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J. Boyd Francis, M.D. Lectureship HIV Primary Care: an Update on Management and Prevention

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J. Boyd Francis, M.D. Lectureship HIV Primary Care: an Update on Management and Prevention J. Boyd Francis, M.D. Lectureship HIV Primary Care: An Update on Management and Prevention Jason R. Faulhaber, M.D. Assistant Professor, VTC-SOM Carilion Infectious Diseases, Fellowship Program Director 23 April 2021 Disclosures I have no relevant financial disclosures Objectives • Develop management plans for newly- and previously- diagnosed patients with HIV • Review basic principles of antiretroviral therapy, including initiation and side effects • Identify methods of HIV prevention and how to utilize them Case A 24yo man presents with a 2-day history of rash, fever, and sore throat. He denies any sick contacts. He is sexually active; he endorses a total of 3 lifetime partners, 2 male and 1 female. He denies ever having any prior STI. His last sexual encounter was ~1 month ago. He engaged in receptive anal intercourse with a condom, which was found to be broken, at which point the partner disclosed he was HIV+. Case o PE: T 101.6 F, HR 100, BP 110/70, RR 14, SaO2=100% on RA. Mild conjunctivitis b/l 2+ tonsillar hypertrophy without exudate Tender enlarged cervical LAD b/l Diffuse maculopapular rash involving the trunk, abdomen, and proximal arms. Case Which of the following tests would be the most appropriate for this patient? A. HIV-1/2 Ag/Ab test B. RPR C. HIV RNA D. Rapid Strep test E. Throat culture CDC 2014 HIV Tests Available Test What is being Utility Can detect tested infection as early as Monitoring Nucleic Acid Test therapy HIV RNA or DNA 7-10 days (Viral Load) Diagnose acute infection HIV p24 Ag Antigen-Antibody Screening 10-14 days HIV Ab Antibody HIV Ab Screening 20-25 days HIV Testing Algorithm CDC 2018 Case (continued) HIV-1/2 Ag/Ab test results positive with HIV-1 antibodies Plasma HIV RNA = 845,000 copies/mL Case (continued) Which of the following is the most appropriate next step in managing this patient? A. Obtain standard labs but start potent ART while lab results are pending B. Obtain standard labs, including genotype, and start ART after results return C. Panic and call ID Initial HIV Evaluation • Genotype • Pregnancy test • CD4 count • Urinalysis • CBC, CMP • Lipid profile • HAV, HBV, HCV • HbA1c • RPR • Pap smear • GC/C from all sites • Toxoplasma Ab • QuantiFERON • HLA-B*5701 Thompson 2020 Rapid Start ART • Initiating ART at earliest possible time, including same-day and in acute infection • Rationale for treating acute/early infection: – Accelerate resolution of symptoms – Minimize immunologic damage – Diminish size of latent HIV reservoir pool – Prevent transmission to others – Improve engagement in care Thompson 2020 Martin 2020 Bacon 2020 60.5% CDC, MMWR 12/2019 https://www.cdc.gov/vitalsigns/test-treat-prevent/index.html Current Antiretrovirals by Class •Nucleosides (NRTIs) •Protease Inhibitors (PIs) – Abacavir (ABC) – Atazanavir (ATV) – Didanosine (ddI) – Darunavir (DRV) – Emtricitabine (FTC) – Fosamprenavir (FPV) – Lamivudine (3TC) – Indinavir (IDV) – Stavudine (d4T) – Lopinavir (LPV) – Tenofovir (TDF, TAF) – Nelfinavir (NFV) – Zidovudine (AZT, ZDV) •Non-Nucleosides (NNRTIs) – Saquinavir (SQV) – – Efavirenz (EFV) Tipranavir (TPV) – Etravirine (ETR) •Entry Inhibitors – Nevirapine (NVP) – Enfuvirtide (ENF) – Rilpivirine (RPV) – Maraviroc (MVC) – Doravirine (DOR) – Ibalizumab (IBA) •Integrase Inhibitors (INSTIs) – Fostemsavir (FOS) – Dolutegravir (DTG) •Pharmacokinetic Enhancers – Elvitegravir (EVG) – Ritonavir (r) – Raltegravir (RAL) – Bictegravir (BIC) – Cobicistat (cobi) – Cabotegravir (CAB) https://www.poz.com/pdfs/POZ_2020_HIV_Drug_Chart_high.pdf Pearls of Starting ART • 3-drug combination – Only class that can double up is NRTIs – 2 NRTIs + InSTI/bPI/NNRTI – *DTG-3TC is possible but with restrictions • Rapid start – Avoid ABC (uncertain HLA-B*5701 status) – Avoid NNRTIs (uncertain VL) – Avoid 2-drug combo (uncertain CD4/VL) DHHS 2021 Selecting an Initial Regimen 2 NRTI BACKBONE: FTC/TAF FTC/TDF 3TC/ABC InSTI Boosted PI NNRTI Bictegravir Darunavir Rilpivirine Dolutegravir Atazanavir Doravirine Raltegravir + (ritonavir OR cobi) Efavirenz Elvitegravir/cobicistat Additional ART Considerations • Ease of administration • Single-tablet regimen • Pill size • Pill burden • Food requirements • Co-infections (e.g., HBV, HCV, TB, OIs) • Renal function • Pregnancy • Drug-drug interactions • PPIs, Statins, Polyvalent cations • Pharmacokinetic booster (CYP3A4, UGT1A1, etc.) DHHS 2021 Thompson 2020 Monitoring on ART • Assess adherence at each visit • Vital signs (including weight) at each visit • Plasma HIV RNA • q4-6 wks after initiation until UD, then • q3-4 mos • If consistently UD >2yrs, then q6 mos • CD4 cell count • q3-6 mos after initiation x 2yrs, or if viremic, or if <300/mL • If 300-500 and UD x 2y, then annually • If >500 and UD x 2y, then optional • CMP with each HIV RNA • Lipids at 1-3mos after starting or changing ART • Depression and substance use screening at each visit UD=undetectable Thompson 2020 Lab Initial Q3mo Q6mo Annually CBC CMP CD4 * * Viral Load * * (VL) STI testing ** ** TB screening Lipids Mental health Substance use Adherence * = if still detectable VL or CD4 <300 ** = dependent on risk = either initially or at 3 months Routine Screening • STIs—at least annually, up to q3mo if high risk • Cancer • CVD • DM • Osteoporosis • Mental health • Substance use, including tobacco • Vaccine-preventable diseases • Avoid live vaccines if CD4 <200/14% Thompson 2020 Switching ART • Rationale • Simplification of regimen (pill or ARV burden) • Drug-drug interactions • Tolerability due to SEs • Decrease short- or long-term toxicity • Resistance • Options • 3-drug to 2-drug • DTG/RPV or DTG/3TC (as long as HBV-uninfected) • Removing boosting agent • Class-switching Major Side Effects of ART • Hyperglycemia1 • 2.5% overall; InSTIs 22% more likely; DTG >> EVG • Weight gain2,3,4,5 • 1.5kg mean increase in weight after 1y new InSTI • Highest RFs—black, female, TDFTAF • More weight gain with DTG-3TC vs DTG-FTC-TDF • InSTI if <8mo post-switch, TAF continued gain • Older age and higher baseline BMI a/w more rapid gain • Dyslipidemia6,7 • TAF > TDF but no change in CV events • PIs and EFV 1 O’Halloran 5 Bourgi 2 McComsey 6 Arribas 3 Palella 7 Grundy 4 Orkin Major Side Effects of ART • Bone Mineral Density1,2,3,4,5,6 • TDF > bPIs • Greatest within 1yr of ART and stabilizes after 