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H IV Primary Care for Adults

H IV Primary Care for Adults . Larry Boly , MD Staff Physician CCRMC Department of Internal Medicine . Goals of Presentation . Discuss screening recommendations for HIV Review the initial evaluation and laboratory testing to be performed in HIV infected patients

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H IV Primary Care for Adults

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  1. HIV Primary Care for Adults Larry Boly, MD Staff Physician CCRMC Department of Internal Medicine

  2. Goals of Presentation • Discuss screening recommendations for HIV • Review the initial evaluation and laboratory testing to be performed in HIV infected patients • Identify DHHS 2013 preferred ARV regimens • Understand concept of designing ARV regimen • Discuss pros and cons of NNRTI, PI, or INSTI regimens

  3. What percentage of the HIV Population in U.S . is not aware of their HIV infection? 1) 0-5% 2) 5-10% 3) 15-20% 4) 20-25% 5) 25-30%

  4. Rates of Adults and Adolescents Living with Diagnosed HIV Infection 2010 – U.S. • CDC estimates 1,148,200 persons in U.S. > 13 living with HIV • CDC estimates 207,600 (18.1%) unaware • (Prevalence is the number of people living with HIV infection at a given time, such as at the end of a given year)

  5. Which of the following is false? • The HIV incidence in black women is 0.24% • The HIV incidence in black women in the U.S. is comparable to adult incidence rates in Sub-Saharan Africa • Risks in U.S. women cluster with poverty and disempowerment • In 2010 the estimated number of new HIV infections was lowest among individuals age 25-34 • Rates of HIV infection are increasing in MSM population in the U.S.

  6. Incidence • Incidence is the number of new HIV infections that occur during a given year. 1) CDC estimates that approximately 50,000 people in the United States are newly infected with HIV each year. 2) In 2010 (the most recent year that data are available), there were an estimated 47,500 new HIV infections. 3) Nearly two thirds of these new infections occurred in gay and bisexual men. 4)Black/African American men and women were also highly affected and were estimated to have an HIV incidence rate that was almost 8 times as high as the incidence rate among whites • CDC Estimates of New HIV Infections in the US (www.cdc.gov/hiv/statistics/surveillance/incidence/index.html

  7. U.S. Preventative Services Task Force 2013 • Routine testing once for everyone age 15-65 (Grade A recommendation) • Paves the way for coverage under ACA • Repeat testing recommended for • Those higher risk for HIV infection (yearly) • Those actively engaged in risky behavior • Those living in high- prevalence setting (seroprevalence>0.1% - 1/1000) Moyer VA, Screening for HIV: U.S. Preventative Services Recommendation Statement Annals of Internal Medicine April 30, 2013

  8. Goals of the Initial Evaluation (1) • Confirm HIV infection • Identify acute problems requiring immediate intervention to prevent morbidity • Assure that the patient understands how to avoid transmitting HIV • Identify chronic medical problems and troubling symptoms • Identify problems requiring referral (medical, housing, psychological, social legal or financial) • Establish stage of HIV disease

  9. Goals of the Initial Evaluation (2) • Establish a baseline of physical findings for comparison with future examinations • Begin to discuss appropriate anti-HIV drug therapy • Identify indications for prophylaxis • Identify social support • Establish a plan based on findings for long term management of identified problems • Communicate recommendations in a process that establishes confidence and trust

  10. Case 40 yo female referred to positive health clinic as recently diagnosed HIV positive. Husband died several years ago from HIV complications, however patient previously not tested. History of meth use in past. Clean for past 18 months. Heterosexual, not sexually active in past 2 years. Has disclosed status to daughter (age 17) and to mother. Has stable housing is unemployed and is receiving SSI. She has NKDA Her history is significant for hyperlipidemia and bipolar illness which is well controlled. She is on the following medications: • Trazadone 100 mg qhs • Oxcarbazepine 1200 mg qhs • Seroquel 200 mg qhs • Lorazepam 1mg qhsprn • Simvastatin 20 mg qd

  11. The Initial History • HPI • Estimation of time of infection, including likelihood of infection with resistant virus • HIV – associated symptoms • PMH • Prior STDs, Hepatitis • TB exposure, TB test results • HO chicken pox or shingles • Vaccination status • Travel history: exposure to endemic pathogens

  12. The Initial PE • Overall: body habitus, vital signs • Skin: fungal infections, edema, pigmented lesions, nodules, molluscum, folliculitis, psoriasis, condylomata, • HEENT careful eye and oral examination (thrush, OHL, ulcers, gingivitis) • Lymphatics: generalized vs focal • Abdomen: HSM • Anogential warts, STDs, ulcerations • Neurologic: mental status, peripheral neuropathy ( decrease vibratory sensation, absent ankle jerks)

