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HIV
Older Patients, Women,
Perinatal Transmission
and Drug/Drug
Interactions
Danielle Gill, PharmD, MPH
Objectives
 Facts on Newly Diagnosed Older Patients
 Older Adults Adherence
 Women HIV Guidelines
 Perinatal, Intrapar...
Newly Diagnosed Older Patients:
Facts The proportion of older adults who are exposed to HIV through male-
to-male contact...
Clinical Question �
Relative to their younger counterparts,
elderly people diagnosed with HIV:
A. Have a shorter survival ...
Newly Diagnosed Older Patients
Relative to their younger counterparts, older adults living
with HIV/AIDS
have a more seve...
Newly Diagnosed Older Patients:
Guidelines
 Older persons experience earlier development of conditions
associated with ag...
Older Adults: Risky Behavior
 Older adults are less likely to use a condom as a form of protection
 Infection rate of ol...
HIV and Older Women
 The number of older women with HIV
infection is expected to increase for two
reasons:
 the rate and...
Treatment Experienced Patients
 Nearly 25% of patients on ART are not virologically suppressed
 Failure of virologic sup...
Clinical Question: �
What are some ways to monitor
adherence in older patients with HIV?
A. Pill counting
B. Checking Refi...
Adherence and the Older Patient
Combination of these measurements is best
Pill count
Self report
Measurements of Viral ...
Adherence and the Older Patient
 Medication adherence >60 years old ranges from 26%-68%
 Strongly related to factors rel...
HIV Infected Women: Guidelines
 The indications for initiation of antiretroviral therapy (ART) and the goals of
treatment...
HIV Infected Women
 Hormonal contraception
 Conflicting data; when drug interactions with ART occur, additional contrace...
Clinical Question: �
A treatment naïve, pregnant women comes into
your clinic and has just been diagnosed with HIV.
She is...
Treatment Naïve Pregnant
Women: Guidelines
 The same regimens as nonpregnant adults should be
used in pregnant women (AII...
Treatment Naïve Pregnant
Women: Guidelines
 All HIV-infected pregnant women should receive a potent
combination ARV regim...
Initial ART Recommendations:
Treatment naïve pregnant women
Preferred regimens for the treatment of ART-naive HIV-
infecte...
Initial ART Recommendations:
Treatment naïve pregnant women
Preferred 2-NRTI Backbone Regimens
Initial ART Recommendations:
Treatment naïve pregnant women
Preferred PI Regimens
Initial ART Recommendations:
Treatment naïve pregnant women
Preferred NNRTI Regimen
Clinical Question: �
 A known HIV positive, treatment
naïve, mother comes into the hospital
to give birth. Which ART is
r...
Intrapartum ARV Therapy/Prophylaxis
 Women should continue their antepartum combination
ARV drug regimen on schedule as m...
Clinical Question: �
A newborn baby with an HIV positive
mother was just transferred into the
NICU. How soon should the ba...
Infant ART Prophylaxis:
Guidelines The 6 week neonatal component of the AZT prophylaxis regimen is
generally recommended ...
Neonatal ART Drug Dosing: Guidelines
Zidovudin
e (ZDV)
Dosing Duration
≥35 weeks’ gestation at birth:4 mg/kg/dose PO twice...
Drugs that Interact with ART
NRTI Drugs that Interact
Tenofovir (TDF) Ambien, didanosine, acyclovir,
ganciclovir, valacycl...
Drugs that Interact with ART
Drugs that Interact with ART
Clinical Question: �
Which of the following drugs interact with
protease inhibitors and needs to be monitored?
A. Nicardip...
Drugs that interact with all PIs
Drugs that interact with ART
Drugs that Interact with ART
Drugs that interact with ART
Fusion Inhibitor Drugs that interact
Enfuvirtide
Drugs that interact with ART
PK Boosters Drugs that interact
Ritonavir Amiodarone, atorvastatin, benzos,
bupropion, clarit...
Key Points
 Older patients are less likely to be screened for HIV and more likely to
experience severe side effects from ...
References
 http://www.med.unc.edu/aging/elderhiv/infected.htm
 http://www.hivguidelines.org/clinical-guidelines/womens-...
AETC Contact Information
 Pennsylvania/MidAtlantic AETC
 Website: www.pamaaetc.org
 Phone: 412-624-1895
 Consultation:...
