countries the greatest negative impact on QoL was the stigma asso-ciated with HIV.
Abstract P066 – Figure 1. Comparison of UK and US individual domain item mean weighted impact scores (HIVDQoL).
Conclusion: The HIVDQoL shows worse generic QoL and greater negative impact of HIV on the QoL of UK participants versus US par-ticipants and highlights potential concerns about the impact on women. The HIVDQoL reveals specific areas of life most negatively impacted by HIV, highlighting how efforts may be prioritised to meet the greatest challenges for individuals and populations with HIV.
References
[1] Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The devel-opment of an individualized questionnaire measure of perceived impact of dia-betes on quality of life: the ADDQoL. Qual Life Res. 1999;8:79-91.
[2] Wee HL, Tan CE, Goh SY, Li SC. Usefulness of the Audit of Diabetes-Depen-dant Quality of Life (ADDQoL) questionnaire in patients with diabetes in a mul-ti-ethnic Asian country. Pharmacoecon. 2006;24:673-82.
P067
Viral load suppression rates among HIV-infected adult
patients using optimised health care worker delivery model
in Western Nigeria
S Usman
Laboratory Services, APIN Public Health Initiatives, Abuja, Nigeria
Background: In sub-Saharan Africa where genotypic drug resistance testing is rarely performed and poor adherence is blamed for the inability to achieve viral suppression and treatment failure, program-matic approaches to preventing and handling these are thus essential. Hypothesis tested was antiretroviral therapy adherence effect on viral load outcome. This study was aimed at determining and monitoring HIV/AIDS disease progression using viral load to provide prognostic information and evaluate patients for viral suppression using the World Health Organization guideline strategies.
Materials and methods: This study was an observational, longitudinal, prospective cohort study of subjects living with HIV already initiated on antiretroviral therapy for at least 6 months, enrolled in health facilities across Ekiti State, Western Nigeria, during a 12-month observation per-iod starting October 2016 till September 2017. Quantitative viral load analysis was done using polymerase chain reaction, Roche COBAS Taq-Man 96 Analyzer. All data were statistically analysed, using SPSS Statis-tics, with multiple comparisons done using post hoc Bonferroni test. Results: A total of 3920 (1005 males and 2915 females) subjects eli-gible for the study were recruited. Most of them are in the age range of 25 to 54 years, with a mean age of 39.35 10.41 years. Three thousand and eighty-six (78.7%) and 2363 (60.3%) of the subjects had viral suppression of<1000 RNA copies/mL and <50 RNA copies/mL, respectively. The 834 subjects went through intensive adherence counselling optimised health care worker delivery model for 3 months and viral load test repeated 3 further months after, which made 3377 (86.1%) and 2578 (65.8%) of the subjects have<1000 RNA copies/ mL and<50 RNA copies/mL, respectively, during the period of obser-vation. ART adherence has significant effect on viral load outcome from the study hypothesis tested.
Conclusion: HIV treatment intensive adherence counselling is key to the achieving viral suppression and determine infection prognosis; thus, routine viral load monitoring will ultimately help in HIV/AIDS disease progression follow-up and reduce treatment failure tendencies. This will help more patients stay on first-line regimen and prolong their life expectancy, indicating that the UNAIDS last 90 target is achievable.
P068
Determinants of switching to two-drug combinations with
HIV-RNA
≤50 copies/mL in a cohort of HIV-infected
indi-viduals seen for care in Italy
A Cozzi-Lepri1; H Diaz-Cuervo2; N Gianotti3; G Lapadula4; A De Luca5; F Maggiolo6; S Rusconi7; N Bobbio8; V Esposito9; M Moioli10; G Madeddu11; A Antinori12; A d’Arminio Monforte13; on behalf of Icona Foundation Study Group
1Institute for Global Health, University College London, London, UK. 2Health Outcomes Research, Gilead Sciences UK, London, UK.3
Infec-tious Diseases, San Raffaele Hospital, Milano, Italy.4Infectious Dis-eases, AO San Gerardo, Monza, Italy.5Infectious Diseases, University of Siena, Siena, Italy.6Infectious Diseases, AO Papa Giovanni XXIII, Bergamo, Italy.7Infectious Diseases, Sacco Hospital, Milano, Italy.
8
Infectious Diseases, Ospedali Galliera, Genova, Italy.9Infectious Dis-eases, AORN Ospedali dei Colli, Napoli, Italy.10Infectious Diseases, Niguarda Hospital, Milano, Italy.11Infectious Diseases, Sassari Univer-sity, Sassari, Italy.12Infectious Diseases, INMI Spallanzani, Roma, Italy.
