PrEP Primary Care SlidesHIV

PrEP and My Patients: Guidance for LGBT CommunityBased Primary Care Providers on Novel Strategies to Reduce Risk of HIV
Acquisition
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PrEP and My Patients

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Faculty Who Contributed to This Program

Susan Buchbinder, MD
Associate Clinical Professor Departments of Medicine, Epidemiology, and Biostatistics University of California, San Francisco Director, HIV Research Section San Francisco Department of Public Health San Francisco, California
Jared M. Baeten, MD, PhD

Associate Professor Department of Global Health and Medicine University of Washington Seattle, Washington

Faculty Who Contributed to This Program (contd)

Connie Celum, MD, MPH
Professor, Department of Global Health and Medicine University of Washington Seattle, Washington
Albert Liu, MD, MPH

Assistant Clinical Professor Department of Medicine University of California, San Francisco Director, HIV Prevention Intervention Studies HIV Research Section San Francisco Department of Public Health San Francisco, California

Disclosures
Jared M. Baeten, MD, PhD, has no significant financial relationships to disclose.
Susan Buchbinder, MD, has no significant financial relationships to disclose.
Connie L. Celum, MD, MPH , has no significant financial relationships to disclose.

Albert L. Liu, MD, MPH, has no significant financial relationships to disclose.
Antiretroviral Therapy for Preventing HIV Acquisition: Available Data and Ongoing Trials
PrEP Background

Using Antiretroviral Medications for HIV-1 Prevention

PrEP PEP ART
Prior to exposure
Time of transmission
After infection
Advantages Demonstrated efficacy
Advantages Shorter course than PrEP
Advantages Clinical benefits and reduced infectiousness Challenges Scale up; resources Long-term adherence Long term toxicity Resistance
Challenges Adherence Delivery Cost-effectiveness Resistance
Challenges Limited data Recognition of risk Initiation < 48 hrs Adherence Public health impact

Tenofovir for PrEP

Completed clinical trials of PrEP have tested tenofovir
Oral TDF, oral TDF/FTC, vaginal gel
Potent: rapid antiretroviral activity
Safe: Substantial treatment safety experience

Easy: Once-daily dosing, few drug-drug interactions Evidence that concept should work
Animal models and postnatal prophylaxis of breastfeeding infants showed high levels of protection
Breakthroughs in PrEP

iPrEx: Eligibility
Male sex at birth (N = 2499)
18 yrs of age or older HIV-seronegative status
Evidence of risk for acquisition of HIV infection
Grant RM, et al. N Engl J Med. 2010;363:2587-2599.

iPrEX Study Sites

Sites Participants 11 2499
San Francisco
9%
Boston Iquitos
Chiang Mai 5%
12% Guayaquil Lima 56% Sao Paulo 15% Rio de Janeiro
Cape Town 4%
Grant R, et al. CROI 2011. Abstract 92.

iPrEx: Baseline Demographics

Characteristic, % Age Younger than 25 yrs 25-39 yrs 40 yrs or older Race White Black Asian Mixed/other Latino Completed some college
Overall (N = 2499)
50 40 10 17 9 5 69 72 43

iPrEx: Efficacy
Efficacy through study end (mITT): 42% (95% CI: 18% to 60%)
0.12 Cumulative Probability of HIV Infection Placebo FTC/TDF
0.10
0.08 0.06 0.04 0.02 0 0
P = .002
Pts at Risk, n Placebo 1248 1198 1157 1119 1030 932 786 638 528 433 344 239 106 FTC/TDF 1251 1190 1149 1109 1034 939 808 651 523 419 345 253 116
12 24 36 48 60 72 84 96 108 120 132 144 Wks Since Randomization
Challenges of PrEP
Drug Resistance

iPrEx: Breakthrough Infections and Resistance

New HIV infections (91 samples tested)[1]
No drug resistance in participants on FTC/TDF 2 with minor variant drug resistance on placebo (1 to TDF, 1 to FTC)
HIV infections already present at enrollment

