Adult ART Table 1.     TOP

Adult ART Table 2.     TOP

Adult ART Table 3.     TOP

Adult ART Table 4.   TOP

Adult ART Table 5.   TOP

Adult ART Table 6.   TOP

Laboratory Monitoring

• Baseline tests, CBC, chemistry profile including liver and renal
  function tests, PAP smear for female patients, Toxoplasma gondii IgG, VDRL (or RPR), anti-HCV, anti-HBc, and PPD (if no prior positive, see TB tables)
• Confirm HIV Ab+ if not documented
• Viral load at baseline (x2) and 2-8 wks after initiating therapy or
  new regimen, then every 3-4 months, clinical event, or significant
  (3x or >0.5 log10 c/mL) change in VL.
• CD4 count at baseline and then every 3-6 months
• Antiretroviral agent toxicity (see Drug Table 2, pg 8)
• Resistance tests
  • Recommended
    • Virologic failure within 4 weeks of stopping ART
    • Suboptimal suppression
    • Acute HIV infection
  • Consider
    • Chronic HIV infection, before therapy
  • Not Usually Recommended
    • After discontinuation of drugs for more than 4 weeks
    • Viral load <1,000 c/mL

Adult ART Table 7.    TOP

Therapeutic Failure  TOP

Definitions

Virologic Failure:

• Failure to achieve VL <400 c/mL by 24 wks or <50 c/mL by 48
  wks. Note: Most patients will have a decrease in VL of ≥1 log₁₀ c/mL
  at 1-4 weeks.
• Viral suppression followed by repeated positive viral load

Immunologic Failure:

Failure to increase CD4 count 25-50 cells/mm³ during first year.
Note: Mean increase is about 150 cells/mm³ in a year with HAART in treatment naïve patients.

Clinical Failure:

Occurrence or recurrence of HIV-related event ≥ 3 months after start of HAART.
Note: Must exclude immune reconstitution syndromes.

Management of Regimen Failure

Assessment

• Adherence: Address cause and/or simplify regimen
• Tolerability
  • Change one drug within class
  • Change classes; e.g. PI-based HAART vs NNRTI-based HAART
• Pharmacokinetic Issues

Virologic Failure

Definition:

1. HIV RNA > 400 c/mL (VL) after 24 weeks of treatment
2. VL > 50 c/mL after 48 weeks of treatment
3. Viral load detectable after achieving undetectable (viral rebound) VL indicating failure should be confi rmed; “Blips” (isolated VL values of 50–1,000 c/mL) do not constitute failure if unconfirmed

Assessment:

• Review treatment history and prior resistance tests
• Access adherence, intolerance and pharmacokinetic issues (food/fasting requirements, drug interactions, malabsorption)
• Distinguish between limited, intermediate, and extensive prior
  treatment and drug resistance
• The viral load that defines an indication for therapeutic intervention is in the range of 400–5000 c/mL; The threshold of 400 may result in multiple drug exposures and limited access to resistance tests (since a threshold of 1000 c/mL is often required to do the test); a delay to a threshold of 5000 c/mL risks accumulation of multiple resistance mutations including class resistance
• Perform resistance tests while the patient is receiving the failed regimen or within 4 weeks of stopping it
• Identify 2–3 active drugs for the next regimen; two active drugs are essential for viral supression
• If no resistance is demonstrated: consider continuation with emphasis on adherence, possibly with therapeutic drug monitoring
• With low level viremia (< 5000 c/mL) and limited drug exposure consider boosting a PI, or intensification by adding a nucleoside or change therapy
• With intermediate or extensive prior drug exposure, consider an agent with a new mechanism of action (enfuvertide) usually combined with a PI including TPV or an experimental drug such as TMC 114
• With extensive treatment failures, multiple resistance mutations and no available regimens likely to achieve virologic goals: the goal of therapy is to preserve immune function and avoid HIV-associated complications; HIV therapy should be continued

Adult ART Table 8.  TOP

Methods to Achieve Readiness to Start HAART & Maintain Adherence

Patient-related

• Negotiate a plan or regimen that the patient understands and to which she or he commits
• Take time needed, >2 visits, to ensure readiness before 1st prescription
• Recruit family, friends, peer and community support
• Use memory aids: timers, pagers, written schedule, pill boxes/medication organizers
• Plan ahead: keep extra meds in key locations, obtain refills
• Use missed doses as opportunities to prevent future misses
• Active drug and alcohol use and mental illness predict poor adherence; race, sex, age, educational level, income, and past drug use do not.

Provider/Health Team-related

• Educate patient re: goals of therapy, pills, food effects, and side effects
• Assess adherence potential before HAART; monitor at each visit
• Ensure access at off-hours and weekends for answering questions or addressing problems
• Utilize full health care team; ensure med refills at pharmacy
• Consider impact of new diagnoses and events on adherence
• Provide training updates on adherence for all team members
  and utilize team to reinforce adherence
• Monitor adherence and intensify management in periods of low adherence
• Educate volunteers, patient-community representatives

Regimen-related

• Avoid adverse drug interactions
• Simplify regimen re: dose frequency, pill burden, and food requirements
• Inform patient about side effects
• Anticipate and treat side effects

Adult ART Table 9.  TOP

Adult ART Table 10.  TOP