Background
Methods
Literature search
Study selection
Data extraction
Results
Study reference | Population characteristics1
| Study design | Objective | Treatment groups | PRO instruments2(validated, not validated) | Types of PRO instruments (validated only) |
---|---|---|---|---|---|---|
Dabaghzadeh (2013) [7] | No prior EFV treatment experience (n = 51) | RCT (double-blind, placebo-controlled) | To assess the effect of cyproheptadine in prevention of neuropsychiatric adverse adverse drug reactions of ARV regimens containing EFV | 1) ARV therapy (including EFV) + cyproheptadine | BDI-II | Psychiatric symptoms (3) |
HAM-A | ||||||
HAM-D | Depression (2) | |||||
2) ARV therapy (including EFV) + placebo | PANSS | Anxiety (1) | ||||
PANSI | Sleep (1) | |||||
PSQI | ||||||
SCL-90 somatization subscale | ||||||
Bucciardini (2012) [8] | Treatment-experienced patients with treatment failure, resistance, or intolerance with HAART (2 NRTIs + NNRTI or PI) (n = 101) | Prospective, observational study (sub-set of ISS-NIA study) | To evaluate rates and determinants of virological failure in triple-class experienced patients receiving raltegravir-based regimens | 1) All patients received RAL-based therapy; study compared patients with and without virologic failure on RAL | ISSQoL | HRQL: General (1) |
Lake (2012) [9] | HIV-infected women with central adiposity and viral suppression on NNRTI- or PI-based HAART (n = 37) | RCT (open-label) | To evaluate effects of a switch from a PI or NNRTI to RAL on adipose tissue volume and metabolic changes | 1) Immediate switch of PI or NNRTI to RAL (continuing prior NRTI backbone) | CES-D | Depression (1) |
Body Image Impact scale | Psychiatric symptoms (1) | |||||
2) Delayed switch (at 24 weeks) of PI or NNRTI to RAL (continuing prior NRTI backbone) | ||||||
Mosam (2012) [10] | Treatment-naïve patients with HIV-associated Kaposi sarcoma (n = 112) | RCT (open-label) | To compare HRQL between 2 ARV regimens: ZDV/3TC/NFV versus ZDV/3TC/NVP | 1) d4T/3TC/NVP | EORTC QLQ-30 | HRQL: General (1) |
2) d4T/3TC/NVP + chemotherapy | ||||||
Cooper (2011) [11] | Treatment-experienced patients on stable ZDV/3TC/EFV regimen (n = 234) | RCT (open-label) | To assess the effect of switching ZDV/3TC/EFV to TDF/FTC/EFV on adherence, beliefs about ARV therapy and HQRL | 1) Continue ZDV/3TC/EFV twice daily | BMQ-ART | HRQL: General (1) |
HAART Intrusiveness Scale | Medication beliefs: HIV-targeted (2) | |||||
2) Switch to TDF/FTC/EFV once daily | SF-12 (v2) | |||||
Nguyen (2011) [12] | Stable EFV-containing HAART regimen (n = 53) | RCT (double-blind, cross-over) | To investigate the effect of replacing EFV with RAL on patient preference, sleep quality, daytime sleepiness, anxiety, and lipid levels | 1) Continue EFV-containing regimen, then switch EFV to RAL (continuing prior NRTI backbone) | ESS | Sleep (3) |
GSQS | ||||||
SSS | ||||||
2) RAL + prior NRTI backbone, then switch RAL to EFV (continue prior NRTI backbone) |
Treatment preference
| |||||
Treatment satisfaction
| ||||||
Nguyen (2011) [13] | Stable EFV-containing HAART regimen (n = 58) | RCT (double-blind, cross-over) | To investigate the effect of replacing EFV with ETR on patient preference, sleep, anxiety, and lipid levels | 1) EFV-based therapy | ESS | Sleep (3) |
