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"Primary Care Guidelines for the Management of Persons Infected with Human Immunodeficiency Virus: 2013 Update by the HIV Medicine Association of the Infectious Diseases Society of America"

current
Published: Clinical Infectious Diseases 58 ; 2013 ; 58 : 1 -34

Abstract

Evidence-based guidelines for the management of persons infected with human immunodeficiency virus (HIV) were prepared by an expert panel of the HIV Medicine Association of the Infectious Diseases Society of America. These updated guidelines replace those published in 2009. The guidelines are intended for use by healthcare providers who care for HIV-infected patients. Since 2009, new antiretroviral drugs and classes have become available, and the prognosis of persons with HIV infection continues to improve. 

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*Every 12 to 18 months following publication, IDSA reviews its guidelines to determine whether an update is required. This guideline was published in November of 2013 and is the most current version.

Recommendations

I. What initial evaluation and immediate follow-up should be performed for HIV-infected patients?

Recommendations

  1. A comprehensive present and past medical history, physical examination, medication/social/family history, and review of systems, including HIV-related information, should be obtained for all patients upon initiation of care (strong recommendation, moderate quality evidence).

HIV Disease Tests

Serological Assays for HIV

Recommendation

  1. Patients who have no documentation of their HIV serostatus or who were tested anonymously should have an HIV serologic test performed upon initiation of care (strong recommendation, low quality evidence).

CD4 Cell Counts and Percentages

Recommendations

  1. A CD4 cell count with percentage should be obtained upon initiation of care (strong recommendation, high quality evidence).
  2. Measurement of the CD8 cell count and the ratio of CD4 cells to CD8 cells is unnecessary as the results are not used in clinical decision making (strong recommendation, high quality evidence). Plasma HIV RNA Levels

Recommendation

  1. A quantitative HIV RNA (viral load) level should be obtained upon initiation of care (strong recommendation, high quality evidence). HIV Resistance Testing

Recommendations

  1. Because drug-resistant virus can be transmitted from one person to another, all patients should be assessed for transmitted drug resistance with an HIV genotype test upon initiation of care (strong recommendation, high quality evidence). If therapy is deferred, repeat testing at the time of antiretroviral therapy (ART) initiation should be considered because of the potential for superinfection (weak recommendation, low quality evidence).
  2. Resistance testing is also indicated for patients who are experiencing virologic failure to guide modification of ART (strong recommendation, high quality evidence).
  3. In persons failing integrase strand transfer inhibitor (INSTI)–based regimens, genotypic testing for INSTI resistance should be ordered (strong recommendation, high quality evidence).

Coreceptor Tropism Assay

Recommendation

  1. Tropism testing should be performed if the use of a CCR5 antagonist is being considered (strong recommendation, high quality evidence).

Laboratory Tests

Complete Blood Count and Chemistry Panel

Recommendation

  1. A complete blood count with differential white blood cell count and chemistry panel should be obtained upon initiation of care (strong recommendation, high quality evidence).

Glucose-6-Phosphate Dehydrogenase

Recommendation

  1. Screening for glucose-6-phosphate dehydrogenase (G6PD) deficiency is recommended upon entry into care or before starting therapy with an oxidant drug in patients with a predisposing racial or ethnic background (strong recommendation, moderate quality evidence).

Fasting Lipid Profile

Recommendation

  1. Because many antiretroviral drugs, HIV infection itself, and host factors are associated with increased cholesterol and triglyceride levels, a fasting lipid profile should be obtained upon initiation of care (strong recommendation, high quality evidence).

HLA B*5701 Screening

Recommendations

  1. HLA-B*5701 testing should be performed before initiating abacavir therapy (strong recommendation, high quality evidence).
  2. Patients who are positive for the HLA B*5701 haplotype are at high risk for hypersensitivity reaction and should not be treated with abacavir (strong recommendation, high quality evidence).

