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Examining Adherence Barriers in Pediatric and Adolescent HIV Patients

Examining Adherence Barriers in Pediatric and Adolescent HIV Patients. Melannie Cummings, PharmD Student Desiree Tomilo, PharmD Student Linda Catanzaro, PharmD Assistant Professor School of Pharmacy and Pharmaceutical Sciences. PACT Clinic, Women and Children’s Hospital of Buffalo .

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Examining Adherence Barriers in Pediatric and Adolescent HIV Patients

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  1. Examining Adherence Barriers in Pediatric and Adolescent HIV Patients Melannie Cummings, PharmD Student Desiree Tomilo, PharmD Student Linda Catanzaro, PharmD Assistant Professor School of Pharmacy and Pharmaceutical Sciences PACT Clinic, Women and Children’s Hospital of Buffalo University at Buffalo © 2004 CDHS, College Relations Group BSC/SUNY Research Foundation

  2. Objectives • Provide an overview of HIV infection and treatment options • Discuss opportunistic infections and prophylaxis • Discuss medication adherence and potential barriers to adherence • Discuss the health consequences of non-adherence • Describe tools and methods used to improve adherence • Discuss what to expect when caring for a child with HIV • Describe the pediatric and adolescent patient population at the PACT Clinic, at Women’s and Children’s Hospital of Buffalo

  3. Global Estimates for adults and children end 2003 • People living with HIV/AIDS 40 million • New HIV infections in 2003 5 million • Deaths due to HIV/AIDS in 2003 3 million About 14,000 new HIV infections a day in 2003 • Almost 2000 are children under 15 years of age • About 12,000 are 15-49 years of age • About 50% of these are 15 -24 years of age

  4. HIV Global Estimates1 • In the year 2003 – estimated 700,000 children under 15 years old became infected • mostly in sub-Saharan Africa • >90% were due to mother to infant transmission • 1. <AVERT.org> 3/3/04.

  5. Incidence of Children with HIV in the United States1 • Most are living in inner cities • poverty • poor housing • drugs • limited access to health care and social services • 1. National Institutes of Allergy and Infectious Disease <www.niaid.nih.gov> 2004.

  6. Good News in New York State • 1996 - “Baby AIDS Law” • mandatory HIV testing added to newborn screening program • mother to infant transmission rates have decreased by 78%1 • study of infants born from 1997-2002 1. NYS Dept. of Health. <www.health.state.ny.us/> May 2004.

  7. Methods of Transmission • sexual contact • contact with infected blood • needle sticks • unprotected administration of first aid • mother to child • perinatally - during delivery of the baby • through breast milk

  8. Prevention of Perinatal Transmission • Early identification of maternal infection • goal: keep viral load <10001 to decrease risk of transmission to baby by up to 70%2 • Antiretroviral prophylaxis with zidovudine during pregnancy, labor, and to newborns2 • Cesarean-Section Delivery • Mother’s viral load >1,000, regardless of therapy1 • Counseling and advisement of infected women to use an alternative to breast milk 1. Committee on Obstetric Practice. ACOG committee opinion scheduled Cesarean delivery and the prevention of vertical transmission of HIV infection. Number 234, May 2000. International Journal of Gynaecology & Obstetrics. 2001 Jun;73(3):279-81. 2. Sperling RS, Shapiro DE, Coombs RW et al. “Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant.” Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Eng J Med, 1996;335(22):1621-9.

  9. Effects of HIV on the Human Body • HIV attacks and weakens the immune system • If the virus is not suppressed and it continues to replicate, further damage to the immune system and progression to AIDS can occur. • The likelihood of developing AIDS or death within 12 months, when a child is not on antiretroviral therapy, can be as high as 51% and 30%, respectively1. 1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. January 20, 2004.

  10. Diagnosis of HIV in Infants • All newborns are tested for HIV, regardless of the mother’s status. • In infants born to infected mothers, diagnostic testing should be done: • before the infant is 48 hours old • at 1-2 months old • at 3-6 months old • Six months after birth, all infected infants can be definitively diagnosed.

  11. Surrogate Markers as Predictors of Disease Progression • Surrogate markers are obtained from an individual’s blood work. • CD4+ T-cells • cells in the immune system that are needed to fight off infection; higher CD4+ percentages indicate better immune status

  12. Surrogate Markers • Viral load (HIV-RNA) • measures how much virus is in the body; the lower the viral load the better • indicates if medication is effective; lower viral load limits the potential for development of resistance to medications

  13. Indications for when to initiate therapy in children > 1 year of age1 1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. January 20, 2004.

  14. Role of Medications • Antiretroviral medications work by suppressing viral replication • seen by low viral load • do not completely eradicate the virus (not a cure)

  15. Choice of Antiretroviral Medication Regimens in Pediatric Patients • The first regimen that is chosen has the best chance of reducing the viral load to undetectable by assay or test(<50 copies/mL). • It is recommended that a regimen consist of: • 2 NRTIs + 1 PI -or- • in children >3 years: 2 NRTIs + Efavirenz (a NNRTI) in children <3 years or who can’t swallow capsules: 2 NRTIs + Nevirapine (a NNRTI)1 1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. January 20, 2004.

