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Coverage provided by Brian A. Boyle, M.D., J.D.

July 10, 2001

• Nevirapine-Containing Antiretroviral Therapy in HIV-1-Infected Patients Results in an Anti-Atherogenic Lipid Profile (Poster 496)
  Authored by Van Der Valk, M.; Kastelein, J.; Murphy, R.; Katlama, C.; Horban, A.; Gelsby, M.; Reiss, P.; Academic Medical Center, International Antiviral Therapy Evaluation Center (IATEC) Location TO-120, Amsterdam, NA, The Netherlands

Nevirapine Has Favorable Effects on Plasma Lipid Profiles

Clinicians who treat HIV-infection are now convinced, and rightly so for most patients, that highly active antiretroviral therapy (HAART) has converted HIV into a chronic condition that must be managed as such. Therefore, significant attention is now paid to issues that were given short shrift just a few years ago. One of these issues is lipid abnormalities. Since most of the currently available protease inhibitors (PIs) are associated with elevated triglyceride, and total and LDL-cholesterol levels, there is concern that the long-term use of these agents may expose patients to an increased risk of coronary artery disease (CAD).

In an effort to determine whether antiretroviral regimens that do not include a protease inhibitor are more "heart friendly," researchers evaluated the data from the Atlantic Study. Most will recall that the Atlantic study compared treatment outcomes in antiretroviral-naive patients treated with a nucleoside analogue backbone of stavudine and didanosine plus either nevirapine, indinavir or lamivudine. In this presentation they reported the lipoprotein profiles of some of the patients randomized to the different arms of that study.

One hundred and fourteen of the 298 patients in the Atlantic Study were included in this substudy. The patients included had remained on randomized treatment for 24 weeks and had sufficient stored nonfasting, plasma samples available from weeks 0, 6 and 24 after the initiation of treatment. At week 24 of treatment, HDL-cholesterol (HDL-c), apoAI, and LpAI -- important lipid markers for coronary artery disease risk -- had increased in the 34 patients in the nevirapine arm, included in the substudy, by 49%, 19% and 38%, respectively. In the 39 patients in the lamivudine arm, included in the substudy, HDL-cholesterol (HDL-c), apoAI, and LpAI had increased by 16%, 7% and 18%, respectively, and in the 41 patients in the indinavir arm included in the substudy by 16%, 5% and 17%, respectively. The increase of HDL-c, LpAI and apoAI in the nevirapine arm was significantly higher when compared to changes in the indinavir and lamivudine arm (p<0.01).

In addition, the total cholesterol/HDL ratio -- which is considered the best predictor for risk of coronary artery disease -- declined by 14% in the nevirapine arm (p=0.002), 9% in the lamivudine arm (p=0.029) and 0.9% in the indinavir arm (p=0.825).

These data indicate that non-protease-inhibitor-based regimens have a lower coronary artery disease risk profile than protease-inhibitor-based regimens; however, the long-term benefit of this profile remains somewhat unclear. Coronary artery disease risk is based upon many years, and in some cases decades, of unfavorable plasma lipid elevation. Whether the generally low-grade and relatively short-term elevations in lipids associated with usage of some antiretrovirals -- which in most cases will be used for several years or so at most -- will have long-term consequences has yet to be established by any clinical trial. And trials conflict regarding whether protease-inhibitors are associated with an increased risk of cardiovascular mortality. Still, these data may be helpful in designing antiretroviral regimens, especially for patients with significant lipid elevations or coronary artery disease risk factors at baseline.

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