Table 2.
Studies of antiretroviral therapy and quality of life
| Author | Study | Drug regimen | Scale used | Follow-up | Patients | Significant finding |
|---|---|---|---|---|---|---|
| Wu et al. [114] | QOL in a placebo controlled trial of AZT in patients with AIDS and ARC | AZT vs. placebo | QWB and KPS | 1 year | 32 | QWB scores were better for AZT at 24 weeks and 1 year. When death was not considered, functional scores were transiently better at 24 weeks but no difference at 1 year |
| Gelber et al. [116] | QOL of AZT therapy in mildly symptomatic HIV infection | AZT vs. placebo | Q-TWiST | 18 months | 711 | 14.5 months (AZT) vs. 14.7 months (placebo) without any serious AE or disease progression. AZT was associated with more Q-TWiST if QOL after HIV disease progression was assumed to be 10–20 % worse than QOL after an SAE |
| Wu et al. [117] | Functional status and wellbeing in a placebo controlled trial of AZT in early symptomatic HIV infection | AZT vs. placebo | MOS HIV survey | 1 year | 70 | QOL was similar in both groups after 1 year (reduced from baseline) |
| Lenderking et al. [118] | QOL and AZT in asymptomatic HIV patients | AZT vs. placebo | Q-TWiST | 18 months | 1,384 | Reduction in QOL in patients on AZT almost balanced the increase in QOL due to delay in disease progression |
| Bozzette et al. [119] | AZT compared to ddI on health status and functioning in advanced HIV infection | AZT vs. ddI | HIV-PARSE | 356 | Sub study of ACTG 116/117. No difference in QOL in AZT or ddI group regardless of prior AZT exposure | |
| Nieuwkerk et al. [110] | QOL in asymptomatic and symptomatic HIV patients | PI-based regimen with either SQV/r vs. RTV/SQV/d4T | MOS-HIV | 48 weeks | 208 | Improvement in QOL in symptomatic patients and worsening in asymptomatic patients (social and cognitive domains) |
| Low-Beer et al. [108] | HRQOL among HIV patients after PI use | 2 NRTIs + PI | MOS-SF-20 | 1 year | 179 | Overall maintained QOL but decreased MHS |
| Brechtl et al. [113] | QOL in advanced HIV patients starting HAART | PI containing regimen | KPS, BPI, HDRS, EFAT | 3 months | 70 | No improvement in QOL scores |
| Fumaz et al. [130] | Switch from PI based regimen to NNRTI | PI vs. EFV containing regimen | MOS-HIV 5 point item scale | 48 weeks | 100 | Improvement in QOL with EFV containing regimen while no change when PIs were continued |
| Carrieri et al. [109] | QOL after 1 year of HAART | PI-containing ARV regimen | MOS SF-36 | 1 year | 654 | Significant improvement in MHS but overall improvement in all domains. Variables affecting QOL were symptoms, virologic success, baseline CD4 and time since HIV positivity |
| Mukherjee et al. [125] | Effect of ATV on patient QOL and utility compared to LPV/r in study 043 | ATV vs. LPV/r | EQ-5D and MOS-HIV | 24 weeks | 290 | ATV group improved in 6 domains (general health, pain, mental health, energy/fatigue, health distress, and quality of life) and worsening in physical function. LPV/r improved in 3 domains (general health, health distress and quality of life) |
| Coplan et al. [43] | Effect of adding IDV on QOL in advanced HIV on treatment with AZT + 3TC | AZT + 3TC vs. AZT + 3TC + IDV | QOL 601–602 | 24 weeks | 1,143 | Significant increase in general health scores, as well as in the pain, energy/fatigue, and role function domains in three drug regimen mainly driven by CD4 < 50 strata |
| Cohen et al. [140] | QOL with ENF | ENF + OBR vs. OBR | MOS-HIV | 24 weeks | 1,013 | Improvement in the QOL score was noted in all the domains except social functioning |
| Sprinz et al. [49] | Switch to LPV/r in patients not tolerating their HAART regimen | NNRTI or PI regimen to LPV/r containing regimen | MOS-HIV, ASDM, Depression scale | 8 weeks | 849 | Significant improvement in QOL in patients experiencing Grade-2 adverse effects |
| Dubois et al. [128] | QOL in treatment experienced HIV patients treated with boosted darunavir | DRV vs. CPI | FAHI | 48 weeks | 637 | Significant improvement from baseline was achieved in the DRV/r group for the physical and emotional wellbeing subscale scores and the total FAHI |
