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A Guide to Primary Care of People with HIV/AIDS Chapter 6: Metabolic Complications of Antiretroviral Therapy 6 LIPID ABNORMALITIES What antiretroviral medications adversely affect lipid levels? Available data suggest that drugs in the protease inhibitor (PI) class have the greatest adverse effect on triglycerides, total cholesterol, and low-density lipoprotein (LDL) cholesterol levels. The mechanism remains unclear. Among the PIs, ritonavir (RTV) and ritonavir-boosted regimens appear to have the greatest impact on triglycerides and total cholesterol levels. Because some patients who receive ritonavir had no significant changes whereas others have dramatic increases, genetic predisposition may play a major role. The PI atazanavir (ATV) does not significantly affect lipid levels. The impact of nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) on lipid levels has not been well defined, but the impact appears much less than changes associated with PIs. In 96-week data from a trial that compared stavudine (d4T) plus lamivudine (3TC) plus efavirenz (EFV) with tenofovir (TDF) plus lamivudine plus efavirenz, those patients in the stavudine arm had significantly higher cholesterol and triglyceride levels. The NNRTI nevirapine (NVP) has no adverse affect on lipids, and the changes with efavirenz are variable. Patients receiving PIs should undergo regular monitoring of lipid levels (see Table 6-2). Do antiretroviral drugs cause an increase in cardiovascular disease? Several isolated case reports initially suggested ART could lead to cardiovascular disease, including death from myocardial infarction, in HIV-infected patients. More recent aggregate data from over 20,000 patients in cohort studies indicate the risk related to ART is low and substantially lower than the risk of smoking (Friss-Moller, et al, 2003). In addition, in a large study that involved more than 36,000 veterans, investigators found the benefit of these drugs far outweighed the risks. Because cardiovascular disease may take 10-15 years to manifest, investigators will need long-term followup of individuals who have received ART to determine the long-term impact. Table 6-2. Recommendations for Assessment and Monitoring of Metabolic Complications of Antiretroviral Therapy for HIV Infection Glucose and lipid abnormalities Body fat distribution abnormalities Lactic acidemia Osteopenia, osteoporosis, and osteonecrosis DEXA HDL LDL NCEP NNRTI NRTI • The following assessments are recommended before initiation of potent ART, at the time of a switch of therapy, 3 to 6 months after starting or switching therapy, and at least annually during stable therapy: - Fasting glucose (if therapy includes a PI) - Fasting lipid panel (total cholesterol, HDL, and LDL cholesterol [calculated or direct], and triglyceride levels) • A blood glucose level after oral administration of 75 g of glucose may be used to identify impaired glucose tolerance in patients with risk factors for type 2 diabetes mellitus or those with severe body fat changes. • No specific technique can be recommended at the present time for routine assessment and monitoring of body fat distribution changes. • Routine measurement of lactic acid levels is not recommended. • Lactic acid levels should be monitored in those receiving NRTIs who have clinical signs or symptoms of lactic acidemia, and in pregnant women receiving NRTIs. • If alternative NRTIs are resumed in those who have interrupted antiretroviral therapy for lactic acidemia, lactate levels should be monitored every 4 weeks for at least 3 months. • Routine screening for osteoporosis or osteonecrosis is not recommended. • Radiographic examination of involved bone is recommended for those with symptoms of bone or joint pain; the contralateral joint should also be assessed. = dual-energy x-ray absorptiometry = high-density lipoprotein = low-density lipoprotein = National Cholesterol Education Program = non-nucleoside reverse transcriptase inhibitor = nucleoside reverse transcriptase inhibitor Source: Schambelan M, Benson CA, Andrew Carr A, et al. Management of metabolic complications associated with antiretroviral therapy for HIV-1 infection: Recommendations of an International AIDS Society-USA Panel. J Acquir Immune defic Syndr. 2002;31:269. Reprinted with permission of Lippincott Williams and Wilkins, http://lww.com. 40 U.S. Department of Health and Human Services, Health Resources and Services Administration, HIV/AIDS Bureau
