Search PubMed⌕ Search

Biomedical subjects

Rochelle P Walensky

Publications and source records attributed to Rochelle P Walensky.

At least 19 recordsLinked to original sources

Visual screening for malignant melanoma: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness of various melanoma screening strategies proposed in the United States. DESIGN: We developed a computer simulation Markov model to evaluate alternative melanoma screening strategies. PARTICIPANTS: Hypothetical cohort of the general population and siblings of patients with melanoma. Intervention We considered the following 4 strategies: background screening only, and screening 1 time, every 2 years, and annually, all beginning at age 50 years. Prevalence, incidence, and mortality data were taken from the Surveillance, Epidemiology, and End Results Program. Sibling risk, recurrence rates, and treatment costs were taken from the literature. MAIN OUTCOME MEASURES: Outcomes included life expectancy, quality-adjusted life expectancy, and lifetime costs. Cost-effectiveness ratios were in dollars per quality-adjusted life year (US dollars/QALY) gained. RESULTS: In the general population, screening 1 time, every 2 years, and annually saved 1.6, 4.4, and 5.2 QALYs per 1000 persons screened, with incremental cost-effectiveness ratios of US dollars 10,100/QALY, US dollars 80,700/QALY, and US dollars 586,800/QALY, respectively. In siblings of patients with melanoma (relative risk, 2.24 compared with the general population), 1-time, every-2-years, and annual screenings saved 3.6, 9.8, and 11.4 QALYs per 1000 persons screened, with incremental cost-effectiveness ratios of US dollars 4000/QALY, US dollars 35,500/QALY, and US dollars 257,800/QALY, respectively. In higher risk siblings of patients with melanoma (relative risk, 5.56), screening was more cost-effective. Results were most sensitive to screening cost, melanoma progression rate, and specificity of visual screening. CONCLUSIONS: One-time melanoma screening of the general population older than 50 years is very cost-effective compared with other cancer screening programs in the United States. Screening every 2 years in siblings of patients with melanoma is also cost-effective.

Boston↗

Expanded HIV screening in the United States: effect on clinical outcomes, HIV transmission, and costs.

BACKGROUND: An extensive literature supports expanded HIV screening in the United States. However, the question of whom to test and how frequently remains controversial. OBJECTIVE: To inform the design of HIV screening programs by identifying combinations of screening frequency and HIV prevalence and incidence at which screening is cost-effective. DESIGN: Cost-effectiveness analysis linking simulation models of HIV screening to published reports of HIV transmission risk, with and without antiretroviral therapy. DATA SOURCES: Published randomized trials, observational cohorts, national cost and service utilization surveys, the Red Book, and previous modeling results. TARGET POPULATION: U.S. communities with low to moderate HIV prevalence (0.05% to 1.0%) and annual incidence (0.0084% to 0.12%). TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: One-time and increasingly frequent voluntary HIV screening of all adults using a same-day rapid test. OUTCOME MEASURES: HIV infections detected, secondary transmissions averted, quality-adjusted survival, lifetime medical costs, and societal cost-effectiveness, reported in discounted 2004 dollars per quality-adjusted life-year (QALY) gained. RESULTS OF BASE-CASE ANALYSIS: Under moderately favorable assumptions regarding the effect of HIV patient care on secondary transmission, routine HIV screening in a population with HIV prevalence of 1.0% and annual incidence of 0.12% had incremental cost-effectiveness ratios of 30,800 dollars/QALY (one-time screening), 32,300 dollars/QALY (screening every 5 years), and 55,500 dollars/QALY (screening every 3 years). In settings with HIV prevalence of 0.10% and annual incidence of 0.014%, one-time screening produced cost-effectiveness ratios of 60,700 dollars/QALY. RESULTS OF SENSITIVITY ANALYSIS: The cost-effectiveness of screening policies varied within a narrow range as assumptions about the effect of screening on secondary transmission varied from favorable to unfavorable. Assuming moderately favorable effects of antiretroviral therapy on transmission, cost-effectiveness ratios remained below 50,000 dollars/QALY in settings with HIV prevalence as low as 0.20% for routine HIV screening on a one-time basis and at prevalences as low as 0.45% and annual incidences as low as 0.0075% for screening every 5 years. LIMITATIONS: This analysis does not address the difficulty of determining the prevalence and incidence of undetected HIV infection in a given patient population. CONCLUSIONS: Routine, rapid HIV testing is recommended for all adults except in settings where there is evidence that the prevalence of undiagnosed HIV infection is below 0.2%.

