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Update on HIV Management

Recommendations of the Johns Hopkins University AIDS Service

March 1997


Viral Burden Testing:


Recommendations Adapted from the International AIDS Society-U.S.A.
  • Testing should be done at times of clinical stability; sequential assays should use the same laboratory facility and technique; assay should have a threshold of detection of Baseline: two assays separated by 2-4 weeks.
  • Test should be repeated at 3-4 month intervals.
  • Evaluation of new antiretroviral therapy or changes in antiretroviral therapy: should measure viral load at 2-4 weeks (alpha slope) and at 10-12 weeks (beta slope).
  • Change of 50% (0.3 log) is considered significant.
  • Viral burden does not supplant need to monitor CD4 counts to assess immune competence [Nature Medicine 1996;2:625].


CD4 Counts


Measure at 3-4 month intervals unless 3 in absence of new antiretroviral therapy. Test should be performed by the same lab, preferably at proximity of the same time of day. The test should be repeated for outlier values and when therapeutic decisions are based on results unless trend data are available.


OI Prophlaxis Recommendations

Endorsement of the recommendations of the U.S. Public Health Service [MMWR 1995; 44:1-34] with the following exceptions (anticipated revisions currently under review):

  • M. avium prophylaxis in patients with CD4 counts 3 is changed from "consider" to "strongly recommended." The preferred agents are azithromycin (1000-1200 mg/wk) or clarithromycin (500 mg/day; some authorities recommend 500 mg bid).
  • Pneumovax is elevated from "consider" status to "strongly recommended" for patients with CD4 counts >200 cells/mm3.
  • Many patients now have marked elevations in CD4 count reflecting the impact of antiretroviral therapy. Decisions regarding prophylaxis based on CD4 count should use the nadir value.


Prophylaxis of Opportunistic Infections:
Recommended as Standard of Care*



Pathogen Indication Preventive Regimens
    First choice Alternative
P. carinii
  • CD4 count <200/mm3**
  • Unexplained fever >2 wks
  • Thrush
  • TMP-SMX, 1 DS/d
  • TMP-SMX, 1 SS/d or 1 DS 3x/wk
  • Dapsone, 100 mg/d
  • Aerosolized pentamidine 300 mg q month
  • Regimen for toxoplasmosis
M. tuberculosis
  • PPD with >5 mm induration
  • Prior positive PPD without treatment
  • Contact with active TB
  • INH, 300 mg/d + pyridoxine 50 mg/d x 12 mo
  • INH, 900 mg + pyridoxine, 50 mg 2x weekly x 12 mo
  • Rifampin, 600 mg/d
    x 12 mo
Toxoplasma gondii
  • IgG antibody to T. gondii + CD4 count <100/mm3**
  • TMP-SMX, 1 DS/d
  • TMP-SMX, 1 SS/d or
    1 DS 3 x wk
  • Dapsone, 50 mg/d +pyrimethamine,
    50 mg/wk + leucovorin,
    25 mg/wk
  • Dapsone, 200 mg/wk + pyrimethamine 75 mg/wk + leucovorin, 25 mg/wk
M. avium*
  • CD4 count <50/mm3**
  • Clarithromycin,
    500 mg qd or bid*
  • Azithromycin,
    1000-1200 mg/wk*
  • Rifabutin, 300 mg/d
S. pneumoniae*
  • All patients with CD4 count >200/mm3
  • Pneumovax, 0.1 ml IM
    q 6 years
 

*Recommendations of U.S. Public Health Service and IDSA. MMWR 1995;44:1-34. Changes are indicated by asterisk and are under review by the USPHS-IDSA Committee.
**Indications based on CD4 count should usually be based on the nadir value.


Routine Lab Tests

Test Frequency Comment
HIV serology x 1 Repeat if no confirmation available, denial of risk or prior use of substandard assay
CBC 3-4 mo.  
VDRL or RPR Annual Annual in sexually active patients
Quantitative HIV RNA 3-4 mo. Repeat at 2-4 wks after new therapeutic regimen
Chest x-ray See comments Baseline x-ray is optional unless +PPD or pulmonary symptoms
Chemistry panel Annual; q 3 mos if on antiretrovirals  
Hepatitis serology See comments HBV vaccine candidates: anti HBc Abnormal LFTs: HBsAg and anti-HCV
CMV serology See comments Low risk patients
Toxoplasma gondii serology x 1 IgG; repeat if previously negative and CD4 count <100/mm3 or clinical features suggesting toxoplasmosis
Pap smear Repeat--6 mo., then annually Repeat if "inadequate;" refer to gynecologist for "atypia" or greater on Bethesda scale.
PPD x 1 May repeat after TB exposure or if in high risk category. Anergy testing not recommended.