Urinalysis and Calculated Creatinine Clearance

Recommendations

  1. A baseline urinalysis and calculated creatinine clearance or estimated glomerular filtration rate should be obtained, especially in black HIV-infected patients and those with advanced disease or comorbid conditions, because of an increased risk of nephropathy (strong recommendation, high quality evidence).
  2. Urinalysis and calculated creatinine clearance assay should also be performed prior to initiating drugs such as tenofovir or indinavir that have the potential for nephrotoxicity (strong recommendation, moderate quality evidence).

Coinfection and Comorbidity Laboratory TestsTuberculosis Screening

Recommendations

  1. Upon initiation of care, HIV-infected patients without a history of tuberculosis or a prior positive tuberculosis screening test should be tested for Mycobacterium tuberculosis infection by either a tuberculin skin test (TST) or by an interferon-γ release assay (IGRA) (strong recommendation, high quality evidence). Those with positive test results should be treated for latent M. tuberculosis infection after active tuberculosis has been excluded [9, 10] (strong recommendation, high quality evidence).
  2. Repeat testing is recommended in patients with advanced HIV disease who initially had negative TST or IGRA results but subsequently experienced an increase in the CD4 cell count to >200 cells/µL on ART and who may thus have developed sufficient immunocompetence to mount a positive reaction (strong recommendation, high quality evidence).
  3. HIV-infected patients who are close contacts of persons with infectious tuberculosis should be treated for latent M. tuberculosis infection regardless of their TST or IGRA results, age, or prior courses of tuberculosis treatment; active tuberculosis should be excluded first (strong recommendation, high quality evidence).

Serologic Testing for Toxoplasma gondii

Recommendations

  1. All HIV-infected patients should be tested for prior exposure to T. gondii by measuring anti-Toxoplasma IgG upon initiation of care (strong recommendation, moderate quality evidence).
  2. Toxoplasma-seronegative adults, representing 70%–90% of the US population, should be counseled on how to avoid new infection (weak recommendation, moderate quality evidence).

Viral Hepatitis Screening and Vaccination Recommendations

Recommendations

  1. HIV-infected patients should be screened for evidence of hepatitis B virus (HBV) infection upon initiation of care by detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and antibody to hepatitis B total core antigen (anti-HBc or HBcAb) (strong recommendation, high quality evidence), and those who are susceptible to infection should be vaccinated against HBV (strong recommendation, high quality evidence). HBsAb should be repeated 1–2 months or at the next scheduled visit after the third vaccine was given to assess for immunogenicity. A second series of vaccine is recommended for those whose HBsAb levels are negative or <10 IU/mL after primary vaccine series (strong recommendation, high quality evidence).
  2. Vaccination should be recommended for nonimmune sexual partners of patients who are positive for HBsAg (strong recommendation, high quality evidence).
  3. Patients who are negative for HBsAg and HBsAb but positive for anti-HBc should be screened for chronic HBV infection by determination of HBV DNA; those without evidence of chronic infection should consider vaccination (strong recommendation, low quality evidence).
  4. HIV-infected patients should be screened for hepatitis C virus (HCV) infection upon initiation of care by a test for HCV antibody and annually thereafter for those at risk (strong recommendation, high quality evidence). 26. HCV RNA should be ordered on all those with a positive HCV antibody test to assess for active HCV disease (strong recommendation, high quality evidence). 27. Infants born to HBV- and /or HCV-infected women should be tested for HBV and HCV transmission, respectively (strong recommendation, high quality evidence). 28. Hepatitis A vaccination is recommended for all susceptible men who have sex with men (MSM), as well as other susceptible individuals with indications for hepatitis A vaccine (eg, injection drug users, persons with chronic liver disease, travelers to countries with high endemicity, or patients who are infected with hepatitis B and/or C) (strong recommendation, high quality evidence). Hepatitis A total or IgG antibody should be repeated 1–2 months or at the next scheduled visit after the second vaccine to assess for immunogenicity. A repeat vaccine series is recommended in those who remain seronegative (strong recommendation, high quality evidence). 29. Hepatitis A vaccine may be considered for all other nonimmune patients (negative anti-HAV total or IgG antibody) (weak recommendation, low quality evidence).

