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Treatment Guidelines Update

Treatment Guidelines Update. Delta AETC Faculty Development Conference Gulfport, MS, 23 June 2012 Ronald D. Wilcox, MD. Welcome!. Adult treatment guidelines March 27, 2012. HIV and the Older Patient Antiretroviral Drug Cost Table (Appendix C). Case 1.

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Treatment Guidelines Update

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  1. Treatment Guidelines Update Delta AETC Faculty Development Conference Gulfport, MS, 23 June 2012 Ronald D. Wilcox, MD

  2. Welcome!

  3. Adult treatment guidelinesMarch 27, 2012 • HIV and the Older Patient • Antiretroviral Drug Cost Table (Appendix C)

  4. Case 1 • 21 year old presents to your clinic for routine primary care. As a part of routine care, an HIV test is ordered. • HIV ELISA and Western Blot are positive • PMH: gonorrhea at age 15 • PSH: appendectomy at age 17

  5. Case 1 • SH: • Male and female partners – 15 in past 6 months • Uses condoms “most of the time” • + EtOH – 3-5 times weekly “until drunk” • Occasionally meth use on weekends; has snorted cocaine a few times • Few tattoos • In college studying pharmacy • No incarcerations • “Army brat” – has lived multiple places across the US

  6. Case 1 • Physical exam: • Some anterior and posterior cervical, axillary, and inguinal LAD bilaterally • 4 tattoos, 2 amateur-appearing • Penile and perianalverrucous lesions • Labs: • + RPR 1:128 • + HIV ELISA and Western Blot

  7. Case 1 • Should this patient be on HAART therapy?

  8. Case 1 • Should this patient be on HAART therapy? • What things do you need to take into consideration in choosing HAART?

  9. Case 1 • Should this patient be on HAART therapy? • What things do you need to take into consideration in choosing HAART? • If yes, which therapy should be offered?

  10. Guidelines for InitiationMarch 2012 • General guidelines: • All patients who are HIV-infected should be offered HIV treatment regardless of CD4 count value • Patient readiness is still key component to initiation

  11. Reasons for Treatment • Treatment as Prevention • Clonal Cells • Aging Effects of Inflammation • KS, NHL, PCNSL • Burkitt’s, cervical, HL, anal • CAD • Renal • Neurologic

  12. Preferred Naïve Treatment Regimens • Tenofovir + Emtricitabine 1 daily • Efavirenz 600 mg daily OR • Darunavir 400 mg (2) plus ritonavir 100 mg daily OR • Atazanavir 300 mg po plus ritonavir 100 mg po daily OR • Raltegravir 400 mg po twice daily

  13. Case 2 • 23 year old girlfriend of patient 1 presents to the clinic and is 8 weeks pregnant. She tests positive for HIV and has a wild-type virus on genotype. • Should she begin HAART therapy at this time? • If yes, what regimens are recommended?

  14. Pregnancy recommended regimens • Zidovudine 300 mg + lamivudine 150 mg po twice daily • Lopinavir/ritonavir 400 mg po twice daily (increase to 600 mg po twice daily in third trimester) OR • Nevirapine 200 mg daily x 14 days followed by XR 400 mg po daily (women with CD4 < 250 at time of initiation)

  15. Case 3 • Patient is a 67 year old female who found out about six months ago that she is HIV+. She went to another clinic and was started on darunavir/r + tenofovir/FTC; initial CD4 counts and viral loads unknown. • On intake labs she is found to have: • HBcAb +, HBsAb –, HBsAg – • HCV Ab + with HCV RNA PCR 10,800,000 • CD4 count 245 with HIV viral load < 200 • Alt 76

  16. Case 3 • What is the interpretation of her Hepatitis B serology? • Does she need therapy for hepatitis C? • What therapy, if indicated, would be recommended based on her HAART?

  17. New Agents • Protease Inhibitors • Boceprevir (Victrelis) • 4 pills TID after week 4 • Telaprevir (Incivek) • 2 (or 3) pills TID weeks 1-12

  18. http://hepatitiscresearchandnewsupdates.blogspot.com/2011/01/future-hepatitis-c-virus-treatment.htmlhttp://hepatitiscresearchandnewsupdates.blogspot.com/2011/01/future-hepatitis-c-virus-treatment.html

  19. CROI 2011 • Boceprevir interactions – presented by Edward O’Mara of Merck (Abstract 118) • Acts as a CYP3A4 inducer • Little effect on tenofovir levels • Boceprevir Cmin lowered by 40% with efavirenz • Boceprevir slightly increased efavirenz levels • Ritonavir slightly decreased boceprevir AUC (20%) • Oral contraceptive levels not affected

  20. Boceprevir in HIVPresented by Jules Lewin at IDSA 2011Study by M Sulkowski et al • Inclusion: • Age 18 to 65 • HIV VL < 50 and CD4 > 200 • Genotype 1, HCV never previously treated • Exclusion • Documented cirrhosis or co-infected HBV • No use of AZT, ddI, d4T, EFV, ETV, NVP • Hb < 11 for women, < 12 for men • Plts < 100,000 • ANC < 1500 (< 1200 for blacks)