Adult↗

Optimizing resource allocation in United States AIDS drug assistance programs.

BACKGROUND: US acquired immunodeficiency syndrome (AIDS) Drug Assistance programs (ADAPs) provide medications to low-income patients with human immunodeficiency virus (HIV) infection/AIDS. Nationally, ADAPs are in a fiscal crisis. Many states have instituted waiting lists, often serving clients on a first-come, first-served basis. We hypothesized that CD4 cell count-based ADAP eligibility would improve ADAP outcomes, allowing them to serve more-diverse patient populations and to prioritize persons who are at greatest risk of HIV-related mortality. METHODS: We used Massachusetts ADAP administrative data to create a retrospective cohort of Massachusetts ADAP clients from fiscal year 2003. We then used a model-based analysis to apply potential eligibility criteria for a limited program and to compare characteristics of patients included under CD4 cell count-based and first-come, first-served eligibility criteria. RESULTS: In fiscal year 2003, Massachusetts ADAPs served 3560 clients at a direct cost of 10.3 million dollars. With use of CD4 cell count-based eligibility (with an eligibility criterion of a current or nadir CD4 cell count < or = 350 cells/microL), it would have served 2253 clients (37% fewer than in fiscal year 2003) and appreciated savings of 2.7 million dollars. Given the same budget constraint and using first-come, first-served eligibility, Massachusetts ADAPs would have served 2406 clients (32% fewer than in fiscal year 2003). The first-come, first-served approach would have excluded patients with median CD4 cell count of 257 cells/microL (interquartile range, 124-377 cells/microL) in favor of serving patients with median CD4 cell count of 659 cells/microL (interquartile range, 511-841 cells/microL). In addition, a CD4 cell count-based scheme would have served a greater proportion of nonwhite individuals (65% vs. 55%; P<.0001), non-English speakers (24% vs. 19%; P=.03), and unemployed people (69% vs. 61%; P=.0009), compared with the population that would have been served by a first-come, first-served policy. CONCLUSIONS: With limited resources, ADAPs will serve more-diverse populations and patients with significantly more advanced HIV disease by using CD4 cell count-based enrollment criteria rather than a first-come, first-served approach.

Anti-HIV Agents↗

Rapid HIV testing at home: does it solve a problem or create one?

The U.S. Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To date, testimony presented before the FDA has been overwhelmingly supportive. Advocates have argued enthusiastically that there is value in empowering individuals to manage their HIV risks and have suggested that the availability of a rapid home HIV test will dramatically increase rates of disease detection in communities that have proven difficult to reach and to link to appropriate care. The authors offer a more cautious perspective. According to what is already known about the market demand for over-the-counter HIV testing kits, their costs, and the performance of rapid HIV tests in that market, the authors do not anticipate that the rapid home test will have a profound impact either on the HIV public health crisis or on the populations in greatest need. Home HIV testing will attract a predominantly affluent clientele, composed disproportionately of HIV-uninfected new couples and "worried well" persons, as well as very recently infected persons with undetectable disease. The authors illustrate how testing in these populations may have the perverse effect of increasing both false-positive and false-negative results. A poorly functioning home HIV test may thereby undermine confidence in the reliability of HIV testing more generally and weaken critical efforts to expand HIV detection and linkage to lifesaving care for the estimated 300,000 U.S. citizens with unidentified HIV infection.

Costs and Cost Analysis↗

Cost-effectiveness of HIV treatment in resource-poor settings--the case of Côte d'Ivoire.

