1. New Treatment Paradigms for Therapeutically-Naïve and Treatment-Experienced HIV Patients A Customized CME Learning Experience

2. Case 1Question 1 What is the percentage of patients from the RESIST studies who initially were susceptible to darunavir and remained fully susceptible to darunavir after failing tipranavir? A. <10% B. 10%-20% C. 30%-50% D. 80%

3. Case 1Question 2 At this stage, which of the following would you do ? a. Repeat resistance test b. Run a tropism assay ( ie, Trofile) c. Recheck her labs in 3 months d. a and b e. a and c f. b and c

4. Case 1Question 2 At this stage, which of the following would you do ? A. Repeat resistance test B. Run a tropism assay ( ie, Trofile) C. Recheck her labs in 3 months D. A and B E. A and C F. B and C

5. Case 1 Question 3 Her PhenoSense GT assay was unchanged from the last one obtained. She had R5 tropic virus. What would you do next? a. Intensify her prescription with maraviroc b. Substitute her darunavir with maraviroc c. Continue to watch her on the same regimen d. Reiterate the importance of drug adherence e. a and d f. b and d

6. Case 1 Question 3 Her PhenoSense GT assay was unchanged from the last one obtained. She had R5 tropic virus. What would you do next? A. Intensify her prescription with maraviroc B. Substitute her darunavir with maraviroc C. Continue to watch her on the same regimen D. Reiterate the importance of drug adherence E. A and D F. B and D

7. Case 2 May of 2003: Hepatitis Profile HAV Ab Negative HBV sAg Negative HBV core Ab, sAb Positive HCV Ab Negative

8. Case 2 Question 1 Is a Hepatitis A vaccine needed at this time? a. Yes b. No

9. Case 2 Question 1 Is a Hepatitis A vaccine needed at this time? A. Yes B. No

10. Case 2: October of 2005: Laboratory Values ALT 1620 U/L AST 1006 U/L Bili 1.84 mg/dl Alk P 216 U/L HIV RNA 151,049 cps/ml CD4 303 (27%)

11. Case 2Question 2 What would you order next? a. IgM HAV b. IgM HBV Core Ab c. HCV Abs d. HCV Viral load e. c and d f. b and c

12. Case 2Question 2 What would you order next? A. IgM HAV B. IgM HBV Core Ab C. HCV Abs D. HCV viral load E. C and D F. B and C

13. His HCV RNA is 123,000 IU/mL (genotype 1a) Case 2 Question 3 Based on this patient’s history which of the following is a reasonable diagnosis? a. Acute HCV b. Chronic HCV

14. His HCV RNA is 123,000 IU/mL (genotype 1a) Case 2 Question 3 Based on this patient’s history which of the following is a reasonable diagnosis? A. Acute HCV B. Chronic HCV

15. Case 2Question 4 At this stage, is it reasonable to expect a spontaneous clearance? a. Yes b. No

16. Case 2Question 4 At this stage, is it reasonable to expect a spontaneous clearance? A. Yes B. No

17. Case2 His laboratory results for the next three months are as follows: September 05October 05December 05 ALT, U/l 1142179101 AST, U/l 56811367 T Bili, mg/dl 0.640.50.7 HCV RNA, IU/ml 525,00010,300,000 35,900,000 CD4, (cells/µl) 257 (19%)195 (19%) HIV RNA, cps/ml 110,67386,217

18. Case 2 A liver biopsy in January of 2006 revealed mononuclear portal inflammatory infiltrate  Moderate piecemeal necrosis  Mild lobular NI activity  Bile duct damage  NI grade 3-4

19. Case 2 Portal fibrosis with occasional septum formation, Stage 2/4

20. Case 2Question 5 Based on this patient’s history and histopathology, this case is compatible with: a. Acute hepatitis C b. Chronic hepatitis C

21. Case 2Question 5 Based on this patient’s history and histopathology, this case is compatible with: A. Acute hepatitis C B. Chronic hepatitis C

22. Case 2: In February of 2006, the patient starts Peg IFN α2a 180 mcg/wk, ribavirin 1200 mg daily Week 6:HCV RNA 15,600 IU/ml (3.0 log ↓) Week 12:HCV RNA < 600 IU/ml ALT/ AST 83/66 HIV RNA76,963 cps/ml CD4167 (16%)