13
Infectious Diseases, San Paolo Hospital, Milano, Italy
Background: Although some two-drug combinations (2DC) are now recommended as alternative in guidelines for use in specific contexts, there is little data documenting how frequently and in which patients these regimens are used in clinical practice.
Methods: The study includes data of HIV patients in the Icona Foun-dation Study cohort with a therapy switch with viral load (VL) ≤50 copies/mL to either triple therapy (TT) or 2DC (first switch after achieving VL≤50 copies/mL considered baseline) over January 2004– June 2018. 2DC were grouped as DTG-based (3TC+DTG or RPV+DTG), PI-based (3TC+DRV+r or cobi, 3TC+LPV+r and 3TC+ATVr) and other 2DC. Chi-square test was used to compare categorical factors and Kruskal-Wallis test to compare medians. Unad-justed percentages in CD4 and eGFR groups were calculated for each treatment group. Multinomial logistic regression was used to identify factors associated with the probability of switching to DTG- and PI-2DC versus TT. For factors with global p≤ 0.5 specific contrasts (DTG-2DC vs. TT; PI-2DC vs. TT) were calculated.
Results: Four thousand one hundred and ninety-eight switches were included. Median age of patients was 44 years, baseline CD4 571 cells/mm3, 22% female, 13% of non-Italian origins. 4.6% switched to
DTG-2DC (3.3% 3TC+DTG, 1.2% RPV+DTG), 7% to PI-2DC (3.0% 3TC+DRV+r or cobi, 0.4% 3TC+LPV+r, 3.3% 3TC+ATVr), 8% to other 2DC and 81% to TT. In the unadjusted analysis, compared to patients switched to TT (6% with CD4 at switch 0 to 200; 13% 200 to 350; 81%>350 cells/mm3), those on DTG-2DC (3%, 6% and 91%, respectively) and PI-2DC (1%, 9% and 90%, respectively) were switched with higher CD4 (p< 0.001) and lower eGFR (3% eGFR <60; 32% 60 to 90; 65% >90 min/mL/1.73 m2
in TT vs. 15%, 47% and 38% in DTG-2DC; 10%, 47% and 43% in PI-2DC; p< 0.001). In the adjusted analysis (Table 1), compared to TT switches to 2DC occurred more frequently in recent years, in older participants and in those with less history of virological failure; participants switched to PI-2DC showed higher CD4 and lower eGFR; DTG-2DC occurred more commonly in people without hypertension.
Conclusions: Although switches to 2DC occurred more frequently in recent years, over 80% of suppressed patients switched to TT. Patients appeared to be selected to 2DC based on older age and less previous failure. Selection to specific 2DC groups is also based on Abstract Supplement HIV Glasgow 2018
Journal of the International AIDS Society 2018, 21(S8):e25187
specific comorbidity profile, while changes to PI-2DC are more fre-quent in patients with higher CD4. Further research is necessary to assess the clinical outcomes of these strategies.
P069
Effectiveness, persistence and safety of E/C/F/TAF, F/
TAF
+3rd agent or R/F/TAF in treatment-experienced HIV-1
infected patients: 12-month results from the German
TAFNES cohort study
H Hillenbrand1; H Knechten2; T Kuemmerle3; S Scholten4;
N Schuebel5; R Haubrich6; M Heinzkill7; K Goerner7and H Stellbrink8
1Clinical Care, MVZ Praxis City Ost, Berlin, Germany.2Clinical Care,
Praxis Dr. Knechten, Aachen, Germany.3Clinical Care, Praxis am
Ebertplatz, Cologne, Germany.4Praxis Hohenstaufenring, Cologne,
Germany.5Clinical Care, Klinikum Osnabr€uck, Osnabr€uck, Germany. 6Clinical Science, Gilead Sciences, Foster City, CA, USA.7Clinical
Science, Gilead Sciences, Munich, Germany.8Clinical Care, ICH Study
Center, Hamburg, Germany
Background: Successful ART has converted HIV infection into chronic disease. Minimising side effects and optimising long-term tolerability
of ART are essential requirements for achieving durable healthy age-ing. In clinical trials, tenofovir alafenamide (TAF) showed comparable effectiveness and less off-target effects on renal and bone markers than tenofovir disoproxil fumarate (TDF). The 24-month prospective TAFNES cohort study was initiated to provide real-world data and evaluate the effectiveness and safety of TAF-based regimens when used in routine clinical care.
