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Side effects of ARV Treatment

Ardis Ann Moe, M.D. UCLA CARE Clinic/NEVHC HIV Clinic Van Nuys. 19 August 2013. Side effects of ARV Treatment. Objectives. To describe the major side effects of HIV treatment To know useful lab tests for HIV side effect monitoring

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Side effects of ARV Treatment

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  1. Ardis Ann Moe, M.D. UCLA CARE Clinic/NEVHC HIV Clinic Van Nuys. 19 August 2013 Side effects of ARV Treatment

  2. Objectives • To describe the major side effects of HIV treatment • To know useful lab tests for HIV side effect monitoring • To be able to change from one set of HIV medications to another to prevent side effects • To review case studies of how to choose initial HIV regimen, and what regimen to switch to in the event of side effects

  3. Quick-and-dirty: Plans A,B,C and D • Plan A: “A pill A day for type A personalities” Atripla, complera, stribild • Low barrier to resistance

  4. Plan B: “Boosted protease inhibitor for batty buddies on the brink” • Most useful when you have desperately ill patients with OI or AIDS cancers OR mentally ill patients OR patients with other adherence risks • Reyataz/norvir/truvada • Lexiva/norvir/truvada • Prezista/norvir/truvada • High barriers to resistance.

  5. Plan C: “Curses, I forgot the Contraception” • Kaletra and Combivir • First choice for pregnant women with HIV

  6. Plan D: for Drug-drug interactions OR DARN I stuck myself • Isentress +truvada • Has fewest drug interactions • Preferred drug for needlestick injuries

  7. Nucleoside Analogs • As a class they are associated with lactic acidosis • Pancreatitis—rare in most of the common nucleoside analogs, common in didanosine (Videx) • Most side effects linked to some form of mitochondrial poisoning; often organ specific.

  8. Tenofovir/emtricitabine: truvada • Most common nucleoside/tide backbone for most HIV cocktails • Tenofovir: nucleotide analog: • Causes Fanconi’s syndrome and renal insufficiency • May lead to irreversible kidney failure if not discontinued in time. • Also treats hepatitis B effectively • May also cause GI upset

  9. Emtricitabine • Rash—most likely to case rash of all the nucleosides • Also treats hepatitis B

  10. Abacavir/lamivudine: Epzicom • Abacavir: associated with hypersensitivity reaction; flu-like illness with high fevers, diarrhea, cough, rash that can progress to anaphylaxis. Occassional headaches • Lamivudine. Probably can be put in the drinking water. • Sometimes patients tolerate the separate ingredients better than the combo drug

  11. Zidovudine/lamivudine: Combivir • Zidovudine: Anemia, leucopenia, fatigue, headache, nausea. Myositis “AZT Butt” • Approved in 1987; first HIV medication • Also causes some facial wasting • BID drug

  12. Less commonly used nucleosides • Didanosine: Videx • High risk of pancreatitis, especially when combined with stavudine (zerit),peripheral neuropathy, lactic acidosis. • Single most dangerous drug in the whole HIV armamentarium

  13. Stavudine (Zerit) • Peripheral neuropathy, facial wasting, lactic acidosis, pancreatitis. • Used as a “bridge” drug when more commonly used nucleosides are not able to be taken.

  14. Stocking-glove pattern of neuropathy

  15. Protease inhibitors • 1st generation PI’s approved 1996; 2nd generation 2003 • As a class they all cause insulin resistance and risk of diabetes. • Diabetes may only be partially reversible once it has occurred and the protease inhibitors are stopped • They all cause diarrhea, nausea and GI upset. • They all have significant drug interactions: cytochrome p450 inhibitors

  16. Protease inhibitors have best data for patient survival after diagnosis of AIDS related cancers or opportunistic infections

  17. 1st generation protease inhibitors: • Lopinavir/ritonavir: Kaletra (BID) • Saquinavir: Invirase (BID) • Indinavir: Crixivan (BID) • Nelfinavir: Viracept (TID)

  18. Except for kaletra, most 1st generation PI’s not used. • All 1st generation PI’s have elevated cholesterol, triglycerides, and fat accumulation problems.

  19. Buffalo hump

  20. “Crix Belly”

  21. Lipodystrophy is one of patient’s major concerns; some patients would rather die of HIV complications than have body-shape changes. • Similar issue to women with breast cancer and mastectomy • For 1st gen PI’s, risk 75% after 2 years of treatment

  22. Second generation protease inhibitors • Atazanavir: Reyataz • Fos-Amprenavir: Lexiva • Darunavir: Prezista • Much less likely to cause lipodystrophy or cause elevated lipids • Overall much better tolerated than 1st gen PI’s.

