Faculty Disclosure

• It is the policy of the Intensive Osteopathic Update (IOU) organizers that all individuals in a position to control content disclose any relationships with commercial interests upon nomination/invitation of participation. Disclosure documents are reviewed for potential conflict of interest (COI), and if identified, conflicts are resolved prior to confirmation of participation. Only those participants who had no conflict of interest or who agreed to an identified resolution process prior to their participation were involved in this CME activity.

• All faculty in a position to control content for this session have indicated they have no relevant financial relationships to disclose.

• The content of this material/presentation in this CME activity will not include discussion of unapproved or investigational uses of products or devices. Sexual Health and STDs

Aekata Shah, DO Family Medicine

2016 Conference on Retroviruses and OI

Taking a Sexual History

- Do you take a sexual history?

- When do you take one?

- Do you take one on everyone? - How do you take a sexual history? https://www.youtube.com/watch?v=T3yqurZyc24 - How many of you have started a patient on PREP? Maintained a patient’s PREP? What is PREP

-PREP is PRE EXPOSURE prophylaxis for HIV -Truvada and Descovy are two options for PrEP

- Both drugs contain emtricitabine and different versions of tenofovir both are NRTI - Both regimens are one pill, once a day TAF vs TDF

- Descovy: Tenofovir alafenamide - Truvada: Tenofovir disoproxil fumarate - Both are converted to tenofovir DP (disphosphate) in cells Who is a candidate for PREP IVDA, the Opioid Epidemic, and HIV Candidates for PrEP

• Must be at or grater than 35kg to start PrEP • Must have a creatitine clearance above 30 mL/min for Descovy, 60 mL/min for Truvada • Truvada is effective for PrEP regarding vaginal receptive and anal receptive intercourse • Descovy was NOT studied in regards to vaginal receptive intercourse • Anal receptive intercourse: effective in 7 days • Vaginal receptive intercourse: effective in 21 days Studies and Efficacy PrEP Studies

- “Partners PrEP” and “iPrEx” were the initial Truvada studies regarding PrEP - Both were randomized, double-blind, placebo-controlled efficacy and safety study in adults - Partners PrEP looked as discordant couples in Kenya and Uganda from July 2008- July 2011 - HIV positive partners in the trial were ineligible for ART - iPrEx looked at negative partners with partners of unknown status in Peru, Ecuador, South Africa, Brazil, Thailand, and the U.S. (Boston, San Francisco) from July 2007 to May 2010 - These studies were then followed by the “DISCOVER Trial” for Descovy - This trial was also a randomized, active controlled, double blind study between patients on Truvada and Descovy from September 2016-current (primary end date January 2019)

DISCOVER

MSM= Men who have sex with men TGW= Transgender woman who have sex with men

- N= 5,387 at 94 study sites in over 11 countries - Of these, 17% of patients (N of 897) were already on Truvada prior to the start of the study - 51% were placed in the Descovy arm of the trial and 49% were placed in the Truvada arm Of the 17% who were on Truvada prior to the start of the study

N of 4,418 at end of 96 weeks - 2196 in the Descovy arm - 2222 in the Truvada arm) Side effects In the DISCOVER trial, 1% of patients on descovy stopped taking the medication due to side effects vs 2% of patients in the Truvada arm of the study Safety

- Renal - Hepatic - Bone density - No renal decline at 48 weeks with Descovy, minimal noted at 96 weeks

- Anecdotal evidence

Other Safety considerations

- Pregnancy

- Breastfeeding

- HBV

- If suddently stopping tenofovir, HBV infection can flare and may require other treatment

- Consult ID

- HCV

- Treatment for HCV can increase level of tenofovir causing toxicity, consult ID Initial Evaluation

DO NOT START IF CONCERNED FOR ACUTE HIV Return visits? INFXN Routine labs Q3 months Initial labs -HIV, BMP -Test 4th gen HIV test (blood) -When to add on CMP -Baseline labs: HIV, BMP (CrCl), UA, STI, U preg, -STD testing? Hep B surface antigen and antibody, HCV antibody test -What STIs to screen for? -When to add on a CMP? Questions your patients may ask you…

• THESE ARE NOT FDA APPROVED IN THE UNITED STATES • OFF LABEL USE PrEP ON DEMAND?

