Durability of First-Line Antiretroviral Regimens in the era of Integrase Inhibitors: A Cohort of HIV-Positive Individuals in Spain, 2014–2015

Abstract

Background: We compared time to treatment change (TC), viral suppression (VS) and change in CD4 + T-cell counts of first-line antiretroviral regimens (ART). Methods: We analysed HIV treatment-naive adults from the Cohort of the Spanish HIV/AIDS Research Network (CoRIS) initiating the most commonly used ART regimens from September 2014 to November 2015. We used proportional hazards models on the sub-distribution hazard to estimate sub-distribution hazard ratios (sHR) for time to TC, logistic regression to estimate odds ratios (ORs) for VS (viral load <50 copies/ml), and linear regression to assess mean differences in CD4 + T-cell changes from ART initiation. Results: Among 960 individuals, tenofovir (TDF)/emtricitabine (FTC)/rilpivirine (RPV) was the most frequently prescribed regimen (24.2%), followed by elvitegravir (EVG)/cobicistat (COBI)/TDF/FTC (22.8%), abacavir (ABC)/lamivudine (3TC)/dolutegavir (DTG; 17.4%), TDF/ FTC+darunavir/ritonavir (DRV/r) or darunavir/cobicistat (DRV/c; 12.1%), TDF/FTC/efavirenz (EFV; 8.8%), TDF/ FTC+raltegravir (RAL; 7.7%) and TDF/FTC+DTG (7.0%). Initiating ART with TDF/FTC+DRV/r or DRV/c (adjusted sHR: 2.96; 95% CI: 1.44, 6.08), TDF/FTC/EFV (2.18; 0.98, 4.82), TDF/FTC+RAL (2.37; 1.08, 5.22) and TDF/FTC+DTG (6.34; 3.18, 12.64) was associated with a higher risk of TC compared to ABC/3TC/DTG. At 24 weeks, VS was lower in TDF/FTC+DRV/r or DRV/c (adjusted OR: 0.37, 95% CI: 0.18, 0.74) compared with ABC/3TC/DTG, and CD4 + T-cell increase was lower in patients initiating with TDF/FTC/RPV (adjusted mean difference: -75.9, 95% CI: -130.6, -21.2) compared with those who did with ABC/3TC/DTG. Conclusions: Time to TC, VS and change in CD4 + T-cell counts varies by initial regimen. These differences may be useful for making decision when initiating ART.

Effectiveness, Safety, and Costs of Dolutegravir/Abacavir/Lamivudine Single-Tablet Regimen in a Real-Life Cohort of HIV-1 Adult Infected Patients

“…The frequency of AEs identified in our study was high (42.2%), with an incidence of interruptions for this reason of 8.7% at W48 (13.6% and 7.6% in ART-naive and TE patients, respectively). Our rates of AEs leading to DTG/ABC/3TC discontinuation were higher than those reported in clinical trials with DTG 1-6 (which ranged between 2.0% and 4.0% within the first year), but also in the CoRIS 15 and ICONA 17 cohorts, which reported an incidence of 3.6 and 3.9%, respectively. In contrast, the rate reported in the TRIUMPH Cohort 16 was closer to ours, with an incidence of interruptions caused by AEs of 6.9%.…”

“…Our virological suppression rate was also lower compared with the rate of 87% found in the Spanish CoRIS cohort for DTG/ABC/3TC at W24. 15 In contrast, the German TRIUMPH Cohort reported a virological suppression rate with DTG/ABC/3TC more similar to ours (78% by mITT), although in this case, the follow-up period was up to 30 months. 16 In the subgroup of TE patients, the virological suppression rate was significantly higher (86% by ITT analysis).…”

“…In contrast, this rate was significantly higher in 2 cohorts 7,8 (8.3% and 9.9%) and lower in the other 2, with only 0.6% and 0.7% of the patients having to stop DTG because of NP-AEs. 15,26…”

“…In contrast, this rate was significantly higher in 2 cohorts 7,8 (8.3% and 9.9%) and lower in the other 2, with only 0.6% and 0.7% of the patients having to stop DTG because of NP-AEs. 15,26 Some important open questions remain unaddressed concerning the causes of neurological toxicity associated with DTG. In addition to concomitant treatment with ABC, a possible association between NP-AEs and age more than 60 years and female sex has been described in some reallife cohorts.…”

Effectiveness and Safety of Antiretroviral Treatment in Pre- and Postmenopausal Women Living with HIV in a Multicentre Cohort

“…In our study, most of the women who changed their initial ART regimens did so because of adverse effects. This could be partly due to the high proportion of women receiving TDF/FTC/EFV, which was found to be the most frequently discontinued regimen in a previous study in the CoRIS cohort, mainly because of side effects [18]. The reasons for treatment change in our study were similar for pre- and postmenopausal women, and changes were due to virological failure only in a minority of women in both groups.…”