Screening and Vaccination Recommendations for Herpes Viruses

Recommendations

  1. Patients at lower risk of cytomegalovirus (CMV) infection (eg, populations other than MSM or injection drug users, both of which may be assumed to be seropositive) should be tested for latent CMV infection with an anti-CMV IgG upon initiation of care (strong recommendation, moderate quality evidence).
  2. Patients who are susceptible to varicella zoster virus (VZV) (those who have not been vaccinated, have no history of varicella or herpes zoster, or are seronegative for VZV) should receive postexposure prophylaxis with varicella zoster immune globulin (VariZIG) as soon as possible (but within 10 days) after exposure to a person with varicella or shingles (strong recommendation, moderate quality evidence).
  3. Varicella primary vaccination may be considered in HIV-infected, VZV-seronegative persons aged >8 years with CD4 cell counts >200 cells/µL (moderate recommendation, low quality evidence) and in HIV-infected children aged 1–8 years with CD4 cell percentages >15% (strong recommendation, moderate quality evidence).

Screening for Syphilis

Recommendations

  1. All patients should be screened for syphilis upon initiation of care and periodically thereafter, depending on risk (strong recommendation, high quality evidence).
  2. A lumbar puncture should always be performed for patients with a reactive syphilis serology who have neurologic or ocular symptoms or signs, irrespective of past syphilis treatment history (strong recommendation, high quality evidence).
  3. A lumbar puncture should be performed in patients who experience serologic treatment failure (ie, whose nontreponemal titers fail to decline 4-fold after stage-appropriate therapy, or whose titers increase 4-fold if reinfection is ruled out) (weak recommendation, low quality evidence).

Screening for Other Sexually Transmitted Diseases (Refer to Section II for Information on Routine Sexually Transmitted Disease Screening)

Recommendation

  1. All women should be screened for trichomoniasis, and all women aged ≤25 years should be screened for Chlamydia trachomatis infection (strong recommendation, high quality evidence).
  2. Men and women should be screened for gonorrhea and chlamydia infection at initial presentation and then annually if at risk for infection (strong recommendation, high quality evidence).
  3. Retesting in 3 months is indicated in men and women found to be positive for gonorrhea and chlamydial infections and women found to be positive for trichomoniasis on initial screening, because of high reinfection rates (strong recommendation, moderate quality evidence).
  4. All of these conditions should be screened for periodically thereafter, depending on the population, reported behaviors, the presence of other sexually transmitted diseases (STDs) in the patient or his/her partner(s), and the prevalence of STDs in the community (strong recommendation, low quality evidence).

Cervical Cancer Screening and Prevention

Recommendations

  1. HIV-infected women should have a cervical Pap test performed upon initiation of care, and this test should be repeated at 6 months and annually thereafter if results are normal (strong recommendation, moderate quality evidence).
  2. Women with atypical squamous cells (both ASC-US [atypical squamous cells of unknown significance] and ASC-H [ASC, cannot rule out high-grade squamous intraepithelial lesion]), atypical glandular cells, low-grade or high-grade squamous intraepithelial lesion, or squamous carcinoma noted by Pap testing should undergo colposcopy and directed biopsy, with further treatment as indicated by results of evaluation (strong recommendation, high quality evidence).

Screening for Anal Human Papillomavirus

Recommendation

  1. HIV-infected men and women with human papillomavirus (HPV) infection are at increased risk for anal dysplasia and cancer. MSM, women with a history of receptive anal intercourse or abnormal cervical Pap test results, and all HIV-infected persons with genital warts should have anal Pap tests (weak recommendation, moderate quality evidence).
  2. HPV vaccination is recommended for all females aged 9–26 years and all males aged 9–21 years. Males aged 22–26 years should also be vaccinated if not vaccinated at younger ages (strong recommendation, high quality evidence).