2) ETR-based therapy | SSS | Anxiety/depression/stress (1) | ||||
GSQS | ||||||
DASS21 | ||||||
Treatment preference
| ||||||
Treatment satisfaction
| ||||||
Campo (2010) [14] | PI-based HAART regimen without history of virological failure (n = 262) | RCT (open-label) | To evaluate the efficacy, safety and PROs of regimen switching to EFV-based HAART | 1) Switch to EFV/3TC/ddI | FAHI | HRQL: HIV (1) |
2) Switch PI to EFV (continuing prior NRTIs) | IIRS | HRQL: General chronic disease (1) | ||||
Treatment preference
| ||||||
Treatment satisfaction
| ||||||
Cella (2010) [15] | Stable, but virologically failing ARV regimen (n = 1,203) | RCT (pooled analysis of DUET-1 and DUET-2) | To study the effects of etravirine versus placebo on the HRQL of HIV-infected patients | 1) ETR 200 mg twice-daily3
| FAHI | HRQL: HIV (1) |
2) Placebo3
| ||||||
Cooper (2010)] [16] | HIV-infected, treatment-naïve patients (n = 87) | RCT (open-label) | To determine the impact of once-nightly versus twice-daily dosing and beliefs about HAART on adherence to EFV-based HAART in ARV-naïve patients | 1) ddI/3TC/EFV once nightly | BMQ-ART | Medication beliefs: HIV-targeted (2) |
2) AZT/3TC twice daily + EFV nightly | HAART Intrusiveness Scale | |||||
HIV-infected treatment-naïve patients (n = 895) | RCT (double-blind) [MERIT] | To evaluate the long-term efficacy, safety, adherence, and HRQL of once-daily EFV-based HAART | 1) ZDV/3TC + MVC 300 mg twice daily | HIV-SI/SDM | HIV symptoms (1) | |
2) ZDV/3TC + MVC 600 mg once daily | ||||||
3) ZDV/3TC + EFV 600 mg once daily | ||||||
PI- or NNRTI-based ARV regimen with virologic suppression (n = 300) | RCT (open-label) | To evaluate the therapeutic switch to a single-tablet formulation of EFV/FTC/TDF among virologically suppressed, HIV-infected adults | 1) EFV/FTC/TDF | SF-36 (v2) | HRQL: General (1) | |
2) Continue baseline ARVs (PI- or NNRTI-based) | HIV-SI/SDM | HIV symptoms (1) | ||||
Treatmet preference
| ||||||
Perceived ease of regimen
| ||||||
Potard (2010) [21] | Treatment experienced, NNRTI-naïve (n = 239) | Prospective, observational study | To assess changes in HRQL after switching to an NNRTI-containing regimen | 1) EFV-based therapy | HADS | Anxiety/depression (1) |
2) NVP-based therapy | HIV-SI/SDM | |||||
WHOQOL-HIV | HIV symptoms (1) | |||||
BREF | HRQL: General (2) | |||||
SF-12 (v2) | ||||||
Clifford (2009) [22] | Treatment-naïve; study reports long-term follow-up of patients after unblinding of the AZT/3TC/ABC treatment arm (n = 303) | RCT (secondary analysis of A5095) | To evaluate the long-term impact of EFV-based regimens on neuropsychological performance | 1) AZT/3TC/EFV | CES-D | Depression (1) |
2) AZT/3TC/ABC | PSQI | Sleep (1) | ||||
STAI | Anxiety (1) | |||||
Neuropsychiatric symptoms
| ||||||
Gutierrez-Valencia (2009) [23] | Patients scheduled to receive an EFV-containing treatment plus 2 NRTIs (n = 114) | RCT (double-blind) | To determine if starting EFV in a stepwise dose schedule decreases EFV-related neuropsychiatric adverse events while maintaining efficacy | 1) EFV-based therapy (stepwise dosing) | OSQ | Sleep (1) |
2) EFV-based therapy (full dose) |
Neuropsychiatric symptoms
| |||||
