Update on Antiretroviral Treatment Guidelines 2015
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1 Update on Antiretroviral Treatment Guidelines 2015 Rajesh T. Gandhi, MD Disclosures: Educational grants to my institution from EBSCO, Gilead and Roche km
2 Learning Objectives Identify recent changes in guidelines regarding initial therapy of HIV infection Apply the most recent guidelines regarding monitoring of patients on antiretroviral therapy Utilize the latest guideline-recommended practices for diagnosing and treating special populations, including those with HCV infection, HIV-2 infection
3 Case Scenario # 1 55 yo African-American F with GERD, allergic rhinitis, newly diagnosed with HIV CD4 count 150, HIV RNA 250,000 Nurse. Irregular meal-times Medications: omeprazole, fluticasone Estimated GFR 60. HLA-B5701 negative She is interested in starting therapy
4 Which regimen would you start? A. Dolutegravir/ABC/3TC B. Dolutegravir + TDF/FTC C. EFV/TDF/FTC D. RPV/TDF/FTC E. EVG/cobi/TDF/FTC F. DRV/r + TDF/FTC G. RAL + TDF/FTC
5 Case Scenario # 2 55 yo white M with newly diagnosed HIV History of hypertension, depression Good adherence with medications (lisinopril, paroxetine). Smokes 1 ppd. Regular meals Exam: obese man. BP 130/80 CD4 count 550. HIV RNA 16,000 Estimated GFR 65. Lipids: TC 210. LDL 160 HLA-B5701 negative He says he s interested in treatment with a single-pill combination
6 You would start which regimen? A. Dolutegravir/ABC/3TC B. Dolutegravir + TDF/FTC C. EFV/TDF/FTC D. RPV/TDF/FTC E. EVG/cobi/TDF/FTC F. DRV/r + TDF/FTC G. RAL + TDF/FTC
7 Updated: April 8,
8 What s New in the Guidelines? New recommendations regarding What to Start, including case-based scenarios to guide selection Expanded section on management of virologic failure, including isolated CNS rebound New section on Poor CD4 cell recovery and persistent inflammation despite viral suppression Acute/early HIV section updated with new CDC diagnostic testing algorithm New information summarizing interactions between antiretroviral medications and HCV therapy Updated section on HIV-2 infection
9 What to Start 9
10 What to Start DHHS Guidelines 2014 Too Many Choices? NNRTI (n=3) PI (n=3) INSTI (n=4) Recommended Regimens (n=10) EFV/TDF/FTC RPV/TDF/FTC* EFV + ABC/3TC* ATV/r + TDF/FTC ATV/r + ABC/3TC* DRV/r + TDF/FTC DTG + ABC/3TC DTG + TDF/FTC EVG/cobi/TDF/FTC RAL +TDF/FTC *Only for patients with VL <100K. Only for patients with CD4 >200
11 Main Changes in What to Start 1. EFV/TDF/FTC moved to Alternative 2. ATV/r + TDF/FTC moved to Alternative 3. Regimens previously recommended only for pts with VL <100,000 moved to Alternative or Other: RPV/TDF/FTC, ATV/r or EFV +ABC/3TC 4. DRV/r + RAL and LPV/r + 3TC included among Other regimens but only for patients who cannot take TDF or ABC 5. ATV/cobi and DRV/cobi included among Alternative regimen options 6. Case scenarios table added to help guide selection
12 What to Start 2015 INSTI (n=4) PI (n=1) Recommended Regimens (n=5) DTG/ABC/3TC DTG + TDF/FTC EVG/cobi/TDF/FTC RAL +TDF/FTC DRV/r + TDF/FTC
13 NNRTI (n=2) PI (n=3) Alternative Regimens EFV/TDF/FTC RPV/TDF/FTC* ATV/r or cobi + TDF/FTC DRV/cobi + TDF/FTC DRV/r or cobi + ABC/3TC *Only if VL <100K and >200. Only if Cr Cl >70 Effective and tolerable but have potential disadvantages, have limitations for use in certain patient populations, or have less supporting data than Recommended Regimens An alternative regimen may be the preferred regimen for some patients
14 Change 1: EFV/TDF/FTC Moved to Alternative EFV: long track record of safety and effectiveness but, compared with new regimens, decreased tolerability, mostly because of CNS side effects DTG + ABC/3TC superior to EFV/TDF/FTC, largely because of more treatment discontinuations in EFV group (10% vs. 2%) More tolerability failures with EFV than RPV SINGLE DTG + ABC/3TC vs. EFV/TDF/FTC Walmsley S et al, NEJM, 2013