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UPDATED OLDER PERI WOMEN

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UPDATED OLDER PERI WOMEN

  1. 1. HIV Older Patients, Women, Perinatal Transmission and Drug/Drug Interactions Danielle Gill, PharmD, MPH
  2. 2. Objectives  Facts on Newly Diagnosed Older Patients  Older Adults Adherence  Women HIV Guidelines  Perinatal, Intrapartum and Postpartem HIV Guidelines  Drug/Drug Interactions
  3. 3. Newly Diagnosed Older Patients: Facts The proportion of older adults who are exposed to HIV through male- to-male contact and injection drug use decreases with older age groups. Exposure to HIV with heterosexual contact increases with age  Over 30% of persons with HIV are > age 50  Sexual contact is the most common risk factor; IV drug use is next  Heterosexual contact accounts for the most rapid growth in infection.  Older adults who participate in risky behaviors are less likely than younger adults who have the same risky behaviors to use HIV/AIDS prevention methods
  4. 4. Clinical Question � Relative to their younger counterparts, elderly people diagnosed with HIV: A. Have a shorter survival rate B. Have fewer opportunistic infections C. Have a less severe disease course D. Have longer AIDS free survival intervals
  5. 5. Newly Diagnosed Older Patients Relative to their younger counterparts, older adults living with HIV/AIDS have a more severe HIV disease course and a shorter survival rate; have less desirable health indices at diagnosis (e.g., lower CD4+ cell counts); have shorter AIDS-free intervals; have a higher number of opportunistic infections and have earlier development of tumors and lesions
  6. 6. Newly Diagnosed Older Patients: Guidelines  Older persons experience earlier development of conditions associated with aging, such as cardiovascular disease and neurocognitive impairment  Older persons may have dampened immunologic responses to ART. ART initiation in older persons should not be delayed.  Current Guidelines recommend ART for all patients older than 50 years of age.  The efficacy, pharmacokinetics, adverse effects, and drug interaction potentials of ART in the older adult have not been studied systematically
  7. 7. Older Adults: Risky Behavior  Older adults are less likely to use a condom as a form of protection  Infection rate of older women surpasses older men, sexually active older women who do not fear pregnancy and do not know about the risk of HIV infection may not insist on using a condom  Older women who were infected through heterosexual contact were less likely to have been tested for HIV  Many older men who have sex with men engage in practices that put them at risk  Older adults who use condoms may not know how to store them properly
  8. 8. HIV and Older Women  The number of older women with HIV infection is expected to increase for two reasons:  the rate and incidence of new infections in this age group are increasing,  And women already in care for HIV infection are expected to live longer due to improved ART and other treatment advances.
  9. 9. Treatment Experienced Patients  Nearly 25% of patients on ART are not virologically suppressed  Failure of virologic suppression often results in resistance mutation  Failure of first line regimens is usually caused by 1. suboptimal adherence  patient factors 2. transmitted drug resistance  ARV regimen factors
  10. 10. Clinical Question: � What are some ways to monitor adherence in older patients with HIV? A. Pill counting B. Checking Refill records C. Checking viral loads (labs) D. All of the above
  11. 11. Adherence and the Older Patient Combination of these measurements is best Pill count Self report Measurements of Viral Load (lab) Measurements of therapeutic drug levels Direct observed therapy Refill records
  12. 12. Adherence and the Older Patient  Medication adherence >60 years old ranges from 26%-68%  Strongly related to factors related with aging (ie. Polypharmacy, cognitive and physical limitations, social isolation, and access to medication)  Unstable housing is directly correlated with non adherence  Older AA men are less likely to be adherent then older white men  Perceptions that ART is effective and nonadherence of medications lead to viral resistance predicts higher adherence  Men aged 50-67 years old listed the following reasons for nonadherence: side effects, busy schedules, fatigue, stigmatization of HIV
  13. 13. HIV Infected Women: Guidelines  The indications for initiation of antiretroviral therapy (ART) and the goals of treatment are the same for HIV-infected women (AI).  Women taking antiretroviral (ARV) drugs that have significant pharmacokinetic interactions with oral contraceptives should use an additional or alternative contraceptive method to prevent unintended pregnancy (AIII).  Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz (EFV)  Alternative regimens that do not include EFV should be strongly considered in women who are planning to become pregnant or sexually active and not using effective contraception (BIII).