A Guide to Primary Care of People with HIV/AIDS Chapter 6: Metabolic Complications of Antiretroviral Therapy Should you treat abnormal lipid levels in HIVinfected persons? Although prospective studies have not clearly defined the long-term adverse cardiovascular effects associated with hyperlipidemia in HIV-infected persons, abnormal lipid levels appear to pose the same long-term risks as have been well established in persons who do not have HIV infection and thus need to be managed appropriately (see Table 6-3). Accordingly, clinicians should address abnormal lipid levels and the individual patient risks, including prior cardiovascular events, smoking, hypertension, diabetes, family history, obesity, and baseline lipid levels. The potential interventions include 1) switching to a regimen less likely to cause abnormal lipids (if possible without sacrificing antiviral effectiveness), 2) implementing dietary changes, 3) using a lipid-lowering agent according to recommendations in Table 6-4, and 4) addressing other lifestyle habits that affect cardiovascular risk, such as smoking and exercise. What statins are recommended for treating patients on PIs? Significant drug interactions may occur with PIs and lipid-lowering statins; for patients on PI-based ART, most experts consider pravastatin and atorvastatin as preferred statins and avoid using lovastatin or simvastatin. Initial therapy should consist of a low dose of either pravastatin (20 mg po qd) or atorvastatin (10 mg po qd), with monitoring of response to therapy and, if required, gradual and cautious increases in doses of the statin. Triglyceride levels in excess of 1000 mg/dL place the patient at risk for developing pancreatitis. Most experts recommend intervening 6 Table 6-3. Recommendations for Treatment of Metabolic Complications of Antiretroviral Therapy for HIV Infection Glucose intolerance and diabetes mellitus Lipid and lipoprotein abnormalities Body fat distribution abnormalities Lactic acidemia Osteopenia, osteoporosis, and osteonecrosis • Weight loss for overweight subjects is recommended. • Follow established guidelines for treating diabetes in the general population, with preference given to insulin sensitizing agents such as metformin (except for those with renal disease or history of lactic acidemia) or thiazolidinediones (except for those with prexisting liver disease). • Avoid use of a PI as initial therapy in patients with preexisting glucose intolerance or diabetes mellitus. • Follow NCEP III guidelines for assessment of risk factors for cardiovascular disease, and dietary and lifestyle alterations for lowering cholesterol and triglyceride levels. • Avoid use of PIs, if possible, in those with preexisting cardiovascular risk factors, family history of hyperlipidemia, or elevated lipid levels. • Follow NCEP guideline thresholds for lipid-lowering therapy. • Fibrates are recommended as initial therapy for those with isolated fasting hypertriglyceridemia. • Pravastatin or atorvastatin are preferred statin agents for those with isolated fasting hypercholesterolemia requiring treatment in the setting of PI or other CYP 3A4 inhibitor therapy. • If combination therapy for hypercholesterolemia and hypertriglyceridemia is indicated, therapy should begin with a statin, followed by the addition of a fibrate if there is insufficient response after 3 to 4 months of treatment. • No therapies for fat distribution abnormalities in the absence of other metabolic complications can be routinely recommended. • ART should be withheld for all patients with confirmed lactate levels >10 mmol/L (90 mg/dL) or those with confirmed lactate levels >5 mmol/L (45 mg/dL) who are symptomatic. • No intervention apart from NRTI cessation is recommended. • Restart combination NNRTI and PI therapy after lactate levels return to normal and symptoms resolve. • Surgical resection of involved bone is the only effective therapy for symptomatic osteonecrosis. • If osteoporosis is demonstrated by radiography or regional DEXA scanning, or if a pathological fracture occurs in the setting of osteoporosis, therapy with a bisphosphonate should be considered. DEXA HDL LDL NCEP NNRTI NRTI = dual-energy x-ray absorptiometry = high-density lipoprotein = low-density lipoprotein = National Cholesterol Education Program = non-nucleoside reverse transcriptase inhibitor = nucleoside reverse transcriptase inhibitor Source: Schambelan M, Benson CA, Andrew Carr A, et al. Management of metabolic complications associated with antiretroviral therapy for HIV-1 infection: Recommendations of an International AIDS Society-USA Panel. J Acquir Immune defic Syndr. 2002;31:269. Reprinted with permission of Lippincott Williams and Wilkins, http://lww.com. U.S. Department of Health and Human Services, Health Resources and Services Administration, HIV/AIDS Bureau 41
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