Antiretroviral Therapy: Drugs



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Agent Usual Regimen Comment
Nucleoside Analogues (NRTIs)
  • Zidovudine (Retrovir, AZT, ZDV)
  • Didanosine (Videx, ddI)
  • Zalcitabine (HIVID, ddC)
  • Stavudine (Zerit, d4T)
  • Lamivudine (Epivir, 3TC)


300 mg bid or 200 mg tid
200 mg bid
0.75 mg tid
40 mg bid
150 mg bid
Empty stomach
Protease Inhibitors (PIs)
  • Saquinavir (Invirase)
  • Ritonavir (Norvir)


  • Indinavir (Crixivan)
  • Nelfinavir (Viracept)


600 mg tid*
600 mg bid

800 mg q8h
750 mg tid


High fat meal
Escalating dose;
refrigerate
Empty stomach or light meal
With meals
Non-Nucleoside RT Inhibitor (NNRTIs)
  • Nevirapine (Viramune)
  • Delavirdine (Rescriptor)**


200 mg bid
400 mg tid
200 mg qd, then 200 mg bid
*Minimum dose; higher doses may be more effective


Therapeutic Recommendations



Recommendations are based on available data from therapeutic trials. Factors to consider in individual patients are the patient's prior exposures to these drugs, viral burden, CD4 count, attitude about therapy and probability of compliance.
  • When To Initiate Therapy (opinion is divided):

    • Acute Retroviral Syndrome or within 6 months of seroconversion
    • Any detectable virus using assay with a threshold of 500 copies/ml.
    • Decision based on viral burden and CD4 count as recommended by the International AIDS Society-U.S.A. (JAMA 1996;276:146):


CD4 count (/mm3) Viral burden (copies/ml) Treatment
>500 Observe
>500 10,000-30,000 Treat or observe
>500 >30,000 Treat
350-500 Treat or observe
350-500 >10,000 Treat
(Any value) Treat


  • Initial Regimen

    • Preferred:*
      2 NRTIs** + protease inhibitor***
      or 2 NRTIs* + NNRTI (nevirapine)
    • Alternatives for selected patients: 2 NRTIs**
    • Minimal/suboptimal therapy: monotherapy with ddI or d4T
    • Contraindicated: Monotherapy with AZT, ddC, 3TC, any protease inhibitor or nevirapine. Combinations of AZT and d4T should be avoided until the issue of antagonism is clarified.

      *Combinations in therapeutic trials that have been associated with a decrease in viral burden to undetectable levels (>18 weeks: indinavir/AZT/ 3TC; ritonavir/AZT/3TC; ritonavir/saquinavir; nelfinavir/AZT/3TC; nevirapine/AZT/ddI; nevirapine/indinavir/3TC.

      **Combinations of NRTIs with extensive and favorable experience: AZT/3TC; AZT/ddI; AZT/ ddC; 3TC/d4T; and d4T/ddI.

      ***Preferred protease inhibitors are indinavir, ritonavir and nelfinavir: saquinavir is problematic due to poor bioavailability that may be improved with concurrent ritonavir, ketoconazole or grapefruit juice or use of the soft-gel capsule.


  • When To Change Therapy

    • Therapeutic failure
    • (this is arbitrarily defined based on initial goals and available options).
      • Preferred: no detectable virus (measured at 4-6 months)
      • Modified goals: significant decrease in viral burden; other considerations include declining CD4 count, or no new AIDS-defining complication
    • Toxicity
    • Non-acceptance
    • New therapy with advantages becomes available


  • How To Change Therapy:

    • Failure of prior regimen: there must be at least two new agents:

      Initial Treatment New regimen (>2 new agents)
      • 2 NRTIs + PI
      2 NRTIs (> 1 new NRTI) + Nevirapine
      2 PIs + NRTI*
      PI + Nevirapine +> 1 new NRTI*
      • 2 NRTIs + nevirapine
      2 NRTIs ( > 1 new NRTI) + PI
      2 PIs + NRTI*
      • 2 NRTIs
      2 NRTIs ( > 1 new NRTI) + PI
      2 NRTIs ( > 1 new NRTI) + Nevirapine
      2 PIs + NRTI*

      * Experience is limited, but these combinations may be preferred in a subset of patients who have had extensive exposure or toxicity with nucleoside analogues.

    • Toxicity/non-acceptance: New regimen with appropriate changes; there is no implicit need to change or add > two drugs when the prior regimen achieved therapeutic goals.



  

This article was provided by Johns Hopkins AIDS Service. It is a part of the publication Hopkins HIV Report.
 

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