  14. 14. HIV Infected Women  Hormonal contraception  Conflicting data; when drug interactions with ART occur, additional contraceptive methods should be recommended  Metabolic complications  More likely to experience increases in central fat with ART, less likely to have TG elevations  More likely to have osteopenia/osteoporosis after menopause  Lactic acidosis  Female predominance with prolonged NRTI use (stavudine, didanosine, and zidovudine)  Nevirapine-associated hepatoxicity  Increased risk of rash-associated liver toxicity in ARV naïve individuals  Women with CD4>250cells/mm3 or elevated transaminases are at greatest risk
  15. 15. Clinical Question: � A treatment naïve, pregnant women comes into your clinic and has just been diagnosed with HIV. She is in her 1st trimester. What is a reasonable regimen to begin while waiting for resistance results ? A. TDF/FTC + ATV/r B. ABC/3TC + ATV/r C. EVG/cobi/TDF/FTC D. TDF/FTC + T20
  16. 16. Treatment Naïve Pregnant Women: Guidelines  The same regimens as nonpregnant adults should be used in pregnant women (AIII)  Multiple factors must be considered when choosing a regimen for a pregnant woman including comorbidities, convenience, adverse effects, drug interactions, resistance testing results, pharmacokinetics (PK)(AII)  PK changes may lead to lower plasma drug levels of drugs and necessitate increased dosages, more frequent dosing, or boosting, especially of protease inhibitors. (AII)
  17. 17. Treatment Naïve Pregnant Women: Guidelines  All HIV-infected pregnant women should receive a potent combination ARV regimen (AI)  The decision as to whether to start the regimen in the first trimester or delay until 12 weeks’ gestation will depend on CD4 count, HIV RNA levels, and maternal conditions. (AIII)  Earlier initiation of a combination ARV regimen may be more effective in reducing transmission,  Fetuses are most susceptible to potential teratogenic effects in the first trimester.
  18. 18. Initial ART Recommendations: Treatment naïve pregnant women Preferred regimens for the treatment of ART-naive HIV- infected pregnant : A dual NRTI combination (abacavir/lamivudine, tenofovir/emtricitabine or lamivudine, or zidovudine/lamivudine) + either a ritonavir-boosted protease inhibitor (ritonavir-boosted atazanavir or ritonavir-boosted lopinavir) or an NNRTI (efavirenz initiated after 8 weeks of pregnancy). (AIII) Refer to Antiretroviral Drug Resistance and Resistance Testing in Pregnancy
  19. 19. Initial ART Recommendations: Treatment naïve pregnant women Preferred 2-NRTI Backbone Regimens
  20. 20. Initial ART Recommendations: Treatment naïve pregnant women Preferred PI Regimens
  21. 21. Initial ART Recommendations: Treatment naïve pregnant women Preferred NNRTI Regimen
  22. 22. Clinical Question: �  A known HIV positive, treatment naïve, mother comes into the hospital to give birth. Which ART is recommended to be given before birth to help prevent perinatal HIV transmission? Why? A. Didanosine B. Zidovudine C. Efavirenz D. Darunavir
  23. 23. Intrapartum ARV Therapy/Prophylaxis  Women should continue their antepartum combination ARV drug regimen on schedule as much as possible during labor and before scheduled cesarean delivery. (AIII)  Intravenous (IV) zidovudine should be administered to HIV-infected women with VL >1,000 copies/mL (or unknown VL) near delivery (AI),  In nonrandomized studies of women on cART, addition of intrapartem AZT appears to reduce risk of perinatal transmission
  24. 24. Clinical Question: � A newborn baby with an HIV positive mother was just transferred into the NICU. How soon should the baby begin receiving ART? A. Immediately B. In 6 months C. After the baby is done breastfeeding D. Within the first year
  25. 25. Infant ART Prophylaxis: Guidelines The 6 week neonatal component of the AZT prophylaxis regimen is generally recommended for all HIV exposure neonates to reduce perinatal transmission of HIV (AI).  Zidovudine, at gestational age-appropriate doses, should be initiated as close to the time of birth as possible, preferably within 6 to 12 hours of delivery (AII).  Infants born to HIV-infected women who have not received cART should receive prophylaxis with zidovudine given for 6 weeks combined with three doses of nevirapine in the first week of life (i.e., at birth, 48 hours later, and 96 hours after the second dose), begun as soon after birth as possible (AI).  The National Perinatal HIV Hotline (1-888-448-8765) provides free clinical consultation on all aspects of perinatal HIV, including infant care.