  16. Classes of Antiretroviral Medications • Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) • Nucleotide Reverse Transcriptase Inhibitors (NtRTIs) • Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) • Protease Inhibitors (PIs) • Fusion Inhibitors- not approved for pediatrics

  17. Nucleoside Analogue Reverse TranscriptaseInhibitors (NRTIs) • Mechanism of Action (MOA): block an enzyme that is needed by the virus in order to make DNA • can be taken without regard to meals

  18. Adverse Effects seen with NRTIs • Common side effects: nausea, vomiting, diarrhea, fatigue, weakness, headache, dizziness, loss of appetite, insomnia • with the exception of fatigue, these side effects usually go away • Severe side effects: pancreatitis, anemia (with AZT), hypersensitivity reaction/rash (with ABC), peripheral neuropathy (tingling and/or numbness in the extremities), liver damage

  19. NRTIs commonly used in pediatrics • zidovudine, AZT (Retrovir) • Available in capsules, tablets, syrup(strawberry) • lamivudine, 3TC (Epivir) • Available in tablets and oral solution(strawberry-banana) • stavudine, d4T (Zerit) • Available in • capsules • powder for oral suspension- once mixed, shake before use, refrigerate and discard after 30 days

  20. NRTIs • didanosine, ddI (Videx) • take on an empty stomach • Available in • chewable tablets (orange flavored)- Do not swallow tablets whole, must be chewed or crushed in water and 1 oz. apple juice; take on empty stomach; many children do not like these • powder for solution- mix with 4 oz. water; once mixed, store in refrigerator; shake well before use and discard after 30d • buffered powder packets for solution- mix with 4 oz. water and discard after 4 hours • enteric coated capsules- must not be opened, swallow whole

  21. NRTIs • Abacavir, ABC (Ziagen) • Available in • tablets • oral solution(strawberry-banana)- may be refrigerated • A life-threatening allergic reaction can occur in 5% of patients; characterized by rash or flu-like symptoms; discontinue medication, do not try to give to patient again, and call MD

  22. Combination NRTIs • lamivudine+zidovudine, 3TC+ZDV (Combivir) • Available in tablets: 150mg 3TC + 300 mg ZDV • abacavir+lamivudine+zidovudine, ABC+3TC+ZDV (Trizivir) • Available in tablets: 300mg ABC + 150mg 3TC + 300mg ZDV • This drug contains abacavir • do not give if patient had a previous allergic reaction to abacavir

  23. NRTIs • These NRTIs do not have sufficient data to support their use in pediatrics: • ddC- zalcitabine (Hivid) • FTC- emtricitabine (Emtriva) • TFV- tenofovir (Viread) • currently being studied in pediatrics

  24. Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) • MOA: block an enzyme needed by the virus in order to make DNA • Side effects: rash, depression, insomnia, vivid dreams, • These symptoms usually resolve within the first few weeks • numerous drug interactions • A single mutation can cause resistance to the entire NNRTI class.

  25. NNRTIs • Efavirenz (Sustiva) • Available in • tablets • capsules - can be opened and added to liquids or foods • Take on an empty stomach and give at bedtime

  26. NNRTIs • Nevirapine (Viramune) • once daily for 14 days, then titrated to 2x/day • increased risk of rash • Available in • tablets • suspension - sweetened, shake before using • Delaviridine (Rescriptor) • Insufficient data to support use in pediatrics

  27. Protease Inhibitors(PIs) • MOA: block an enzyme needed to assemble the infectious virus particles • Side effects: fat maldistribution, liver damage, elevated triglycerides, diabetes • These usually occur over long periods of time. • numerous drug interactions

  28. PIs • Nelfinavir (Viracept) • Available in • tablets - may be crushed and added to 3 oz. water or a small amount of food • powder - may be mixed in a small amount of food, milk, formula, soy milk or formula, dietary supplements, or soft foods; refrigerate solution and discard after 6 hours • Should be given with a meal or light snack.

  29. PIs • Ritonavir (Norvir) • children 2-16 years of age • Available in • soft gelatin capsules - store in refrigerator or use within 30 days if at room temperature • solution - shake before use; can mix with milk, chocolate milk, Ensure and give within 1 hour of mixing; do not refrigerate

  30. PIs • Amprenavir (Agenerase) • children >3 years of age • Available in • Soft gelatin capsules • Solution (grape-bubblegum-peppermint) • Keep both at room temperature • Do not give with a high fat meal • Avoid using supplements containing vitamin E

  31. PIs • Lopinavir/ritonavir (Kaletra) • Children >6 months • Available in • capsules • solution • Keep both in refrigerator; if at room temperature, use within 2 months. • Give with food

  32. PIs • These PIs do not have sufficient data to support their use in pediatrics: • Indinavir (Crixivan) • Saquinavir (Fortovase) • Fosamprenavir (Lexiva) • Atazanavir (Reyataz) • currently being studied in pediatrics

  33. Opportunistic Infections • Cause of 90% of deaths in HIV infected patients • Caused by common organisms • Develop due to loss of cell-mediated immunity • Development can be predicted by CD4+ lymphocyte levels 1. Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy A Pathophysiologic Approach, 5th edition. The McGraw-Hill Companies, Inc. 2002.