Jayaweera (2009 ) [24] | Treatment-experienced patients (n = 65) | Prospective, single-arm trial (open-label) [DART I] | To evaluate the long-term efficacy, safety, adherence, and HRQL of once-daily EFV-based HAART | 1) ddI/3TC/EFV once-daily | MOS-HIV | HRQL: HIV (1) |
Jayaweera (2009) [24] | Treatment-experienced patients (n = 70) | Prospective, single-arm trial (open-label) [DART II] | To evaluate the long-term efficacy, safety, adherence, and HRQL of once-daily EFV-based HAART | 1) d4T/3TC/EFV once-daily | MOS-HIV | HRQL: HIV (1) |
Boyle (2008) [25] | Treatment-experienced patients on stable twice-daily or more frequent HAART (n = 320) | RCT (open-label) | To evaluate the effect of regimen simplification on maintenance of virologic suppression and treatment adherence | 1) Continue baseline ARVs (BID + dosing) | FAHI | HRQL: HIV (1) |
IIRS | HRQL: General (1) | |||||
2) Switch to once-daily d4T/3TC/EFV |
Treatment preference
| |||||
Treatment satisfaction
| ||||||
DeJesus (2008) [26] | Stable regimen of fixed-dose AZT/3TC with EFV, experiencing AZT/3TC-related adverse effects or who might benefit from a simplified regimen (n = 402) | Prospective, single-arm trial | To evaluate the impact of switching from twice-daily AZT/3TC to once-daily TDF/FTC with EFV) | 1) Switch from twice-daily AZT/3TC to once-daily TDF/FTC with EFV | SF-36 (v2) | HRQL: General (1) |
HIV-SI/SDM | HIV symptoms (1) | |||||
Treatment satisfaction
| ||||||
Bucciardini (2007) [27] | Treatment-naïve (n = 139) | RCT (secondary analysis of INITIO-QoL data) | To detect differences in patient’s HRQL among the 3 study treatment groups in the INITIO trial | 1) ddI/d4T/EFV | MOS-HIV | HRQL: HIV (1) |
2) ddI/d4T/NFV | ||||||
3) ddI/d4T/EFV/NFV | ||||||
Lafaurie (2008) [28] | NNRTI-naïve, receiving stable HAART consisting of at least 1 PI, 1 NRTI and AZT (n = 158) | RCT (open-label; secondary analysis of ALIZE data) | To assess if patients who have tolerated long-term AZT regimens will benefit from a switch to EFV/ddI/FTC | 1) Maintenance of stable PI-containing regimen | MOS-HIV | HRQL: HIV (1) |
2) Switch to once-daily EFV/ddI/FTC | ||||||
Journot (2006) [29] | NNRTI-naïve, receiving unchanged HAART for ≥6 months consisting of at least 1 PI and 2 NRTIs (n = 355) | RCT (open-label; secondary analysis of ALIZE data) | To determine whether EFV use is associated with a higher incidence of depressive disorders compared to PI-containing regimens | 1) Continue PI-based therapy | CES-D | Depression (1) |
2) Switch to EFV-based therapy | ||||||
Portsmouth (2005) [30] | Treatment-experienced patients with virologic suppression receiving d4T/3TC/EFV or ZDV/3TC/EFV (n = 43) | RCT (open-label) | To assess whether virologically controlled HIV-1-infected individuals switched from a twice-daily antiretroviral regimen to a once-daily regimen demonstrate improved adherence and quality of life while maintaining virological control | 1) Continue twice-daily regimen of d4T(IR)/3TC/EFV or ZDV/3TC/EFV | MOS-HIV | HRQL: HIV (1) |
2) Switch to once-daily d4T(PRC)/3TC/EFV | ||||||
Casado (2004) [31] | Treatment-naïve; subset of patients with HRQL data in original COMBINE trial (n = 127) | RCT (secondary analysis of COMBINE) | To compare HRQL between 2 ARV regimens: ZDV/3TC/NFV versus ZDV/3TC/NVP | 1) ZDV/3TC/NFV | MOS-HIV | HRQL: HIV (1) |
2) ZDV/3TC/NVP | ||||||