  13. Case • Physical exam • VSS • HEENT no lesions no thrush edentulous • Neck no adenopathy thyroid wnl • Chest Clear to A+P • CV rr without mrg • Abd soft nontender without HSM • GU/Rectal deferred • EXT no edema • Neuro CN intact , reflexes =, strength =, no dysmetria • Skin no lesions

  14. CMV Retinitis

  15. Oral Thrush

  16. Oral Candidiasis – Hypererythematous

  17. Oral leukoplacia

  18. Oral Kaposi Sarcoma

  19. Kaposi sarcoma ( plaque and nodule phase)

  20. MolluscumContagiosum

  21. Secondary Syphilis

  22. Baseline tests All of the following should be obtained except: • CMV IgG • G6PD • HAV,HBV and HCV • Cryptococcal antigen • Toxoplasmosis IgG

  23. Baseline tests (1) • HIV antibody test • Do if HIV infection not clearly documented • CD4+ T lymphocyte cell count and percent • Estimates stage of HIV disease • Urgency of anti- HIV therapy • Plasma HIV RNA (viral load) • Estimates risk of progression • HIV Genotype • Upon initiation of care • In persons failing integrase strand transfer inhibitor (INSTI) – INSTI resistance should be ordered • Aberg JA, CID 2013

  24. Baseline tests (2) • CBC and chemistry panel • G6PD ( AA, mediterranean descent) • Fasting lipid panel, HGA1C • UA (protein) and CrCl • PPD, Quantiferon (T spot) • ToxoIgG • HBsAG, HBsAB, HBcAB ( if HBcAB+ only – check HBVDNA) • HCV AB if + - HCV RNA • HAV ab • CMV IgG • RPR, Trich (women), GC, chlamydia at presentation and annually AbergJA, CID 2013

  25. Baseline tests (3) • Cervical cancer screening • PAP upon initiation of care, repeat in 6 months and annually thereafter if results are normal • Women with ASC-US, ASC-H , atypical glandular cells , low grade or high grade squamous intraepithelial lesions or squamous Ca should undergo colposcopy and direct biopsy • Screening for Anal HPV Annually (weak recommendation) • HPV vaccination all females 9-26 and males 9-21 (22-26 if not previously vaccinated) • AbergJA, CID 2013

  26. Case • Patient is seen back in clinic in 2 weeks. She continues to feel well. Her laboratory exam is significant for the following: • H/H 13.4/38.8 WBC 5.6 Plat 234,000 • CD4 85 ( %) • HIV RNA 93,100 • HIV genotype – “wild type” virus (no significant mutations) • HGA1C 5.3 Chol 96 TG 179 • Cr 0.9 UA no protein lytes normal • Quantiferon negative • G6PD 8.3 • ToxoIgG < 0.91 • HBsAB, HBcAB, HBsAGneg, HCV AB neg, HAV AB neg • RPR negative

  27. Case Which of the following is not indicated at this point in time? • Begin PCP prophylaxis with TMP/SMX • Begin MAI prophylaxis with Azithromycin • Begin ARV regimen • Begin Toxo prophylaxis with TMP/SMX • Obtain T spot

  28. Recommended Prophylaxis

  29. Patient wishes to start ARV How are ARV regimens designed?

  30. ART Basic Rules • 3 Drugs from 2 drug classes • Backbone of regimen 2 Nucleosides • Anchor of Regimen • NNRTI • PI • INSTI

  31. Backbone: Nucleoside Analogs • Preferred • Tenofovir (TDF) • Emtricitabine (FTC) • (Truvada = TDF/FTC) • Alternative • Abacavir (ABC) • Lamivudine (3TC) • (Epzicom =ABC/3TC)

  32. Preferred Regimens • Have shown potent virologic efficacy as measured by the proportion of subjects achieving and maintaining viral suppression in comparative clinical trials • In two comparative clinical trials TDF/FTC was more effective than ABC/3TC • Sax PE, NEJM. 2009;361(23):2230-2240 • Post FA, JAIDS. 2010;55(1): 49-57 • In a third comparative clinical trial TDF/FTC and ABC/3TC showed comparable efficacy • Smith KY, AIDS.2009;23(12):1547-1556

  33. Clinical Findings with Tenofovir Toxicity • Reductions in GFR ( not seen in clinical trials but these studies excluded individuals with baseline reduced GFR) • Proteinuria (can precede GFR reduction) • Kelly, AIDS 2013 Jan 28:27(3) 479-81 • Proximal tubule dysfunction/Fanconi’s syndrome • Aminoaciduria • Phosphaturia • Glucosuria

  34. How should we monitor for tenofovir toxicity ? • Monthly renal panel (Cr + lytes) +UA • Q3 month renal panel + UA • Q6 month renal panel + UA • Q6 month renal panel + UA + phosphate excretion • Something else

