CROI 2016 Abstract eBook

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Poster Abstracts

Results: BL pVL (Mean+SD) was 4.43 (0.50), 4.30 (0.45) and 4.31 (0.52) for PADDLE, SINGLE and SPRING-1 respectively. Rapid decline in viral load was observed in the three regimens. Two-way ANOVA revealed significant effects for treatment (F 2,1605 =30.3 p<0.001) and time (F 4,1605 =22.8 p<0.001), without significant interactions. Average effects of treatment in PADDLE, SPRING-1 and SINGLE were -2.75±0.45 (Mean ±SD), -2.53±0.49 and -2.61±0.48 log 10 respectively. Significant differences were observed between PADDLE and SPRING-1 or SINGLE studies (p<0.01 and p<0.05). The figure shows the viral load change at each time point in the studies (Mean ± Standard error of the mean) Conclusions: Viral load change was of similar magnitude after a dual therapy regimen DTG/3TC compared to 2 DTG-based triple therapy regimens. These results, albeit encouraging, should be interpreted with caution, as the analysis is based on a cross-study comparison of mean values and PADDLE is a small pilot study. Full powered, randomized studies are in progress to evaluate DTG/3TC as a valid option for first line therapy.

948

Unexpectedly High Rate of Intolerance for Dolutegravir in Real-Life Setting Guido van den Berk; Josephine Oryszczyn;Willem Blok; Narda van der Meche; Rosa Regez; Daoud Ait Moha; Kees Brinkman OLVG Hosp, Amsterdam, Netherlands

Background: Integrase inhibitors are now preferred antiretrovirals in first line cART. Dolutegravir (DGV) is possibly considered as one of the most efficacious, convenient and tolerated INSTI, with hardly any chance for drug-drug interactions. Since we encountered many patients who stopped DGV because of intolerance, we analyzed the experience with DGV in our whole patient population since licensing in the Netherlands. Methods: In our hospital cohort we retrospectively analyzed all patients who started DGV, either as initial therapy or after switching from other antiretrovirals for any reason. Baseline characteristics at the moment of DGV start were recorded. We calculated the proportion of patients who stopped DGV, analyzed the reason for interruption and evaluated potential risk factors. We used the Chi-squared test to check for significant differences between groups. Results: In our cohort of almost 3000 hiv infected patients (97,6% on cART), 388 patients started DGV from August 2014 for a median period of 219 days (range 5-376) and at a median age of 48 years (range 23-77); 46 were female. In total 65 started as naieves (median CD4 495/mm3 (range 70-1610). One patient died from progressive prostate carcinoma and was excluded form the analysis. DGV treatment was stopped in 62/387 (16,0%) patients after a median of 78 days (range 5-327). Of the naieves 9/65 (13,8%) stopped DGV compared to 53/322 (16,4%) of non- naieves (p=ns). Of the women 5/46 (10,9%) stopped, compared to 57/341 men (16,7%) (p=ns). Of those who used DGV-only tablets 24/158 (15,6%) stopped, compared to 38/230 (16,5%) using combination-tablet (with ABC/3TC) (p=ns). Main reason for DGV interruption was intolerance in 55/62 (88,7%) patients: 19/55 (34,5%) sleeping problems, 18/55 (32,7%) gastrointestinal problems, 12/55 (21,8%) psychiatric problems, 7/55(12,7%) headache, 6/55 (10,9%) musculoskeletal problems and 6/55 (10,9%). Some patients reported more than one toxicity. There were no virological failures. Conclusions: In a real life setting a substantial proportion of patients (16%) unexpectedly interrupted DGV treatment for reasons of intolerance, in particular sleeping-, gastrointestinal- and psychiatric problems. This was much higher than reported in clinical trials, where discontinuation of DGV due to adverse reactions is reported to be less than 3%. 949 Association of Antiretroviral Use and Abnormal Uterine Bleeding inWomenWith HIV Christina Valiaveettil 1 ; Sheila Caddy 2 ; MarkYudin 3 ; Anita Benoit 4 ; Erin Ding 5 ; Angela Kaida 6 ; Alexandra de Pokomandy 7 ; Robert S. Hogg 6 ; Mona Loutfy 4 1 Univ of Toronto, Toronto, ON, Canada; 2 South Hlth Campus, Calgary, AB, Canada; 3 St Michael’s Hosp, Toronto, ON, Canada; 4 Women’s Coll Rsr Inst, Univ of Toronto, Toronto, ON, Canada; 5 British Columbia Cntr for Excellence in HIV/AIDS, Vancouver, BC, Canada; 6 Simon Fraser Univ, Burnaby, BC, Canada; 7 McGill Univ Hlth Cntr, Montréal, QC, Canada Background: Abnormal uterine bleeding is thought to be more common in women with HIV. Menstrual irregularity is a key health outcome that leads to anemia and poor quality of life. Factors associated with menstrual cycle disruption in HIV-positive women have not been well delineated. We measured the prevalence of abnormal uterine bleeding among women with HIV, and the association with current use of antiretroviral therapy (ART) and other covariates. Methods: We used cross-sectional questionnaire data from the Canadian HIV Women’s Sexual and Reproductive Health Cohort Study (CHIWOS) enrolling women with HIV (self-identified, aged>=16 years) from British Columbia, Ontario and Québec. Eligible participants for this analysis were aged 16 to 45 years, and responded to questions on menstruation and ART use. Participants were excluded if they reported: a history of gynecologic cancer; amenorrhea attributed to spontaneous, surgery-induced, chemotherapy or radiation therapy-related menopause; premature ovarian failure; current pregnancy or hormonal contraception at or within 6 months prior to interview. Our primary outcome was presence of abnormal uterine bleeding, which included amenorrhea, oligomenorrhea, and/or intermenstrual bleeding. Multivariable logistic regression analysis examined independent correlates of abnormal uterine bleeding, including current use of ART. Results: Of 1335 women enrolled in CHIWOS, 493 (37%) met the eligibility criteria. Overall, 71% reported abnormal uterine bleeding. In adjusted analyses, African, Caribbean and Black Canadian women and women who identify as “Other” or with multiple ethnicities had increased odds of abnormal uterine bleeding (AOR 5.82, 95%CI:2.99-11.30) compared to Caucasian women (and Indigenous women). Lower odds of abnormal uterine bleeding was found in women with no history of recreational drug use versus current users (AOR 0.06, 95%CI:0.02-0.15) as well as women who were treatment naïve (AOR 0.26, 95%CI:0.12-0.53) compared to women currently on ART. Conclusions: Abnormal uterine bleeding was commonly reported by women with HIV participating in CHIWOS (71%) as compared to rates in the general population (30%). Correlates of abnormal uterine bleeding included current ART use, reporting an ethnicity other than Caucasian or Indigenous and recreational drug use. The mechanisms for abnormal uterine bleeding with regards to the identified correlates warrants further research in order to identify solutions.

Poster Abstracts

402

CROI 2016