- What is “on demand” Prep or event driven - Take 2 tablets 2-24 hours prior to sexual activity (loading dose) - Then take 1 tablet daily while sexually activity - Continue for 2 days after sexual activity has stopped - If done more than once a week, the loading dose should be 1 tablet daily - NOT APPROVED IN THE UNITED STATES - Has not been studied in heterosexual people - Takes 21 days to protect against transmission with vaginal intercourse - PrEP for vacation start PrEP 1 week prior for men and 3 for woman; continue 1 month after exposure Seroconversion while on PREP

- Typically involve patients who are not compliant with truvada (via hair and plasma analysis) - Cases with compliance have been reported - What to consider if a patient converts and has been using PREP

- How have they been using their PREP

- Risks of drug resistance in regards to treatments Acquisition of HIV-1 Despite High Level Adherence to Daily TDF/FTC PrEP as Measured by Dried Blood Spot (DBS) and Segmental Hair Analysis • At the time of this study there were 5 cases of seroconversion despite high adherance to PrEP • Case Study: 21 y/o polysexual Latino man on daily FTC/TDF for PrEP in SF sexually active with men, cis women and TGW Month 0 Pooled NAT Rapid Ab Urine GC 3 partners PrEP started -Month 10- Testing: Plasma positive for neg neg positive reported recent dosing (12 weeks prior to Month 3 Pooled NAT Rapid Ab 3 partners PrEP seroconversion) neg neg reported continued -Month 13- methamphetamine use Month 6 Pooled NAT Rapid Ab Urine GC 4 partners PrEP reported along with CRAI neg neg positive, reported continued -Month 13.25 genital HSV -Hair analysis performed on day of 2 PCR (+) ART initiation indicated high drug adherence for the last 6 months Month Pooled NAT Rapid Ab 5 partners PrEP -DBS performed 2 days after ART 10 neg neg reported continued initiation indicated greater than 4 doses Month Urine GC 2 partners PrEP per week on average in the last 6 weeks 12 positive reported continued -Partner services identified one of his Month Pooled NAT Rapid Ab Urine GC 5 partners partners as HIV(+) and not in care 13 positive neg positive reported -Phenotype: TDF Susceptible, FTC resistant- for patient studied and partner Month Pooled NAT Rapid Ab ART started 13.25 positive positive who was found to be HIV positive and not in care Resistance The Office, the ER, and Inpatient

- PrEP use was associated with increased receipt of routinely recommended primary care due to Q3 visits in a Fenway Clinic study in Boston - PEP is frequently initiated in the ER setting→ starting the conversation for PREP - Linking ER and ID physicians - Consider linking ER and PCP physicians - Consider starting the conversation in the inpatient setting→ admission H&P 2 0 1 8 Fast facts for STDs

- If positive for gonorrhea, treat for both gonorrhea and chalmydia - If positive for clamydia, treat only for chalmydia - For anal chlamydia, treat with doxycycline - SYPHILIS IS ON THE RISE - Check RPR (non-treponemal) with reflex RPR TITER and FTA-ABS (treponemal)

- Consider prior hx of syphilis/treatment

- Consider false positives

- Treatment- early syphilis vs late syphilis Resource

• https://www.cdc.gov/nchhstp/newsroom/2016/croi-2016.html#Graphics • https://www.cdc.gov/nchhstp/newsroom/2019/2018-STD-surveillance-report.html • Centers for Disease Control and Prevention. NCHHSTP AtlasPlus. https://www.cdc.gov/nchhstp/atlas/index.htm. • HIV and People Who Inject Drugs. https://www.cdc.gov/hiv/group/hiv-idu.html • US National Library of Medicine. Clinical trials website. Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection (DISCOVER) https://clinicaltrials.gov/ct2/show/NCT02842086 • Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2017 Update: A Clinical Practice Guideline. http://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017 • US National Library of Medicine. Clinical Trials website. Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men (iPrEx) https://clinicaltrials.gov/ct2/show/NCT00458393 • Antiretroviral Prophylaxis for HIV-1 Prevention among Heterosexual Men and Women • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3770474/ • Tenofovir alafenamide versus tenofovir disoproxil fumarate: is there a true difference in efficacy and safety? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5892670/ • Acquisition of TDF-susceptible HIV Despite High Level Adherence to Daily TDF/FTC PrEP as Measured by Dried Blood Spot (DBS) and Segmental Hair Analysis: A Case Report Stephanie E. Cohen, MD, MPH; Darpun Sachdev, MD; Sulggi Lee, MD, PhD; Susan Scheer, PhD MPH; Oliver Bacon, MD, MPH; Miao-Jung Chen, PhD, MPH; Clarissa Ospina Norvell, FNP; Hideaki Okochi, PhD; Peter Anderson, PharmD; Susa Coffey, MD; Hyman Scott, MD; Diane Havlir, MD, FIDSA; Monica Gandhi, MD, MPH https://idsa.confex.com/idsa/2018/webprogram/Session10539.html • Aidsinfo.nih.gov • Uptodate • Descovyhcp.com • Truvadahcp.com