Table 1.
Baseline characteristics of people with HIV-1 using dolutegravir + lamivudine from cohort lead studies reporting outcomes in populations naive to antiretroviral therapy or with prior antiretroviral therapy experience with N ≥ 10 individuals.
| Cohort lead study | Country | Study type | People using DTG + 3TC | Inclusion criteria | VL ≥ 100,000 copies/mL, n (%) | CD4+ cell count <200 cells/mm3, n (%) | People with GRT, n (%) [RAMs] | Comorbidities in ≥ 10% of people using DTG + 3TC, n (%) |
|---|---|---|---|---|---|---|---|---|
| Naive to ART | ||||||||
| Wei et al[39] | China | Prospective | 200 | – | ≥30 (≥15)* | 67 (34) | 118 (59) | – |
| Long et al[43] | China | Prospective | 145 | – | 14 (10) | 70 (48) | – | AIDS-defining OIs: 48 (33) HTN: 34 (23) Diabetes: 15 (10) |
| Dou et al[26] | China | Prospective | 96 | 24-wk follow-up after initiating DTG + 3TC | 42 (44) | 51 (53) | – | OI: 36 (38) |
| Inan et al[60] | Türkiye | Retrospective | 56 | Age > 18 yr, baseline VL ≥ 500,000 copies/mL, ≥24 wk of follow-up data | 56 (100) | – | 27 (48) | Dyslipidemia: 18 (27) HTN: 9 (16) Diabetes: 7 (13) |
| Hui et al[28] | China | Prospective | 54† | Exclusion criteria: pregnancy, breastfeeding, HBV co-infection, grade 4 laboratory abnormalities, eGFR < 60 mL/min/1.73 m2 via MDRD | 34 (77) | 23 (45) | 0 | Co-metabolic disease: 8 (15)‡ |
| Hou et al[33] | China | Retrospective | 46 | Age ≥ 18 yr | 9 (20) | 10 (22) | – | Syphilis: 5 (11) |
| Zhao et al[29] | China | Retrospective-prospective | 42 | – | 32 (76) | 32 (76) | 0 | OI or tumor: 33 (79) Kidney injury/high risk: 26 (62) HTN: 11 (26) CVD: 10 (24) Osteoporosis/bone disease: 9 (21) Diabetes: 6 (14) Anemia (Hb < 90): 4 (10) |
| Lee et al[67] | South Korea | Retrospective | 20 | Age > 19 yr and follow-up for > 12 mo | – | – | 18 (90) [5 (25); NNRTI: 4 (20); INSTI: 2 (10)] |
Osteopenia: 3 (15) Syphilis: 3 (15) HTN: 2 (10) Diabetes: 2 (10) Dyslipidemia: 2 (10) CVD: 2 (10) Psychiatric illness: 2 (10) |
| Cheng et al[63] | Taiwan | Prospective | 19 | –§ | – | – | –§ | – |
| Ling et al[27] | China | Prospective | 14 | No HBsAg-resistant HBV infection, no M184V | 9 (64) | 9 (64) | 11 (79) [no M184V] | “Joint disease”: 11 (79) Other OI: 3 (21) Tuberculosis: 2 (14) |
| Cecchini et al[66] | Argentina | Retrospective | 12 | Adult | – | – | – | – |
| Basova et al[65] | Russia | Prospective | 11 | – | 0 | 0 | – | – |
| Cohort lead study | Country | Study type | People using DTG + 3TC | Inclusion criteria | Time on ART, median, yr | Previous ART, n (%) | People with GRT, n (%) [RAMs] | Comorbidities in ≥ 10% of people using DTG + 3TC, n (%) |
| Switching ART | ||||||||
| Cheng et al[64] | Taiwan | Retrospective | 512 | Negative HBsAg status, no DTG- or 3TC-selective RAMs |
Mean: 6.5 | DTG/ABC/3TC: 72% DTG/RPV: 17% EFV/FTC/TDF: 3% RPV/FTC/TAF: 2% BIC/FTC/TAF: 2% EVG/c/FTC/TAF: 2% MTR: 2% RPV/FTC/TDF: <1% |
512 (100) [48 (9); NRTI: 20 (4); NNRTI: 34 (7); PI: 5 (1); INSTI: 2 (<1)] |
– |
| Iglessias et al[62] | Brazil | Retrospective | 383‖ | – | Mean: 13.5 | INSTI-based: 218 (57) | –¶ | Bone-related: 110 (29) Kidney-related: 95 (25) |
| Basova et al[65] | Russia | Prospective | 258 | – | – | NNRTI: 72% PI: 58% INSTI: 3% |