BACKGROUND: As antiretroviral therapy is increasingly used in settings with limited resources, key questions about the timing of treatment and use of diagnostic tests to guide clinical decisions must be addressed. METHODS: We assessed the cost-effectiveness of treatment strategies for a cohort of adults in Côte d'Ivoire who were infected with the human immunodeficiency virus (HIV) (mean age, 33 years; CD4 cell count, 331 per cubic millimeter; HIV RNA level, 5.3 log copies per milliliter). Using a computer-based simulation model that incorporates the CD4 cell count and HIV RNA level as predictors of disease progression, we compared the long-term clinical and economic outcomes associated with no treatment, trimethoprim-sulfamethoxazole prophylaxis alone, antiretroviral therapy alone, and prophylaxis with antiretroviral therapy. RESULTS: Undiscounted gains in life expectancy ranged from 10.7 months with antiretroviral therapy and prophylaxis initiated on the basis of clinical criteria to 45.9 months with antiretroviral therapy and prophylaxis initiated on the basis of CD4 testing and clinical criteria, as compared with trimethoprim-sulfamethoxazole prophylaxis alone. The incremental cost per year of life gained was 240 dollars (in 2002 U.S. dollars) for prophylaxis alone, 620 dollars for antiretroviral therapy and prophylaxis without CD4 testing, and 1,180 dollars for antiretroviral therapy and prophylaxis with CD4 testing, each compared with the next least expensive strategy. None of the strategies that used antiretroviral therapy alone were as cost-effective as those that also used trimethoprim-sulfamethoxazole prophylaxis. Life expectancy was increased by 30% with use of a second line of antiretroviral therapy after failure of the first-line regimen. CONCLUSIONS: A strategy of trimethoprim-sulfamethoxazole prophylaxis and antiretroviral therapy, with the use of clinical criteria alone or in combination with CD4 testing to guide the timing of treatment, is an economically attractive health investment in settings with limited resources.

Adult↗

The survival benefits of AIDS treatment in the United States.

BACKGROUND: As widespread adoption of potent combination antiretroviral therapy (ART) reaches its tenth year, our objective was to quantify the cumulative survival benefits of acquired immunodeficiency syndrome (AIDS) care in the United States. METHODS: We defined eras corresponding to advances in standards of human immunodeficiency virus (HIV) disease care, including opportunistic infection prophylaxis, treatment with ART, and the prevention of mother-to-child transmission (pMTCT) of HIV. Per-person survival benefits for each era were determined using a mathematical simulation model. Published estimates provided the number of adult patients with new diagnoses of AIDS who were receiving care in the United States from 1989 to 2003. RESULTS: Compared with survival associated with untreated HIV disease, per-person survival increased 0.26 years with Pneumocystis jiroveci pneumonia prophylaxis alone. Four eras of increasingly effective ART in addition to prophylaxis resulted in per-person survival increases of 7.81, 11.05, 11.57, and 13.33 years, compared with the absence of treatment. Treatment for patients with AIDS in care in the United States since 1989 yielded a total survival benefit of 2.8 million years. pMTCT averted nearly 2900 infant infections, equivalent to 137,000 additional years of survival benefit. CONCLUSIONS: At least 3.0 million years of life have been saved in the United States as a direct result of care of patients with AIDS, highlighting the significant advances made in HIV disease treatment.

Acquired Immunodeficiency Syndrome↗

Optimizing treatment for HIV-infected South African women exposed to single-dose nevirapine: balancing efficacy and cost.

