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Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents. V - Special Issues AETC NRC Slide Set Version 1.0, February 2001. Disclaimer.
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Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents V - Special Issues AETC NRC Slide Set Version 1.0, February 2001
Disclaimer These slides were developed using the most recent treatment guideline information at the time of production. However, in the rapidly changing field of HIV care this information could become out of date quickly. The user is encouraged to compare the date of this slide set with the date of the most recent guidelines. Also, it is intended that these slides be used, as prepared, without changes in either content or attribution. Users are asked to honor this intent. -AETC NRC
V. Special Issues:Contents • Acute HIV infection • Advanced HIV infection • Adolescents • Interruption of therapy • Adherence
Acute Retroviral Syndrome:Signs and Symptoms - I • Fever 96% • Lymphadenopathy 74% • Pharyngitis 70% • Rash 70% • Myalgia or arthralgia 54% • Diarrhea 32%
Acute Retroviral Syndrome:Signs and Symptoms - II • Headache 32% • Nausea and Vomiting 27% • Hepatosplenomegaly 14% • Weight Loss 13% • Thrush 12% • Neurological Symptoms 12%
Acute Retroviral Syndrome:Rash • Erythematous maculopapular with lesions on the face and trunk and sometimes extremities including palms and soles • Mucocutaneous ulceration involving mouth, esophagus or genitals (distinguishes HIV from mononucleosis (EBV))
Acute Retroviral Syndrome:Neurological Symptoms • Meningoencephalitis or aseptic meningitis (uncommon) • Peripheral neuropathy or radiculopathy • Facial palsy • Guillain-Barre syndrome • Brachial neuritis • Cognitive impairment or psychosis
Early Intervention Theory • Should be limited to the clinical trial setting • Suppress the initial burst of viral replication • Decrease the severity of acute disease • Alter the viral “set point” • Reduce the rate of mutation • Reduce risk of viral transmission • Preserve immune function
BENEFITS Avoid negative effects on quality of life Avoid drug-related adverse events Delay in development of drug resistance Preserve maximum number of available and future drug options when HIV disease risk is highest RISKS Possible risk of irreversible immune system depletion Possibly greater difficulty in suppressing viral replication Easier to transmit HIV to others Risks and Benefits of Delayed Initiation of Therapy
BENEFITS Control of viral replication easier to achieve and maintain Delay or prevention of immune system compromise Lower risk of resistance with complete viral suppression Decreased risk of HIV transmission RISKS Drug-related reduction in quality of life Greater cumulative drug-related adverse events Earlier development of drug resistance, if viral suppression is sub optimal Limitation of future antiretroviral treatment options Risks and Benefits of Early Therapy
Primary HIV Infection Treatment Regimen • Same as chronic infection
Treatment of the Patient With Advanced HIV Disease • Offer to all with AIDS and patients with symptomatic HIV infection with thrush or unexplained fever
Clinical Issues in the Patient With Advanced HIV Disease • Drug toxicity • Ability to adhere • Drug interactions • Laboratory abnormalities
Advanced HIV Infection • Often complicated drug regimens • Wasting and anorexia • Co-infection
Treatment of the Patient with Advanced HIV Disease • Recovery of immune function • Immune reconstitution syndromes : Immunologic response to sub-clinical pathogen, e.g.: MAC or CMV • Immune reconstitution syndromes are different from clinical failure • Treat new opportunistic infections
The HIV Infected Adolescent • Timing of infection; perinatal vs. acquired as an adolescent • Early intervention
The HIV Infected Adolescent • Normal adolescent development • Drug pharmacology in puberty • Dosing based on Tanner stages
Interruption of Antiretroviral Therapy • Intolerable side effects • Drug interactions • First trimester pregnancy • Unavailability of drugs • Numerous other possible causes
Interruption of Antiretroviral Therapy • Stop all antiretroviral medications at once
Adherence • The “rule” of thirds… • 1/3 take medication as prescribed • 1/3 are intermittently adherent • 1/3 take little or no medication
Who Will Be Adherent? • Age, race, sex, socioeconomic level educational level, socioeconomic status, and a past history of alcoholism or drug use are not reliable predictors of poor adherence
Adherence – Predicting Success • The more severe the symptoms or illness the better adherence • Improved adherence if patients believe in efficacy of treatment
Predicting Poor Adherence • Active drug use or alcoholism • Unstable housing, mental illness, and major life crises
Adherence – Keep It Simple • Once daily therapy - 90% adherence • Twice daily therapy - 80% adherence • Three or more times daily - 65% adherence
Improving Adherence • A trusting provider-patient relationship • Education • Development of treatment plan with patient • Social support network • Simple regimen
Adherence in Special Populations • Flexible clinic hours • Accessible clinical staff • Incentives • Bilingual staff • Adherence discussion during support groups • Individualized adherence programs • Others?
Adherence Strategies • Negotiate a treatment plan • Assess patient readiness • Educate • Reminder devises • Social support • Others?
Poor Adherence – Now What? • Increase the intensity of clinical follow up • Shorten the follow up interval • Recruit additional health team members • Mental health • Chemical dependency counselor • Others • Involve family and friends • Take a break
Poor Adherence – Now What? • Simplify dosing schedule • ddI • Nevirapine • Dual PI
Simplified Dosing Strategies - NRTIs • Initially Amended • recommended dose (mg) dose (mg) • ddI 200 BID 400 QD • (pill, suspension) • AZT 100 five times a day 300 BID • AZT + 3TC AZT 300 BID 1 (300/150) pill BID • 3TC 150 BID (Combivir) • AZT + 3TC + ABC AZT 300 BID 1 (300/150/300) pill BID • 3TC 150 BID (Trizivir) • ABC 300 BID
Simplified Dosing Strategies-NNRTIs Initially Amended recommended dose dose (mg) (mg) NVP 200 BID 400 QD EFV 600 QD No change
Simplified Dosing Strategies - PIs Initially Amended dose(mg) recommended dose (mg) RTV* 600 BID (escalating) No change + SQV-HCG* or 600 TID* 400 RTV + 400 SQV BID + SQV-SGC* 1,200 TID* + IDV* 800 TID* 400 RTV + 400 IDV BID or 200 RTV + 800 IDV BID + AMP* 1200 BID* 200 RTV + 600 AMP NFV 750 TID* 1,250 BID* * dose as single agent
Web Sites to Access the Guidelines • www.aids-ed.org • www.hivatis.org