2 cases of FTC resistance in FTC/TDF arm[2] Resistance dropped to undetectable levels within 6 mos after stopping PrEP[1]
1. Liegler T, et al. CROI 2011. Abstract 97LB. 2. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
Safety and Tolerability

iPrEx: Adverse Events

No significant differences in adverse events between arms
Adverse Event FTC/TDF (n = 1251) % Any grade 3/4 event Death Serious adverse event Elevated creatinine Creatinine elevation confirmed on next visit 12 <1 5 2 0.4 Events 248 1 76 28 7.0 Placebo (n = 1248) % 13 <1 5 1 0 Events 285 4 87 15 0 .51 .18 .57 .08 .06 P Value

iPrEx: BMD Changes and Fracture Rates

BMD changes were small (~1%); no evidence of negative effect on health[1]
No differences in fracture rates between groups[1,2] All fractures were trauma related Need longer follow-up to evaluate effects on bone density and fracture risk over time
1. Liu AY, et al. Plos One. 2011;6:e23688.2. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.

iPrEx: Nausea on History

12 Patients Reporting Nausea (%)
10 8 6 4 2 0 FTC/TDF Placebo
12
24 36 48 60 72 Wks Since Randomization
84
96

iPrEx: Weight Gain

Patients Reporting Weight Gain (%) 4
Placebo FTC/TDF
12
84
96
Adherence

iPrEx: Detected Drug in Infected vs Uninfected Participants

100 Drug Detection Rate (%) 80 51% 60 40 11% 8% 20 0
0 >21 15-21 9-15 3-9 0-3 0-3 3-9 9-15 15-21 >21
Drug Detection at Visit with First Evidence of HIV Infection for Case
P = .77
44%
HIV infection occurred during periods of low drug exposure

P = .001 Months
Pre-HIV Infection Time Points

Number of Time Points 31 59 27 96 61 90 145 207
Post-HIV Infection Time Points

71 36 21
Case Control
35 48 79 144 73 130
Anderson PL, et al. CROI 2012. Abstract 31LB.

TDF Levels in PMBC With 2, 4, or 7 Days of DOT: Understanding iPrEX Results

STRAND 2/wk 4/wk 7/wk 21 22 n: 21 TFV-DP (fmoI/106 cells) 100 iPrEx Visit With First Evidence of HIV Cases Controls 48 144
0%
18%
10
1 % Detected: 100 100 100 Median: 11 32 42 IQR: 6-13 25-39 31-47 Anderson PL, et al. CROI 2012. Abstract 31LB.
8 11 4-15
44 16 9-27
Risk Behavior

iPrEx: Numbers of Sexual Partners

20 Placebo, mean partners FTC/TDF, mean partners Placebo, median partners FTC/TDF, median partners
Sexual Partners in Previous 12 Wks (n)
15
10
12
84
96

iPrEx: Condom Use With High-Risk Sex

100 Receptive Intercourse Using Condoms (% of Partners) 80 60 40 20 0 Placebo FTC/TDF
12
24
32 48 60 72 84 96 108 120 132 Wks Since Randomization

A Perspective on Risk Compensation

Effect of 90% male circumcision 30% risk reduction
2.0 Incidence Rate (per 100 Yrs) No intervention
1.5 Circumcision intervention only
1.0
Reductions in risk behavior 0.5 Reductions in risk behavior + circumcision 0
Intervention
Hallett TB, et al. PLoS One. 2008;3:e2212.

Limitations of Current Data

Only ~ 10% of iPrEx population from the US
Arguably, prevention benefit should not differ by geography
Long-term adherence and adherence at time of HIV exposure unknown (in those who became infected) Long-term health effects of FTC/TDF in HIV negative and HIV seroconverters unknown Adherence, risk behavior, PrEP interest likely to be different now that results are known compared with clinical trial population
CDC. MMWR Morb Mortal Wkly Rep. 2011;60:65-68. Grant RM. N Engl J Med. 2010;363:2587-2599.

What We Are Poised to Learn

PrEP use when MSM know iPrEx results (adherence, risk practices)
iPrEx Open-Label Extension (OLE) Demonstration projects
What is intermittent dosing and should we consider it?

(Answer: Not yet . . . )
Efficacy and safety of new drugs and new delivery systems

Long-acting injectables Rectal microbicides Vaginal rings

How Much Is Enough? A Primary Prevention Comparison

iPrEx[1] Intervention Primary outcome Population Risk factor Frequency of outcome in placebo arm Relative risk reduction FTC/TDF daily HIV Men 18-67 yrs of age
(N = 2499)
MSM behavior 4% per yr 44%

(95% CI:15% to 63%)
1. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.

