Later cART Initiation in Migrant Men from Sub-Saharan Africa without Advanced HIV Disease in France

International audienceObjectiveTo compare the time from entry into care for HIV infection until combination antiretroviral therapy (cART) initiation between migrants and non migrants in France, excluding late access to care.MethodsAntiretroviral-naïve HIV-1-infected individuals newly enrolled in the FHDH cohort between 2002–2010, with CD4 cell counts >200/μL and no previous or current AIDS events were included. In three baseline CD4 cell count strata (200–349, 350-499, ≥500/μL), we examined the crude time until cART initiation within three years after enrolment according to geographic origin, and multivariable hazard ratios according to geographic origin, gender and HIV-transmission group, with adjustment for baseline age, enrolment period, region of care, plasma viral load, and HBV/HBC coinfection.ResultsAmong 13338 individuals, 9605 (72.1%) were French natives (FRA), 2873 (21.4%) were migrants from sub-Saharan Africa/non-French West Indies (SSA/NFW), and 860 (6.5%) were migrants from other countries. Kaplan-Meier probabilities of cART initiation were significantly lower in SSA/NFW than in FRA individuals throughout the study period, regardless of the baseline CD4 stratum. After adjustment, the likelihood of cART initiation was respectively 15% (95%CI, 1–28) and 20% (95%CI, 2–38) lower in SSA/NFW men than in FRA men who had sex with men (MSM) in the 350-499 and ≥500 CD4 strata, while no difference was observed between other migrant groups and FRA MSM.ConclusionSSA/NFW migrant men living in France with CD4 >350/μL at entry into care are more likely to begin cART later than FRA MSM, despite free access to treatment. Administrative delays in obtaining healthcare coverage do not appear to be responsible

Treatment as prevention (TasP) and perceived sexual changes in behavior among HIV-positive persons: a French survey in infectious diseases departments in Paris

International audienceWe evaluated awareness of treatment as prevention (TasP) among adults people living with HIV (PLHIV) in five infectious disease departments in Paris, then how they perceived its impact on their sexual well-being. This cross-sectional multicenter survey was conducted in 2014 during scheduled clinical appointments using a self-administered questionnaire. We analyzed 520 questionnaires (42% women, 54% men of whom 57% were MSM [men who have sex with men]). 75% of women were born abroad, most commonly in sub-Saharan Africa, whereas 64% of men were French-born. The mean time since HIV diagnosis was 12.8 ± 7.8 years. Eighty-seven percent [84-90%]95 % reported being aware of the impact of ART on HIV transmission, 94% MSM, 86% women, 83% heterosexual men. PLHIV reported that they gained awareness of TasP through medical doctors (86%). The fear of transmission was perceived as alleviated for 73% [69%;78%]95%, more often among MSM; the sexual life was reported to be improved for 28% [24%;33%]95%; and ART adherence to be improved for 45% [40%;50%]95%, more often among women. The awareness of TasP was relatively high, but it seems important to understand the features of male and female populations of PLHIV to adapt counseling during follow-up appointments, as women's answers differed in various regards

Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study

BACKGROUND: Dolutegravir has been shown to be non-inferior to an integrase inhibitor and superior to a non-nucleoside reverse transcriptase inhibitor (NNRTI). In FLAMINGO, we compared dolutegravir with darunavir plus ritonavir in individuals naive for antiretroviral therapy. METHODS: In this multicentre, open-label, phase 3b, non-inferiority study, HIV-1-infected antiretroviral therapy-naive adults with HIV-1 RNA concentration of 1000 copies per mL or more and no resistance at screening were randomly assigned (1:1) to receive either dolutegravir 50 mg once daily or darunavir 800 mg plus ritonavir 100 mg once daily, with investigator-selected tenofovir-emtricitabine or abacavir-lamivudine. Randomisation was stratified by screening HIV-1 RNA (≤100,000 or >100,000 copies per mL) and nucleoside reverse transcriptase inhibitor (NRTI) selection. The primary endpoint was the proportion of patients with HIV-1 RNA concentration lower than 50 copies per mL (Food and Drug Administration [FDA] snapshot algorithm) at week 48 with a 12% non-inferiority margin. This trial is registered with ClinicalTrials.gov, NCT01449929. FINDINGS: Recruitment began on Oct 31, 2011, and was completed on May 24, 2012, in 64 research centres in nine countries worldwide. Of 595 patients screened, 484 patients were included in the analysis (242 in each group). At week 48, 217 (90%) patients receiving dolutegravir and 200 (83%) patients receiving darunavir plus ritonavir had HIV-1 RNA of less than 50 copies per mL (adjusted difference 7·1%, 95% CI 0·9-13·2), non-inferiority and on pre-specified secondary analysis dolutegravir was superior (p=0·025). Confirmed virological failure occurred in two (<1%) patients in each group; we recorded no treatment-emergent resistance in either group. Discontinuation due to adverse events or stopping criteria was less frequent for dolutegravir (four [2%] patients) than for darunavir plus ritonavir (ten [4%] patients) and contributed to the difference in response rates. The most commonly reported (≥10%) adverse events were diarrhoea (dolutegravir 41 [17%] patients vs darunavir plus ritonavir 70 [29%] patients), nausea (39 [16%] vs 43 [18%]), and headache (37 [15%] vs 24 [10%]). Patients receiving dolutegravir had significantly fewer low-density lipoprotein values of grade 2 or higher (11 [2%] vs 36 [7%]; p=0·0001). INTERPRETATION: Once-daily dolutegravir was superior to once-daily darunavir plus ritonavir. Once-daily dolutegravir in combination with fixed-dose NRTIs represents an effective new treatment option for HIV-1-infected, treatment-naive patients. FUNDING: ViiV Healthcare and Shionogi & Co

Influence of geographic origin on AIDS and serious non-AIDS morbidity/mortality during cART among heterosexual HIV-infected men and women in France.