  26. 26. Neonatal ART Drug Dosing: Guidelines Zidovudin e (ZDV) Dosing Duration ≥35 weeks’ gestation at birth:4 mg/kg/dose PO twice daily, started as soon after birth as possible and preferably within 6–12 hours of delivery (or, if unable to tolerate oral agents, 3 mg/kg/dose IV, beginning within 6– 12 hours of delivery, then every 12 hours) Birth through 4-6 weeks ≥30 to <35 weeks’ gestation at birth:2 mg/kg/dose PO (or 1.5 mg/kg/ dose IV), started as soon after birth as possible, preferably within 6–12 hours of delivery, then every 12 hours, advanced to 3 mg/kg/dose PO (or 2.3 mg/kg/dose IV) every 12 hours at age 15 days Birth through 6 weeks <30 weeks’ gestation at birth:2 mg/kg body weight/dose PO (or 1.5 mg/ kg/dose IV) started as soon after birth as possible, preferably within 6–12 hours of delivery, then every 12 hours, advanced to 3 mg/kg/dose PO (or 2.3 mg/kg/dose IV) every 12 hours after age 4 weeks Birth through 6 weeks All HIV-Exposed Infants *initiate as soon as possible after delivery*
  27. 27. Drugs that Interact with ART NRTI Drugs that Interact Tenofovir (TDF) Ambien, didanosine, acyclovir, ganciclovir, valacyclovir, NSAIDS, vancomycin Abacavir (ABC) EtOH, Amitriptyline, Fluconazole, Isoniazid, NSAIDS, Phenobarbital Lamivudine (3TC) Cimetidine, Ethambutol, TMP/SMX Zidovudine (ZDV, AZT) Antineoplastics, Methadone, Fluconazole, Pentoxifylline, Rifampin, TMP/SMX Didanosine (ddl) EtOH, Antineoplastics, Ketoconazole, Methadone, Tetracyclines Stavudine (d4t) Cisplatin, Disulfiram, TMP/SMX, Vincristine Zalcitabine Antacids, Cimetidine, Cisplatin, Disulfiram, Phenytoin, Probenecid
  28. 28. Drugs that Interact with ART
  29. 29. Drugs that Interact with ART
  30. 30. Clinical Question: � Which of the following drugs interact with protease inhibitors and needs to be monitored? A. Nicardipine B. Voriconazole C. Simvastatin D. All of the above
  31. 31. Drugs that interact with all PIs
  32. 32. Drugs that interact with ART
  33. 33. Drugs that Interact with ART
  34. 34. Drugs that interact with ART Fusion Inhibitor Drugs that interact Enfuvirtide
  35. 35. Drugs that interact with ART PK Boosters Drugs that interact Ritonavir Amiodarone, atorvastatin, benzos, bupropion, clarithromycin, diltiazem, piroxicam, quinidine, zolpidem Cobicstat (cobi) *potent inhibitor of CYP450 3A4 and 2D6* Rifampin, dihydroergotamine, cisapride, St. John’s Wort, lovastatin/simvastatin, pimozide, triazolam, oral midazolam
  36. 36. Key Points  Older patients are less likely to be screened for HIV and more likely to experience severe side effects from ART  HIV infected women on hormonal contraceptives should be monitored and use back up methods  Efavirenz should not be prescribed in HIV infected women who are trying to become pregnant  Protease Inhibitors have multiple drug/drug interactions  Many drugs used prophylactically against opportunisitic infections have drug interactions with ART, monitor carefully!  IV Zidovudine is recommended 3 hours before labor for HIV positive, treatment naïve mothers or mothers with viral loads over 1000
  37. 37. References  http://www.med.unc.edu/aging/elderhiv/infected.htm  http://www.hivguidelines.org/clinical-guidelines/womens-health/medical- care-for-menopausal-and-older-women-with-hiv-infection/  http://www.avert.org/antiretroviral-drugs-side-effects.htm  Assessment and Predictors of ART Adherence in Older HIV Infected Patients. Wutoh, AK, Elekwachi, O., Clarke-Tasker, V., Daftary, M., Powell, NJ., Campusano, G. Journal of Acquired Immune Deficiency Syndromes. 33: S106-S114. 2003  http://www.hiv-druginteractions.org/Interactions.aspx  Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1- Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Aidsinfo.nih.gov.guidelines
  38. 38. AETC Contact Information  Pennsylvania/MidAtlantic AETC  Website: www.pamaaetc.org  Phone: 412-624-1895  Consultation: 888-664-AETC  National Clinician Consultation Service  800-933-3413  PEP Line  888-448-4911  Linda Frank, PhD, MSN, FAAN, ACRN  412-624-9118  frankie@pitt.edu

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