  34. Opportunistic Infections HAART (Highly Active Anti-Retroviral Therapy) was introduced in the United States in 1995 1 • From 1996-1998 • PCP rates decreased 21% per year 2 • MAC rates decreased 39.9% per year 2 • 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001 • Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy A Pathophysiologic Approach, 5th edition. The McGraw-Hill Companies, Inc. 2002.

  35. Opportunistic Infections • Appropriate treatment of HIV is essential • Prevention and management of opportunistic infections is still a very important part of the care of HIV infected patients 1. Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy A Pathophysiologic Approach, 5th edition. The McGraw-Hill Companies, Inc. 2002.

  36. Opportunistic Infections • Pneumocystis carinii Pneumonia (PCP) • Mycobacterium avium Complex (MAC) • Vaccinations • Pneumococcal • H. influenzae type b (Hib)

  37. Pneumocystis carinii Pneumonia (PCP)

  38. Who Should Receive PCP Prophylaxis? • Infants 1-12 months old - if HIV-infected or HIV-indeterminate • Children 1-5 years old - with a CD4+ count <500 cells/µL or CD4+ percentage <15% • Children 6-12 years old - with a CD4+ count <200 cells/µL or CD4+ percentage <15% 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  39. Who Should Receive PCP Prophylaxis? • Adolescents and Adults - with a CD4+ count <200 cells/µL or a history of orophangeal candidiasis • Consider prophylaxis for adolescents and adults with a CD4+ percentage <14% or with a history of AIDS defining illness 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  40. Recommended PCP Prophylaxis • Children • Trimethoprim/Sulfamethoxazole (TMP/SMZ) • 150/750 mg/m2/d in 2 divided doses given by mouth three times a week on consecutive days • Other options: varying doses of • Trimethoprim/Sulfamethoxazole (TMP/SMZ) • Dapsone • Aerosolized Pentamadine • Atovaquone 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  41. Recommended PCP Prophylaxis • Adolescents and Adults • Trimethoprim/Sulfamethoxazole (TMP/SMZ) one double strength tablet per day • Other options: varying doses of • Trimethoprim/Sulfamethoxazole (TMP/SMZ) • Dapsone (with or without pyrimethamine) • Aerosolized Pentamadine • Atovaquone • 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV  November 28, 2001

  42. Discontinuation of PCP Prophylaxis Children • Continue through first year of life • Children with a history of PCP infection should receive lifelong prophylaxis • Safety and efficacy of discontinuation has not been studied thoroughly 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  43. Discontinuation of PCP Prophylaxis Some clinicians consider discontinuing if: • a child 1-5 years old has had a CD4+ count >500 cells/µL or CD4+ percentage >15% for at least three months • A child 6-12 yearsold has had a CD4+ count >200 cells/µL or CD4+ percentage >15% for at least three months 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  44. Discontinuation of PCP Prophylaxis Adolescents and Adults • Discontinue when the CD4+ count has been >200 cells/µL for at least three months • 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  45. Mycobacterium avium Complex (MAC)

  46. Who Should Receive MAC Prophylaxis? • Children • <1 year old: CD4+ count <750 cells/µL • 1-2 years old: CD4+ count <500 cells/µL • 2-6 years old: CD4+ count <75 cells/µL • ≥6 years old: CD4+ count <50 cells/µL • Adolescents and Adults • CD4+ count <50 cells/µL 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  47. Recommended MAC Prophylaxis • Children • Clarithromycin 7.5mg/kg (max 500mg) by mouth twice daily • Azithromycin 20mg/kg (max 1200mg) by mouth every week 1 • Adolescents and Adults • Clarithromycin 500 mg by mouth twice daily 2 • Azithromycin 1200 mg by mouth once weekly 2 • 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001 • Lexi-Comp Online, 2004. Available at: http://www.crlonline.com/crlsql/servlet/crlonline

  48. Discontinuation of MAC Prophylaxis Children • Safety has not been studied in children • Children with a history of MAC infection should receive lifelong prophylaxis 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  49. Discontinuation of MAC Prophylaxis Some clinicians consider discontinuing MAC prophylaxis in children if: • <1 year old: CD4+ count >750 cells/µL for at least three months • 1-2 years old: CD4+ count >500 cells/µL for at least three months • 2-6 years old: CD4+ count >75 cells/µL for at least three months • ≥6 years old: CD4+ count >50 cells/µL for at least three months 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

  50. Discontinuation of MAC Prophylaxis Adolescents and Adults • CD4+ count >100 cells/µL for at least three months 1. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with HIV - November 28, 2001

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