  21. Boceprevir in HIVPresented by Jules Lewin at IDSA 2011Study by M Sulkowski et al • 2:1 Boceprevir + PIA/RBV (n=64) arm vs placebo + PIA/RBV (n=34) • 4 weeks lead in then 44 weeks therapy • 2/3 male • 1/5 non-white • HCV Viral load > 800,000 IU/ML in 88% • ARV • nRTIS: TDF, ABC, 3TC, FTC • PIs: ATV/r > LPV/r > DRV/r > fAMP/r, SQV/r • CCR5-Inhibitors 2-3% • ISTIs: 12-17%

  22. Boceprevir in HIVPresented by Mark SulkowskiCROI 2012 Adverse Drug Effects (Boceprevir versus placebo) Anemia 41% versus 26% Fever 36% versus 21% Weakness 34% versus 24% Loss of appetite 34% versus 18% Diarrhea 28% versus 18% Vomiting 28% versus 15% Dysgeusia 28% versus 15% Neutropenia 19% versus 6% • Completed treatment phase • 61% in boceprevir arm had SVR 12 weeks after completion versus 27% of those on placebo • 2 relapses on triple drug arm versus 1 in placebo From article on www. Hivandhepatitis.com by Liz Highleyman published 07 March 2012

  23. Telaprevir Interactions with ARVData presented at CROI 2011Abstract 119 http://www.natap.org/2011/CROI/croi_115.htm

  24. Co-Infection Trial – Study 110Presented by Douglas Dietrich CROI 2012 From Clinical Care Options

  25. Co-Infection Trial – Study 110Presented by Douglas Dietrich CROI 2012 • All treatment naïve • Most patients male • > 50% of part A participants black • 1/3 of part B participants black • Most had high HCV viral loads • 10% had bridging fibrosis on biopsy From Clinical Care Options

  26. Co-Infection Trial – Study 110Presented by Douglas Dietrich CROI 2012 • Adverse Drug Effects (TVR vs. placebo) • Nausea: 34% vs 23% • Pruritus: 39% vs 9% • Dizziness: 22% vs 5% • Headache: 37% vs 27% • Fever: 21% vs 9% • Anorexia: 19% vs 9% • Depression: 21% vs 9% • Vomiting: 19% vs 9% • Rash: 34% vs 23% • Mild 16% vs 14% • Moderate 11% vs < 1% • Severe 0% vs 0% From article on www. Hivandhepatitis.com by Liz Highleyman published 07 March 2012 and data presented at CROI 2011 and IDSA 2011

  27. Co-Infection Trial – Study 110Presented by Douglas Dietrich CROI 2012 • 4 weeks • 68% of those on telaprevir had RVR • No ART – 71% • EFV-based – 75% • ATV-based – 60% • 5% of those not on telaprevir had RVR • No ART – 0% • EFV-based – 12% • ATV-based – 0% • 24 weeks • 71% of those on telaprevir had cEVR • No ART – 86% • EFV-based – 75% • ATV-based – 67% • 55% of those not on telaprevir had cEVR • No ART – 33% • EFV-based – 50% • ATV-based – 75%

  28. Co-Infection Trial – Study 110Presented by Douglas Dietrich CROI 2012 • 12 weeks after completion of therapy (SVR12) • 74% of those on telaprevir had SVR12 • No ART – 71% • EFV-based – 69% • ATV-based – 80% • 45% of those not on telaprevir had SVR12 • No ART – 33% • EFV-based – 50% • ATV-based – 50% • 3% of telaprevir and 15% of placebo recipients had HCV relapse From article on www. Hivandhepatitis.com by Liz Highleyman published 07 March 2012

  29. What to Use for Treatment?

  30. DHHS Guidelines for Treatmentof HCV/HIV Co-InfectionMarch 27, 2012 • Boceprevir or Telaprevir use in HIV • Not FDA approved • Do NOT use either with zidovudine • Boceprevir should only be used with a raltegravir + 2 NRTI regimen or a patient NOT on ART • Telaprevir can be used at standard dose with no ART or with a raltegravir or boosted atazanavir + 2 NRTI • Telaprevir can be used at an increased dose (3 pills q8) with an efavirenz + 2 NRTI regimen Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents; Developed by the HHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC).

  31. DHHS Guidelines for Treatmentof HCV/HIV Co-InfectionMarch 27, 2012 • For patients on other ART: • If HCV disease minimal, wait on therapy • If good prognostic indicators present, ie IL28B CC genotype or low HCV RNA viral load, consider treatment with PegIFN/RBV without DAA • If possible based on ARV history, change ART to one listed on preceding slide • Consult with experts if complex ARV history Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents; Developed by the HHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC).

  32. Case 4 • 44 year old immigrant from Botswana presents to your clinic. She has a history of HIV and is treatment naïve. • Initial CD4 count 175 and viral load 200 • Quantiferon Gold assay is positive • CXR with RUL cavity • Thoughts so far? • Why the low viral load with a low CD4 count? • Treat TB or HIV first? Simultaneously?

  33. TB Treatment • CD4 < 50 • Initiate HAART within 2 weeks of TB therapy • CD4 50 and up with “clinical disease of major severity” (low Karnofsky, low BMI or Hb or Albumin, organ system dysfunction) • Initiate HAART within 2-4 weeks of TB therapy • CD4 50 and up without above criteria • Initiate HAART after 2-4 weeks but before 8-12

  34. TB Treatment • All pregnant HIV+ women with TB should be started early on HAART and tbtx • Patients with MDR-TB need to start HAART early • Rifapentine should NOT be used with HAART except as part of a clinical trial • Rifabutin dosing with PIs: • 150 mg daily or 300 mg thrice weekly

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