BACKGROUND:The influence of geographic origin on the risk of severe illness and death on cART has not been explored in European countries. METHOD:We studied antiretroviral-naïve heterosexual HIV-1-infected individuals enrolled in the FHDH-ANRS CO4 cohort in France who started cART between 2006 and 2011. Individuals originating from France (French natives), sub-Saharan Africa (SSA) and non-French West-Indies (NFW) were studied until 2012. Crude and adjusted rate ratios (aRR) of severe morbid events/deaths (AIDS-related and non-AIDS-related) were calculated using Poisson regression models stratified by sex, comparing each group of migrants to French natives. RESULTS:Among 2334 eligible men, 1379 (59.1%) originated from France, 838 (35.9%) from SSA and 117 (5.0%) from NFW. SSA male migrants had a higher aRR for non-AIDS infections, particularly bacterial infections (aRR 1.56 (95% CI 1.07-2.29), p = 0.0477), than French natives. Among 2596 eligible women, 1347 (51.9%) originated from France, 1131 (43.6%) from SSA, and 118 (4.5%) from NFW. SSA and NFW female migrants had a higher aRR for non-AIDS infections, particularly non-bacterial infections (respectively, 2.04 (1.18-3.53) and 7.87 (2.54-24.4), p = 0.0010), than French natives. We observed no other significant differences related to geographic origin as concerns the aRRs for AIDS-related infections or malignancies, or for other non-AIDS events/deaths such as cardiovascular disease, neurological/psychiatric disorders, non-AIDS malignancies and iatrogenic disorders, in either gender. CONCLUSION:Heterosexual migrants from SSA or NFW living in France have a higher risk of non-AIDS-defining infections than their French native counterparts. Special efforts are needed to prevent infectious diseases among HIV-infected migrants

First-line cART regimens started during follow-up, N = 8543.

<p>Data are counts (proportions).</p><p>^a Mainly PI/r + II or PI/r + NNRTI or 2 PIs/r.</p><p>^b Mainly PI/r monotherapy or 1 II + 1 PI/r or 1 PI/r + 1 NNRTI.</p><p>Abbreviations: FRA, French natives; SSA, sub-Saharan Africa; NFW, non-French West Indies; OTH, Other regions of the world; MSM, Men who have sex with men; cART, combination antiretroviral therapy; NRTI, Nucleoside Reverse Transcriptase Inhibitor; PI/r, ritonavir-boosted protease inhibitor; NNRTI, Non-nucleoside Reverse Transcriptase Inhibitor; II, Integrase inhibitor; PI, Protease Inhibitor.</p><p>First-line cART regimens started during follow-up, N = 8543.</p

Univariate and multivariate Hazard Ratios (HRs) for cART initiation according to geographic origin, gender and HIV transmission group in baseline CD4 cell count strata (Cox model).

<p>* HR adjusted for age at enrolment, enrolment period, region of care, pVL at enrolment, and hepatitis B antigen and hepatitis C antibody status; Abbreviations: cART, Combination antiretroviral therapy; FRA, French natives; SSA, sub-Saharan Africa; NFW, non-French West Indies; OTH, Other regions of the world; MSM, Men who have sex with men.</p

Individuals selection.

<p>Abbreviations: ADE, AIDS-defining event; cART, combination antiretroviral therapy; NRTI, Nucleoside Reverse Transcriptase Inhibitor.</p

Kaplan-Meier survival estimates of first-line cART initiation by geographic origin and CD4 cell counts [/μL] at enrolment.

<p>Abbreviations: cART, combination antiretroviral therapy; FRA, French natives; SSA, sub-Saharan Africa; NFW, non-French West Indies; OTH, Other regions of the world.</p

Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With HIV-1 Infection: ~5-Year Results From the LATTE-2 Study

Background. In the Long-Acting Antiretroviral Treatment Enabling Trial 2 (LATTE-2) phase 2b study, long-acting (LA) injectable cabotegravir + rilpivirine dosed every 8 weeks (Q8W) or every 4 weeks (Q4W) demonstrated comparable efficacy with daily oral antiretroviral therapy (ART) through 96 weeks in ART-naive adults with human immunodeficiency virus type 1 (HIV-1). Here we report efficacy, tolerability, and safety of cabotegravir + rilpivirine LA over approximately 5 years. Methods. After 20 weeks of oral cabotegravir + abacavir/lamivudine, participants were randomized to cabotegravir + rilpivirine LA Q8W or Q4W or continue oral ART through the 96-week maintenance period. In the extension period through week 256, participants continued their current LA regimen (randomized Q8W/Q4W groups) or switched from oral ART to Q8W or Q4W LA therapy (extension-switch groups). Endpoints assessed included proportion of participants with HIV-1 RNA 1 participant. Conclusions. Cabotegravir + rilpivirine LA exhibited long-term efficacy and tolerability, demonstrating its durability as maintenance therapy for HIV-1 infection