  35. AJKD Guidelines • Measure eGFR pre-treatment • Reduce dose if eGFR < 60 ml/min • Assess risk factors for kidney toxicity • Age • Body weight • Measure every 3 months for one year then biannually • GFR • Fractional excretion of phosphate • Urine protein/creatinine ratio • Urine glucose • Tubular proteinuria if available • Am J Kidney Dis 57(5):773-780. 2011

  36. Anchor of Regimen •NNRTI (Non nucleoside reverse transcriptase inhibitor) Efavirenz (EFV) •PI (Protease inhibitor) Atazanavir/r (ATV/r) Darunavir/r (DRV/r) •INSTI (Integrase Inhibitor) Ralegravir (RAL)

  37. What Percentage of the HIV population in US has achieved goal of therapy ? (complete virological suppression ) • 82% • 66% • 50% • 33% • 25%

  38. CDC “vital statistics” July 2012 • 82% - Diagnosed • 66% - Linked to care • 37% - Retained in care • 33% - Prescribed ART • 25% - Virally suppressed

  39. NNRTI (EFV)– Pros and Cons • PROS • Lower pill burden (Atripla = TDF/FTC/EFV) • Generally well tolerated • CONS • Lower genetic barrier to resistance • CNS side effects • Rash • Dyslipidemia • Differing pharmacokinetics from Nucs • Potential teratogenicity

  40. NNRTIs -EFV- Pros and Cons Atripla (TDF/FTC/EFV) PROS • Atripla has been studied in the greatest number of clinical trials • Available in single tablet once daily formulation • Generally well tolerated CONS • CNS side effects • Higher incidence of rash (including severe skin reactions) • Dyslipidemia • Lower genetic barrier to resistance (differing pharmacokinetics) • Potential teratogenicity (animal studies and some human case reports)

  41. PI (ATZ/r ; DRV/r) Pros and Cons • PROS • High genetic barrier to resistance • Reasonable pill burden • CONS • Metabolic Effects (elevated lipids) • GI side effects • Ritonavir boosting (drug drug interactions p450/CYP3A)

  42. If using a PI boosted regimen which of her drug(s) is/are contraindicated? • Trazadone 100mg qhs • Oxcarbazepine 1200 mg qhs • Seroquel 200 mg qhs • Lorazepam 1 mg qhs prn • Simvastatin 20 mg qd • All of the above

  43. Boosted PI (Drv/r ; Atv/r) • Initial treatment with ritonavir (RTV) boosted PI containing regimens is unique from the resistance perspective, as virologic failure rarely selects for PI-resistance and NRTI resistance is uncommon • Consider for patients at higher risk for virological failure due to suboptimal adherence/ inconsistent follow-up • No fully powered clinical trials that compare virologic efficacy of DRV/r and ATV/r • ATV/r – cons indirect hyperbilirubinemia, needs acid environment for absorption – dosing guidelines for acid reducing agents

  44. Integrase Inhibitor (RAL) Pros and Cons • Pros • Low pill burden • Well tolerated • Better lipid profile • Cons • Lower genetic barrier to resistance • Well tolerated • BID dosing

  45. Single Pill Regimens NN anchoring regimen • Atripla (TDF/FTC/EFV) • Complera (TDF/FTC/ ) Not indicated if HIV VL >100,000 INST anchoring regimen • Stribild • ABC/3TC/Dolutegravir

  46. Which regimen would be least recommended? • Atripla (TDF/FTC/EFV) - single pill • Complera (TDF/FTC ) - single pill • Truvada (TDF/FTC) Darunavir 800 mg /100 mg Norvirqd • Truvada (TDF/FTC) Darunavir 600mg/100 mg Norvir bid • Truvada (TDF/FTC) Atazanavir 300 mg/100mg Norvirqd

  47. Case • Patient elects Atripla as she prefers a one tablet daily regimen • CNS side effects discussed with patient • Patient placed on TMP/SMX for PCP prophylaxis • Patient started on HAV and high dose HBV vaccine • Patient returns to clinic for 2 week follow up • No significant side effects noted • Patient adherent with regimen • HIV VL 1,010 copies (baseline 93,100)

  48. Case • Patient returns to clinic for cervical and anal Pap • Patient adherent with medications and denies SE • HIV VL 23 copies/ml (week 12) • CD4 135 (15%) • Urine prot/cr ratio 0.10 • Cr 0.8

  49. Case • Patient returns for follow up week 24 – adherent with medications. Complains of bad dreams but denies worsening of her depressive symptoms • CD4 198 (16%) • HIV VL < 20 copies/ ml • Pap reveals – ASCUS • Anal Pap reveals – SIL • Uprot/cr ratio 0/16 • Cr 0.8

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