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Brief Summary

GUIDELINE TITLE

Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medicine Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • July 24, 2008, Ziagen (abacavir sulfate): The U.S. Food and Drug Administration (FDA) has notified the maker of abacavir and abacavir-containing medications of the need to add information to the current BOXED WARNING about the recommendation to test all patients for the HLA-B*5701 allele before starting or restarting therapy with abacavir or abacavir-containing medications.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Definitions for the quality of the evidence (I-III) and strength of recommendation (A-E) are given at the end of the Major Recommendations.

Effects of Switching Antiviral Therapies

In patients with a favorable treatment history (i.e., no previous receipt of a nucleoside reverse-transcriptase inhibitors (NRTI)-based regimen that was less than fully suppressive and no history of virologic rebound occurring while receiving treatment), switching from a potentially lipid level-increasing protease inhibitors (PI) to nevirapine or abacavir may be preferable to a pharmacologic intervention with a lipid-lowering drug (C-III).

Evaluation of Patients

Measurement of Lipid Values

  • Evaluation of serum lipid levels should be performed after fasting for a minimum of 8 h, and preferably for 12 h, and the levels should be determined before initiation of antiretroviral therapy (B-III).
  • The standard screening lipid profile should include measurement of total cholesterol, high-density lipoprotein-cholesterol (HDL-C), and triglyceride levels. Using these measured values, low-density lipoprotein-cholesterol (LDL-C) and non–HDL-C levels are calculated. This should be repeated within 3 to 6 months after the initiation of highly active antiretroviral therapy (HAART), then yearly, unless abnormalities are detected or therapeutic interventions are initiated (B-III).

Treatment

Hypercholesterolemia

  • Nondrug therapies
    • Hormone replacement with estrogen/progestin is no longer recommended for primary or secondary coronary heart disease (CHD) prevention (A-I).
  • Drug therapies for human immunodeficiency virus (HIV)-infected individuals
    • A statin is a recommended first choice for elevated LDL-C levels or for elevated non–HDL-C levels when triglyceride levels are 200 to 500 mg/dL (B–I).
    • Fibrates are less optimal alternative agents for hypercholesterolemia (C-I).
    • Because niacin causes insulin resistance (even in nondiabetic individuals), it has been suggested that niacin should generally be avoided as first-line therapy for patients receiving PIs or who have lipodystrophy until additional safety data are available (C-III).
    • Use of bile-sequestering resins (cholestyramine, colestipol, and colesevalam) is not recommended (C-III).

Hypertriglyceridemia

  • Nondrug therapies
    • Fish oils (omega-3 fatty acid supplements) variably decrease triglyceride synthesis and may be tried (C-III).
  • Drug therapies
    • Niacin is effective therapy for hypertriglyceridemia but should be avoided as first-line therapy in patients receiving HIV PIs or who have lipoatrophy (C-III).
    • Statins are not generally recommended as first-line therapy for isolated hypertriglyceridemia, particularly when triglyceride levels are >500 mg/dL (C-III).

Choice of Initial Drug Treatment for Hyperlipidemia

  • Elevated LDL-C level or elevated non–HDL-C level with triglyceride level of 200 to 500 mg/dL
    • Either pravastatin, (20–40 mg daily [q.d.] starting dose) (A-I), or atorvastatin (10 mg q.d. starting dose) (B-II) is recommended (see the section Drug-Drug Interaction Considerations, in the original guideline document), along with careful monitoring of virologic status and for hepatic and skeletal muscle toxicity. Fluvastatin (20–40 mg q.d. starting dose) is a reasonable alternative (B-II).
    • A fibrate, either gemfibrozil (600 mg twice a day [b.i.d.]) (B-I) or micronized fenofibrate (54–160 mg q.d.) (B-I), are reasonable alternative agents only when statins are not appropriate.
  • Triglyceride level, >500 mg/dL
    • First-line treatment is gemfibrozil (600 mg b.i.d.) given 30 min before morning and evening meals (B-I) or micronized fenofibrate (54–160 mg q.d.) (B-I). Fish oils and niacin are alternative agents (C-III).

Approach to Refractory Disorders

  • When used in combination with fibrates, pravastatin (B-I) and fluvastatin (C-III) may be the preferred statins.
  • For elevated triglyceride levels that are inadequately responsive to fibrate therapy and maximal lifestyle changes, the addition of a fish oil supplement or niacin can be considered (C-III)

Drug-drug Interaction Considerations

  • Simvastatin and lovastatin should not be used in patients taking PIs or delavirdine (E-III) (see table 6 in the original guideline).
  • Atorvastatin can probably be used with caution, at low initial doses, in patients taking PIs (B-I), although extensive safety data are lacking.
  • Pravastatin appears to be safe for use with PIs (A-I).
  • Fluvastatin may also be a safe alternative for use with PIs (B-II) on the basis of its known metabolism and the relative lack of significant interaction with other CYP3A4 and CYP2C9 inhibitors.
  • Any of the statins can probably be used safely in persons taking efavirenz or nevirapine (C-III), although more data are needed.

Quality of Evidence

  1. Evidence from >1 properly randomized, controlled trial
  2. Evidence from >1 well-designed clinical trial, without randomization; from cohort or case-controlled analytic studies (preferably from >1 center); from multiple time-series; or from dramatic results from uncontrolled experiments
  3. Evidence from opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

Strength of Recommendation

  1. Good evidence to support a recommendation for use
  2. Moderate evidence to support a recommendation for use
  3. Poor evidence to support a recommendation
  4. Moderate evidence to support a recommendation against use
  5. Good evidence to support a recommendation against use

CLINICAL ALGORITHM(S)

A clinical algorithm is provided in the original guideline document for "General Approach to Lipid Disorders and Cardiovascular Risk in HIV-infected Patients Receiving HAART".

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2003 Sep 1

GUIDELINE DEVELOPER(S)

Infectious Diseases Society of America - Medical Specialty Society

SOURCE(S) OF FUNDING

Infectious Diseases Society of America (IDSA)

GUIDELINE COMMITTEE

Cardiovascular Subcommittee of the Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Panel Members: Michael P. Dube, Indiana University, Indianapolis; James H. Stein, University of Wisconsin, Madison; Judith A. Aberg, Washington University, St. Louis, MO; Carl J. Fichtenbaum, University of Cincinnati, OH; John G. Gerber, University of Colorado, Denver; Karen T. Tashima, Brown University, Providence, RI; W. Keith Henry, University of Minnesota, St. Paul; Judith S. Currier, University of California at Los Angeles; Dennis Sprecher, Cleveland Clinic, OH; Marshall J. Glesby, Cornell University, New York

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the Infectious Disease Society of America (IDSA) Web site.

Print copies: Available from Infectious Diseases Society of America, 1300 Wilson Boulevard, Suite 300, Arlington, VA 22209.

AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

  • Kish MA. Guide to development of practice guidelines. Clin Infect Dis 2001 Mar 15;32(6):851-4.

Electronic copies: Available from the Clinical Infectious Diseases Journal Web site.

Print copies: Available from Infectious Diseases Society of America, 1300 Wilson Boulevard, Suite 300, Arlington, VA 22209.

A PDA version of the original guideline document is available from www.idsaguidelinesforhandhelds.org.

PATIENT RESOURCES

None available

NGC STATUS

This NGS summary was completed by ECRI on May 6, 2004. This summary was updated on January 21, 2005, following the release of a public health advisory from the U.S. Food and Drug Administration regarding the use of nevirapine. This summary was updated by ECRI Institute on August 11, 2008 following the U.S. Food and Drug Administration advisory on Ziagen (abacavir sulfate).

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

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