15 Efavirenz and Suicidality In retrospective analysis of multiple ACTG studies, increased suicidality in those randomized to EFV-containing regimens as compared to EFV-free regimens Mollan K et al, Ann Int Med, 2014
16 Change 2: ATV/r + TDF/FTC Moved to Alternative ACTG A5257 HIV+ adults, no previous ART (n=1809) Randomized 1:1:1. Open Label Therapy ATV/r + FTC/TDF RAL + FTC/TDF DRV/r + FTC/TDF RAL superior to both PI/r regimens for combined tolerability and virologic efficacy; DRV/r superior to ATV/r Lennox J et al, Ann Int Med, 2014
17 All 3 regimens had equivalent virologic efficacy ATV/r less well tolerated than DRV/r or RAL (mainly because of hyperbilirubinemia/jaundice) Tolerability failure: ATV/r: 14% RAL: 1% DRV/r: 5% Other ATV drawbacks: absorption impaired by acid-lowering therapy; kidney- and gall-stones Intriguing association between ATV/r use and slower progression of carotid IMT (ACTG A5260s), but no known clinical advantage Lennox J et al, Ann Int Med, 2014; Stein J et al, JACC 2014
18 Change 3: Regimens Recommended Only for Patients with VL <100,000 Moved Regimens with decreased potency in patients with VL >100K: ABC/3TC + EFV or ATV/r (ACTG 5202) 1 ; RPV/TDF/FTC 2 ECHO/ THRIVE RPV + 2 NRTI* EFV + 2 NRTI* *ECHO: TDF/FTC; THRIVE: investigator selected NRTI Wk 96 VL <50 VL >100 K, CD4<200: more virologic failures with RPV RPV/TDF/FTC moved to Alternative ABC/3TC + EFV or ATV/r moved to Other 78% 78% 1 Sax P et al, NEJM, 2009; 2 Cohen C et al, AIDS, 2013
19 NRTI-limiting Regimens for Patients who cannot take TDF or ABC DRV/r + RAL (NEAT001) 1 or LPV/r + 3TC (GARDEL) 2 DRV/r + RAL non-inferior to DRV/r + TDF/FTC overall but among those with: CD4 count <200: DRV/r + RAL inferior to DRV/r + 2 NRTI VL >100 K: More failures in NRTI-sparing group LPV/r + 3TC non-inferior to LPV/r + 2 NRTI LPV/r + 3TC: greater pill burden and potential toxicities than other 1 st line regimens 1 Raffi F et al, Lancet, 2014; 2 Cahn P et al, Lancet 2014
20 Choosing An Initial Regimen EFV RPV EVG/cobi EFV EVG/cobi ATV/r DRV/r ATV/r DTG RAL DTG EFV DTG DRV/r RAL ATV/r
21 Choosing an Antiretroviral Regimen: Two decisions Step 1: Decide which NRTIs to use Step 2: Decide which drug to use within the NNRTI, PI or INSTI class
22 ABC/3TC TDF/FTC or ABC/3TC TDF/FTC NRTI PROS CONS TDF/FTC ABC/3TC Single pill options available (with EFV, RPV, EVG/cobi) Active vs. HBV Lowers lipids Not nephrotoxic Coformulated with DTG and 3TC Nephrotoxicity (particularly in those receiving other nephrotoxic agents, PIs) Increased loss of bone mineral density Must confirm HLA-B5701 negative Some studies, but not all, show association with MI
23 Choosing Between NRTIs Scenario HLA-B5701+ Kidney Disease High cardiac risk Hyperlipidemia Osteoporosis Pre-ART VL >100 K HBV Preferred Therapy TDF (cannot use ABC) ABC Favor TDF Favor TDF Favor ABC If using with EFV or ATV/r TDF/FTC TDF/FTC or TDF/3TC
24 Choosing Between INSTI, NNRTI, PI: Pre-ART Characteristics CD4 < 200 Scenario HIV RNA > 100K Must treat before drug resistance results known Consideration Because of higher rates of virologic failure, do not use: RPV-based regimens DRV/r + RAL Do not use the following regimens: RPV-based regimens ABC/3TC with EFV or ATV/r DRV/r + RAL Avoid NNRTI-based regimen. Consider using PI (DRV/r)
25 ART Specific Characteristics Scenario One pill once daily regimen desired Food effects Consideration Options include: DTG/ABC/3TC EFV/TDF/FTC EVG/c/TDF/FTC RPV/TDF/FTC (if VL <100 K, CD4 >200) Take with food: Boosted ATV or DRV EVG/c/TDF/FTC RPV/TDF/FTC (at least 390 cal) Take on empty stomach: EFV-based regimens
26 Presence of Other Conditions Scenario Consideration Psychiatric illnesses Consider avoiding EFV Acid-lowering therapy Concomitant CYP3A4 metabolized medication Polyvalent cation (Al, Ca, Mg, Fe, Zn) Metformin Caution with RPV, ATV Avoid or caution with PIs, cobi Caution with INSTI (reduced absorption) Caution with DTG