– | – |
| Nagashima et al[52] | Japan | Retrospective | 221 | – | – | DTG/ABC/3TC: 144 (65) DTG + FTC/TAF: 38 (17) INSTI-based: >90 |
– | – |
| Cecchini et al[66] | Argentina | Retrospective | 174 | Adult | – | – | – | – |
| Watanabe et al[54] | Japan | Retrospective | 157 | People who started DTG/3TC at a different site excluded | – | DTG/ABC/3TC: 135 (86) DTG + ABC/3TC 9 (6) |
– | – |
| Ikegaya et al[48] | Japan | Retrospective | 149 | – | – | INSTI + 2 NRTIs: 136 (91) DTG + 2 NRTIs: 109 (73) |
– | – |
| Zhou et al[42] | China | – | 146 | – | 2.9# | DTG-based 3DR: 45% EFV-based: 33% Other: 22% |
– | AIDS-related OIs: 21% Abnormal renal function: 15% CVD: 14% Syphilis: 14% |
| Lee et al[67] | South Korea | Retrospective | 131 | Age > 19 yr, follow-up for > 12 mo | – | PI + 2 NRTIs ATV/c: 2 (2) ATV: 1 (<1) LPV/r: 1 (<1) INSTI + 2 NRTIs DTG: 102 (78) RAL: 9 (7) BIC: 8 (6) EVG/c: 2 (2) NNRTI + 2 NRTIs EFV: 5 (4) ETR: 1 (<1) |
51 (39) [14 (11); NRTI: 1 (1); NNRTI: 11 (8); INSTI: 3 (2); H51H/D/N/Y] |
Dyslipidemia: 52 (40) Syphilis: 45 (35) HTN: 30 (23) Diabetes: 25 (19) Osteopenia: 20 (15) Tuberculosis: 19 (15) |
| Yang[44] | China | Retrospective | 121 | Age ≥ 18 yr, VL < 50 copies/mL | – | – | 4 (3) had archived M184V/I | – |
| Adachi et al[46] | Japan | Retrospective | 119 | Previous regimen of either DTG/ABC/3TC, DTG + FTC/TAF, or BIC/FTC/TAF; VL < 50 copies/mL for ≥ 6 mo; ≥2 blood tests post-switch to DTG + 3TC | – | DTG/ABC/3TC: 85 (71) DTG + FTC/TAF: 21 (18) BIC/FTC/TAF: 13 (11) |
– | HTN: 37 (31) Dyslipidemia: 33 (28) Diabetes: 17 (14) |
| Zhong et al[30] | China | Retrospective | 112 | No HBV, VL < 500,000 copies/mL, completed 48-wk follow-up | 2.5 | INSTI + 2 NRTIs: 54 (48) NNRTI + 2 NRTIs: 39 (35) bPI + 2 NRTIs: 11 (10) Other: 8 (7) |
– | – |
| Yağci-Çağlayik et al[55] | Türkiye | Retrospective | 107 | – | – | INSTI + 2 NRTIs: 73/98 (74) PI + 2 NRTIs: 10/98 (10) NNRTI + 2 NRTIs: 6/98 (6) PI + INSTI: 6/98 (6) INSTI + PI + 2 NRTIs: 3/98 (3) |
37** [4 with relevant 3TC mutations: T69A/D: 1 K65R: 3 K70T/S: 2 M184V: 1] |
CKD: 20/98 (20) Osteoporosis: 13/98 (13) |
| Xin[40] | China | Retrospective | 100 | VS for > 3 mo, TDF-inclusive 3DR as previous ART | – | TDF-inclusive 3DR | – | Abnormal eGFR: 20 (20) Abnormal BMD: 20 (20) CKD: 20 (20) Osteoporosis: 20 (20) Diabetes: 10 (10) |
| Minami et al[50] | Japan | – | 91 | Participants under good virologic control | – | – | – | – |
| Hou et al[32] | China | Retrospective | 79 | VS at time of switch | 5 | NNRTI + 2 NRTIs: 36 (46) INSTI + 2 NRTIs: 26 (33) PI + 2 NRTIs: 8 (10) |
– | Dyslipidemia: 18 (23) |
| Ergen et al[56] | Türkiye | Retrospective | 63 | Age ≥ 18 yr, not pregnant, switched from a 3DR, VL < 100 IU/mL or undetectable for ≥ 6 mo, using DTG + 3TC ≥ 6 mo | 3.5 | PI/R + 2 NRTIs LPV: 16 (25) IDV: 1 (2) NNRTI + 2 NRTIs EFV: 6 (10) INSTI + 2 NRTIs DTG: 36 (57) EVG: 8 (13) RAL: 7 (11) |
– | HTN: 10 (16) |
| Ling et al[27] | China | Prospective | 53 | No HBsAg-resistant HBV infection, no M184V | 2.6 | INSTI + 2 NRTIs: 18 (34) NNRTI + 2 NRTIs: 16 (30) bPIs + 2 NRTIs: 11 (21) PI + NRTI: 8 (15) |