2y • RAL a/w inferior loss (or possibly increased) • Renal7,8 • TDF: proximal tubulopathy • ATV: nephrolithiasis • DTG, BIC: mild Cr bump (less tubular secretion) • Cardiovascular9 • InSTIs had 2.5x incidence of CVD <6mo but comparable to unexposed thereafter 1 Delpino 4 Compston 7 Alfano 2 Han 5 Bedimo 8 Wearne 3 Hoy 6 Brown 9 Neesgaard Major Side Effects of ART: ADVANCE Trial • Johannesburg • 1053 participants • TAF-FTC/DTG vs TDF-FTC/DTG vs TDF/FTC/EFV • Weight • 7.1kg vs 4.3kg vs 2.3kg • New obesity in women: 28% vs 18% vs 12% • Visceral Fat • Increased for all 3 groups, most w/TAF, women > men • BMD • Higher in TAF vs other TDF groups Venter Projected Burden of Multi-Morbidity • PEARL (ProjEctingAge, multimoRbidity, and poLypharmacy) simulation for 2009-2030 • Based on data from NA-ACCORD • 9 major comorbidities: depression, anxiety, treated HTN, DM, HL, CKD, Ca, MI, ESLD • Modeled in presence/absence of 3 underlying RFs: smoking, HCV infection, BMI change @2y • Projected 928,000 ART users by 2030 • Projected increase from 30% to 36% for those with >2 physical comorbidities Kasaie Kasaie New ART • Cabotegravir-Rilpivirine LA (approved) • InSTI + NNRTI • Oral lead-in x 1mo, then IM injection q4wk • Islatravir (Phase III) • Translocation inhibitor • Oral once monthly • Lenacapavir (Phase II/III) • Capsid inhibitor • Oral lead-in x 2wks, then SC injection q6mo • MK-8507 (Phase IIb) • NNRTI • Oral once weekly • GSK3640254 (Phase IIa) • Maturation inhibitor • Oral once daily ART for Prevention • Treatment as Prevention (TasP) • Prevention of mother-to-child transmission (PMTCT) • Post-exposure prophylaxis (PEP) • Pre-exposure prophylaxis (PrEP) TasP STUDY SUBJECTS RESULTS HPTN 0521 1763 heterosexual discordant couples Early had 96% reduced (Africa, 9 countries) Early vs Delayed-start ART transmission vs Delayed PARTNER2 1166 discordant couples, HIV+ partner 0 linked transmissions after (Europe, 14 countries) on ART and UD, condomless sex >58,000 condomless sex acts over a 4-year period PARTNER23 972 discordant MSM couples 0 linked transmissions after (extension with new >76,000 condomless sex acts enrollment) over 8-year period Opposites Attract4 358 discordant MSM couples 0 linked transmissions after (Australia, Rio, Bangkok) >16,000 condomless sex acts over a 4-year period 1 Cohen 2016 2 Rodger 2016 3 Rodger 2019 4 Bavinton 2018 U = U NIH. Available at https://www.niaid.nih.gov/diseases- conditions/10-things-know-about-hiv-suppression PrEP • ~1.2 million Americans likely eligible1 – 1 in 4 sexually active MSM (814,000) – 1 in 5 PWIDs (73,000) – 1 in 200 heterosexual adults (258,000) • CDC reported PrEP coverage2 – 2016: 9% – 2017: 13% – 2018: 18% 1 Smith 2015 2 Harris 2019 PrEP • Multiple studies have demonstrated PrEP is highly effective when taken as prescribed1 – Sexual transmission: ~99% effective – IDU transmission: ~80% effective • Studies only looked at using TDF alone • Daily vs On-Demand PrEP2 – CDC only recommends daily at this time – ANRS Prévenir: both regimens highly effective 1 Chou 2 Molina PrEP Options TDF/FTC (TruvadaTM) TAF/FTC (DescovyTM) Approved for ALL persons seeking NOT approved for use in cisgender PrEP women (at risk of acquiring through vaginal sex) Carries rare
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