Impact of Discontinuation of Initial Protease Inhibitor Therapy on Further Virological Response in a Cohort of Human Immunodeficiency Virus–Infected Patients

Moing, Vincent Le; Chêne, Geneviève; Leport, Catherine; Lewden, Charlotte; Duran, Ségolène; Garré, M; Masquelier, Bernard; Dupon, M.; Raffi, F.

doi:10.1086/324354

Cited by 27 publications

(17 citation statements)

References 25 publications

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“…1,7,[9][10][11][12][13][14] The most frequently reported side effects are gastrointestinal, including nausea, vomiting, and diarrhea. The ICONA study demonstrated that 25% of participants discontinued a HAART regimen by 1 year due to toxicity.…”

Section: Discussionmentioning

confidence: 99%

“…23 Psychosocial factors, such as the position of many women as the primary caregiver for others, are other possible differences that could lead to higher rates of discontinuation in females. 13,21,[23][24][25] These findings highlight the need for further investigation regarding the pharmacokinetic differences and psychosocial factors leading females to be more likely to discontinue HAART regimens so that effective interventions may be developed.…”

Section: Robison Et Al 1352mentioning

confidence: 99%

“…[7][8][9] Several observational studies have shown that medication side effects are the most common cause of discontinuation of HAART regimens. 1,7,[9][10][11][12][13][14] Gastrointestinal (GI)-related side effects such as nausea, vomiting, and diarrhea have been among the most commonly reported medication toxicities leading to regimen discontinuation in numerous studies. 1,7,12,13,15,16 Other studies have shown that certain patient characteristics such as race, gender, or socioeconomic status may predict higher rates of regimen discontinuation.…”

Section: Introductionmentioning

confidence: 99%

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Short-Term Discontinuation of HAART Regimens More Common in Vulnerable Patient Populations

Robison

Westfall

Mugavero

et al. 2008

AIDS Research and Human Retroviruses

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The durability of HAART regimens is often limited by antiretroviral toxicity and nonadherence, which lead to virologic failure. We sought to determine sociodemographic and psychosocial patient factors predictive of shortterm discontinuation of HAART regimens overall and stratified by the reason for discontinuation. A retrospective cohort study of the UAB 1917 Clinic Cohort evaluated short-term HAART regimen discontinuation (within 12 months of regimen initiation) between 1/1995 and 8/2004 classified as (1) gastrointestinal (GI) toxicity, (2) non-GI toxicity, (3) virologic failure or nonadherence (VF/NA), (4) loss to follow-up, and (5) other. Multivariable multinomial logistic regression models accounting for dependent observations were fit to assess the relationship between patient factors and type-specific regimen discontinuation. Among the 738 study participants, 1026 of 1852 HAART regimens (55%) were discontinued within 12 months of initiation. In multivariable analysis, discontinuation for GI toxicity was more common in patients lacking private health insurance and those with a history of intravenous (IV) drug use, whereas non-GI toxicity was more common in younger patients and females. African-American patients and those with a history of IV drug use were more likely to stop a regimen due to VF/NA. Loss to follow-up was more common in younger patients, individuals who were uninsured, and those with a history of IV drug use. Short-term discontinuation of HAART regimens is more common in vulnerable populations that bear a disproportionate burden of the U.S. HIV/AIDS epidemic. More vigilant monitoring of patient populations at higher risk of toxicity and virologic failure may allow for improved HAART regimen durability. 1347

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Section: Discussionmentioning

confidence: 99%

Section: Robison Et Al 1352mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Short-Term Discontinuation of HAART Regimens More Common in Vulnerable Patient Populations

Robison

Westfall

Mugavero

et al. 2008

AIDS Research and Human Retroviruses

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“…Xavier Duval, 1 Valé rie Journot, 2 Catherine Leport, 1 Geneviè ve Chê ne, 2 Michel Dupon, 3 Lise Cuzin, 5 Thierry May, 6 Philippe Morlat, 4 Anne Waldner, 7,a Roger Salamon, 2 Franç ois Raffi, 8 HAART has led to a substantial decrease in morbidity and mortality and has become the standard-of-care for treatment of HIV infection [1]. Eradication of HIV is currently elusive with available therapy; because interruption of treatment leads to the resumption of viral replication, HAART needs to be continued indefinitely for clinical and immunovirological benefit to be pre-served.…”