How Much Is Enough? A Primary Prevention Comparison

iPrEx[1] Intervention Primary outcome Population Risk factor Frequency of outcome in placebo arm Relative risk reduction FTC/TDF daily HIV Men 18-67 yrs of age
(N = 2499)
WOSCOPS[2] Pravastatin daily MI Men 45-65 yrs of age

(N = 6595)
MSM behavior 4% per yr 44%

(95% CI:15% to 63%)
High cholesterol 1.6% per yr 31%

(95% CI:17% to 43%)
1. Grant RM, et al. N Engl J Med. 2010;363:2587-2599. 2. Shepherd J, et al. N Engl J Med. 1995;333:1301-1307.
Other Studies of ART for Prevention

Partners PrEP: TDF vs TDF/FTC vs Placebo in HIV-Serodiscordant Couples

Follow-up: 36 mos
Oral Tenofovir QD (n = 1584)
HIV-negative partners in HIV-serodiscordant heterosexual couples

(N = 4747)
Oral Tenofovir/Emtricitabine QD (n = 1579)
Oral Placebo* (n = 1584)
*Placebo arm terminated early on July 10, 2011, by data and safety monitoring board. Baeten J, et al. IAS 2011. Abstract MOAX0106.

Partners PrEP: Both PrEP Strategies Significantly Reduce HIV Acquisition

Primary Efficacy Outcome, mITT Analysis HIV acquisitions, n HIV incidence/100 PY Efficacy vs placebo, % (95% CI) P value TDF (n = 1584) 17 0.65 67 (44-81) < .0001 TDF/FTC (n = 1579) 13 0.50 75 (55-87) < .0001 Placebo (n = 1584) 52 1.99 ---
Both PrEP strategies associated with significant reduction in HIV acquisition vs placebo in both men and women
TDF efficacy: 71% in women, 63% in men
TDF/FTC efficacy: 66% in women, 84% in men

Baeten J, et al. CROI 2012. Abstract 29.

Partners PrEP: Other Outcomes

Rates of death, serious adverse events, laboratory events low and not significantly different between arms
Mild GI effects and fatigue, primarily during Month 1
Reported unprotected sexual behavior decreased on study, with similar decline observed across arms No resistance to TDF or FTC in those who acquired HIV after randomization (n = 27)
Resistance mutations found in 2/8 retrospectively found to have acute HIV-1 at PrEP initiation
K65R (n = 1); M184V (n = 1)
Baeten J, et al. CROI 2012. Abstract 29.

TDF2: PrEP With TDF/FTC in HIV-Negative Heterosexuals in Botswana

12-mo follow-up
HIV-uninfected adults, heterosexually active, aged 18-39 yrs (N =1219)*
Oral Tenofovir/Emtricitabine (n = 601)
Oral Placebo (n = 599)
*n = 19 patients excluded for failure to start study medication or HIV infection.
Thigpen MC, et al. IAS 2011. Abstract WELBC01.

TDF2: PrEP With TDF/FTC Significantly Reduces HIV Acquisition

9 vs 24 patients seroconverted in TDF/FTC vs placebo arms, respectively Overall protective efficacy of TDF/FTC: 62.6% (95% CI: 21.5-83.4; P = .0133) Reduction in HIV acquisition with TDF/FTC observed in both men and women but study underpowered to demonstrate sex-based differences in outcomes
0.10 Failure Probability 0.08 0.06 0.04 0.02 0 0 1 Yrs
Thigpen MC, et al. IAS 2011. Abstract WELBC01.
Time to Seroconversion (ITT Analysis)
Placebo
TDF/FTC

Disappointing Results of PrEP in Women: FEM-PrEP and VOICE

FEM-PrEP: Phase III study of oral TDF/FTC planned for 3900 high-risk women in Africa (2120 randomized)
Announced April 18, 2011, that study was ended early because of lack of efficacy
VOICE: Phase IIB placebocontrolled trial of > 5000 women in South Africa, Uganda, and Zimbabwe[2]
Daily oral TDF; daily oral TDF/FTC; daily vaginal TFV 1% gel DSMB stopped the daily oral TDF arm in September 2011 and the daily vaginal gel arm in November 2011, both for lack of efficacy Daily oral TDF/FTC arm continues
35 vs 33 new HIV infections in the placebo and FTC/TDF arms[1]

TFV blood levels that use was too low (< 40%) to assess efficacy
4 vs 1 patient with M184V/I in the TDF/FTC and placebo arms
1. Van Damme L, et al CROI 2012. Abstract 32LB. 2. These data are available in press release format only, have not been peer reviewed, may be incomplete, and we await presentation or publication in a peer-reviewed format before conclusions should be made from these data.