Methods: Evaluation of Month-12 (M12) outcomes in treatment-experienced adults of the TAFNES cohort who were switched to either E/C/F/TAF, F/TAF+3rd agent or R/F/TAF at least 9 months prior to data-cut (May 2018). Outcome measures included ART persistence, virological effectiveness (HIV-RNA< 50 copies/mL, modified ITT analy-ses [mITT], discontinuation= failure, loss-to-follow-up/missing = ex-cluded), serious/non-serious adverse drug reactions (SADRs/ADRs) and health-related quality of life (HRQoL) using validated questionnaires (SF-36, HIV Symptom Index [HIV-SI], treatment satisfaction [TS]). Results: Four hundred and thirty-four patients (90.6% men, median age 51 years) were eligible for analysis, 154 patients switched to E/C/ F/TAF, 146 to F/TAF+3rd agent (30% dolutegravir, 16% nevirapine, 13% raltegravir, 11% darunavir/ritonavir) and 134 to R/F/TAF. Baseline characteristics and previous antiretroviral regimens are shown in Table 1; 95.3% were on suppressive ART prior to switch, 92.6% were switched from TDF-based ART. Reasons for switch (multiple responses allowed) to F/TAF-based ART were simplification (n= 127, 29.3%), patient wish (n= 138, 31.8%), side effects on previous ART (n = 185, 42.6%) and other (n= 77, 17.7%; including aiming at minimising long-term toxicity (n= 55, 12.7%)). ART persistence did not differ signifi-cantly between groups (Figure 1); 8.1% (n= 35/434) discontinued from the study before M12 visit, after a median time of 26 weeks (in-cluding discontinuation of F/TAF-based regimens due to ADRs (2.1%), virological failure (0.7%), death (0.5%), patient decision (1.4%) or other reasons (2.1%), and loss-to-follow-up (1.4%)). At M12 visit, 89.9% (n= 372/414) had HIV-RNA levels <50 copies/mL (mITT), i.e. 94.4% of patients treated with E/C/F/TAF (n= 134/142), 86.6% of patients on F/TAF+ 3rd agent (n = 123/142) and 88.5% of patients on R/F/TAF (n= 115/130). By M12, 16 ADRs (in 2.8% of patients (N = 12) and seven SADRs (in 0.9% of patients (N= 4)) were documented. SF-36 and HIV-SI scores remained stable, TS increased significantly.
Conclusion: F/TAF-based regimens showed good persistence in this observational cohort of adult treatment-experienced patients with low discontinuation rates due to ADRs (2%) or virological failure (<1%). Significant improvements in treatment satisfaction demonstrate a high degree of patient acceptability of using F/TAF as part of single-or multi-tablet regimens.
Abstract P068– Table 1. Adjusteda odds ratio (aOR) of switching
to 2DC versus TT from fitting a multinomial multivariable logistic regression
Factors DTG-basedb PI-basedc
Global p valued
Age 0.003
Per 10 years older 1.21 (0.75 to 1.95) 1.20 (1.03 to 1.39) p valuee 0.004 0.02 CD4 count cells/mm3 0.002 201 to 350 0.70 (0.35 to 1.42) 0.60 (0.37 to 0.98) 0 to 200 vs. 350+ 0.85 (0.30 to 2.37) 0.26 (0.09 to 0.76) p valuee 0.99 0.02 Year of switch <0.001
Per more recent 1.95 (1.72 to 2.22) 1.14 (1.09 to 1.19) p valuee <0.001 <0.001 Number of ARVs previously failed <0.001 Per 3 additional 0.67 (0.57 to 0.79) 0.71 (0.63 to 0.80) p valuee <0.001 <0.001 Hypertension 0.01 Yes vs. no 0.56 (0.39 to 0.81) 0.90 (0.67 to 1.21) p valuee 0.002 0.5 eGFR (CKD-EPI) 0.001 Per 10 mL/min/1.73 m2 lower 1.08 (0.96 to 1.21) 1.14 (1.04 to 1.25) p valuee 0.18 0.007 a
adjusted for gender, mode of HIV transmission, origin, HBV-status, HCV-status, smoking, duration of exposure to ART, AIDS diagnosis, diabetes and cardiovascular disease.
b3TC-DTG or RPV-DTG. c3TC-DRV
+r or cobi or 3TC-LPV+r or 3TC-ATVr.
dglobal chi-square for the association of factors with one of the switch
strategies (triple therapy as the comparator).
econtrasts chi-square p values.
Abstract P069– Figure 1. Kaplan-Meier analyses: time on study drug. Abstract Supplement HIV Glasgow 2018
Journal of the International AIDS Society 2018, 21(S8):e25187