Negredo (2004) [32] | HAART experienced patients with long-lasting viral suppression (n = 169) | Prospective, observational study | To explore the long-term safety, and the virological and immunological efficacy of once-daily ddI/TDF/NVP in previously HAART-experienced subjects with long-lasting viral suppression | 1) Continue twice-daily ARV therapy (PI- or NNRTI-based) | MOS-HIV | HRQL: HIV (1) |
2) Switch to once-daily ddI/TDF/NVP | ||||||
van Leth (2004) [33] | Treatment-naïve; subset of patients with HRQL data in original 2NN clinical trial (n = 917) | RCT (secondary analysis of 2NN data) | To investigate whether these differences in the safety profiles of EFV and NVP translates into differences in HRQL | 1) d4T/3TC/EFV | MOS-HIV | HRQL: HIV (1) |
2) d4T/3TC/NVP | ||||||
3) d4T/3TC/EFV/NVP |
Name | Instrument type | Items (N) | Domains/scales/concepts | Score type(s) | ||
---|---|---|---|---|---|---|
Dimension | Summary1
| Total | ||||
BDI-II | Psychiatric symptoms2
| 21 | Severity of depression | X | ||
BMQ-ART | Medication beliefs (HIV-targeted) | 19 | HAART necessity scale (beliefs about personal need for HAART for controlling HIV, maintaining their health, preventing illness), HAART concerns scale (potential adverse effects, dependence, embarrassment about treatment, etc.) | X | ||
Body Image Impact | Psychiatric symptoms | 3 | Belly size, belly image distress, belly profile | X | ||
CES-D | Psychiatric symptoms2
| 20 | Frequency and severity of depression symptoms | X | ||
DASS21 | Psychiatric symptoms2,3,4
| 21 | Depression, anxiety, stress | X | ||
EORTC QLQ-30 | HRQL (general) | 30 | 6 functioning scales (physical, role, cognitive, emotional, social, global QOL), 9 symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact) | X | ||
ESS | Sleep5
| 8 | Rates chances of dozing during the daytime in 8 situations | X | ||
FAHI | HRQL (HIV-targeted) | 47 | Physical well-being, functional and global well-being, emotional well-being/living with HIV, social well-being, cognitive functioning | X | X | |
GSQS | Sleep6
| 15 | Questions about quality of previous night’s sleep | X | ||
HAART Intrusiveness Scale | Medication beliefs (HIV-targeted) | 12 | Degree to which ART is perceived to interfere with aspects of daily life (e.g., social life, ability to work, relationships) | X | ||
HADS | Psychiatric symptoms2,3
| 14 | Anxiety, depression | X | ||
HAM-A | Psychiatric symptoms3
| 14 | Severity of anxiety | X | ||
HAM-D | Psychiatric symptoms2
| 17 | Severity of depression | X | ||
HIV-SI / SDM | HIV symptoms | 20 | HIV- or treatment-related symptoms (e.g., fatigue, dizziness, nausea, depression, anxiety) | X7
| X | |
IIRS | HRQL (general) | 13 | Relationships and personal development, intimacy, instrumental | X | X | |
ISSQoL | HRQL (HIV-targeted) | 62 | QOL core (satisfaction with QOL, physical well-being, role well-being, social functioning, depression/anxiety, energy/vitality, health distress, cognitive functioning, sexual life), Additional important areas (social support, interaction with medical staff, treatment impact, body changes, life planning, motherhood/fatherhood) | X | ||
MOS-HIV | HRQL (HIV-targeted) | 35 | General health perceptions, physical functioning, role functioning, social functioning, pain, energy/fatigue, health distress, mental health, cognitive functioning, and quality of life | X | X1