Questions That Arise From These Data

Why were there differences between these studies and the other TDF-based studies?
Adherence? Penetration of drug in vaginal tissue?
But promising data on oral PrEP in women in Partners (TDF and TDF/FTC) and TDF2 (TDF) trials
Degree of HIV exposure?
Genital inflammation?

What Have We Learned?

We have proof-of-concept that antiretroviral agents provide primary protection against HIV-1
Adherence to PrEP is critical for its effectiveness
Key component of new PrEP strategies and execution of future PrEP trials
Biomedical prevention is behavioral We still have much to learn about biologic and behavioral factors that drive HIV-1 risk in women and how those may undermine PrEP benefits
Treatment of HIV-Infected Persons for Prevention of Transmission

HPTN 052: Immediate vs Delayed ART for HIV Prevention in Serodiscordant Couples
HIV-infected, sexually active serodiscordant couples; CD4+ cell count of the infected partner: 350-550 cells/mm3 (N = 1763 couples) Immediate HAART Initiate HAART at CD4+ cell count 350-550 cells/mm3 (n = 886 couples) Delayed HAART Initiate HAART at CD4+ cell count 250 cells/mm3* (n = 877 couples)
*Based on 2 consecutive values 250 cells/mm3.
Primary efficacy endpoint: virologically linked HIV transmission Primary clinical endpoints: WHO stage 4 events, pulmonary TB, severe bacterial infection and/or death Couples received intensive counseling on risk reduction and use of condoms
Cohen MS, et al. N Engl J Med. 2011;365: 493-505.

HPTN 052: HIV Transmission Reduced by 96% in Serodiscordant Couples

Total HIV-1 Transmission Events: 39 (4 in immediate arm and 35 in delayed arm; P < .0001)
Linked Transmissions: 28
Unlinked or TBD Transmissions: 11
Delayed Arm: 27
Immediate Arm: 1
Single transmission in patient in immediate HAART arm believed to have occurred close to time therapy began and prior to suppression of genital tract HIV
P < .001
Cohen MS, et al. N Engl J Med. 2011;365: 493-505.

What Do These Results Mean for Others?

Likely that ART prevents transmission in others, although
Only 2 couples from US in HPTN 052 Other routes of transmission (needles, anal intercourse) and clades (HIV subtypes) may have different transmission biology No protection for outside partnerships (28% of infections)
Why Use PrEP if Treatment Is So Effective?

Challenges in Linkage to Care and Successful Treatment

1,200,000
1,000,000 800,000 600,000 400,000 200,000 0
1,106,400 874,056 655,542 437,028 349,622
100% 79%
59%
40%
Estimated that only 19% of HIV-infected individuals in the US have undetectable HIV viral load
32%
24%
262,217
19%
209,773
Gardner EM, et al. Clin Infect Dis. 2011;52:793-800.

What Will It Take to Substantially Reduce HIV Transmission in an Entire Population?

1,200,000 Number of Individuals 1,000,000 800,000 600,000 400,000 200,000 0 Current DX 90% Engage 90% Treat 90% VL < 50 Dx, in 90% Engage, Tx, and VL < 50 in 90% 19% 22% 34% 28% 21% 66% Undiagnosed HIV Not linked to care Not retained in care ART not required ART not utilized Viremic on ART Undetectable HIV-1 RNA
Answer: Treatment AND Prevention

Gardner EM, et al. Clin Infect Dis. 2011;52:793-800.
Concluding Thoughts

Treatment . . . costs are unsustainable. Greater emphasis must be placed on preventing new infections.
Institute of Medicine Report Brief, November 2010
IoM. Preparing for the future of HIV/AIDS in Africa: a shared responsibility. November 29, 2010.
Exploring the Practicalities of Providing Antiretroviral Therapy for PrEP
The Data and the Need

HIV Diagnoses Among Adult/Adolescent Males by Transmission Group: 2006-2009

40 states and 5 US dependent areas
25,000 20,000 Diagnoses (n) 15,000 10,000 5000 0 2006 2007 2008 Yr of Diagnosis 2009 Heterosexual contact* Other Male-to-male sexual contact
Injection drug use Male-to-male sexual contact and injection drug use
*Heterosexual contact with a person known to have or to be at high risk for HIV infection. Includes hemophilia, blood transfusion, perinatal exposure, and risk factor not reported or identified. Note: Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays and missing risk-factor information but not for incomplete reporting.
CDC. HIV surveillance in men who have sex with men (MSM). 2011.

