Substitution with Lopinavir/Ritonavir Improves Patient-Reported Outcomes Including Quality of Life in Patients Who Were Intolerant to Their Antiretroviral Therapy

Sprinz, Eduardo; Neto, J. Andrade; Bargman, Eduardo; Green, Stephen L.; Luo, Michelle; Sylte, Jacquelyn; McMillan, F; King, Kathryn R.; Rode, Richard A.; Brun, Scott; Hanna, George J.; Podsadecki, Thomas

doi:10.1310/hct0706-291

Cited by 11 publications

(8 citation statements)

References 22 publications

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“…Although a medium effect was observed in the PHS score in the switch arm (mean change −1.76, effect size 0.53), the difference in change from baseline to 48 weeks in both PHS and MHS scores was not statistically significant between treatment groups ( P =0.57 and P =0.42, respectively). Sprinz et al (2006) [16] evaluated the effect of substituting lopinavir/ritonavir (LPV/r) for the PI component of a HAART regimen in patients experiencing treatment-related Grade-2 side effects. Treatment arms in this study were immediate substitution (IS) versus deferred (week 4) substitution (DS).…”

Section: Resultsmentioning

confidence: 99%

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

Hanson²,

Harding³

et al. 2013

Health Qual Life Outcomes

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BackgroundSelection of an appropriate patient-reported outcome (PRO) instrument for a clinical trial requires knowledge of the instrument’s responsiveness to detecting treatment effects. The purpose of this study was to examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D).MethodsA systematic review identified clinical trials using the MOS-HIV or EQ-5D to assess outcomes for HIV-infected adults. Data abstracted from each study included study type, treatment regimen(s), PRO results, and effect size (either reported or calculated). Effect size was calculated as the difference between baseline and follow-up mean scores divided by the baseline standard deviation. Magnitude was categorized as small (d=0.20), medium (d=0.50), and large (d=0.80).ResultsBetween 2005 and 2010, the MOS-HIV was administered in 12 trials. Significant differences were observed between groups and over time in physical health summary (PHS) and mental health summary (MHS) scores (P<0.05) in subjects switching therapy after experiencing Grade-2 adverse events. Effect sizes were medium (0.55 and 0.49 for PHS and MHS, respectively) among treatment-naïve adults beginning therapy (two studies), but negligible among treatment-experienced adults (0.04 and 0.13 for PHS and MHS, respectively; three studies). The EQ-5D was used in five trials between 2001 and 2010. It was responsive to occurrences of adverse events and opportunistic infections, with small-to-medium effect sizes (range 0.30–0.50) in each of its five dimensions.ConclusionsA systematic review of PRO study results showed both the MOS-HIV and EQ-5D were responsive to changes between groups and/or over time in treatment-naïve HIV-infected patients. These instruments may be used either individually or together in clinical trials to measure changes in HRQL.

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Section: Resultsmentioning

confidence: 99%

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

Hanson²,

Harding³

et al. 2013

Health Qual Life Outcomes

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“…Similarly the ACTG symptoms distress module (ASDM) [48] was created to assess symptoms related to ART. It has 22 questions, and each question is scored from 0 to 4 [49]. A higher score means that patients have increased symptoms or are more bothered by their symptoms [49].…”

Section: Brief Review Of Selected Hrqol Toolsmentioning

confidence: 99%

“…It has 22 questions, and each question is scored from 0 to 4 [49]. A higher score means that patients have increased symptoms or are more bothered by their symptoms [49]. …”

Section: Brief Review Of Selected Hrqol Toolsmentioning

confidence: 99%

“…In a prospective, randomized, open-label multi-country study, boosted lopinavir (PIs can be combined with low-dose ritonavir to boost their serum levels thereby reducing dosages and side effects) was substituted in patients experiencing side effects on other PIs (indinavir, nelfinavir) or efavirenz, nevirapine. A total of 849 patients were randomized to obtain the pre-study NRTI plus boosted lopinavir either immediately or after 4 weeks and were followed up for 8 weeks [49]. Using the MOS-HIV scale, ACTG-ASDM and a depression scale, significant improvement in all scales in patients from all prior ARV treatment groups was seen.…”

Section: Hrqol With Specific Art Regimensmentioning

confidence: 99%

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Health-related Quality of Life Assessment after Antiretroviral Therapy: A Review of the Literature

Gakhar

Kamali

Holodniy

2013

Drugs

119

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Antiretroviral (ARV) treatment for HIV infection has resulted in significant improvement in immunologic and virologic parameters, as well as a reduction in AIDS-defining illnesses and death. Over 25 medications are approved for use, usually in combination regimens of three or four ARVs. Several ARVs are now available as combinatorial products, which have been associated with better adherence. However, while ARV therapy has prolonged life, ARVs also pose a challenge for quality of life as they can cause significant side effects in addition to the potential for drug toxicity and interaction. Given the many complications, side effects and symptoms of HIV/AIDS in addition to associated medical and psychiatric co-morbidities, the need to understand and assess how these interactions may affect health-related quality of life (HRQOL) has grown. Numerous instruments (some validated, others not) are available and have been applied to understanding how ARV treatment affects HRQOL in those with HIV infection, both in clinical trials and clinical practice. In general, ARV treatment improves HRQOL, but this is dependent on the population being studied, the HRQOL instrument being used and the timeframe during which HRQOL has been studied. This article provides a review of the literature on quality of-life assessment as it relates to ARV treatment in developed countries and briefly reviews the HRQOL instruments used, how they have been applied to ARV utilization, and where future research should be applied in HRQOL assessment and HIV infection.

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“…Antiretroviral therapy may be associated with adverse effects in some patients; various alternative strategies have been shown to reduce certain side effects. Switching from one boosted PI to another may simplify the dosing regimen or reduce certain side effects (63)(64)(65)(66). For example, switching from a PI other than darunavir to atazanavir, boosted atazanavir, nevirapine, abacavir or raltegravir may improve the lipid profile and reduce hyperlipidemia (67)(68)(69)(70)(71)(72)(73)(74).…”

Section: Switching Antiretroviral Agentsmentioning

confidence: 99%

Antiretroviral therapy for adults infected with HIV: Guidelines for health care professionals from the Quebec HIV care committee

Rouleau

Fortin²,

Trottier³

et al. 2011

Canadian Journal of Infectious Diseases and Medical Microbiolog

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The appropriate use of antiretrovirals reduces morbidity and mortality caused by HIV infection. The present article provides health care professionals with a practical guide for the use of antiretrovirals. Therapy should be initiated based predominantly on clinical presentation and CD4 count, and should consist of three active drugs or at least two active drugs when this is not possible, as in cases of some treatment-experienced patients. This is the most effective way to achieve long-term suppression of viral replication. Selection of individual drugs in the regimen should consider the weight of the evidence supporting these choices, as well as their tolerability profiles and ease of use, the patients' comorbidities and treatment history. Treatment interruption is not recommended, either in aviremic patients or in those who have experienced virological failure. Instead, the therapeutic regimen should be adjusted to minimize side effects, promote adherence and suppress viral replication.

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Substitution with Lopinavir/Ritonavir Improves Patient-Reported Outcomes Including Quality of Life in Patients Who Were Intolerant to Their Antiretroviral Therapy

Abstract: Substitution with LPV/r improved patient-reported outcomes including QOL in patients experiencing Grade-2 SEs, while maintaining viral suppression.

Cited by 11 publications

References 22 publications

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

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

Health-related Quality of Life Assessment after Antiretroviral Therapy: A Review of the Literature

Antiretroviral therapy for adults infected with HIV: Guidelines for health care professionals from the Quebec HIV care committee

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