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Once‐daily raltegravir with tenofovir disoproxil/emtricitabine as HIV post‐exposure prophylaxis following sexual exposure

Accepted 9 July 2020 Once-daily raltegravir (2 9 600 mg tablets; Isentress ; MSD Ltd, Hertfordshire, UK) was licensed in September 2017 for treatment of HIV-1 infection after it demonstrated virological noninferiority against raltegravir 400 mg twice daily with tenofovir disoproxil fumarate/ emtricitabine [1,2]. The once-daily regimen was well tolerated, with only minor drug-related adverse events reported: nausea (7%), headache (3%) and dizziness (12%) [3]. Raltegravir 600 mg has a higher relative bioavailability than 400 mg as a result of improved in vivo dissolution, but both dosages demonstrate similar systemic pharmacokinetics with no food impact on exposure [3]. Once-daily dosing is preferred to facilitate adherence. Current UK national guidance for HIV post-exposure prophylaxis after sexual exposure (PEPSE) [4] recommends raltegravir 400 mg twice daily in combination with Truvada (Gilead sciences LTD., London, UK). However, it is reported widely that PEPSE adherence and completion are suboptimal [5]. As once-daily raltegravir is well tolerated, effective for HIV treatment and easier to adhere to than multiday dosing, it is appealing for PEPSE regimens. We share our audit data for raltegravir 1200 mg in combination with tenofovir disoproxil/emtricitabine (TD/FTC) as HIV PEPSE in our Genitourinary Medicine (GUM) clinic. The audit was conducted following a change in prescribing practice as part of clinical governance. A retrospective review was undertaken of 148 prescriptions for PEPSE issued by the clinic between 1 May 2018 and 31 December 2019 to 13 (8.7%) women and 135 (91.3%) men aged 16–64 years. Ten (6.8%) identified as bisexual, 27 (18.2%) identified as heterosexual and 111 (75%) were men who have sex with men (MSM). Time from potential exposure to obtaining PEPSE ranged from 3 to 70 h; 45 (30.5%) received PEPSE within 24 h, 58 (39%) between 24–48 h after exposure and 45 (30.5%) between 48–72 h after exposure. Prior to review of tolerability, five patients were excluded, including one who did not take the medication, one who obtained PEPSE for use as pre-exposure prophylaxis and three patients who stopped PEPSE early as their sexual partner tested HIVnegative. Of the remaining 143 patients, 101 (70.6%) patients had a negative HIV test 8 to 12 weeks after initiation of PEPSE, nine (6.3%) tested negative between 4 and 8 weeks after initiation of PEPSE, and 33 (23.1%) did not attend for follow-up after the 2-week clinical review. In total, 128 of 143 (89.5%) individuals had no documented side effects whilst on PEPSE; common side effects included nausea (nine of 143; 6.3%) and diarrhoea (three of 143; 2.1%). No reports of dizziness were noted. One patient (0.7%) reported poor sleep and feeling suicidal, comparable to the frequency in the Isentress 400 mg and 600 mg summary of product characteristics (≥ 0.1% to < 1%) [1]. Two (1.4%) individuals stopped PEPSE early because of side effects, the first on day 7 because of abdominal pain, and the second on day 14 because of diarrhoea, nausea, sweating and low mood. Both tested HIV negative at follow-up. No serious laboratory abnormalities were noted. Six of 143 (4.2%) patients had mildly elevated liver function tests (< 2.5 9 upper limit of normal). Two of 143 (1.4%) patients experienced a creatinine rise of 22 and 13 μmol/L, respectively, 2 weeks after initiation of PEPSE. In conclusion, our experience supports raltegravir 1200 mg in combination with TD/FTC as a well-tolerated and convenient once-daily option for PEPSE.