HIV Diagnoses Among Adult/Adolescent MSM by Age Group: 2006-2009

40 states and 5 US-dependent areas
7000 6000 35-44 25-34 13-24 45-54
Diagnoses (n)
5000
4000
3000 2000 1000 0 2006
55
2007 2008 Yr of Diagnosis
2009
Note: Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays and missing risk-factor information but not for incomplete reporting.
CDC. HIV surveillance in men who have sex with men (MSM). 2011

HIV Diagnoses Among MSM 13-24 Yrs by Race: 2006-2009

40 states and 5 US-dependent areas
3500 3000 Black
Diagnoses (n)
2500 2000 1500 1000 White Multiple races Native Hawaiian/Other Pacific Islander American Indian/Alaska Native Asian 2006 2007 2008 Yr of Diagnosis 2009 Hispanic/Latino*
500 0
*Hispanics/Latinos can be of any race. Note: Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays and missing risk-factor information but not for incomplete reporting. Data exclude men who reported sexual contact with other men and injection drug use.
CDC. HIV surveillance in men who have sex with men (MSM). 2011.
Are We Ready to Give PrEP to Men in the United States?

Note: This is interim guidance CDC and other USPHS agencies are developing formal guidelines for the use of PrEP in MSM in the US Additional guidance for other populations will become available as data from newer studies are more fully analyzed
CDC. MMWR Morb Mortal Wkly Rep. 2011;60:65-68.

Goals of CDC Interim PrEP Guidance

CDC interim guidance reinforced:
TDF/FTC is the only proven effective PrEP regimen for MSM Daily dosing of PrEP is the only proven effective regimen
Intermittent use efficacy unknown
PrEP efficacy was demonstrated with HIV testing and other prevention services Until analyses complete from other PrEP trials, PrEP recommended only for MSM populations
Before Initiating PrEP: Risk Assessment

Before Initiating PrEP: Risk Assessment

Guidance applies only to MSM
Components of CDC behavioral risk assessment
Risk-reduction measures (eg, condoms) not used or used consistently Risk for HIV acquisition is high
Frequent partner changes Partners with HIV-positive or unknown HIV status Geographic setting with high HIV prevalence

Will Men Be Interested in PrEP?

After yrs of telling men not to get HIV because the medications are awful
Messaging about safety and tolerability of FTC/ TDF is important
Helping men decide whether they would likely benefit from PrEP is essential

CDC: PrEP Eligibility

HIV uninfected
Antibody negative, immediately before starting PrEP If patient has symptoms consistent with acute HIV infection, either wait for 1 mo and confirm HIV negative and/or test for acute HIV infection
Adequate renal function

Creatinine clearance 60 mL/min (Cockcroft-Gault)
Additional recommended actions

Screen for hepatitis B infection
If HBV uninfected and susceptible vaccine (MSM in US should be vaccinated against HBV)
If HBV infected, treat for HBV (potentially with FTC/TDF)
Screen and treat STDs


Prescribing PrEP
Coformulated FTC 200 mg/TDF 300 mg, 1 tablet daily
No more than 90-day supply Renewable only if HIV testing confirms the patient remains HIV uninfected
Anticipate, at minimum, quarterly HIV testing
CDC. MMWR Morb Mortal Wkly Rep. 2011;60:65-68. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.

Counseling
Continued behavioral risk reduction
Importance of PrEP adherence
No data on intermittent, event-driven use
Adverse events
Very well tolerated and safe May experience mild nausea in first few wks

Follow-up
HIV testing
Every 2-3 mos; document negative result
Evaluate and support adherence
Continued risk-reduction counseling

Assess for STD symptoms at each visit Screen asymptomatic patients every 6 mos
Renal safety
Test creatinine after 3 mos on PrEP and annually thereafter

Discontinuing PrEP
HIV testing
If HIV positive, stop PrEP
Resistance testing Establish linkage to HIV care
If HIV negative, risk-reduction support services
If person has chronic hepatitis B infection