| Bucciardini et al. [122] | HRQOL in 3 drug vs. 4 drug regimen | ddI + d4T + EFV/ NFV or both | MOS-HIV | 3 years | 153 | PHS scores increased in both groups but only MHS increased in three drug regimen |
| Bucciardini et al. [141] | QOL in HIV patients with ENF in combination with optimized background therapy | ENF + OBR | ISSQoL and EQ-5D | 6 months | 16 | Positive impact on QOL was seen in most of the domains except social functioning |
| Grant et al. [143] | Effect of switch from EFN to RAL | ENF to RAL | MOS-HIV | 24 weeks | 14 | No significant change in QOL |
| Jayaweera et al. [134] | QOL on once daily EFV regimen in treatment naïve patients | ddI + 3TC + EFV vs. d4T-ER + 3TC + EFV | MOS-HIV | 96 weeks | 135 | QOL increased on both groups of patients (significant increase in total wellbeing score over 96 weeks in regimen 1 and over 12 weeks in regimen 2) |
| Malan et al. [125] | QOL improvement in treatment naïve patients with boosted and unboosted ATV | 3TC + d4T + ATV/r or ATV | MOS-HIV | 96 weeks | 200 | Significant improvement in PHS and MHS with both regimens at 24 weeks |
| Huang et al. [127] | QOL on boosted TPV | TPV vs. other PI including regimens | MOS-HIV | 48 weeks | 984 | Overall similar adverse effects but more treatment related adverse effects in TPV group. Maintained QOL over 48 weeks with pain being the only significantly different domain between the two groups |
| Campo et al. [130] | Switch from PI to EFV based regimen | PI based regimen to EFV based regimen | FAHI and IIRS | 48 weeks | 262 | Significant increase in QOL in both physical and emotional domains |
| Potard et al. [131] | QOL after switch from virologically effective regimen to regimen with EFV/NVP | NNRTI naïve patients on cART to NNRTI containing regimen | HAD, WHO-QOL, SF-12 | BL, 1, 6 and 12 months | 239 | Physical, independence and spirituality domains of QOL improved significantly at 1 year along with decreased anxiety and perceived symptoms |
| Boulet et al. [142] | Impact of QOL due to switch from ENF to RAL | ENF vs. RAL | MOS-HIV | 24 weeks | 169 | QOL scores increased significantly in PHS, pain and social functioning in RAL group |
| Hodder et al. [135] | Patient reported outcomes after switch to single tablet regimen | SBR vs. single tablet EFV/ FTC/ TDF | SF-36 | 48 weeks | 300 | QOL maintained with improved ease of use and treatment satisfaction. Overall, PHS scores improved significantly in single tab group |
| Cooper et al. [133] | Continuation of ZDV/3TC or switch to TDF/FTC, each with EFV | Combivir® + EFV vs. Truvada® + EFV | SF-12 | 48 weeks | 234 | No improvement in QOL |
BL baseline, QOL quality of life, AZT zidovudine, ARC AIDS-related complex, QWB quality of well-being, KPS Karnofsky Performance Score, AE adverse events, ddI didanosine, ACTG AIDS Clinical Trials Group, SQV saquinavir, r/RTV ritonavir, d4T stavudine, PI protease inhibitors, NRTI nucleoside reverse transcriptase inhibitors, MHS Mental Health Score, HAART highly active antiretroviral therapy, BPI Brief Pain Inventory, HDRS Hamilton Depression Rating Scale, EFAT Edmonton Functional Assessment Tool, NNRTI non-nucleoside reverse transcriptase inhibitor, EFV efavirenz, NVP nevirapine, ATV atazanavir, LPV lopinavir, IDV indinavir, 3TC lamivudine, ENF enfuvirtide, OBR optimized background regimen, ASDM ACTG symptoms distress module, CPI comparable PI regimens, SBR stay on baseline regimen, DRV darunavir, PHS physical health score, SAE serious adverse events, FTC emtricitabine, TDF tenofovir disoproxil fumarate, EQ-5D Euroqual-5D, MOS-HIV Medical Outcome Study HIV, Q-Twist quality-adjusted time without toxicity, RAL raltegravir, ISSQoL Instituto Superiore di Sanità Quality of Life, KPS Karnofsky Performance Status, FAHI Functional Assessment of HIV Infection, IIRS Illness Intrusiveness Rating Scale, PARSE Patient-Assessed Report of Status and Experience