Pre exposure Prophylaxis (PrEP): Stepping Up HIV Prevention

Transcription

1 Pre exposure Prophylaxis (PrEP): Stepping Up HIV Prevention Dawn K. Smith, MD, MS, MPH Centers for Disease Control and Prevention The findings and conclusions in this presentation have not been formally disseminated by the CDC and should not be construed to represent any agency determination or policy HIV Incidence in the United States Pre ARV ARVs, pre HAART HAART HIV Incidence (thousands) Year 1

2 Estimated New HIV Infections, 2010 (for the most affected subpopulations) 12,000 10,000 8,000 6,000 4,000 2, HIV Incidence Young MSM Black White Hispanic

3 Daily Oral PrEP Efficacy by Adherence Intervention mitt Drug detected MSM (iprex, TDF/FTC) Heterosexuals (Partners PrEP, TDF/FTC) IDU (Bangkok Tenofovir Study, TDF) 44% 92% 75% 90% 49% 70% Grant RM et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. NEJM. 2010;363(27): Baeten JM et al. Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women. NEJM. 2012;367(5): Choopanya K et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand. Lancet 2013;381(9883): Efficacy and Adherence Over Time Activated drug (TVF) across multiple visits in Partners PrEP trial % Relavitive risk reduction Never Measurable Sometimes Measurable Always Measurable Overall TVF level 3

4 No Evidence of Serious Clinical Risks No serious renal risks seen No serious bone health risks seen Source: Martin, Michael, et al. Clinical Infectious Diseases 2014 Clinical Practice Guideline Provides comprehensive Review of efficacy and safety evidence Guidance on identifying patients with Indications for PrEP Contraindications for PrEP Guidance on prescribing, laboratory testing, and follow up care Guidance on supporting medication adherence and risk reduction 4

5 Key Message Daily, oral PrEP with Truvada Is recommended as one prevention option for persons at substantial risk of HIV infection including: Sexually active MSM Heterosexually active men and women Injection drug users Special Populations Adolescent Minors Consider legal age for autonomous consent to medical care PrEPception and pregnancy Consider all safer conception options Consider increased HIV acquisition risk in pregnancy Corrections populations Consider discharge planning 5

6 Potential PrEP Providers STD care providers Primary care providers HIV uninfected at substantial risk HIV care providers Drug Treatment Providers Assessing Indications for PrEP Brief sexual history Sexual activity with men, women, or both? Condom use consistency Number and HIV status of sex partners Recent STI history Brief drug use history Injection drug use behaviors Drug treatment Most recent potential HIV exposure 6

7 Assessing contraindications Targeted medical history HIV testing Recent signs/symptoms of acute viral illness Renal or bone disease Medications Initial laboratory testing HIV test creatinine Hepatitis B serology (if unvaccinated) Pregnancy test STI testing (extragenital if MSM) 7

8 HIV Tests and Acute HIV Infection 3 rd gen Ab tests 4th gen Ag/Ab tests 1 st or 2 nd gen Ab tests HIV PCR tests Excluding Acute or Established HIV Infection 8

9 Beginning PrEP If HIV uninfected, at substantial risk, with normal renal function Prescribe Truvada ( 90 day supply) Instruct to take one pill daily Educate about side effects and management Provide adherence education/support Counsel about safer sex/injection behaviors Assist with insurance/medication assistance program Schedule follow up in 3 months (or sooner) PrEP Follow up Visits Conduct HIV test every 3 months Conduct creatinine test at 3 months then every 6 months Pregnancy test every 3 months STI tests every 6 months if asymptomatic Assess Medication adherence HIV risk and protective behaviors Prescribe Truvada ( 90 day supply) Schedule follow up visit in 3 month 9

10 Case Study #1 22 year old black man presents with penile ulcer consistent with primary syphilis Has never had an HIV test Does not know HIV status of most recent partner Has been sexually active with men and women in past 6 months Rarely uses condoms with male partners Adherence Matters Daily PrEP medication can provide high levels of prevention effectiveness but only if taken consistently PrEP medication has some forgiveness if occasional doses are missed There is no evidence that PrEP medication is effective when taken sporadically or intermittently 10

11 PrEP works if you take it (in community settings) iprex Open Label Extension Study (MSM) STD clinics (MSM) Adherence by Drug Concentration HIV Incidence per 100 PY 0 pills/week 4.7 <2 pills/week pills/week pills/week 0.0 Percent Compliant Based on Blood Levels or more doses per week Miami DC SF All sites Adherence and Resistance 11

12 Mitigating PrEP Costs PrEP covered by most private employer, schoolbased and public insurers (e.g., Medicaid) For those with low income and no insurance coverage, Gilead Sciences provides: Medication Assistance Program for free Truvada to provider Medication co pay assistance card Free HIV testing and hepatitis B screening Free HIV resistance testing for patients who seroconvert on PrEP Free condoms for patients Case Study #2 30 year old woman presents with cellulitis at drug injection site (heroin) Recent relapse from drug treatment Tested HIV negative 6 months ago Injects with main sexual partner (unknown HIV status) No needle/syringe exchange in your city Infrequently uses condoms 12

13 Why is PrEP alone not enough? PrEP medication does not reduce the risk of other adverse health outcomes STIs Unwanted pregnancies Health consequences of injection drug use For HIV prevention Combining methods improves protection When medication doses are missed When medication alone doesn t completely block HIV transmission Discontinuing PrEP For HIV seroconversion Offer immediate transition to treatment regimen Document HIV resistance test results For HIV negative persons Document HIV and creatinine test results Assure that HIV prevention plan is in place If chronic hepatitis B infection, treat and monitor liver function in consultation with expert 13

14 Estimating PrEP Uptake (55% of retail pharmacies) Rawlings et al. 53rd ICAAC. September 10 13, Denver. Abstract H 663a. Bush et al. 9 th Int. Conf on HIV Treatment and Prevention Adherence, June Miami. Abstract P 353. Potential Impact of PrEP for MSM in New York City Koppenhaver et al. J Acquir Immune Defic Syndr (2011) 58(2):e51 e52 14

15 Additional Information PrEPline (clinician telephone consultation) PHS PrEP Clinical Practice Guidelines PHS PrEP Providers Supplement CDC Patient PrEP materials (English and Spanish) Truvada for PrEP Medication Assistance Program Gilead PrEP information for healthcare providers (855 HIV PREP) resources/pepresources/prep/ pdf sistance_program.pdf dd Dr. Dawn K. Smith The United States will become a place where new HIV infections are rare National HIV/AIDS Strategy 15