PrEP Case Studies
Case 1 62 year old single gay man First contact with clinic in Nov 2011 Unprotected sex 60 hours previously Received PEP Remained HIV-negative Repeat exposures requiring PEP in 2013, 2014 and 2015 Primary sex partner is HIV-positive on ART Enquired about PrEP in July 2015
Case 1 Does he need PrEP? Yes! Ongoing exposure risk not using condoms constantly Confirmation of HIV-negative status? HIV fourth generation negative previously and on this visit Sexual history last possible exposure 10 days ago Clinical assessment current URTI (presumed viral) What other baseline investigations are required? Creatinine and creatinine clearance (>60 ml/min) Hepatitis B surface antigen and antibody STI screen
Case 1: Results HIV rapid test negative Creatinine 98 umol/l MDRD GFR >60 ml/min HBsAg-negative HBsAb-positive Do you start PrEP? Delay PrEP and review in 2-4 weeks Counselling / condoms / lubricant 2 Week visit: HIV-negative and clinically well Start PrEP
Case 1: 1 Month Follow Up Correct pill-taking confirmed No current STIs Ongoing potential HIV exposures Side effects settled after 5 days What tests are required? Confirmation of HIV-negative status STI screening? Repeat creatinine and creatinine clearance Creatinine 117 Cr Cl 56
Case 1: Ongoing management Stop PrEP Client is a doctor! Counselled about risks and benefits Ongoing high risk of HIV exposure Unwilling to increase condom use Social event with excess alcohol the day before monitoring occurred Chooses not to stop but to increase monitoring
Case 1: Ongoing management Search for alternative causes of renal dysfunction Not hypertensive Normal random glucose Total fasted cholesterol 5.3 No nephrotoxic agents (e.g. no NSAIDs) No family history Normal urine dipstix (no proteinuria) Repeat Renal Function: Creatinine 103 Cr Cl >60
Case 1: 3 Month Follow Up Correct pill taking confirmed No current STIs Repeat creatinine Scripted 3 months of PrEP Creatinine 135 Cr Cl 48 Stop PrEP Counselling/advice about HIV prevention
Case 1: Outcome Patient does not want to stop PrEP Elected to continue despite medical advice with close monitoring Renal function has improved slightly and stabilised (Cr Cl approx 55) Increasing comfort level that tenofovirinduced renal dysfunction may plateau AGAINST current guidelines!
Case 2 48 year old MSM from Cape Town Single No past medical history of note Sexual history About 5 partners per month Sex at a sex-on-site venue once per week Bottom (preference for receptive anal sex) Condom use about half the time No prior STI diagnosis No regular GP
Case 2 Complains of 1 month severe fatigue 2 weeks of jaundice and itch Jaundiced, not pale, not acutely unwell No signs of chronic liver disease What is your differential diagnosis? What tests would you perform?
Case 2: Results Liver Function Test Result Total bilirubin 58 Conjugated bilirubin 29 ALP 216 ALT 1429 AST 1706 Test Hepatitis A IgM and IgG Hepatitis B surface antigen Hepatitis B surface antibody Hepatitis B E antigen Rapid syphilis Results Negative Positive Negative Positive Positive
Case 2: Follow up Referred to tertiary hospital liver clinic Conservative management of viral hepatitis Clinically well LFTs remained elevated (ALT 42, AST 45) Participant requests PrEP
Case 2 Does he need PrEP? Yes! Ongoing exposure risk not using condoms consistently Confirmation of HIV-negative status? HIV fourth generation negative previously and on this visit Sexual history No recent possible HIV exposures Clinical assessment clinically well What other baseline investigations are required? Creatinine and creatinine clearance (>60 ml/min) : normal Liver USS : normal
Case 2 Would you prescribe PrEP? Yes! Two indications for tenofovir / emtricitabine Ongoing concern of risk of transmission of sexual viruses Increased condom use but still high risk behaviours Most studies to date have excluded HepB + people from PrEP studies. Why? Risk of LFT flare if stop HBV treatment if chooses to cycle off PrEP. One patient in a clinical trial has died after worsening of chronic hepatitis B on stopping PrEP
The safety of PrEPin the presence of hepatitis B infection HBV is common in countries that don t vaccinate HBV common in South Africa 20% of incident infections become chronic TDF/FTC suppresses HBV and thus acts as treatment Concern about flares if stop TDF/FTC or resistance develops PrEP exclusion
The safety of PrEPin the presence of hepatitis B infection Sub-study of HBV + participants in iprex 13/2499 (0,5%) chronic HBV 6 were in the group assigned TDF/FTC 0/6 experienced flares after stopping PrEP 2 participants had evidence of acute HBV and started PrEP severe elevatedlfts (as expected in acute infection) which settled and both cleared virus and became immune
Case 2: Outcome Ineligible for sponsored PrEP in Cape Town Started private sector PrEP Using generic medications Hepatitis B viral load now undetectable Liver function tests completely normal Normal renal function Good pill taking Remains HIV-negative
Sex Worker Case Studies
Case Study: Lebo Lebo is a 27 year old woman living in Hillbrow. She comes into the clinic with complaints of an STI. She works as a part-time domestic helper during the day and she also works at a bar some evenings. She has two small children, and her husband has passed. She is not on contraception as she does not like the side effects. She wants to take an HIV test and look at potential options for contraception with low side effects. She also wants a box of condoms, because after some conversation, she admits she has a couple of sexual partners. 263
Case Study: Lebo What are the steps you would undertake to further assess what Lebo might need in terms of contraception and HIV prevention? What messages will you give her around risk and prevention of unwanted pregnancies, STIs, and HIV? Do you think Lebo should consider PrEP as an HIV prevention option? Why or why not? If you give her PrEP as an option, what will you tell her about taking the drug (e.g. side effects and adherence)? 264
