Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies

Wu, Albert W.; Hanson, Kristin A; Harding, Gale; Haider, Seema; Tawadrous, Margaret; Khachatryan, A.; Pashos, Chris L.; Simpson, Kit N.

doi:10.1186/1477-7525-11-42

Cited by 45 publications

(61 citation statements)

References 21 publications

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“…Instruments include generic instrument such as the SF‐36, disease‐specific instruments like the Chronic Liver Disease Questionnaire (CLDQ‐HCV), and instruments designed to measure fatigue (FACIT‐F) and work productivity (WPAI: SHP). Although the EQ‐5D is a single generic measure of HR‐QoL, a systematic review of PRO showed that this instrument was responsive to changes between groups and/or over time in patients living with HIV . The EQ‐5D has been noted to have problems with ceiling effects and therefore the use of the scale in individuals with early asymptomatic HIV infection is not recommended .…”

Section: Discussionmentioning

confidence: 99%

Real‐world impact of direct acting antiviral therapy on health‐related quality of life in HIV/Hepatitis C co‐infected individuals

Saeed

Moodie

Strumpf

et al. 2018

Journal of Viral Hepatitis

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Clinical trial results of direct acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) have shown improvements in health-related quality of life (HR-QoL). However, the extent to which these results are broadly generalizable to real-world settings is unknown. We investigated the real-world impact of oral DAA therapy on HR-QoL among individuals coinfected with HIV/HCV. We used data from the Canadian HIV/HCV Co-Infection Cohort Study that prospectively follows 1795 participants from 18 centres. Since 2007, clinical, lifestyle, and HR-QoL data have been collected biannually through self-administered questionnaires and chart review. HR-QoL was measured using the EQ-5D instrument. Participants initiating oral DAAs, having at least one visit before treatment initiation and at least one visit after DAA treatment response was ascertained, were included. Successful treatment response was defined as a sustained viral response (SVR). Segmented multivariate linear mixed models were used to evaluate the impact of SVR on HR-QoL, controlling for pretreatment trends. 227 participants met our eligibility criteria, 93% of whom achieved SVR. Before treatment, the EQ-5D utility index decreased 0.6 percentage-point/y (95% CI, -0.9, -0.3) and health state was constant over time. The immediate effect of SVR resulted in an increase of 2.3-units (-0.1, 4.7) in patients' health state and 2.0 percentage-point increase (-0.2, 4.0) in utility index. Health state continued to increase post-SVR by 1.4 units/y (-0.9, 3.7), while utility trends post-SVR plateaued over the observation period. Overall using real-world data, we found modest improvements in HR-QoL following SVR, compared to previously published clinical trials.

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Section: Discussionmentioning

confidence: 99%

Real‐world impact of direct acting antiviral therapy on health‐related quality of life in HIV/Hepatitis C co‐infected individuals

Saeed

Moodie

Strumpf

et al. 2018

Journal of Viral Hepatitis

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“…Because the questions are not disease specific, the measured HRQoL of HIV-positive and HIV-negative people can be directly compared—an important feature for this study. EQ-5D has been used previously to study HRQoL in the general population and in people living with HIV in LMICs and high-income countries, 6 , 7 , 8 and it is an appropriate generic tool for measuring HRQoL in patients with HIV/AIDS. 9 …”

Section: Methodsmentioning

confidence: 99%

Differences in health-related quality of life between HIV-positive and HIV-negative people in Zambia and South Africa: a cross-sectional baseline survey of the HPTN 071 (PopART) trial

Thomas

Burger

Harper

et al. 2017

The Lancet Global Health

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SummaryBackgroundThe life expectancy of HIV-positive individuals receiving antiretroviral therapy (ART) is approaching that of HIV-negative people. However, little is known about how these populations compare in terms of health-related quality of life (HRQoL). We aimed to compare HRQoL between HIV-positive and HIV-negative people in Zambia and South Africa.MethodsAs part of the HPTN 071 (PopART) study, data from adults aged 18–44 years were gathered between Nov 28, 2013, and March 31, 2015, in large cross-sectional surveys of random samples of the general population in 21 communities in Zambia and South Africa. HRQoL data were collected with a standardised generic measure of health across five domains. We used β-distributed multivariable models to analyse differences in HRQoL scores between HIV-negative and HIV-positive individuals who were unaware of their status; aware, but not in HIV care; in HIV care, but who had not initiated ART; on ART for less than 5 years; and on ART for 5 years or more. We included controls for sociodemographic variables, herpes simplex virus type-2 status, and recreational drug use.FindingsWe obtained data for 19 750 respondents in Zambia and 18 941 respondents in South Africa. Laboratory-confirmed HIV status was available for 19 330 respondents in Zambia and 18 004 respondents in South Africa; 4128 (21%) of these 19 330 respondents in Zambia and 4012 (22%) of 18 004 respondents in South Africa had laboratory-confirmed HIV. We obtained complete HRQoL information for 19 637 respondents in Zambia and 18 429 respondents in South Africa. HRQoL scores did not differ significantly between individuals who had initiated ART more than 5 years previously and HIV-negative individuals, neither in Zambia (change in mean score −0·002, 95% CI −0·01 to 0·001; p=0·219) nor in South Africa (0·000, −0·002 to 0·003; p=0·939). However, scores did differ between HIV-positive individuals who had initiated ART less than 5 years previously and HIV-negative individuals in Zambia (−0·006, 95% CI −0·008 to −0·003; p<0·0001). A large proportion of people with clinically confirmed HIV were unaware of being HIV-positive (1768 [43%] of 4128 people in Zambia and 2026 [50%] of 4012 people in South Africa) and reported good HRQoL, with no significant differences from that of HIV-negative people (change in mean HRQoL score −0·001, 95% CI −0·003 to 0·001, p=0·216; and 0·001, −0·001 to 0·001, p=0·997, respectively). In South Africa, HRQoL scores were lower in HIV-positive individuals who were aware of their status but not enrolled in HIV care (change in mean HRQoL −0·004, 95% CI −0·01 to −0·001; p=0·010) and those in HIV care but not on ART (−0·008, −0·01 to −0·004; p=0·001) than in HIV-negative people, but the magnitudes of difference were small.InterpretationART is successful in helping to reduce inequalities in HRQoL between HIV-positive and HIV-negative individuals in this general population sample. These findings highlight the importance of improving awareness of HIV status and expanding ART to prevent losses in HRQoL...