| X |
OSQ | Sleep6
| 13 | Subjective sleep quality, somnolence, insomnia, nightmares | X | ||
PANSI | Psychiatric symptoms | 14 | Positive suicidal ideation, negative suicidal ideation | X | ||
PANSS | Psychiatric symptoms | 30 | Positive items (e.g., delusions, hallucinations), Negative items (e.g., blunted affect, emotional withdrawal), General Psychopathology (e.g., anxiety, depression, disorientation) | X | X | |
PSQI | Sleep6
| 19 | Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction | X | ||
SCL-90 Somatization subscale | Psychiatric symptoms | 12 | Distress arising from perceptions of bodily dysfunction, such as cardiovascular, gastrointestinal, respiratory, and autonomic symptoms | X | ||
SF-12 | HRQL (general) | 12 | Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health | X | X1
| |
SF-36 | HRQL (general) | 36 | Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health, reported health transition | X | X1
| |
SSS | Sleep5
| 1 | Subjects select 1 statement to best describe typical sleepiness at work during the prior week | X | ||
STAI | Psychiatric symptoms3
| 40 | State anxiety, trait anxiety | X | ||
WHOQOL-HIV BREF | HRQL (HIV-targeted) | 31 | Physical, psychological, level of independence, social relationships, environment, spirituality | X |
Instrument type and name | Study count |
---|---|
Instruments measuring quality of life
| |
Generic
| |
SF-36 (v2) | 2 |
SF-12 (v2) | 2 |
EORTC QLQ-30 | 1 |
Illness Intrusiveness Rating Scale (IIRS) | 2 |
Istituto Superiore di Sanità Quality of Life (ISSQoL) | 1 |
HIV-targeted
| |
Medical Outcomes Study HIV (MOS-HIV) | 81
|
Functional Assessment of HIV Infection (FAHI) | 3 |
World Health Organization Quality of Life (WHOQOL)-HIV BREF | 1 |
Instruments measuring symptoms
| |
General HIV symptoms
| |
HIV Symptom Index (HIV-SI) /AIDS Clinical Trials Group Symptom Distress Module (SDM) | 32
|
Sleep
| |
Pittsburgh Sleep Quality Index (PSQI) | 2 |
Epworth Sleep Score (ESS) | 2 |
Stanford Sleepiness Scale (SSS) | 2 |
Groningen Sleep Quality Score (GSQS) | 2 |
Oviedo Sleep Questionnaire (OSQ) | 1 |
Anxiety (only)
| |
Hamilton Anxiety Rating Scale (HAM-A) | 1 |
State-Trait Anxiety Inventory for Adults (STAI) | 1 |
Depression (only)
| |
Centers for Epidemiological Studies-Depression (CES-D) | 3 |
Beck Depression Inventory-2nd edition (BDI-II) | 1 |
Hamilton Depression Rating Scale (HAM-D) | 1 |
Anxiety and depression (only)
| |
Hospital Anxiety and Depression Scale (HADS) | 1 |
Anxiety, depression, and stress
| |
Depression Anxiety and Stress Scale-short version (DASS21) | 1 |
Psychiatric symptoms
| |
Positive and Negative Syndrome Scale (PANSS) | 1 |
Positive and Negative Suicide Ideation (PANSI) | 1 |
Symptom Checklist-90 (SCL-90) - Somatization Subscale | 1 |
Body Image Impact scale | 1 |
Instruments measuring beliefs about medications
| |
Beliefs about Medicines Questionnaire-ART version (BMQ-ART) | 2 |
HAART Intrusiveness Scale | 2 |
Study reference | Treatment/dosing regimen | Domain | Baseline score mean (SD) | Follow-up score[time, mean] | Effect size | Summary of PRO results |
---|---|---|---|---|---|---|
Instrument:
Centre for Epidemiologic Studies – Depression Scale (CES-D)