  23. Atazanavir: • Can also cause unconjugated bilirubin elevation and scleral icterus. Usual bilirubin levels 2-3.0 • Need to change meds when scleral icterus evident or bilirubin levels >3.5 • Has drug interaction with proton pump inhibitors; Needs to be taken 12 hours away from dosing of PPI. • Best GI tolerance of all PI’s.

  24. Fosamprenavir: • Can be taken with PPI’s • Some risk of rash

  25. Darunavir: • Has sulfa moiety ;some risk of rash, esp in sulfa allergic patients (not a contraindication) • Has worst GI tolerance of second generation PI’s • Can be used for salvage treatment, but if patient is resistant to this PI, cannot salvage with any other PI

  26. Non nucleoside analogs • As a class they all cause rash and have significant drug interactions (cytochrome p450)

  27. Efavirenz: Sustiva • Best known of all the nucleoside analogs • Causes severe depression, panic attacks, insomnia (interfere with REM sleep), vivid dreams. • May also increase cholesterol • Neural tube defects in newborns • Used with truvada to make Atripla. • Has to be taken on an empty stomach at bedtime

  28. Neviripine: Viramune • Most likely to cause Stevens-Johnson syndrome

  29. Etravirine: Intelence • Twice daily dosing • Vivid dreams • Gritty taste; dissolves in mouth

  30. Rilpivirine: Edurant. Used with truvada to make Complera • “Atripla Junior” can cause some depression and vivid dreams; usually less than efavirenz • Has to be taken with a substantial meal. • Cannot be taken on the same day as PPI’s or H2 blockers.

  31. Delavirine: Rescriptor • Rarely used • Twice daily • Rash, birth defects

  32. Integrase inhibitors • Raltegravir: Isentress • Dolutegravir: Tivicay • Elvitegravir (used with cobisistat) • As a class, they all cause diarrhea and occasional vivid dreams.

  33. Raltegravir: • BID drug; can be given safely with most cytochrome p450 active meds • Needs to be taken 2 hours away from PPI’s

  34. Stribild: truvada + elvitegravir +cobisistat • Boosting agent: cobisistat: cytochrome p450 active agent. • Also needs to be taken 2 hours away from PPI’s • Has all the side effects of truvada as well.

  35. Dolutegravir: • Common: headache and insomnia. • Can worsen liver function when patient has hep C or hep B

  36. Entry inhibitors • Enfuviritide. • Twice daily injectable drug. • GP41 inhibitor “condom for HIV virus” • Painful lumps on skin from local reaction to medication • No drug interactions. • $2,000 for this medication alone • Generally used for deep salvage treatment of HIV

  37. Maraviroc: Selzentry • Twice daily drug • Risk of orthostatic hypotension • Risk of rash (small) Only effective in CCKR5 trophic HIV virus. “condom for CD4 cell” Can be used in initial therapy, or as salvage.

  38. Blood tests necessary for monitoring • Abacavir: use HLA B5701 allele testing PRIOR to dosing. • If POSITIVE, then patient has high likelihood of developing abacavir hypersensitivity reaction

  39. Creatinine; urinalysis. • Use this prior to dosing and every 3-6 months for patient on tenofovir containing regimens. Elevated urine protein, elevated creatinine are indications to considers switching tenofovir to another medication

  40. Bilirubin, ALT, AST • Bilirubins can be used as a marker for compliance for atazanavir • Bilirubin >3.5 or symptomatic scleral icterus may be indication for changing atazanavir • All HIV meds (except for fuzeon) have some liver toxicity so ALT, Ast should be monitored as well. • Hep C can get better with HIV treatment (avoid atazanavir, dolutegravir) • Hep B treatment gets better with truvada

  41. CBC with plts and diff • Thromboctopenia can improve within a few days of starting HIV meds • AZT may initially worsen, and then improve anemia

  42. Hemogloblin A1C, glucose • PI’s make diabetes more likely • Insulin resistance presents as elevated HBA1c first.

  43. Amylase, lipase • Perform when clinical suspicion of pancreatitis • Not helpful for routine monitoring if patient does not have symptoms of pancreatitis.

  44. Clinical cases: • 32 yo homeless man, HIV+ new diagnosis. • Alcoholic, depressed,Cr 2.3. Hepatitis C. • What drug regimen would you try to AVOID. • What initial labs do you need to make a drug choice decision?

  45. 65 yo male new dx of HIV infection. • Hx of afib and cardiac arrythmia. On amiroidarone and warfarin. Cr. 1.0 • What HIV medications do you need to AVOID? • What drug cocktails can be used in him?

  46. 31 yo pregnant woman with HIV. • Chronic active hepatitis B • What HIV medications should she AVOID • What are her best choices of HIV meds?

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