Costs and benefits of on-demand HIV preexposure prophylaxis in MSM

International audienceObjectives: We undertook the economic evaluation of the double-blind randomized ANRS-IPERGAY trial, which showed the efficacy of on-demand preexposure prophy-laxis (PrEP) with tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) in preventing HIV infection among high-risk MSM. Design and methods: The economic evaluation was prospective. Counseling, drugs (TDF-FTC at s500.88 for 30 tablets), tests, visits, and hospital admissions were valued based on in-trial use. The cost of on-demand PrEP/HIV infection averted was compared with the yearly and lifetime costs of HIV infection in France in a cost and benefits analysis. Results: The yearly number of participants needed to treat to prevent one HIV infection was 17.6 (95% confidence interval ¼ 10.7-49.9). The annual cost of counseling was s690/participant. The total 1-year costs of PrEP were s4271/participant, of which s3129 (73%) were drug costs corresponding to 15 tablets of TDF-FTC/month. The yearly cost of on-demand PrEP to avoid one infection was s75 258. Using TDF-FTC generic (s179.9/30 tablets) reduced the 1-year costs of on-demand PrEP to s2271/ participant and s39 970/infection averted, respectively. Using TDF-FTC at international market discounted prices (s60/30 tablets) reduced the costs to s1517/participant and the cost to s26 787/infection averted, comparable with the yearly treatment cost of HIV infection in France. On-demand PrEP was found to be cost saving in France if the duration of exposure was less than 7.5 years at current drug price and 13 years at generic price. Conclusion: On-demand PrEP in high-risk MSM with TDF-FTC can be considered cost saving. Other benefits include the treatments of other diseases and reductions in secondary infections

HIV Pre-Exposure Prophylaxis in Men Who Have Sex with Men Analysis of the ANRS IPERGAY study with a one-year follow-up

International audienc

HIV Pre-Exposure Prophylaxis in Men Who Have Sex with Men Analysis of the ANRS IPERGAY study with a one-year follow-up

International audienc

Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial.

International audienceIn the ANRS EASIER trial where treatment-experienced patients switched from enfuvirtide (ENF) to raltegravir (RAL), a high incidence of transaminase elevation was reported in the RAL arm. We compared the incidence of emergent liver enzyme elevations (LEE) of grade 2 or more among patients randomized to the maintenance ENF arm or the switch RAL arm up to W24. We also assessed the overall incidence of LEE over the 48-week duration of the trial and baseline risk factors for grade 2 or more alanine aminotransferase (ALT) elevation using univariate and multivariate analyses. During the first 24 weeks, 6/84 (7.1 %) and 2/85 patients (2.4 %) presented with ALT elevation of grade 2 or more in the RAL and ENF arms, respectively (p = 0.21). Grade 2 or more γGT and ALP elevations were seen in 18 and 11 % (p = 0.35), and 5 and 1 % (p = 0.14) of patients in the RAL and ENF arms, respectively. The 48-week incidence of grade 2 or more LEE was 11.6 per 100-pts-years for ALT, 24.5 per 100-pts-years for γ-GT and 4.5 per 100-pts-years for ALP, respectively. In the multivariate analysis, tipranavir/ritonavir use (OR 3.66; 95 % CI [1.20-11.1], p = 0.022) and elevated ALT at baseline (OR 10.3; 95 % CI [2.67-39.6], p < 10(-3)) were significantly associated with a grade 2 or more ALT elevation during follow-up. The incidence of LEE was relatively high in these highly treatment-experienced patients switching to a RAL-based regimen. Both tipranavir/ritonavir use and high baseline ALT levels were associated with an increased risk of ALT. ClinicalTrials.gov identifier: NCT00454337

Inflammatory Markers During Early Treatment of Seroconverters in a Randomized Placebo-Controlled Trial of PrEP (ANRS-IPERGAY)