Serum Testosterone Level

Recommendation

  1. Morning serum testosterone levels are recommended in adult men with decreased libido, erectile dysfunction, reduced bone mass or low trauma fractures, hot flashes, or sweats, and should be considered in the setting of less specific symptoms such as fatigue and depression (strong recommendation, moderate quality evidence).
  2. Obtaining testosterone levels in women in nonresearch settings is not recommended (strong recommendation, low quality evidence).

Chest Radiography

Recommendation

  1. A baseline chest radiograph should be obtained in all HIV-infected patients with a positive tuberculosis screening test result to rule out active tuberculosis; it may also be useful in other patients who are likely to have preexisting lung abnormalities (strong recommendation, moderate quality evidence).

Other Laboratory Tests

Recommendation

  1. Routine testing for cryptococcal infection with serum cryptococcal antigen or for disseminated Mycobacterium avium complex infection by culture of blood for acid-fast bacilli are not recommended, but may be considered in selected patients with CD4 cell counts <50 cells/µL (strong recommendation, moderate quality evidence).

Behavioral Intervention

Recommendations

  1. General messages regarding risk reduction should be provided at all healthcare encounters, regardless of risk behaviors reported by the patient or perceived risk on the part of the healthcare provider. Such messages can be delivered by the provider, by others in the healthcare setting, or by educational materials (eg, pamphlets, posters, and videos) in the healthcare setting (strong recommendation, low quality evidence).
  2. Tailored messages are critical for patients who report persistent high-risk behavior or who have symptoms or signs of STDs. In nearly all situations, the provider should offer brief counseling; in general, persons exhibiting risk behavior should also be referred to programs capable of offering more extensive intervention programs (strong recommendation, moderate quality evidence).

Schedule-of-Care Evaluation for HIV-Infected Patients

Adults

Recommendations

  1. Viral load is generally monitored every 3–4 months in untreated patients and patients on stable ART. This interval may be prolonged to 6 months for adherent patients whose viral load has been suppressed for more than 2–3 years and whose clinical and immunologic status is stable. Viral load should be monitored more frequently after initiation or change in ART: preferably within 2–4 weeks, and not more than 8 weeks, after initiation or modification, with repeat testing every 4–8 weeks until viral load becomes undetectable (strong recommendation, moderate quality evidence).
  2. CD4 cell counts should be monitored both to assess the urgency for initiation of ART or the efficacy of ART and to determine the need for prophylaxis against opportunistic infections (strong recommendation, high quality evidence). CD4 cell counts should generally be monitored every 3–4 months. For patients on suppressive ART regimens whose CD4 counts have increased well above the threshold for opportunistic infection risk, the CD4 count can be monitored every 6–12 months unless there are changes in the patient's clinical status [11] (strong recommendation, moderate quality evidence).
  3. STD screening and tuberculosis screening tests should be repeated periodically depending on symptoms and signs, behavioral risk, and possible exposures (strong recommendation, moderate quality evidence).
  4. Vaccinations for pneumococcal infection (strong recommendation, high quality evidence), influenza (strong recommendation, high quality evidence), varicella (strong recommendation, moderate quality evidence), and hepatitis A (strong recommendation, high quality evidence) and B (strong recommendation, high quality evidence) should be offered as indicated (Table 2). The likelihood of a response to any vaccine is greatest in patients with higher CD4 cell counts and in patients receiving suppressive ART.

II. What are the special considerations for women and the prevention of mother-to-child transmission?

Contraception and Preconception Care

Recommendation

  1. All HIV-infected women of childbearing age should be asked about their plans and desires regarding pregnancy upon initiation of care and routinely thereafter (strong recommendation, low quality evidence). Breast Cancer Screening

Recommendations

  1. Mammography should be performed annually in women aged >50 years (strong recommendation, high quality evidence).
  2. In women aged 40–49 years, providers should perform individualized assessment of risk for breast cancer and inform them of the potential benefits and risks of screening mammography (strong recommendation, high quality evidence).