– | “Joint disease”: 22 (42) Tuberculosis: 7 (13) Other OI: 6 (11) |
| Tsukiji et al[53] | Japan | Retrospective | 47 | Switched before Mar 31, 2021, with 48-wk follow-up | – | DTG/3TC/ABC: 23 (49) DTG + TAF/FTC: 9 (19) Not specified: 3 (6)†† |
– | – |
| Hirano et al[47] | Japan | Retrospective | 51 | – | – | Most common: BIC/FTC/TAF: 21 (41) DTG + FTC/TAF: 6 (12) DTG/ABC/3TC: 6 (12) |
– | – |
| Sönmezer et al[58] | Türkiye | Prospective | 40 | Age > 18 yr | – | – | – | – |
| Shiyun et al[31] | China | Retrospective | 33 | Aged ≥ 18 yr, negative for HBsAg |
2.1 | INSTI-based: 15 (45) PI + NRTI: 8 (24) NNRTI + 2 NRTIs: 7 (21) PI + 2 NRTIs: 2 (6) bPI: 1 (3) |
30 (91) had GRT performed at baseline; 26 (79) had previous GRT results M184V/I: 6 (18) NRTI: 6 (18) NNRTI: 12 (36) PI: 1 (3) |
Hyperlipidemia: 13 (39) HTN: 12 (36) |
| Konishi et al[49] | Japan | – | 10 | Aged ≥ 18 yr, VL < 50 copies/mL for ≥ 3 mo, switch from 3DR, no HBsAg-positive or HBV | – | For total population‡‡: DTG + FTC/TAF: 5 DTG/ABC/3TC: 4 RAL + FTC/TAF: 2 |
– | – |
| Combined (both naive to ART and switching ART) | ||||||||
| Véras et al[61] | Brazil | Retrospective | 19,622 total (naive/switch distribution not reported) |
Switched to 2DR (DTG + 3TC or DRV/R + 3TC) per Ministry of Health electronic records | – | DTG-containing regimens: 72% | – | – |
– = no data, 2DR = 2-drug regimen, 3DR = 3-drug regimen, 3TC = lamivudine, ABC = abacavir, ART = antiretroviral therapy, ATV = atazanavir, BIC = bictegravir, BMD = bone mineral density, bPI = boosted protease inhibitor, c = cobicistat, CKD = chronic kidney disease, CVD = cardiovascular disease, DRV = darunavir, DTG = dolutegravir, EFV = efavirenz, eGFR = estimated glomerular filtration rate, ETR = etravirine, EVG = elvitegravir, FTC = emtricitabine, GRT = genotypic resistance testing, Hb = hemoglobin, HBsAg = hepatitis B surface antigen, HBV = hepatitis B virus, HTN = hypertension, IDV = indinavir, INSTI = integrase strand transfer inhibitor, LPV = lopinavir, MDRD = modification of diet in renal disease, MTR = multi-tablet regimen, NNRTI = non-nucleoside reverse transcriptase inhibitor, NRTI = nucleoside reverse transcriptase inhibitor, OI = opportunistic infection, PI = protease inhibitor, r = ritonavir, RAL = raltegravir, RAM = resistance-associated mutation, RPV = rilpivirine, TAF = tenofovir alafenamide, TDF = tenofovir disoproxil fumarate, VL = viral load, VS = virologic suppression.
Total number not reported at baseline; n = 30 individuals with wk 12 data had baseline VL ≥ 100,000 copies/mL.
Outcomes reported for n = 21 people using DTG + 3TC.
4/21 (19%) with an OI.
Study population was mixed naive/switch, but information about inclusion criteria and GRT availability only mentioned switch population.
Did not explicitly report that full study population was switch but reported mean duration of HIV-1 (16.9 yr) and ART exposure (13.5 yr).
At least n = 1 individual had previous M184V mutation.
Value not specified as median or mean.
Denominator not specified.
Study did not list previous ART for the n = 3 individuals who discontinued DTG/3TC.
Includes previous ART for n = 1 individual in the analysis who switched to DTG + RPV.