International audienceHIV-related inflammation is associated with poor outcomes. We describe inflammatory biomarkers in 17 participants in a pre-exposure prophylaxis trial who seroconverted with very early initiation of antiretroviral therapy. Inflammation peaked at the time of HIV infection and returned to baseline within 6-12 months. Starting antiretroviral therapy very early could help mitigate long-lasting HIV-related inflammation

Risk factors for HIV infection among men who have sex with men in the ANRS IPERGAY PrEP trial

International audienceObjectives We aimed to assess among men who have sex with men (MSM) risk factors for HIV infection, to identify those who require urgent pre-exposure prophylaxis (PrEP) prescription. Methods All participants enrolled in the placebo arm of the ANRS IPERGAY trial, or infected between screening and day 0, were included. Baseline characteristics were described and HIV incidence rate ratios (RRs) were estimated with their 95% CIs. Results 203 MSM were included with a median follow-up of 9 months. During the study period, 16 participants acquired HIV infection while not receiving tenofovir disoproxil and emtricitabin (TDF/FTC) over 212.4 person-years (PYs) of follow-up (incidence rate 7.5/100 PYs, 95% CI: 4.3 to 12.2). Being enrolled in Paris was associated with a significant increased risk of HIV infection (RR: 4.1; 95% CI: 1.1 to 28.3). A high number of sexual partners in prior 2 months (≥10 vs 5 vs <5) were strong predictors for HIV acquisition (RR: 10.6 (2 to 260.2) and 3.3 (1.2 to 10.2), respectively). Those who reported more often or only receptive sexual practices were also at increased risk (RR: 9.8 (2.0 to 246.6)). The use of recreational drugs in prior 12 months, especially gamma hydroxybutarate/gamma butyrolactone (RR: 5.9; 95% CI: 2 to 21.7), was associated with a significantly increased risk of HIV acquisition even after adjustment for sexual practices. Conclusions MSM who have frequent condomless receptive anal sex and multiple partners, or use recreational drugs should be targeted in priority for PrEP prescription especially if they live in an area with a high prevalence of HIV infection

Effect of On-Demand Oral Pre-exposure Prophylaxis With Tenofovir/Emtricitabine on Herpes Simplex Virus-1/2 Incidence Among Men Who Have Sex With Men: A Substudy of the ANRS IPERGAY Trial

International audienceWe evaluated the impact of on-demand oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for pre-exposure prophylaxis (PrEP) on herpes simplex virus (HSV)-1/2 incidence among men who have sex with men (MSM) enrolled in the ANRS IPERGAY trial. Serum samples were tested at baseline and at the last visit for HSV-1/2 antibodies. Overall HSV-1 incidence was 11.7 per 100 person-years; 16.2 and 7.8 per 100 person-years in the TDF/FTC and placebo arm, respectively (P = .19). Overall HSV-2 incidence was 7.6 per 100 person-years; 8.1 and 7.0 per 100 person-years in the TDF/FTC and placebo arm, respectively (P = .75). On-demand oral PrEP with TDF/FTC failed to reduce HSV-1/2 incidence in this population

High Concentration of Raltegravir in Semen of HIV-Infected Men: Results from a Substudy of the EASIER-ANRS 138 Trial ▿

Raltegravir concentrations and human immunodeficiency virus type 1 (HIV-1) RNA levels in semen samples from 10 treatment-experienced HIV-1-infected patients were measured after 24 weeks of raltegravir-based highly active antiretroviral therapy (HAART). Semen and plasma HIV-1 RNA levels were below 100 copies/ml and 50 copies/ml, respectively, in all samples. The median raltegravir concentrations in semen samples (n = 10) and in plasma samples (n = 9) drawn simultaneously were 345 (range, 83 to 707) ng/ml and 206 (range, 106 to 986) ng/ml, respectively. The median semen-to-plasma ratio of raltegravir concentration was 1.42 (range, 0.52 to 6.66), indicating good although variable levels of drug penetration of raltegravir in the seminal compartment