| ||||||
Lake (2012) [9] | Immediate switch of PI or NNRTI to RAL (continuing prior NRTI backbone) | Depression | NR | 24 weeks, NR | N/A | ● The CES-D was administered at 0, 4, 8, 12, 18, and 24 weeks, but patient-reported depression scores were not reported in this study. |
Delayed switch (at 24 weeks) of PI or NNRTI to RAL (continuing prior NRTI backbone) | Depression | NR | 24 weeks, NR | N/A | ||
Clifford (2009) [22] | ZDV/3TC/EFV | Depression | 12.2 (10.5) | 184 weeks1, 10.1a
| 0.20 | ● In participants who continued EFV-based regimens, neuropsychological performance improvement from baseline was maintained over 3 years. |
ZDV/3TC/ABC | Depression | 11.8 (10.5) | 184 weeks1, 10.4 | 0.13 | ● There was statistically significant decrease in depression symptoms over the course of the study with the median score decline of 1.0 (P = 0.03). | |
Various regimens (± EFV) | Depression | 13.3 (11.1) | 184 weeks1, 16.6 | −0.30 | ● In the long-term EFV-treated group, the percent with CES-D scores >16 declined from 34.1% to 22.3% over the duration of the study. | |
ZDV/3TC/ABC initially, then EFV added (± ABC) | Depression | 13.8 (12.5) | 184 weeks1, 8.6 | 0.42 | ||
Journot (2006) [29] | PI-based therapy | Depression2
| 23% | 48 weeks, 25% | N/A | ● Proportion of patients with depression was approximately 24% at BL and remained stable during the 48 week follow-up with no difference between treatment arms, P = 0.65). |
EFV-based therapy | Depression2
| 25% | 48 weeks, 24% | N/A | ||
36 months, 24% | N/A | |||||
● Patients with a history of depression experienced depressive symptoms more frequently than those without such history (53% and 22% at week 48, respectively; P = 0.03). | ||||||
Instrument:
Functional Assessment of HIV Infection (FAHI)
| ||||||
Campo (2010) [14] | Switch to EFV/3TC/ddI | Total Score | 130 | 48 weeks, 134a
| N/A | ● In the overall patient population, FAHI total score increased significantly from BL to week 48 (P < 0.001) and at every other time point; changes in total score were associated with improvements in the physical and emotional well-being domains (P < 0.001 for both). |
Switch PI to EFV (continuing prior NRTIs) | Total Score | 132 | 48 weeks, 138a
| N/A | ● No significant between-group differences observed. | |
Cella (2010) [15] | ETR 200 mg twice-daily3
| Total Score | 121.7 (23.7)5
| 24 weeks, 127.3a,b
| 0.21 | ● The change in physical well-being, emotional well-being/living with HIV and total scores from BL to Week 24 were statistically different from zero for both groups, with statistically significant greater improvements observed in the ETR group. |
Placebo3
| Total Score | 120.9 (26.7)5
| 24 weeks, 124.0a,b
| 0.11 | ||
Boyle (2008) [25] | Continue BL ARVs (BID+ dosing) | Total Score | 130.4 | 48 weeks, NR | N/A | ● A small improvement (5% or less) for the emotional well-being and a small reduction (9% or less) for functional and global well-being were observed at some time points in both arms; however, these were not considered clinically relevant, as the effect sizes were small. |
Switch to once-daily d4T/3TC/EFV | Total Score | 131.4 | 48 weeks, NR | N/A | ● No significant differences observed between arms. | |
Instrument:
HIV Symptom Index / Symptom Distress Module (HIV-SI / SDM)