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“…Study visits at baseline, weeks 4 and 8 (PI-mono group only), week 12, and every 12 weeks thereafter included assessment of clinical status, drug adherence (standardised questions), viral load, CD4 cell count, and safety blood tests (measured at site laboratory). Visits at baseline, week 12, week 48, and every 48 weeks thereafter included additional assessments of cardiovascular disease risk (Framingham equation), 13 neurocognitive function (standard five-test battery), 14 , 15 symptomatic peripheral neuropathy (Brief Peripheral Neuropathy Screen), 16 and quality of life (self-completed Medical Outcomes Study HIV Health Survey questionnaire 17 , 18 ). We classified clinical and laboratory events with protocol-defined diagnostic criteria (on the basis of Centers for Disease Control and Prevention criteria for AIDS, 19 INSIGHT criteria for serious non-AIDS events, 20 and Division of AIDS criteria for adverse events 21 ), and an independent physician at the coordinating centre reviewed them.…”

Section: Methodsmentioning

confidence: 99%

Protease inhibitor monotherapy for long-term management of HIV infection: a randomised, controlled, open-label, non-inferiority trial

et al. 2015

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SummaryBackgroundStandard-of-care antiretroviral therapy (ART) uses a combination of drugs deemed essential to minimise treatment failure and drug resistance. Protease inhibitors are potent, with a high genetic barrier to resistance, and have potential use as monotherapy after viral load suppression is achieved with combination treatment. We aimed to assess clinical risks and benefits of protease inhibitor monotherapy in long-term clinical use: in particular, the effect on drug resistance and future treatment options.MethodsIn this pragmatic, parallel-group, randomised, controlled, open-label, non-inferiority trial, we enrolled adults (≥18 years of age) positive for HIV attending 43 public sector treatment centres in the UK who had suppressed viral load (<50 copies per mL) for at least 24 weeks on combination ART with no change in the previous 12 weeks and a CD4 count of more than 100 cells per μL. Participants were randomly allocated (1:1) to maintain ongoing triple therapy (OT) or to switch to a strategy of physician-selected ritonavir-boosted protease inhibitor monotherapy (PI-mono); we recommended ritonavir (100 mg)-boosted darunavir (800 mg) once daily or ritonavir (100 mg)-boosted lopinavir (400 mg) twice daily, with prompt return to combination treatment if viral load rebounded. All treatments were oral. Randomisation was with permuted blocks of varying size and stratified by centre and baseline ART; we used a computer-generated, sequentially numbered randomisation list. The primary outcome was loss of future drug options, defined as new intermediate-level or high-level resistance to one or more drugs to which the patient's virus was deemed sensitive at trial entry (assessed at 3 years; non-inferiority margin of 10%). We estimated probability of rebound and resistance with Kaplan-Meier analysis. Analyses were by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number registry, number ISRCTN04857074.FindingsBetween Nov 4, 2008, and July 28, 2010, we randomly allocated 587 participants to OT (291) or PI-mono (296). At 3 years, one or more future drug options had been lost in two participants (Kaplan-Meier estimate 0·7%) in the OT group and six (2·1%) in the PI-mono group: difference 1·4% (−0·4 to 3·4); non-inferiority shown. 49 (16·8%) participants in the OT group and 65 (22·0%) in the PI-mono group had grade 3 or 4 clinical adverse events (difference 5·1% [95% CI −1·3 to 11·5]; p=0·12); 45 (six treatment related) and 56 (three treatment related) had serious adverse events.InterpretationProtease inhibitor monotherapy, with regular viral load monitoring and prompt reintroduction of combination treatment for rebound, preserved future treatment options and did not change overall clinical outcomes or frequency of toxic effects. Protease inhibitor monotherapy is an acceptable alternative for long-term clinical management of HIV infection.FundingNational Institute for Health Research.

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Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies

Cited by 45 publications

References 21 publications

Real‐world impact of direct acting antiviral therapy on health‐related quality of life in HIV/Hepatitis C co‐infected individuals

Real‐world impact of direct acting antiviral therapy on health‐related quality of life in HIV/Hepatitis C co‐infected individuals

Differences in health-related quality of life between HIV-positive and HIV-negative people in Zambia and South Africa: a cross-sectional baseline survey of the HPTN 071 (PopART) trial

Protease inhibitor monotherapy for long-term management of HIV infection: a randomised, controlled, open-label, non-inferiority trial

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