INTRODUCTION: Nevirapine (NVP) resistance may decrease the effectiveness of viral suppression with NVP-based antiretroviral therapy (ART) in women infected with human immunodeficiency virus (HIV) with previous exposure to single-dose NVP. However, the alternative lopinavir-ritonavir-based ART regimen is more expensive. Our objectives were to project the tradeoffs regarding life expectancy, cost, and cost-effectiveness of these ART regimens for NVP-exposed, HIV-infected women in South Africa. METHODS: We developed a simulation model in which NVP-exposed, HIV-infected South African women received 1 of 5 treatment strategies: HIV care without ART, NVP-based ART, lopinavir-ritonavir-based ART, NVP-based ART followed by lopinavir-ritonavir-based ART, or lopinavir-ritonavir-based ART followed by NVP-based ART. The prevalence of NVP resistance was 39%; other data were obtained from the published literature. RESULTS: Projected life expectancy was 43.7 months for women who did not receive ART, 77.4 months for women who received a single NVP-based regimen, and 84.5 months for women who received a single lopinavir-ritonavir-based regimen. NVP resistance reduced survival time by up to 11.6 months among women who received NVP-based ART. The cost-effectiveness of NVP-based ART was $800 (US dollars) per year of life saved, compared with no ART, and the cost-effectiveness of lopinavir-ritonavir-based therapy was $4400 per year of life saved, compared with NVP-based ART. Lopinavir-ritonavir followed by NVP-based ART yielded the greatest life expectancy (105.4 months), had a cost-effectiveness of $2300 per year of life saved, and, if the efficacy of NVP-based regimens improved >6 months postpartum, further increased survival. CONCLUSIONS: NVP resistance substantially decreased the projected survival time associated with NVP-based ART, and lopinavir-ritonavir-based ART resulted in a superior survival time but at higher cost. A sequential regimen starting with lopinavir-ritonavir-based ART followed by NVP-based ART maximized projected survival and was cost effective in South Africa.

Adult↗

Assessing the impact of federal HIV prevention spending on HIV testing and awareness.

OBJECTIVES: The United States allocates more than $900 million annually for the prevention of HIV infection. We assessed the impact of this funding on HIV testing and knowledge. METHODS: We linked data from the Behavioral Risk Factor Surveillance System with tracking of Centers for Disease Control and Prevention (CDC) HIV prevention funding. We developed and validated regression models of the relation between HIV prevention funding to a respondent's state and the odds that the respondent (1) had been tested for HIV, and (2) was aware of methods to prevent mother-to-child HIV transmission (MTCT). RESULTS: The odds of having been tested for HIV increased with increased CDC funding to states (P=.009), as did awareness of prevention of MTCT (P=.002). We estimate that CDC HIV prevention funds led to 12.8 million more people being tested for HIV between 1998 and 2003 than would have been tested had all states received funds equal to the lowest quintile of funding. CONCLUSIONS: Federal HIV prevention funds independently correlate with increased HIV testing and knowledge of prevention of MTCT. Proposed reductions in HIV prevention spending would likely have adverse public health consequences.

AIDS Serodiagnosis↗

Beneficial and perverse effects of isoniazid preventive therapy for latent tuberculosis infection in HIV-tuberculosis coinfected populations.

In sub-Saharan Africa, where the emergence of HIV has caused dramatic increases in tuberculosis (TB) case notifications, new strategies for TB control are necessary. Isoniazid preventive therapy (IPT) for HIV-TB coinfected individuals reduces the reactivation of latent Mycobacterium tuberculosis infections and is being evaluated as a potential community-wide strategy for improving TB control. We developed a mathematical model of TB/HIV coepidemics to examine the impact of community-wide implementation of IPT for TB-HIV coinfected individuals on the dynamics of drug-sensitive and -resistant TB epidemics. We found that community-wide IPT will reduce the incidence of TB in the short-term but may also speed the emergence of drug-resistant TB. We conclude that community-wide IPT in areas of emerging HIV and drug-resistant TB should be coupled with diagnostic and treatment policies designed to identify and effectively treat the increasing proportion of patients with drug-resistant TB.

AIDS-Related Opportunistic Infections↗

Implementing a routine, voluntary HIV testing program in a Massachusetts county prison.

