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Uptake and Effectiveness of Two-drug Compared to Three-drug
Antiretroviral Regimens among HIV-positive Individuals in Europe
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IAC: Non-Inferior Efficacy of Dolutegravir (DTG) Plus Lamivudine (3TC) vs DTG Plus Tenofovir/Emtricitabine (TDF/FTC) Fixed-Dose Combination in Antiretroviral Treatment-Naive Adults With HIV-1 Infection-Week 48 Results From the GEMINI Studies - (07/25/18)
Viral load and CD4 responses similar with 2 or 3 ARVs in big European cohort
22nd International AIDS Conference, Amsterdam, Netherlands, July 23-27, 2018
Mark Mascolini
People in the EuroSIDA cohort who started a 2-drug antiretroviral (ARV) regimen had 6- and 12-month virologic and CD4 responses similar to people who started 3 antiretrovirals [1]. A higher proportion of people starting 2 versus 3 antiretrovirals began treatment with an undetectable viral load, and the 2-drug group had more comorbidities.
Several clinical trials show similar virologic response rates with 2- and 3-drug antiretroviral combinations, including the 1433-person GEMINI studies presented at AIDS 2018 and reported separately by NATAP [2]. Because little is known about response to 2-drug regimens in clinical practice, a EuroSIDA team undertook this analysis.
EuroSIDA researchers combed their database to find people who started a 2-drug combo including boosted darunavir or lopinavir, raltegravir, dolutegravir, rilpivirine, or etravirine and people who started a 3-drug medley including one of those antiretrovirals plus two nucleosides between July 2010 and December 2016. They defined treatment failure as (1) a viral load at or above 400 copies, (2) no viral load 6 or 12 months after starting their regimen, (3) a regimen change, or (4) AIDS or death. They defined immunologic response as a 100-cell or 25% CD4 gain at 12 months.
The study group consisted of 423 people who started 2 antiretrovirals and 4347 who started 3. Thus the 2-drug group made up 9% of the whole study population. Compared with people starting 3 drugs, those starting 2 were older (median 52.1 vs 46.4 years, P < 0.0001), had a higher CD4 count (552 vs 536, P = 0.032), had a higher proportion with a viral load below 400 copies (87% vs 74%, P < 0.0001), and had more antiretroviral experience (17.0 vs 11.5 years, P < 0.0001). People starting 2 antiretrovirals had significantly higher rates of prior AIDS, hypertension, abnormal lipids, diabetes, cardiovascular disease, non-AIDS cancer, and chronic kidney disease but a significantly lower prevalence of HCV infection.
Only 8 of 423 people (2%) took 2 antiretrovirals as their first regimen, and 87% switched to 2 drugs with an undetectable viral load. In comparison, 13% of the 3-drug group started their combination as a first regimen and 73% switched from another regimen with an undetectable load.
More than 93% of people with data available had a viral load below 400 copies after 6 or 12 months of therapy, with little difference between the 2- and 3-drug groups. CD4 gains through 6 and 12 months were virtually identical with 2 or 3 antiretrovirals.
Logistic regression modeling adjusted for age group, gender, race, baseline CD4 count and viral load, and other variables discerned no difference between 2- and 3-drug regimens in odds of virologic or CD4 response at 6 or 12 months.
The EuroSIDA team concluded that "virologic and immunologic outcomes were in line with results from clinical trials and suggest immunologic and virologic responses to 2-drug regimens were similar to 3-drug regimens." They cautioned that their analysis cannot exclude confounding by indication, which is this study might favor 2-drug regimens in people with better controlled HIV infection.
References
1. Pelchen-Matthews A, Neesgaard B, on behalf of the EuroSIDA Study in RESPOND. Uptake and effectiveness of two-drug compared to three-drug antiretroviral regimens among HIV-positive individuals in Europe. AIDS 2018: 22nd International AIDS Conference, Amsterdam, Netherlands, July 23-27, 2018. Abstract THPEB052.
2. Cahn P, Madero JS, Arribas J, et al. Non-inferior efficacy of dolutegravir (DTG) plus lamivudine (3TC) versus DTG plus tenofovir/emtricitabine (TDF/FTC) fixed-dose combination in antiretroviral treatment-naive adults with HIV-1 infection: 48-week results from the GEMINI studies. AIDS 2018: 22nd International AIDS Conference, Amsterdam, Netherlands, July 23-27, 2018. Abstract TUAB0106LB.
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Uptake and Effectiveness of Two-drug Compared to Three-drug Antiretroviral Regimens among HIV-positive Individuals in Europe
A Pelchen-Matthews1, B Neesgaard2, L Peters2, A Roen1, V Svedhem-Johansson3, A Clarke4, T Benfield5, V M Mitsura6, S Moreno7, M Beniowski8, J Begovac9, R Matulionyte10, T Trofimora11,
E Florence12, D Elbirt13, M Kundro14, V Vullo15, G Behrens16, T Staub17, L Ragone18, V Vannappagari18, J Lundgren2and A Mocroft1on behalf of the EuroSIDAstudy in RESPOND1University College London, UK; 2CHIP, University of Copenhagen, Denmark; 3Karolinska University Hospital, Sweden; 4Royal Sussex County Hospital, Brighton, UK; 5Hvidovre UniversitetsHospital, Copenhagen, Denmark; 6Gomel State Medical University, Belarus; 7Hospital Ramon y Cajal, Madrid, Spain; 8Szpital Specjalistyczny, ChorzówPoland, 9University Hospital of Infectious Diseases, Zagreb, Croatia; 10Vilnius University Hospital SantarosKlinikos, Lithuania; 11Novgorod Centre for AIDS Prevention and Control, Russia; 12Institute of Tropical Medicine, Antwerp, Belgium; 13Kaplan Medical Center, Rehovot, Israel; 14Hospital JM Ramos Mejia, Buenos Aires, Argentina;
15Poloclinico Umberto 1, Rome, Italy; 16Medizinische Hochschule Hannover, Germany; 17Centre Hospitalierde Luxembourg; 18ViiV Healthcare, RTP, North Carolina, USA.
The EuroSIDAStudy Group: https://chip.dk/Studies/EuroSIDA
Funding: EuroSIDAwas supported by the European Union's Seventh Framework Programme for research, technological development and demonstration under EuroCoordgrant agreement n˚ 260694. Current support includes unrestricted grants by ViiVHealthcare LLC, GlaxoSmithKline R&D Limited, Janssen Scientific Affairs, Janssen R&D, Bristol-Myers Squibb Company, Merck Sharp& Dohme Corp, and Gilead Sciences. The participation of centres from Switzerland was supported by The Swiss National Science Foundation (Grant 148522). The study is also supported by a grant [grant number DNRF126] from the Danish National Research Foundation and by the International Cohort Consortium of Infectious Disease (RESPOND).
This analysis was funded by ViiVHealthcare who did not influence the analyses presented or the decision to publish study findings.
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