Section: Incidence Of and Risk Factors For Adverse Drug Reactions In mentioning

confidence: 99%

Incidence of and Risk Factors for Adverse Drug Reactions in a Prospective Cohort of HIV-Infected Adults Initiating Protease Inhibitor--Containing Therapy

Duval

Journot

Leport

et al. 2004

Clinical Infectious Diseases

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Risk factors associated with the occurrence of protease inhibitor (PI)-related severe and serious adverse drug reactions (SADRs) were analyzed in a prospective cohort of 1155 patients who initiated PI-containing therapy. During a total follow-up of 2037 patient-years, 169 SADRs were reported, yielding a rate of 8 incidents per 100 patient-years (95% confidence interval [CI], 6.8-8.6). The most frequent SADRs were elevated transaminase levels (in 49 events); renal colic (27); abnormal hematological findings (23); and metabolic (18), neuromuscular (7), pancreatic (6), cutaneous (6), cardiovascular (5), and psychiatric disorders (5). Among baseline characteristics, plasma human immunodeficiency virus RNA levels of >or=5 log(10) copies/mL (hazard ratio [HR], 1.5; 95% CI, 1.1-2.2), elevated aspartate aminotransferase levels (HR, 1.1 for each 20 IU of elevation; 95% CI, 1.1-1.2), creatinine clearance levels of <70 mL/min (HR, 2.1; 95% CI, 1.2-3.7), test results positive for hepatitis C virus antibodies or hepatitis B surface antigenemia (HR, 2.6; 95% CI, 1.8-3.7), and receipt of indinavir (HR, 1.7; 95% CI, 1.2-2.4) were independently predictive of a SADR. SADRs were frequent in the first 4 months after initiation of highly active antiretroviral therapy but continued to occur after that time period.

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“…Additionally, antiretroviral (ARV) medications, particularly the protease inhibitor (PI) class, have been recognized as frequent causes of GI complaints leading to ARV discontinuation. 7-9 …”

Section: Introductionmentioning

confidence: 99%

Clinical Implications of the Nelfinavir‐Proton Pump Inhibitor Drug Interaction in Patients with Human Immunodeficiency Virus

et al. 2011

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Study Objective To determine if the concomitant use of nelfinavir (NFV) and proton pump inhibitors (PPIs) among HIV-positive individuals results in the loss of virologic control. Design Cohort study. Setting Kaiser Permanente Northern California (KPNC). Patients A total of 1,147 HIV-positive adults initiating NFV between November 1998 and June 2003 were included. The earlier date corresponds to the availability of the branched-DNA HIV viral load assay at KPNC and the later date corresponds to over-the-counter availability of PPIs. Measurements and Main Results The effect on two virologic outcomes, achieving undetectable HIV viral load and subsequent virologic rebound, were compared between subjects receiving NFV alone and NFV with PPIs. Cox proportional hazard models were utilized with adjustment for age, sex, race, HIV risk factors, hepatitis B or C co-infection, and other concurrent medications known to affect the metabolism of NFV. The use of PPIs had little effect on the ability to achieve an undetectable HIV viral load (adjusted hazard ratio (HR) = 0.82; 95% confidence interval (95% CI) = 0.58, 1.19; p = 0.29), but there was an approximate 50% increased risk of virologic rebound with the use of PPIs (adjusted HR = 1.53; 95% CI = 1.06, 2.19; p = 0.02). Short-term use of PPIs (defined as within 30 days of initial PPI dispensation) was not associated with increased risk of virologic rebound (HR = 1.07; 95% CI = 0.26, 4.41; p = 0.93) in comparison to no use. Conclusion Use of PPIs should be minimized or avoided in individuals who have attained an undetectable HIV viral load on a NFV-based antiretroviral regimen. However, concomitant use of these medications may be acceptable for indications where PPIs are required for < 30 days.

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Impact of Discontinuation of Initial Protease Inhibitor Therapy on Further Virological Response in a Cohort of Human Immunodeficiency Virus–Infected Patients

Cited by 27 publications

References 25 publications

Short-Term Discontinuation of HAART Regimens More Common in Vulnerable Patient Populations

Short-Term Discontinuation of HAART Regimens More Common in Vulnerable Patient Populations

Incidence of and Risk Factors for Adverse Drug Reactions in a Prospective Cohort of HIV-Infected Adults Initiating Protease Inhibitor--Containing Therapy

Clinical Implications of the Nelfinavir‐Proton Pump Inhibitor Drug Interaction in Patients with Human Immunodeficiency Virus

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