23. Case 2Question 6 Which of the following is appropriate at this time? a. Sulfamethocazole and trimethoprim b. Combination antiretrovirals c. Watchful waiting d. a and b e. a and c f. b and c

24. Case 2Question 6 Which of the following is appropriate at this time? A. Sulfamethocazole and trimethoprim B. Combination antiretrovirals C. Watchful waiting D. A and B E. A and C F. B and C

25. Case 2Question 7 How long should HCV therapy be continued? a. 24 weeks b. 48 weeks c. 52 weeks d. 1.5 years

26. Case 2Question 7 How long should HCV therapy be continued? A. 24 weeks B. 48 weeks C. 52 weeks D. 1.5 years

27. Case 3Question 1 All of the following are appropriate at this time, except: a. Confirm with Orasure Western Blot b. There are no potential barriers to adhere to HIV treatment c. Refer the couple for marriage counseling if western Blot positive d. Offer HIV antibody testing for the wife now, and if negative, in 3 and 9 months e. If Western Blot positive, check CD4 and viral load

28. Case 3Question 1 All of the following are appropriate at this time, except: A. Confirm with Orasure Western Blot B. There are no potential barriers to adhere to HIV treatment C. Refer the couple for marriage counseling if Western Blot positive D. Offer HIV antibody testing for the wife now, and if negative, in 3 and 9 months E. If Western Blot positive, check CD4 and viral load

29. Case 3Question 2 Which of the following strategies would you recommend at this time? a. Check baseline resistance testing b. Discuss possible antiretroviral regimens c. Delay antiretroviral therapy until his CD4+ cell count is < 350 cells/mm 3 d. Initiate antiretroviral therapy at this visit e. a and b

30. Case 3Question 2 Which of the following strategies would you recommend at this time? A. Check baseline resistance testing B. Discuss possible antiretroviral regimens C. Delay antiretroviral therapy until his CD4+ cell count is < 350 cells/mm 3 D. Initiate antiretroviral therapy at this visit E. A and B

31. Case 3Question 3 Which of the following would be most appropriate for this patient if he tests negative for any drug resistance mutations and is asking for the lowest amount of pills, once a day and a regimen that doesn’t increase his chances for IDU to relapse or causes any depression? a. Emtricitabine/tenofovir/efavirenz b. Tenofovir/emtricitabine/nevirapine once a day c. Ritonavir/atazanavir/emtricitabine/ tenofovir d. Fosamprenavir/ritonavir/emtricitabine/tenofovir e. Darunavir/ritonavir/abacavir/lamivudine

32. Case 3Question 3 Which of the following would be most appropriate for this patient if he tests negative for any drug resistance mutations and is asking for the lowest amount of pills, once a day and a regimen that doesn’t increase his chances for IDU to relapse or causes any depression? A. Emtricitabine/tenofovir/efavirenz B. Tenofovir/emtricitabine/nevirapine once a day C. Ritonavir/atazanavir/emtricitabine/ tenofovir D. Fosamprenavir/ritonavir/emtricitabine/tenofovir E. Darunavir/ritonavir/abacavir/lamivudine

33. New Treatment Paradigms for Therapeutically-Naïve and Treatment-Experienced HIV Patients A Customized CME Learning Experience

34. Case Vignettes A Customized CME Learning Experience

35. Case 4Question 1 Based on his history, what is the 10-year CHD risk in this patient? a. <5% b. 5 to 10% c. 10 –20% d. >20%

36. Case 4Question 1 Based on his history, what is the 10-year CHD risk in this patient? A. <5% B. 5 to 10% C. 10 –20% D. >20%

37. Case 4Question 2 What would you do at this stage? a. Aggressive smoking cessation b. Treat his dyslipidemia c. Change his HIV therapy d. Diet and exercise e. All the above

38. Case 4Question 2 What would you do at this stage? A. Aggressive smoking cessation B. Treat his dyslipidemia C. Change his HIV therapy D. Diet and exercise E. All of the above

39. Case 4Question 3 First time use of enfuvirtide has been shown to enhance antiviral activity in the TORO (1&2), RESIST (1 & 2), POWER (1 & 2) BENCHMRK (1 & 2), DUET (1 & 2) and MOTIVATE (1 & 2) studies. a. True b. False

