South African Guidelines for the Safe Use of. Dr. Oscar Radebe

Transcription

1 South African Guidelines for the Safe Use of PrEP in MSM Dr. Oscar Radebe

2 Background Globally MSM(men who have sex with men) have been disproportionately at high risk of HIV transmission. Biological & behavioural factors, as well as structural and social factors have been linked with HIV acquisition in this high risk group. The South African department of health and stakeholders jointly developed guidelines for the safe use of pre exposure prophylaxis among MSM. The working group was chaired by Dr Linda Gail Bekker from DTHIV and Dr Kevin Rebe from Anova Health Institute

3 Statistics HIV incidence in USA / Western Europe declined by 5.2% per year increased by 3.3% per year Sullivan PS et al. Re emergence of the HIV epidemic among men who have sex with men in North America, Western Europe, and Australia, Science Direct 2009; 19: South Africa Emerging data show rates of 10.4 to 33.9% in various studies 45% Johannesburg / 27.5% Durban (>80% black African MSM) JEMS Study. HIV prevalence and risk practices among men who have sex with men in two South African cities. J Acquir Immune Defic Syndr Feb 4 iprex recruitment in Cape Town: 4 5% HIV incidence overall Grant R et al. Pre exposure Chemoprophylaxis for HIV Prevention in MSM. NEJM 2010; 363(27);

4 MSM and HIV in Southern Africa HIV prevalence among MSM in cross sectional surveys in South Africa has ranged from 10 50% 8% of the new HIV infections in South Africa are among MSM population. Scheibe, Brown, Duby, Bekker et al. Southern African guidelines for the safe use of pre exposure prophylaxis in MSM at risk for HIV infection.sajhivmed June 2012, Vol. 13, No. 2

5 Risk Factors for HIV acquisition among MSM High risk in sexual practice(unprotected anal intercourse, multiple partners &sex work) Substance and alcohol use including methamphetamines and heroin. Stigma and homo prejudice Discrimination Homophobia

6 Prevention strategies Post exposure prophylaxis (PEP) Pre exposure prophylaxis (PREP) Male circumcision Treating and preventing STIS Treating HIV to lower viral load

7 WHAT IS PRE EXPOSURE PROPHYLAXIS (PrEP)? HIV negative person uses combinations of antiretroviral medication over a long period of time to prevent established HIV infection occurring should they be exposed to the virus.

8 The global iprex trial Double blinded, randomised placebo controlled trial to assess the safety and efficacy of daily oral Truvada for the prevention of HIV among MSM and transgender women. 88 MSM from South Africa were enrolled (3.5% of total cohort) The iprex study was able to demonstrate the safe use of antiretrovirals and other prevention strategies can reduce HIV infection by significant proportion~(44%) (95% confidence interval 15 63%; p=0.005)

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10 Indications for the use of PrEP MSM engaging in anal sex and are HIV negative MSM at high risk for HIV acquisition and with multiple partners MSM engaging in transactional sex, including sex workers MSM who use or abuse drugs and alcohol More than 1 episode of a STI in the last year

11 Contraindications for PrEP: HIV 1 infected or evidence of possible acute HIV infection Allergy to tenofovir disoproxil fumarate and/or emtricitabine Poor renal function (estimated creatinine clearance <60ml/min) Unwilling or unable to return for 3 monthly HIV testing, counselling and safety monitoring visits.

12 Baseline investigations for PrEP initiation among MSM Renal function HIV infection Hepatitis B screen STI screen Estimated creatinine clearance (ml/min) Rapid HIV antibody test Surface antigen (HBsAg) Symptomatic screen Examination if indicated Urine dipstix for urethritis Serological screening for syphilis (rapid or laboratory)

13 Potential predictable side effects Major side effects: renal toxicity and metabolic complications (decreased bone mineral density) Minor side effects: gastrointestinal symptoms (diarrhoea, nausea, vomiting and flatulence), unintentional weight loss and a small risk of lactic acidosis and hepatic steatosis or steatohepatitis Less predictable side effects: may include hypersensitivity reactions and flares of hepatitis B in clients who are chronic carriers who receive and then stop tenofovir, lamivudine or emtricitabine

14 PrEP: What we don t know? The long term efficacy of PrEP for MSM? The effect of PrEP on sexual behaviour and HIV risk? The long term effects of truvada on renal function, bone mineral density, chronic viral hepatitis B and other effects in HIV negative MSM? Will resistance be a common event among those infected while using PrEP?

15 PrEP: What we don t know? The ideal PrEP regimen and dosing interval? Predictors of adherence for MSM who use PrEP? Which MSM are most likely to benefit from PrEP? The role of PrEP among sero discordant MSM couples? The long term effect on treatment programmes that share ART medications with PrEP programs?

16 Recommendations MSM attending HIV clinics should be offered PrEP SA guidelines and CDC give additional support for safe use of PrEP All HCW should keep record & report the adverse events experienced by patients on PrEP Prevention packages for MSM must include STI screening and treatment together with combination prevention interventions such as counselling for behaviour change, early ART, PEP, PrEP, distribution of condoms and lube and hopefully microbicides and vaccines in future

17 Acknowledgement Prof James Mcintyre (Executive Director) Helen Struthers(Chief Operating Officer) Glenn de Swardt (Program Manager Health4Men) Top to Bottom organisers Health4Men Team Soweto DOH both Provincial and COJ for their support All staff working these facilities SA HIV society & contributors to the development of the guidelines To all the funders for their continuous support

18 Questions and discussion