| ||||||
Hodder (2010) [19] | EFV/FTC/TDF | Dizziness | 28% | 4 weeks, 39%a,b
| N/A | ● Simplification from PI-based or NNRTI-based regimens to EFV/FTC/TDF was associated with transient worsening or emergence of dizziness and sustained improvements in several other HIV-related symptoms: diarrhea or loose bowel movements; bloating, pain or gas in the stomach, changes in body appearance, and problems having sex. |
48 weeks, 28% | N/A | |||||
Remain on BL antiretroviral regimen | Dizziness | 27% | 4 weeks, 25%b
| N/A | ||
48 weeks, 28% | N/A | |||||
Potard (2010) [21] | EFV- or NVP-based therapy | Symptom Count | 11.9 (9.1) | 12 months, 9.0a
| 0.32 | ● Overall, there was a small improvement in HIV symptoms at 1 year (effect size 0.32). |
Symptom Bother Count | 7.7 (5.9) | 12 months, 6.0a
| 0.29 | ● An initial difference between groups in mean change in other symptoms, bothersome symptoms, and other bothersome symptoms observed at 1 month was not maintained at months 6 and 12. | ||
Regnault (2009) [18] | ZDV/3TC + MVC 300 mg twice dailyZDV/3TC + MVC 600 mg once dailyZDV/3TC + EFV 600 mg once daily | Symptom Count | Mean score ranged from ~5 (European Romance group) to ~10 (Bantu group) | 96 weeks, NR | N/A | ● This study assessed the cross-cultural validity of the HIV-SI using pre-ARV treatment cross-sectional data of the MERIT trial. |
● Statistically significant differential item functioning between cultural groups was observed for 4 items: fatigue, fevers, anxiety, and headache. | ||||||
Symptom Bother Count | Mean score ranged from 10.08 (European Romance group) to 24.00 (Bantu group) | 96 weeks, NR | N/A | ● The authors concluded that the absence of meaningful explanations for statistically significant differences between cultural groups supports the cross-cultural validity of the HIV-SI versions used in the MERIT trial. | ||
DeJesus (2008) [26] | Switch from twice-daily AZT/3TC to once-daily TDF/FTC with EFV | Symptom Count | NR | 24 weeks, NR | N/A | ● Significant differences were observed in the percentage of patients reporting the absence of the symptom at Week 24 compared to BL for 17 of the 20 items assessed. |
Symptom Bother Count | NR | 24 weeks, NR | N/A | ● Compared to BL, significantly more patients reported the absence of fatigue, absence of nausea and vomiting, absence of diarrhea, and absence of headache. | ||
Instrument:
Medical Outcomes Study HIV health survey (MOS-HIV)
| ||||||
Jayaweera (2009) [24] | ddI/3TC/EFV once-daily | Total Score | 874 | 96 weeks, 924 | N/A | ● The overall MOS-HIV QoL score, which is the sum of all individual MOS-HIV scores (range: 0 to 1,100), significantly improved from BL (874) to Week 96 (924; P < 0.05). |
Jayaweera (2009) [24] | d4T/3TC/EFV once-daily | Total Score | 832 | 12 weeks, 880 | N/A | ● The overall MOS-HIV QoL score significantly improved from BL (832) to Week 12 (880; P < 0.05). |
Lafaurie (2008) [28] | PI-containing regimen | PHS | 56.5 (50.0-61.8)3
| 48 weeks, -1.044
| 0.24 | ● The mean change from BL to week 48 in the PCS and MCS were −1.04 and +0.0 in the maintenance arm and −1.76 and +1.01 in the switch arm, respectively (P = 0.57 and 0.42). |
MHS | 40.2 (33.8-45.3)3
| 48 weeks, 0.004
| 0.00 | |||
EFV/ddI/FTC | PHS | 57.4 (51.5-60.4)3