40. Case 4Question 3 First time use of enfuvirtide has been shown to enhance antiviral activity in the TORO (1&2), RESIST (1 & 2), POWER (1 & 2) BENCHMRK (1 & 2), DUET (1 & 2) and MOTIVATE (1 & 2) studies. A. True B. False

41. Case 4Question 4 Based on these data and his treatment history, which of the following is a reasonable option in his new combination regimen? a. Darunavir/ritonavir b. Etravirine c. Raltegravir d. Lamivudine e. All the above

42. Case 4Question 4 Based on these data and his treatment history, which of the following is a reasonable option in his new combination regimen? A. Darunavir/ritonavir B. Etravirine C. Raltegravir D. Lamivudine E. All of the above

43. Case 4Question 5 Which of the following agents should NOT be coadministered with etravirine? a. Darunavir/ritonavir b. Tipranavir/ritonavir c. Raltegravir d. Lamivudine e. Maraviroc

44. Case 4Question 5 Which of the following agents should NOT be coadministered with etravirine? A. Darunavir/ritonavir B. Tipranavir/ritonavir C. Raltegravir D. Lamivudine E. Maraviroc

45. Case 4Question 6 According to the US Department of Health and Human Services guidelines regarding the use of antiretroviral therapy in HIV- infected adults, which of the following statements best describes the HIV treatment goal for highly antiretroviral–experienced patients with multidrug-resistant HIV? a. Reduce HIV-1 RNA by ≥ 1 log10 copies/mL b. Achieve HIV-1 RNA < 50 copies/mL c. Achieve HIV-1 RNA < 400 copies/mL d. Regain and maintain undetectable HIV-1 RNA e. None of the above

46. Case 4Question 6 According to the US Department of Health and Human Services guidelines regarding the use of antiretroviral therapy in HIV-infected adults, which of the following statements best describes the HIV treatment goal for highly antiretroviral–experienced patients with multidrug-resistant HIV? A. Reduce HIV-1 RNA by ≥ 1 log10 copies/mL B. Achieve HIV-1 RNA < 50 copies/mL C. Achieve HIV-1 RNA < 400 copies/mL D. Regain and maintain undetectable HIV-1 RNA E. None of the above

47. Case 4Question 7 Prior to initiating this salvage regimen, would you store blood for a tropism (Trofile) assay ? a. Yes b. No

48. Case 4Question 7 Prior to initiating this salvage regimen, would you store blood for a tropism (Trofile) assay ? A. Yes B. No

49. Case 5 Question 1 K103N, G190a mutations confer resistance to all of the following except: A. Efavirenz B. Etravirine C. Viramune D. Delarvidine

50. Case 5 Question 2 Is a phenotype indicated in the management of this patient? A. Yes B. No

51. Case 5 Question 3 The M184V mutation can phenotypically resensitize a resistant virus to which of the following drugs? A. Tenofovir B. Zidovudine C. Lamivudine D. A and B E. None of the above

52. Case 5 Question 4 A follow up PhenoSense assay confirmed the broad resistance to the NRTI, NNRTI and PI class with a fold change for darunavir of 18. A fold change of 18 to darunavir confers: A. No resistance B. Intermediate resistance C. High level resistance

53. Case 5 Question 5 In the BENCHMRK study the percent of patients who achieved viral load reductions to less than 50 copies/ml at week 48 when using raltegravir added to regimens containing first- use of enfuvirtide or darunavir was A. 30%-40% B. 50%-60% C. 70%-80% D. 80%-90% E. >95

54. Case 5 Question 6 According to the DHHS guidelines, virologic failure on treatment can be defined as: A. HIV RNA level >400 copies/mL after 24 weeks, >50 copies/mL after 48 weeks B. HIV RNA level >500 copies/mL after 24 weeks, >60 copies/mL after 48 weeks C. HIV RNA level >600 copies/mL after 24 weeks, >70 copies/mL after 48 weeks D. HIV RNA level,<500 copies/mL after 24 weeks, <60 copies/mL after 48 weeks E. None of the above

55. New Treatment Paradigms for Therapeutically-Naïve and Treatment-Experienced HIV Patients A Customized CME Learning Experience