HIV & THE MEDICAL HOME A NEW FRONT FOR GETTING TO ZERO 29th Annual East Bay HIV Update June 3, 2016 Brent K. Sugimoto, MD, MPH Kaiser Permanente Photo Credit: C. GoldsmithContent Providers: CDC/ C. Goldsmith, P. Feorino, E. L. Palmer, W. R. McManus
Objectives Understand the role of primary care in HIV Pre-Exposure Prophylaxis delivery (PrEP) Increase recognition of those who may be appropriate for HIV PrEP Identify the primary care needs of individuals living with HIV
Truvada (Tenofovir disoproxil fumarate/emtricitabine) (TDF/FTC)
PrEP Truvada taken daily to prevent acquisition of HIV in high risk individuals is a CDC Grade A Recommendation Phase III iprex showed 92% efficacious in preventing HIV if taken perfectly iprex OLE showed 100% effectiveness in those taking at least 4 doses a week
PrEP works if you take it. CREDIT: AVAC: Global Advocacy for HIV Prevention http://www.avac.org/infographic/prep-by-the-numbers Accessed June 1, 2016
PrEP People for whom PrEP may be indicated Men who have sex with men Heterosexual men & women at high risk for HIV Injection drug users People with HIV positive partners Note: Not approved for minor teens
PrEP In 2014, only 40% of Massachusetts infectious disease specialists thought PrEP should be readily available, and that only 9% had prescribed it (Mimiaga et al, AIDS Care, 2014). Concluded that those at risk were not presenting to ID physicians (Krakower and Mayer, Ann Intern Med, 2012).
PrEP PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES - 2014 http://www.cdc.gov/hiv/pdf/ prepguidelines2014.pdf
VS Truvada (TDF/FTC) Descovy (TAF/FTC)
Descovy (TAF/FTC) Pro-drug of TDF Higher intracellular levels of active form Lower vaginal/rectal concentrations Truvada (TDF/FTC) Only drug FDA approved for PrEP Could be generic by 2017 Higher vaginal/rectal concentrations
ARV-BASED PREVENTION PIPELINE CREDIT: AVAC: Global Advocacy for HIV Prevention http://www.avac.org/infographic/prep-by-the-numbers Accessed June 1, 2016
Case No. 1 19 year-old African-American male with sore throat for the past 3 days. Fever, chills, fatigue Endorses sex with both women and men with 6 partners in the past 2 months. Last sex 1 week ago Sexual debut at age 14 No drug use Denies ever having an STI. But no prior STI or HIV testing
Case No. 1 (cont d) Vitals: T = 38.1 C, HR = 94, RR = 16, SPO 2 = 98% Tired appearance, but no distress, normal weight +/- swollen tonsils + cervical/axillary lymphadenopathy Normal genital exam No rash
Case No. 1 (cont d) Rapid strep test POSITIVE MonoSPOT negative RPR 1:256 HIV-1 antibody negative Pharyngeal GC negative, Urine GC negative Rectal GC POSITIVE
~ 1 in 15 with rectal GC/CT will seroconvert in ONE year Bernstein, KT. JL Marcus et al. Rectal Gonorrhea and Chlamydia Reinfection Is Associated With Increased Risk of HIV Seroconversion. JAIDS. 2009: 1-7.
~ 1 in 13 with syphilis will seroconvert in ONE year Solomon, MM. KH Mayer et al. Syphilis Predicts HIV Incidence Among Men and Transgender Women Who Have Sex With Men in a Preexposure Prophylaxis Trial. CID. 2014(59): 1020-1026.
Should the patient be started on PrEP now?
Reprinted from Patel P, Bennett B, Sullivan T, Parker MM, Heffelfinger JD, Sullivan PS; CDC AHI Study Group. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. J Clin Virol. 2012;54(1):43
Case No. 1 (cont d) You ask the patient to abstain from unprotected sex for 2 more weeks (to avoid the window period) Patient says that s not possible You order an HIV viral load test Viral load is undetectable
Should the patient be started on PrEP now?
Case No. 1 (cont d) Patient is insured but got a Bronze Plan from the health care exchange His Truvada would cost him about $13,000 per year What now?
Figuring Out Costs Gilead Co-Pay Assistance Program PrEP Navigators Patient Advocate Foundation (copays.org) for insured patients up to $7,500 co-pay assistance Patient Access Network is no longer accepting applications Clinical Trials
Case No. 2 29 year-old HIV negative woman with Behçet s and IBD, currently on Truvada for PrEP She started Truvada 6 weeks ago to increase her career opportunities in the adult film industry by being able to go condom-less She states that the Truvada really upsets her stomach She heard about the IPERGAY & HPTN 067 ADAPT studies and wants to know if Intermittent PrEP could help her
PrEP works if you take it. CREDIT: AVAC: Global Advocacy for HIV Prevention http://www.avac.org/infographic/prep-by-the-numbers Accessed June 1, 2016
What is Intermittent PrEP?
IPERGAY (ANRS) n = 400 2 pills 24 hours before sex, 1 dose every 24 hours after first dose for 2 doses. Efficacy 86% compared to placebo
n = 540, 3 groups Daily dosing HPTN 067 ADAPT Twice-weekly dosing; extra dose after sex Event driven: Dose up to 48 hours before sex, 2nd dose 2 hours after sex 90% of participants in each arm had detectable drug with no statistical difference 6 seroconversions - all reported to have low drug levels
Case No. 3 56 year-old MSM with HIV since 1996, CD4 nadir 116, virologically suppressed for 2 years on Stribild, current CD4 count 568. Only OI was thrush before ARVs. He feels well. You are his PCP but this is your first visit together Otherwise good health, he stopped smoking in 2002 after smoking a pack daily since age 15 Now monogamous, but over 60 lifetime sexual partners
Case No. 3 (cont d) You review his chart and note that he has had frequent visits for his HIV, vaccines are up to date, and he has had frequent lab monitoring Vitals: T=37 C, BP 112/70, HR = 68, SPO 2 = 99%, BMI 22.3 3 months ago: Triglycerides 78, LDL 108, FBS 92, A1c 5.2%, PSA 1.2 Colonoscopy normal at age 55. No other preventive health screening
Your next steps?
Case No. 3 (cont d) What would be appropriate for this visit? A. Discuss CAD risk reduction B. Perform a chest CT C. Site appropriate STI testing D. Perform an anal pap
Case No. 3 (cont d) A. Discuss CAD risk reduction People with HIV are known to be at elevated risk for CAD even while on suppressive therapy and without traditional risk factors. Statins have been shown to reduce some of the inflammatory markers associated with CAD, and often higher in those with HIV (e.g., Lp-PLA 2 )
Case No. 3 (cont d) B. Perform a chest CT HIV moderately raises the risk of cancers without a known infectious cause Skin (both melanoma, non-melanoma) neck, and lung cancers (Silverberg, AIDS, 2009) USPSTF recommends a low-dose chest CT in those with 30 pack-years of smoking and who have quit less than 15 years ago.
Case No. 3 (cont d) C. Site appropriate STI testing
Case No. 3 (cont d) D. Perform an anal pap Rates of anal cancer increased after the initiation of the ART era Risk is associated with HPV infection, and therefore number of partners, as well as CD4 count. HIV infection dramatically increases anal cancer risk (122 per 10 5 per year vs 13 per 10 5 per year) (Silverberg et al (2012), CID).
CONTACT INFO BKS1@CORNELL.EDU @BRENTICUSMD Photo Credit: C. GoldsmithContent Providers: CDC/ C. Goldsmith, P. Feorino, E. L. Palmer, W. R. McManus