Impact of archived M184V/I mutation on the effectiveness of switch to co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide among virally suppressed people living with HIV
Authors: Chen Guan-Jhou , Lee Yu-Lin , Lee Chen-Hsiang , Sun Hsin-Yun , Cheng Chien-Yu , Tsai Hung-Chin , Huang Sung-Hsi , Lee Yi-Chieh , Hsieh Min-Han , Chang Sui-Yuan , Chuang Yu-Chung , Su Li-Shin , Chang Sui-Fang , Tang Hung-Jen , Hung Chien-Ching ,   the Taiwan HIV Study Group, Sun Hsin-Yun , Huang Yu-Shan , Chang Sui-Yuan , Wu Pei-Ying , Chen Ling-Ya , Zhang Jun-Yu , Chang Hsi-Yen , Liu Wen-Chun , Su Yi-Ching , Hung Chien-Ching , Wang Ning-Chi , Lin Te-Yu , Lin Kuan-Yin , Yang Chia-Jui , Tsai Mao-Song , Lee Yi-Chieh , Cheng Chien-Yu , Cheng Shu-Hsing , Huang Yi-Chia , Huang Sung-Hsi , Lee Yuan-Ti , Lin Jia-Juen , Lin Shih-Ping , Hsieh Chia-Yin , Wang Hsiu-Wen , Ho Mao-Wang , Liu Chung-Eng , Lee Yu-Lin , Chen Guan-Jhou , Lin Chi-Ying , Hung Tung-Che , Tang Hung-Jen , Ku Huei-Chun , Li Chia-Wen , Lee Nan-Yao , Ko Wen-Chien , Lu Po-Liang , Chen Yen-Hsu , Lee Chen-Hsiang , Tsai Hung-Chin , Chen Tun-Chieh , Sun Hsin-Yun , Huang Yu-Shan , Chang Sui-Yuan , Wu Pei-Ying , Chen Ling-Ya , Zhang Jun-Yu , Chang Hsi-Yen , Liu Wen-Chun , Su Yi-Ching , Hung Chien-Ching , Wang Ning-Chi , Lin Te-Yu , Lin Kuan-Yin , Yang Chia-Jui , Tsai Mao-Song , Lee Yi-Chieh , Cheng Chien-Yu , Cheng Shu-Hsing , Huang Yi-Chia , Huang Sung-Hsi , Lee Yuan-Ti , Lin Jia-Juen , Lin Shih-Ping , Hsieh Chia-Yin , Wang Hsiu-Wen , Ho Mao-Wang , Liu Chung-Eng , Lee Yu-Lin , Chen Guan-Jhou , Lin Chi-Ying , Hung Tung-Che , Tang Hung-Jen , Ku Huei-Chun , Li Chia-Wen , Lee Nan-Yao , Ko Wen-Chien , Lu Po-Liang , Chen Yen-Hsu , Lee Chen-Hsiang , Tsai Hung-Chin , Chen Tun-Chieh 
Published: June 2020

Abstract

Objectives
Real-world experience regarding the effectiveness of co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (EVG/C/FTC/TAF) as a switch regimen is sparse among people living with HIV (PLWH) harbouring the M184V/I mutation with or without thymidine analogue-associated mutations (TAMs).

Methods
In this retrospective multicentre study, PLWH who were switched to EVG/C/FTC/TAF after having achieved viral suppression (plasma HIV RNA &lt;200 copies/mL) for 6 months or longer were included. Patients with archived M184V/I mutation (case patients) were matched to controls without M184V/I mutation at a 1:4 ratio. Patients with a history of virological failure or resistance to elvitegravir were excluded. The primary endpoint was virological non-success (plasma HIV RNA ≥50 copies/mL) at Week 48 of switch using a modified FDA snapshot analysis.

Results
Overall, 100 case patients with the M184V/I mutation were identified, including 6 (6.0%) with K65R and 13 (13.0%) with at least one TAM, and were matched to 400 controls in terms of gender, age (mean = 40.3 versus 39.7 years) and cumulative exposure duration to tenofovir disoproxil fumarate (median = 146 versus 143 weeks). At Week 48, the rate of virological non-success for the case patients and controls was 5.0% (5/100) and 3.3% (13/400), respectively (difference = 1.7%; 95% CI = −2.9%–6.3%), while the rate of virological success was 88.0% and 89.5% for the case patients and controls, respectively. The presence of the K65R mutation or TAMs was not associated with virological non-response.

Conclusions
Among virally suppressed PLWH, EVG/C/FTC/TAF is effective in maintaining viral suppression at Week 48 despite archived M184V/I mutation with or without TAMs.