 (Abstract no. 165).
5-Year Results of Kaletra-based Therapy in Treatment-naïve HIV Patients
© Copyright 2003 by HIV and Hepatitis.com. All Rights Reserved. Reproduction for personal or educational use is encouraged and does not require permission. Written permission is required to re-print copyrighted articles but is almost always granted (email publisher@HIVandHepatitis.com).
031210
IB30410-09
©2003. I-BASE HIV Treatment Bulletin. Permission to reproduce courtesy of HIV i-Base, Third Floor East, Thrale House, 44-46 Southwark Street, London SE1 1UN - T: +44 (0) 20 7407 8488 F: +44 (0) 20 7407 8489
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.
