Pre-Exposure Prophylaxis (PrEP) for HIV Prevention

Jorge Sanchez, MD, MPHAsociación Civil IMPACTA Salud y Educación

MSM Global Forum

Vienna, 17th July 2010

Prevention with Antiretrovirals• ARV treatment of infected persons (ART)Prevent sexual transmission

Prevent vertical transmission (pMTCT for mothers)

• ARV prophylaxis of uninfected persons (‘ARP’)Prevent horizontal transmission (M F; M M)

Prevent vertical transmission (pMTCT for fetus & breastfeeding infants)

• Antiretroviral prophylaxis approachesMucosal (topical) or systemic (oral, SC, IM) or both

Pre- or post-exposure or both

Intermittent or continuous dosing

Can a pill prevent HIV?

http://www.avac.org/ht/a/GetImageAction/i/27514

Four continents participating in this enterprise

More than 20,000 volunteers participating

PrEP Timeline

http://www.avac.org/ht/a/GetImageAction/i/27512 Results to be presented at the XVIII International AIDS Conference(Vienna, 2010)

Extended Safety Trial/ CDC 4323: Clinical and behavioral safety, and adherence• A total of 400 MSM randomly assigned to one of four study arms: Two arms receive either tenofovir or placebo immediately upon

enrollment Two arms receive either tenofovir or placebo after nine months of

enrollment.

IPREX Initiative: Safety, Efficacy, Behavior, and Biology• A totol of 2,499 MSM at high risk were enrolled• Followed on Drug for: HIV seroconversion, Adverse Events (especially renal & liver), Metabolic

Effects (Bone, Fat, Lipids), HBV Flares among HBsAg+, Risk Behavior & STIs, Adherence, and If infected

Drug ResistanceViral load Immune responses & CD4 Count

PREP among MSM

Community Forums While Planning and Designing a Large Scale TDF-Containing PrEP Efficacy Trial Focusing MSM at

High Risk in the Andean Region (2005)

Lim

a, P

eru

We love/want you!

Be part of something big

Willingness to Participate in a HIV PrEP Trial in the Andean Region (2006)

• Objective: To assess the feasibility of a tenofovir-containing daily-oral HIV PrEP efficacy trial and identify potential volunteers´ willingness, attitudes and concerns for participation.

• Methods: Survey nested in a cross-sectional HIV sentinel surveillance conducted in Lima, Peru and Guayaquil, Ecuador during 2006, among MSM at high risk.

• Results: n = 1,202

34.4%

49.1%

16.6% Definitively will participate

Probably will participate

Will not participate

84.6

82.0

79.6

77.0

72.9

89.3

89.5

88.5

85.7

74.4

80.9

76.2

72.6

70.0

71.7

0.0 20.0 40.0 60.0 80.0 100.0

Permanent injury/death

Short-term side effects

Acquisition of a drug resistant virus

Partner not wanting to use condom

Large amount of blood for testing

Percentage

Items of Concern

All Participants Guayaquil, Ecuador Lima, Peru

Most Common Rated Concerns for Participation

Participants Characteristics and

Expressed Concerns for Study

Participation

Definite Willing to Participate

OR 95% CI P

Take a pill every day 0.39 0.28 - 0.55 < 0.001

Monthly study visits during 18 months 0.63 0.44 - 0.91 0.014

Large amount of blood for testing 0.47 0.34 - 0.64 < 0.001

One year increase on age 1.02 1.00 – 1.04 0.026

Short time side ef fects 0.54 0.38 – 0.79 0.001

Predictors of Study Participation

Lama JR, et al. Submitted for publication.

TLGB Forum

• Sept 30th, 2008

• New Peruvian Regulations for Clinical Trials

• Pros and cons for clinical trials among MSM

Tell the Truth

• Barriers and Facilitators to Pre-exposure Prophylaxis Adherence

• Next Step Counseling and Neutral Assessment in the iPrEx Study

• Implementation and Evaluation.Approach

Participants (focus groups)

Counselors, Nurses, Pharmaci

sts (key informants)

Project Coordinators, Investigators, and Outreach (key informants)

Theory, Literature, Research, Experiences in other PrEP trials

Rivet Amico et al.

What questions will likely remain even after the current PrEP trials are completed?

• Current effectiveness trials would leave several other important questions unanswered:

Are there dosing strategies other than ongoing, once-daily dosing that could be used with oral PrEP drugs to reduce individuals’ risk of HIV?

Can safe and effective PrEP strategies be developed for adolescents and pregnant women—two groups not included in current effectiveness trials?

Can other compounds be developed for potential PrEP drugs?

What are the long-term safety consequences of PrEP use?

What are the rates of drug resistance associated with individuals using PrEP who become HIV infected?

How does this impact future treatment options?

What if PrEP works? What are the possible implementation challenges?

• Identify and invest in additional research priorities including research on delivery, impact, safety, and alternative dosing

• Plan now for optimal use of PrEP by developing tools and consultations to explore

• Plan now for optimal use of PrEP by developing tools and consultations to explore (cont´d)

• Prepare for procurement and delivery of PrEP

• Provide adequate financing

• Increase HIV testing capacity

http://www.avac.org/ht/a/GetDocumentAction/i/3302

Acknowlegments

FOTO DEL CRILLON

To thousands of Peruvian MSM who participated in clinical Trials

To IPREX Team

…and thousand of Peruvian MSM

participanting in Clinical Trials