Candice is an 18 year old transgender woman Her parents have died Case Study: Candice She engages in sex work to support her young brother. She is worried about recurring STIs and has been to the clinic previously to start PrEP. She admits that she only started taking her PrEP after two weeks of getting the script filled and has not been very consistent in taking the pills every day. She has experienced some very minor side effects (upset stomach), and is unsure about continuing to take PrEP. 265
Case Study: Candice Whose decision is it as to whether Candice should continue PrEP? What messages will you give her around risk and adherence to PrEP? How can you help her decide whether to continue PrEP and what strategies she could use? What are the steps you would undertake to further assess what Candice should do in terms of preventing HIV and STIs? 266
Case Study: Thandi Thandiis a 28 year old woman living in Hillbrow She has been taking PrEP for six months. She previously told you she is a sex worker and she only uses condoms for contraception. When she comes to the clinic for her next check-in, she tests positive for pregnancy. At this visit, she tells you she is unsure if she is going to terminate the pregnancy because of the risk of PrEP effects on her baby. How do you counsel her about continuing PrEP use? 267
Case Study: Thandi Thandihas been taking PrEP for six months. When she comes to the clinic for her next check-in, she tests positive for pregnancy. She previously told you she is a sex worker. At this visit, she tells you she is unsure if she is going to terminate the pregnancy because of her current life circumstances. She decides to go off of PrEP, and deliberate about whether she will terminate her pregnancy or not. She comes back to the clinic and tells you she ended up terminating and she wants to restart PrEP. What do you do at this point? Note: she has been offered contraception at every visit 268
Adolescents Case Studies
Case 1: Jackie Jackie is 15 and lives in an area where gangs and crime are rife. She has been raped once, so have many of her friends. Her mother brings her in the clinic to discuss the prevention against HIV and pregnancy. She also suspects her daughter and her boyfriend are having sex, although Jackie denies it. Her mother has heard about this PrEP pill and thinks this should be given to her daughter.
Case 1: Jackie What is your personal feeling about this? How would you handle this professionally? Is Jackie eligible for PrEP? What additional information do we need to confirm eligibility? What are her rights? what are her mother s right to protect her? What issues would you discuss with them?
Case 2: Lerato Leratois a 16 year old adolescent She is an orphan and has been brought up by her aunt, who sells alcohol as a means of income. Leratois sexually active and has a boyfriend She also does favours for her aunt's clients so that they can keep coming back. Her aunt is aware of that and advised Leratoto use an injection to prevent pregnancy. Her aunt does not believe Leratocan contract HIV from her customers because they are high profile and respectable men. Leratois, on the other hand, thinking of making extra money for herself by doing transactional sex with some of the customers
Case 2: Lerato Can Leratobe considered to be high risk from contracting HIV? Would she be eligible for PrEP? What prevention strategies can be recommended to Lerato other than prep? What are the possible disadvantages of PrEP for girls her someone aged 16?
Discordant Couple: Case Study 22 year old woman attends your CHC Previously well, no medical history of note Recently married Her husband his HIV positive and has been honest about his status Husband s CD4 count is 1000 cells/mm 3 She has been using condoms but her husband is not happy to continue using them
Discordant Couple: Case Study What HIV prevention strategies are applicable to this couple? Condoms and lube PEP PrEP TasP/ UTT
Discordant Couple: Follow Up Husband Advise treatment and link to care at nearest state ART facility Promote condom use Discussion that he should wait until he is virally suppressed before planning a family Wife comes to see you one month later Husband has not yet attended for ART Requests PrEP
Discordant Couple: Case Study Does she need PrEP? Yes! Ongoing exposure risk husband not keen on condoms and she may not have the ability to negotiate consistent condom use Confirmation of HIV-negative status? HIV fourth generation negative previously and on this visit What other baseline investigations are required? Creatinine and creatinine clearance (>60 ml/min) Hepatitis B surface antigen and antibody STI screen Pregnancy test! Advise contraception All results are favourable Start PrEP Advise contraception
Discordant Couple: Case Study All well at months 1, 3 and 6 Correct pill-taking Using condoms about 50% of the time Reports using oral contraceptive Husband started ART 4 weeks previously USS scan confirms viable 20 week male foetus
What do you do now? Do you stop PrEP? Mother Stop PrEP Ongoing HIV risk to mom (5% incidence in some studies) Continue PrEP Protects mom Baby Minimisesrisk to baby Risk of bone abnormalities but insufficient data MCC contra-indicates Truvada use for PrEP during pregnancy Tenofovir is FDA category B risk in pregnancy Lots of experience of use in pregnant HIV-positive mothers Case by case decision based on risks and benefits
Discordant Couple: Outcome Elected to stop PrEP Couple were prepared to use condoms consistently as long as not permanent Successful normal delivery Baby (and mom) remain HIV-negative Husband now on ART and VL LDL