| 48 weeks, -1.764
| 0.53 | ● Specific items such as physical functioning, social functioning, and emotional functioning remained unchanged in both treatment groups during follow-up. | |
MHS | 38.3 (33.4-43.6)3
| 48 weeks, 1.014
| −0.27 | |||
Bucciardini (2007) [27] | ddI/d4T/EFV | PHS | 50 (11) | 3 years, 54.9 | −0.45 | ● Similar results reported for follow-up at years 1 and 2 (data not shown). |
MHS | 49 (10) | 3 years, 49.5 | −0.05 | |||
ddI/d4T/NFV | PHS | 46 (13) | 3 years, 50.9 | −0.38 | ● During follow-up, an increase of PHS score was observed in all treatment arms (NS). | |
MHS | 48 (10) | 3 years, 53.5 | −0.55 | |||
ddI/d4T/EFV/NFV | PHS | 48 (12) | 3 years, 50.0 | −0.17 | ● The MHS score of both NNRTI- and PI-based 3-drug regimens showed a trend toward improvement but remained substantially unchanged with the four-drug combination. | |
MHS | 50 (9) | 3 years, 53.4 | −0.38 | |||
Portsmouth (2005) [30] | Continue twice-daily regimen of d4T(IR)/3TC/EFV or ZDV/3TC/EFV | Total Score | NR | 24 weeks, NR | N/A | ● There were no significant differences in quality of life between the IR and PRC arms based on overall (sum of 11 domains) change from BL to week 24. |
Cognitive Function | NR | 24 weeks, NRa
| N/A | ● Both arms showed significant improvement in the cognitive function domain (P < 0.001) during the course of the study, based on BL cognitive scores at weeks 12 and 24. | ||
Switch to once-daily d4T(PRC)/3TC/EFV | Total Score | NR | 24 weeks, NR | N/A | ● Differences between groups were not observed. | |
Cognitive Function | NR | 24 weeks, NRa
| N/A | |||
Casado (2004) [31] | ZDV/3TC/NFV | PHS | 54.16 (8.97) | 12 months, 52.79 | −0.15 | ● In the ZDV/3TC/NVP arm, there were statistically significant changes in the PHS score (P < 0.01) and a trend toward statistically significant change in the MHS score (P = 0.07). |
MHS | 45.72 (11.10) | 12 months, 49.20 | 0.31 | |||
ZDV/3TC/NVP | PHS | 50.95 (11.37) | 12 months, 56.73a
| 0.51 | ||
MHS | 43.78 (9.92) | 12 months, 48.22 | 0.45 | ● There were no statistically significant changes over time in the ZDV/3TC/NFV arm in both summary scores. | ||
Negredo (2004) [32] | Continue twice-daily ARV therapy (PI- or NNRTI-based) | General Health | NR | NR | N/A | ● Although quality of life tended to increase in both groups, no significant differences were found during the study in general health and health transition scales. |
Health Transition | NR | NR | N/A | |||
Switch to once-daily ddI/TDF/NVP | General Health | NR | NR | N/A | ||
Health Transition | NR | NR | N/A | |||
van Leth (2004) [33] | d4T/3TC/EFV | PHS | 50.5 | 48 weeks, 53.9 | N/A | ● PHS and MHS BL values were comparable in all 3 treatment groups (P = 0.883 and P = 0.937, respectively). |
MHS | 46.9 | 48 weeks, 53.9 | N/A | |||
d4T/3TC/NVP | PHS | 51.0 | 48 weeks, 54.9 | N/A | ● No significant differences between the 3 treatment groups in increases in dimension scores. | |
MHS | 46.7 | 48 weeks, 52.8 | N/A | ● After adjusting for all significantly associated variables, the increase of PHS was 4.6 for NVP, 4.8 for EFV and 3.8 for NVP + EFV (P = 0.790); the adjusted increase of MHS was 6.1, 7.3 and 3.8, respectively (P = 0.093). | ||
d4T/3TC/EFV/NVP | PHS | 50.9 | 48 weeks, 53.8 | N/A | ||
MHS | 47.1 | 48 weeks, 51.0 | N/A |