Menopause

Recommendations

  1. Hormone replacement therapy, particularly if prolonged, has been associated with a small increased risk of breast cancer and cardiovascular and thromboembolic morbidity, and its routine use is not currently recommended (strong recommendation, high quality evidence).
  2. Hormone replacement therapy may be considered in women who experience severe menopausal symptoms (eg, vasomotor symptoms and vaginal dryness) but should generally be used only for a limited period of time and at the lowest effective doses (weak recommendation, low quality evidence).

Mother-to-Child Transmission

Recommendations

  1. To prevent infection of their fetus, pregnant women should be treated for HIV infection, regardless of their immunologic or virologic status (strong recommendation, high quality evidence).
  2. Infants exposed to HIV in utero should receive antiretroviral postexposure prophylaxis and undergo HIV virologic diagnostic testing at 14–21 days of life, at 1–2 months of age, and at 4–6 months of age (strong recommendation, high quality evidence).
  3. High-risk exposed infants should have virologic testing at birth (strong recommendation, moderate quality evidence).

III. What are the special considerations for children?

Recommendations

  1. HIV-infected infants should undergo HIV resistance testing (strong recommendation, high quality evidence) and, because of the rapid progression of disease, should initiate therapy in the first year of life regardless of CD4 cell count, RNA level, or clinical status (strong recommendation, high quality evidence).
  2. After the first year of life, initiation of therapy in HIV-infected children is based on age, CD4 count/percentage, viral load, and symptoms. ART should be initiated in all symptomatic children (strong recommendation, high quality evidence).
    1. CD4 cell counts and viral loads should be monitored no less than every 3–4 months (strong recommendation, moderate quality evidence).
    2. Childhood vaccinations should be administered according to Advisory Committee on Immunization Practices schedules for HIV-infected infants and children (strong recommendation, high quality evidence).
  3. HIV-infected infants and children should be managed by a specialist with knowledge of the unique therapeutic, pharmacologic, behavioral, and developmental issues associated with this disease (strong recommendation, low quality evidence).

IV. What are the special considerations for adolescents?

  1. HIV-infected adolescents require an individual and developmental approach to therapy and care given by an HIV specialist with expertise in this population (strong recommendation, low quality evidence).
  2. Adolescents infected with HIV should have a coordinated, deliberate transition to adult care (strong recommendation, low quality evidence).

V. What are the metabolic comorbidities associated with HIV and antiretroviral therapy?

Recommendations

  1. Fasting blood glucose and/or hemoglobin A1c should be obtained prior to and within 1–3 months after starting ART. Patients with diabetes mellitus should have a hemoglobin A1c level monitored every 6 months with a goal of <7%, in accordance with the American Diabetes Association Guidelines (strong recommendation, moderate quality evidence).
  2. Fasting lipid levels should be obtained prior to and within 1–3 months after starting ART. Patients with abnormal lipid levels should be managed according to the National Cholesterol Education Program Guidelines (strong recommendation, moderate quality evidence).
  3. Baseline bone densitometry (DXA) screening for osteoporosis in HIV-infected patients should be performed in postmenopausal women and men aged ≥50 years (strong recommendation, moderate quality evidence).

VI. How can patient adherence to HIV care be optimized?

Recommendations

  1. All HIV-infected patients should be provided timely access to routine and urgent primary medical care (strong recommendation, moderate quality evidence).
  2. HIV care sites should make every effort to provide care in a way that is linguistically and culturally appropriate and competent (strong recommendation, moderate quality evidence).
  3. HIV care sites should utilize a multidisciplinary model but identify a primary provider for each patient and support the development of trusting long-term patient–provider relationships (strong recommendation, moderate quality evidence).
  4. All patients should be evaluated for depression and substance abuse, and if present, a management plan that addresses these problems should be developed and implemented in collaboration with appropriate providers (strong recommendation, high quality evidence).

Additional Resources

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