27 Monitoring Patient on ART 27
28 Monitoring after Starting ART Chemistries, BUN/Cr, LFTs: wk 2-8, then every 3-6 mo. CBC/diff: every 3-6 mo. Fasting glucose or HbA1c: every 3-6 mo. if previously abnormal; every 12 mo. if normal Lipids: if abnormal, every 6 mo; normal: every 12 mo. U/A every 12 months (every 6 mo. if on tenofovir) Tenofovir Fanconi s syndrome: glucosuria, proteinuria ( 1+), urinary phosphate wasting Cobicistat, dolutegravir inhibit creatinine secretion serum Cr without affecting renal function If >0.4 mg/dl increase in Cr on cobi check for TDF toxicity DHHS guidelines, ; Aberg J et al, CID, 2013
29 Clinical Scenario VL Monitoring CD4 Monitoring First 2 yrs of ART Every 3 to 4 mo. Every 3 to 6 mo. After 2 yrs of ART, VL suppressed, CD After 2 yrs of ART, VL suppressed, CD4 >500 Change in clinical status, e.g. new HIV clinical sx or drug that may affect CD4 count Can extend to every 6 mo. Every 3 mo. Every 12 mo Optional Perform CD4 count, repeat as clinically indicated
30 Poor CD4 Cell Recovery and Persistent Inflammation Despite Viral Suppression Persistently low CD4 cell counts (<200) despite viral suppression associated with increased mortality and non-aids morbidity Adding ARV to a suppressive regimen does not improve CD4 cell recovery, and is not recommended Persistent immune activation and inflammation may independently mediate risk of mortality and non-aids morbidity -- but specific interventions unproven Focus should be on healthy lifestyle, smoking cessation, managing HTN, dyslipidemia, DM 30
31 Special Populations: HCV Check for when and what to start This website is constantly being updated. Please remember to always refresh your page.
32 Interactions between HIV and HCV Drugs Ledipasvir/sofosbuvir TDF: levels increased; monitor for toxicity ABC: OK EFV: monitor for TDF toxicity b/o increased levels RPV: OK If PI/r or PI/c used with TDF, consider alternative HCV therapy; if coadministered, close monitoring RAL, DTG OK. Avoid EVG/cobi/TDF/FTC
33 Interactions between HIV and HCV Drugs Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir NRTI, including TDF: OK Avoid all NNRTI Only HIV PI that is OK: ATV 300 mg at same time as 3D regimen Discontinue RTV or cobi in HIV regimen while on HCV therapy RAL OK, DTG likely OK. Avoid EVG/cobi/TDF/FTC
34 Special Populations: HIV-2 HIV-2 should be considered in persons of West African origin or in those with sexual exposure to persons from that area Diagnosis: HIV-1/2 Ab differentiation assay HIV-2 RNA testing now available through U. Washington and NY State Dept. of Health HIV-2: resistant to NNRTI, enfuvirtide Therapy should be with 2 NRTI + INSTI or HIV-2 active boosted PI (DRV, LPV, SQV) 34
35 Case Scenario # 1 55 yo F with newly diagnosed HIV Salient considerations GERD, requiring proton-pump inhibitor (affects RPV, ATV/r) Allergic rhinitis, on nasal fluticasone (interacts with PI, cobi) Low CD4 count (150), high VL (250,000) avoid RPV Irregular meal-times (nurse) Estimated GFR 60 HLA-B5701 negative
36 Which regimen would you start? A. Dolutegravir/ABC/3TC B. Dolutegravir + TDF/FTC C. EFV/TDF/FTC D. RPV/TDF/FTC E. EVG/cobi/TDF/FTC F. DRV/r + TDF/FTC G. RAL + TDF/FTC
37 Case Scenario # 2 55 yo white M with newly diagnosed HIV Salient considerations: High risk for cardiovascular disease (HTN, smoking) 2013 AHA risk calculator: 10 yr ASCVD risk is 13% Low VL (16,000), high CD4 count (550) Estimated CrCl 65 (cobi with TDF only recommended if CrCl >70) Borderline lipids (favors TDF) Regular meals Prefers single-pill combination
38 You would start which regimen? A. Dolutegravir/ABC/3TC B. Dolutegravir + TDF/FTC C. EFV/TDF/FTC D. RPV/TDF/FTC E. EVG/cobi/TDF/FTC F. DRV/r + TDF/FTC G. RAL + TDF/FTC
39 Activity Code TA673 39
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