Check liver function tests (case reports of hepatitis flares after discontinuing FTC/TDF)

PrEP Safety
PrEP with FTC/TDF or any other medication currently has no label indication
FDA currently considering application for an indication for FTC/TDF for PrEP
Serious adverse events

Should be reported to the FDAs MedWatch (www.fda.gov/safety/medwatch)

PrEP Reimbursement
Public or private insurance may or may not cover the costs associated with PrEP
ADAP funds cannot be used to pay for PrEP
Options being investigated

Likely to be influenced by FDA decision and/or CDC recommendations

Unknowns
Populations in which PrEP can be used effectively and safely
Long-term toxicity in HIV-negative person unknown
Adherence
Long term
Intermittent use
Resistance
Longer time between HIV tests
Persistence and spread of resistant virus, if occurs
Behavior
How much will behavior change if PrEP is partially protective? How much will that impact efficacy?

Summary: Prescribing PrEP

Daily FTC/TDF shown to have moderate efficacy for HIV-1 prevention among MSM
High efficacy among those with high adherence PrEP is a promising HIV prevention strategy for MSM
Daily TDF and FTC/TDF safe and efficacious among heterosexual couples and young heterosexuals in Partners PrEP and TDF2
Mixed results from other trials; more interpretation necessary
Additional data forthcoming on oral FTC/TDF in women, and TDF in IDUs CDC and WHO guidelines forthcoming Providers should be prepared to do risk assessment, counseling, and prescribe for high-risk MSM Risk assessment and counseling tools to aid providers and prospective users are under development
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PrEP and My Patients: Guidance for LGBT CommunityBased Primary Care Providers on Novel Strategies to Reduce Risk of HIV

This program is supported by an educational grant from

PrEP and My Patients

About These Slides

PrEP and My Patients

Faculty Who Contributed to This Program

Jared M. Baeten, MD, PhD

PrEP and My Patients

Faculty Who Contributed to This Program (contd)

Albert Liu, MD, MPH

PrEP and My Patients

Connie L. Celum, MD, MPH , has no significant financial relationships to disclose.

PrEP and My Patients

Using Antiretroviral Medications for HIV-1 Prevention

Advantages Demonstrated efficacy

Advantages Shorter course than PrEP

Challenges Adherence Delivery Cost-effectiveness Resistance

PrEP and My Patients

Tenofovir for PrEP

Potent: rapid antiretroviral activity

Safe: Substantial treatment safety experience

PrEP and My Patients

Evidence of risk for acquisition of HIV infection

Grant RM, et al. N Engl J Med. 2010;363:2587-2599.

PrEP and My Patients

iPrEX Study Sites

12% Guayaquil Lima 56% Sao Paulo 15% Rio de Janeiro

Grant R, et al. CROI 2011. Abstract 92.

PrEP and My Patients

iPrEx: Baseline Demographics

PrEP and My Patients

12 24 36 48 60 72 84 96 108 120 132 144 Wks Since Randomization

Grant R, et al. CROI 2011. Abstract 92.

PrEP and My Patients

iPrEx: Breakthrough Infections and Resistance

HIV infections already present at enrollment

Safety and Tolerability

PrEP and My Patients

iPrEx: Adverse Events

Grant R, et al. CROI 2011. Abstract 92.

PrEP and My Patients

iPrEx: BMD Changes and Fracture Rates

PrEP and My Patients

iPrEx: Nausea on History

24 36 48 60 72 Wks Since Randomization

Grant RM, et al. N Engl J Med. 2010;363:2587-2599.

PrEP and My Patients

iPrEx: Weight Gain

24 36 48 60 72 Wks Since Randomization

Grant RM, et al. N Engl J Med. 2010;363:2587-2599.

PrEP and My Patients

iPrEx: Detected Drug in Infected vs Uninfected Participants

HIV infection occurred during periods of low drug exposure

Pre-HIV Infection Time Points

Post-HIV Infection Time Points

Anderson PL, et al. CROI 2012. Abstract 31LB.

PrEP and My Patients

TDF Levels in PMBC With 2, 4, or 7 Days of DOT: Understanding iPrEX Results

PrEP and My Patients

iPrEx: Numbers of Sexual Partners

Sexual Partners in Previous 12 Wks (n)

24 36 48 60 72 Wks Since Randomization

Grant R, et al. CROI 2011. Abstract 92.