1. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Review of HIV Therapy Ronald D. Wilcox MD FAAP Project Director / Principal Investigator, DAETC Assistant Professor of Internal Medicine and Pediatrics, LSUHSC

2. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Disclaimer The speaker receives funding for research from the following companies: – Tibotec – Pfizer – Boeringer-Ingelheim – GlaxoSmithKline – Bristol-Myers-Squibb – Merck

3. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Objectives Review the life cycle of the HIV virus Review the current medications for treatment of HIV Review the current recommendations for initiation of HAART Review appropriate prophylaxis for OIs

4. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Question How familiar are you with the different classes of HIV medications? 1.Very familiar – know all 7 classes and most of the agents 2.Can name at least 5 classes 3.Can name at least 3 classes 4.Can name at least 1 class 5. Know none of the classes of medications

5. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org HIV Life Cycle Attaches at CD4 marker with help of CXCR4 and CCR5 Injects RNA into the cytoplasm cDNA is made using reverse transcriptase cDNA is integrated into the cell DNA using integrase and replication occurs Protease cleaves the subsequent RNA and proteins into individual segments Buds off or disrupts cell membrane for release

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7. HAART Therapy 4 major targets: – Fusion inhibition CD4 receptor inhibitor CCR5-Inhibitor – Reverse transcriptase enzyme Nucleoside Reverse Transcriptase Inhibitors Nucleotide Reverse Transcriptase Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors – Integrase Integrase Inhibitor – Protease enzyme Protease inhibitors

8. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Nucleoside RT Inhibitors Abacavir (ABC) (1998) Didanosine (ddI) (1991) Emtricitabine (FTC) (2003) Lamivudine (3TC) (1995) Stavudine (d4T) (1994) Zalcitabine (ddC) (1992) Zidovudine (AZT, ZDV) (1987)

9. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Case 1 28 year old obese patient is being seen by one of your colleagues. His current (second) HAART is d4T + Efavirenz + ddI and his viral load last month was < 400 on this regimen. He is also on dapsone for PcP prophylaxis. The patient comes to your office complaining of some abdominal cramping over the past week that has steadily increased along with some nausea with one episode of emesis. No hematochezia, hematemesis, melena, diarrhaea, or constipation. He has also had lower extremity pain for 2 months.

10. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Case 1 Laboratory work-up reveals a WBC 8.2 with diff 66 s and 30 l. His H/H and platelets are within normal limits. His chemistry reveals a Na 128, K 3.4, Cl 98, CO2 14, BUN/Creat 22/1.4, glucose 88, and his AST and ALT are elevated at 2x the upper limits of normal. Lipase was 34.

11. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Question Which of the following is the most likely cause of the patient’s symptoms? 1.Methemoglobinemia from the dapsone 2.Pancreatitis from the ddI 3.Hepatitis from the efavirenz 4.Lactic acidosis from the d4T 5.Cryptosporidiosis of the gallbladder

12. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Adverse Side Effect of Class Lactic Acidosis + / - hepatic steatosis

13. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Hepatic Steatosis / Lactic Acidosis Mechanism: – Inhibitor of DNA polymerase gamma (mitochondrial DNA synthesis) Incidence: “Low” but with high fatality rate Risk Factors: – Female sex, Obesity, Prolonged Use, Pregnancy Presentation: – Non-specific GI (nausea, anorexia, pain, diarrhea), weakness, dyspnea, hepatomegaly, increased lactate, mild increase in transaminases, increased anion gap Highest risk with d4T, esp when paired with ddI

14. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Hepatic Steatosis

15. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Hepatic Steatosis / Lactic Acidosis CT:SOME pts have enlarged, fatty liver Screening:Do NOT stop RTI in every pt with lactate or transaminase elevation Therapy:Stop RT if pt is symptomatic, acidotic, or lactate > 5 ? Riboflavin, Carnitine, Thiamine, Coenzyme Q Rechallenge:Are any nucleosides safe?

16. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Question All of the following are considered examples of mitochondrial toxicity effects of nRTIs EXCEPT: 1.cardiomyopathy 2.pancreatitis 3.lipoatrophy 4.peripheral neuropathy 5.insulin resistance

17. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Abacavir (ABC, Ziagen) Pregnancy Risk Factor:C Dosing: – 8 mg/kg BID up to 300 mg po BID – May give as 600 mg po daily HYPERSENSITIVITY REACTION: – 2-8%;presents as anaphylaxis, fever, rash, fatigue, malaise, diarrhea, abdominal pain, N/V, respiratory symptoms, headache, myalgias/arthralgias – Screen with assay for HLA-B*5701 Other ADEs: depression, dizziness, anxiety, thrombocytopenia, increased transaminases, myocardial infarction (90% increase)

18. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Didanosine (ddI, Videx, Videx EC) Pregnancy Risk Class:B Comes as EC capsule or chewable tablets or liquid Dosing: – Peds:180-240 mg / m 2 / day divided q12 – Adults:> 60 kg: 200 BID or 400 daily < 60 kg: 125 mg BID or 250 daily MUST be on an EMPTY stomach (except when given with tenofovir) Adverse side effect: Pancreatitis (2-3%), peripheral neuropathy (17-20%), retinal changes and optic neuritis, GI disturbances, increased transaminases and alkaline phosphatase, myocardial infarction (49% increase)

19. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Emtricitabine (FTC, Emtriva) Pregnancy Risk Class: B Dosing: – Children > 33 kg and older: 200 mg daily with or without food – Children < 33 kg: 6 mg/kg/day (liquid) Adverse Drug Effects: – Rash; Headache, dizziness, insomnia, diarrhea, nausea, weakness with increased CK, cough, abnormal dreams.

20. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Lamivudine (3TC, Epivir) Pregnancy Risk Class:C Dosing:150 mg bid or 300 mg daily – <50 kg: 2 mg/kg bid (liquid) Adverse drug effects: – Well tolerated – Headache and fatigue > 10%, pancreatitis (higher in peds), peripheral neuropathy, neutropenia

21. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Stavudine (d4T, Zerit) Pregnancy Risk Class:C Dosing: – Peds:1 mg/kg bid (liquid) – Adults: 60 kg: 40 mg bid Adverse effects: – Peripheral neuropathy – Increased transaminases, triglycerides – Increased risk of lactic acidosis – Lipo-atrophy – Severe motor weakness

22. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Zidovudine (AZT, ZDV, Retrovir) Pregnancy Risk Class: C Dosing: – 200 mg tid or 300 mg bid – Peds: 480 mg/m2 divided q6-q12 (liquid) – Postnatal: 2 mg/kg q6 x 6 weeks Adverse drug effects: – Bone Marrow Suppression (23% anemia, 39% granulocytopenia in children)Myopathies – Headache (42%)GI Upset – MacrocytosisBluish-brown Nails – Hair texture change in African-Americans

23. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Combined Forms Combivir:AZT + 3TC (1997) Trizivir:AZT + 3TC + ABC (2000) TruvadaTDF + FTC (2004) EpzicomABC + 3TC (2004)

24. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Nucleotide RT Inhibitors Adefovir Tenofovir (TDF) (2001)

25. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Adefovir No longer used in HIV care secondary to renal impairment

26. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Tenofovir (TDF, Viread) Pregnancy Risk Class:C Dosing: – 300 mg daily – No peds dosing Adverse drug effects: (equal to placebo) – Fanconi syndrome, renal insufficiency Must change dosing with ClCr < 50 – 30-49:every 48 hours – 10-29:twice weekly – Hemodialysis:once weekly

27. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Non-Nucleoside RT Inhibitors Delavirdine (DLV) (1997) Nevirapine (NVP) (1996) Efavirenz (EFV) (1998) Etravirine (ETV) (2008)

28. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Delavirdine (DLV, Rescriptor) Pregnancy Risk Class:C – Avoid use in lactating women Dosing: (no peds dosing) – 400 mg tid or – 600 mg bid Adverse drug effects: – RashElevated transaminases – Headache Booster effect on some PIs: lopinavir, ritonavir, saquinavir

29. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Nevirapine (NVP, Viramune) Pregnancy Risk Class: B Dosing: – 200 mg daily x 14 days then bid – (May give as 400 mg daily) – Peds: 120 mg/m2 bid (liquid) Adverse Drug Effects: – RASH (15-20%) – Elevated transaminases – especially when used in PEP – Initiate cautiously with women with CD4 > 250 or men with CD4 > 400 – Neutropenia, diarrhea

30. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Efavirenz (EFV, Sustiva) Pregnancy Risk Class: D Dosing: 600 mg qHS – Peds: based on weight {>10 kg} Adverse Drug Effects: – CNS Stimulation: nightmares/abnormal dreams, dizziness, depression, anxiety, insomnia, jitteriness, daytime somnolence, psychosis, problems with memory and concentration – Rash (up to 46% in pediatrics) – Increased transaminases – Hyperlipidemia

31. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Etravirine (TMC-125, Intelence) Approved January 18, 2008 Dosing: 100 mg (2) po BID ADEs: rash (16.9%) and nausea (13.9%) Salvage medication – must be used with a boosted protease inhibitor in the regimen

32. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Protease Inhibitors Amprenavir (1999) / fos-Amprenavir (fAMP) (2003) Atazanavir (ATV) (2003) Darunavir (DRV) (2006) Indinavir (IND) (1996) Lopinavir / rtv (LPV/r) (2000) Nelfinavir (NLF) (1997) Ritonavir (RTV) (1996) Saquinavir (SQV) (1997) Tipranavir (TPV) (2005)

33. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Case 2 33 year old male patient presents to you office after being on d4T + ddI + Indinavir for 2 years with new complaints of increased urinary frequency and increasing fatigue. The patient reports that his shirt collar and pants are getting more tight and he reports concern about possible breast development.

34. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Question All of the following are metabolic side effects of the protease inhibitors EXCEPT: 1.Lipoatrophy 2.Lipodystrophy 3.Osteopenia 4.Insulin resistance 5.Hyperlipidemias

35. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Case 2 Laboratory work-up reveals: – Glucose 273 – UA with >1000 glucose – TG 875 with a total cholesterol of 266 – HDL 25

36. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Insulin resistance New onset DM or worsening of current DM – Insulin resistance – Impairment of glucose tolerance – Hyperglycemia – Frank diabetes rare

37. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Lipid metabolism Increase in triglycerides Increase in cholesterol

38. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Morphologic changes Fat accumulation: – Abdominal obesity – Buffalo Hump – Lipomatosis – Breast enlargement

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40. Lipoatrophy - nRTIs Fat loss – Appendices – Face – Buttocks

41. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Osteopenia Highest incidence – Femoral head – osteonecrosis Screen with DEXA scans

42. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org fos-Amprenavir (fAMP, Lexiva) Pregnancy Risk Class:C Dosing: – Unboosted:1400 mg BID – Boosted Lexiva: 1400 mg with 100 mg Norvir daily (naive) OR 700 mg with 100 mg Norvir BID Pediatric Dosing: (50 mg/ml) (2 years and older) – Unboosted:30 mg/kg BID – Boosted:18 mg/kg + Ritonavir 3 mg/kg BID Adverse Drug Effects: – GI upset (N/V, diarrhea, taste disorders) – Rash – Circumoral paresthesias

43. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Atazanavir (ATV, Reyataz) Pregnancy Risk Class:B Dosing: – PI-naïve patients: 200 mg (2) daily or ritonavir- boosted – PI-experienced patients: 300 mg daily with 100 mg Norvir Adverse Drug Effects: hyperbilirubinemia, jaundice (5%) Recent reports of kidney stones PPI use – only in treatment-naïve patients on boosted atazanavir and given 12 hours apart Cannot give with nevirapine

44. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Darunavir (TMC-114, Prezista) Pregnancy Risk Class:B Dosing: – PI-experienced patients: 300 mg (2) or 600 mg (1) with 100 mg Norvir BID Adverse Drug Effects: – Diarrhea, nausea & vomiting, headache, rash (7% and included all severities including Stevens-Johnson) – Elevated liver enzymes/hepatitis – Also perioral paresthesia, hepatitis, fat redistribution, hyperlipidemia, Type 2 diabetes are possible Must take with food

45. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Indinavir (IND, Crixivan) Pregnancy Risk Class:C Taken on empty stomach if given alone Dosing: – Forms: 333 mg, 400 mg capsules – 800 mg q8 – Boosted – 800 mg bid with Norvir 100 mg with food – Peds:500 mg/m2 q8 Adverse Drug Effects: – NephrolithiasisHyperbilirubinemia – GI intolerance 42-64 oz of fluids per day required Best PI for CNS penetration studied

46. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Lopinavir/RTV (LPV/r, Kaletra) Pregnancy Risk Class:C Dosing: – 400 mg/100 mg bid – 800 mg/200 mg po daily – naïve pts – 3 forms:tablets – 200 mg/50 mg tablets – 100mg/25 mg liquid – 5 cc Adverse Drug Effects: – GI intolerance – Hyperlipidemias

47. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Nelfinavir (NLF, Viracept) Pregnancy Risk Class:B* Must be taken after meals (500 kcal / 30% fat) Dosing: – 250 mg or 625 mg tablets; 50 mg “scoops” – 750 mg tid OR 1250 mg bid – Peds:20-30 mg/kg tid OR 50-55 mg/kg bid (mix with formula but avoid acidic juices) Adverse Drug Effects: – DiarrheaRash – Weakness

48. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Ritonavir (RTV, Norvir) Pregnancy Risk Class:B Dosing: – 600 mg bid – Booster effect: 100-200 mg bid Taken with food Store in refrigerator Adverse drug effects: – GI IntoleranceTaste Perversion – Circumoral, peripheral paresthesia – Elevated transaminasesFatigue

49. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Saquinavir (SQV, Fortovase, Invirase) Pregnancy Risk Class:B Dosing:500 mg tablets of Invirase – 1000 mg with Norvir 100 mg BID – 2000 mg with Norvir 100 mg Daily – No peds dosing Adverse drug effects: – GI intolerance – Headaches – Elevated transaminases

50. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Tipranavir (TPV, Aptivus) Pregnancy Risk Class:B Dosing:250 mg tablets – 500 mg with Norvir 200 mg BID – No peds dosing – Cannot give with other PIs Adverse drug effects: – GI intoleranceHeadaches – Elevated transaminases – Intracranial hemorrhages

51. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Fusion Inhibitors Enfuvirtide (T-20) (2003) Maraviroc (MRV) (2007)

52. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Enfuvirtide (T-20, Fuzeon) Pregnancy Risk Class: B Dosing: – 90 mg SQ bid Adverse Drug Reactions: – Injection site reactions, diarrhea, nausea, fatigue, peripheral neuropathy, decreased appetite, pneumonia?

53. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Maraviroc (MRV, Selzentry) Pregnancy Risk Class: B Mechanism of Action:CCR5 inhibition Dosing: – 150 – 600 mg po BID, dependent on concomitant meds – no data yet in patients < 16 y/o Adverse Drug Reactions: – Infections (50.2% versus 38.3%) {Candida, URI, and HSV}; similar to placebo for hypotension; a case of possible MRV-induced hepatotoxicity with allergic features has been reported in a study of healthy volunteers

54. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Raltegravir (Isentress) First integrase inhibitor approved by FDA (2007) Pregnancy risk class: C 400 mg po bid Side effects – rare reports of weakness and CK elevation Recent (8-08) reports of liver toxicity when co- administered with tipranavir (3 patients)

55. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Atripla Combination of Tenofovir + Emtricitabine + Efavirenz (2006) given once daily

56. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Question Which of the following patients would probably NOT need HAART therapy? 1.42 y/o with treated pulmonary TB, CD4 count 220, and viral load 42,000 2.35 year old with PcP and CD4 count 20 3.24 year old 16 weeks pregnant patient with CD4 count 525 and viral load 10,000 4.68 year old with night sweats, LAD, fever, and CD4 count 367 with viral load 55,000 5.52 year old otherwise healthy with CD4 count 370 and viral load 85,000

57. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Guidelines for Initiation General guidelines: – Consider: Viral load > 100,000 and CD4 count > 350 – Offer: CD4 < 350 Pregnancy Chronic hepatitis B HIV-Associated Nephropathy Exceptions: – Symptomatic HIV disease – Acute Retroviral Syndrome

58. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Question Patient newly diagnosed with HIV. Initial CD4 count is 94 (8.2%) with HIV viral load of 125,000 copies/ml. Toxo serology is 1.2 and CMV IgG is 10.0. PPD shows 3 mm induration. The patient would need prophylaxis for which of the following diseases (more than one answer may be correct)? – 1.Pneumocystis jiroveci (PcP) only – 2.PcP + Toxoplasmosis – 3. PcP + Cytomegalovirus – 4.MAC + PcP + Tuberculosis + toxoplasmosis – 5.MAC + PcP + Toxoplasmosis + Tb + CMV

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60. Prophylaxis Pneumocystis jiroveci pneumonia (PcP) – Adults / Adolescents: CD4 < 200 or < 14% AIDS-defining OI Oropharyngeal candidiasis – Pediatrics < 12 months: begin at 4-6 weeks of age if exposed 1-5 years: CD4 < 500 or <15% 6-12 years: same as adolescent

61. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Prophylaxis PcP – Medications: TMP/SMX SS or DS daily or DS TIW – Peds: TMP/SMX 10 mg/kg/day divided BID qMTW {begin at 4-6 weeks of age} Dapsone 50 to 100 mg daily – Peds: Dapsone 2 mg/kg daily or 4 mg/kg weekly

62. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Prophylaxis PcP: – Medications cont.: Atovaquone 1500 mg po daily – Peds:1-3 & > 24 months: 30 mg/kg daily 4-24 months: 45 mg/kg daily Aerosolized pentamidine 300 mg monthly for adults or children

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64. Prophylaxis Toxoplasmosis – Adults / Adolescents: CD4 count < 100 and serology (IgG) positive – Pediatrics: Age > 12 months: qualify for PcP prophylaxis and are seropositive

65. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Prophylaxis Toxoplasmosis – Medications: TMP/ SMX DS or SS daily – Peds: 10 mg/kg divided BID qMTW Atovaquone 1500 mg daily – Peds: 1-3 & > 24 months: 30 mg/kg daily 4-24 months: 45 mg/kg daily Pyrimethamine 50 mg + leucovorin 25 mg weekly

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67. Prophylaxis MAC: – Adults / Adolescents: CD4 count < 50 – Pediatrics: <1 year: CD4 count < 750 1-2 years: CD4 count < 500 2-6 years: CD4 count <75 6-12 years: CD4 count <50

68. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Prophylaxis MAC: – Azithromycin 1200 mg qWeek Peds: 20 mg/kg Weekly (max 1200) OR 5 mg/kg daily – Clarithromycin 500 mg BID Peds: 7.5 mg/kg BID (max 500 mg) – Rifabutin 300 mg daily Peds: only in children > 6 years of age: 150-450 mg daily

69. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Discontinuation Criteria PcP Prophylaxis – Primary and Secondary: CD4 count > 200 (and above 14%) for at least 3 months Toxoplasma prophylaxis – Primary: Same criteria as PcP prophylaxis discontinuation – Secondary: Treatment for > 12 months and CD4 > 200 for at least 3 months MAC – Primary prophylaxis: CD4 count > 100 for 6 months – Secondary prophylaxis: Treatment for > 12 months and CD4 > 100 for 6 months

70. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Question How familiar are you NOW with the different classes of HIV medications? 1.I could identify the seven major classes and the most common side effects from the classes 2.I could identify 5 of the classes and many of the side effects 3.I could identify 3 of the classes and some side effects 4.I could identify 2 of the classes but almost none of the side effects 5.There are medications to treat HIV?

71. DELTA REGION AIDS EDUCATION AND TRAINING CENTER deltaaetc.org Tha-tha-tha-that’s all, folks!