Although U.S. prison inmates have higher rates of HIV infection than the general population, most inmates are not routinely tested for HIV infection at prison entry. The study objective was to implement a routine, voluntary HIV testing program in a Massachusetts county prison. During admission, inmates were given group HIV pre-test counseling and were subsequently offered private HIV testing. This intervention was compared to a control period during which HIV testing was provided only upon inmate or physician request. Between November 2004 and April 2005, 1,004 inmates met inclusion criteria and were offered routine, voluntary HIV testing. Of these, 734 (73.1%) accepted, 2 (0.3%) were HIV-infected, and 457 (45.5%) had been tested for HIV in the previous year. The testing rate of 73.1% was significantly increased from the rate of 18.0% (318 of 1,723) during the control period (p<0.001). Among the inmates tested for HIV in the prior year, 78.2% had received their last HIV test in the prison setting. Careful attention should be paid to prevent redundancy of testing efforts in the prison population. Implementing a routine HIV testing program among prison inmates greatly increased testing rates compared to on-request testing.

Counseling↗

Refusing HIV testing in an urgent care setting: results from the "Think HIV" program.

Efforts to increase HIV case identification through routine, voluntary HIV testing are hindered by high refusal rates. Our objective was to identify patients most likely to refuse routine HIV testing. We developed a new HIV testing program at four Massachusetts urgent care centers. Patients were asked if they were interested in routine HIV testing. We performed analyses to assess differences in characteristics between those who refused testing and those who accepted it. Data were available for 9129/10,354 (88%) patients offered routine HIV testing from January to December 2002. Of these 9129 patients, 67% refused testing. In the crude analysis, HIV test refusal was associated with female gender, white race, older age, and higher educational level. In multivariate analysis, non-English-speaking patients who were Hispanic, Haitian, and other race were more likely to refuse testing than their English-speaking counterparts. Among all patients, "not at risk" and "already tested" were the most common reasons for test refusal. Two thirds of patients refused routine HIV testing when it was offered in a statewide urgent care-based program. If routine HIV testing programs are to be successful, strategies must be developed to increase HIV test acceptance among patients most likely to refrain from testing.

AIDS Serodiagnosis↗

The lifetime cost of current human immunodeficiency virus care in the United States.

OBJECTIVE: We sought to project the lifetime cost of medical care for human immunodefiency virus (HIV)-infected adults using current antiretroviral therapy (ART) standards. METHODS: Medical visits and hospitalizations for any reason were from the HIV Research Network, a consortium of high-volume HIV primary care sites. HIV treatment drug regimen efficacies were from clinical guidelines and published sources; data on other drugs used were not available. In a computer simulation model, we projected HIV medical care costs in 2004 U.S. dollars. RESULTS: From the time of entering HIV care, per person projected life expectancy is 24.2 years, discounted lifetime cost is Dollars 385,200, and undiscounted cost is Dollars 618,900 for adults who initiate ART with CD4 cell count < 350/microL. Seventy-three percent of the cost is antiretroviral medications, 13% inpatient care, 9% outpatient care, and 5% other HIV-related medications and laboratory costs. For patients who initiate ART with CD4 cell count < 200/microL, projected life expectancy is 22.5 years, discounted lifetime cost is Dollars 354,100 and undiscounted cost is Dollars 567,000. Results are sensitive to drug manufacturers' discounts, ART efficacy, and use of enfuvirtide for salvage. If costs are discounted to the time of infection, the discounted lifetime cost is Dollars 303,100. CONCLUSIONS: Effective ART regimens have substantially improved survival and have increased the lifetime cost of HIV-related medical care in the U.S.

AIDS-Related Opportunistic Infections↗

Should resistance testing be performed for treatment-naive HIV-infected patients? A cost-effectiveness analysis.

BACKGROUND: Data from the United States and Europe show a population prevalence of baseline drug resistance of 8%-10% among human immunodeficiency virus (HIV)-infected patients who are antiretroviral naive. Our objective was to determine the clinical impact and cost-effectiveness of genotype resistance testing for treatment-naive patients with chronic HIV infection. METHODS: We utilized a state-transition model of HIV disease to project life expectancy, costs, and cost-effectiveness in a hypothetical cohort of antiretroviral-naive patients with chronic HIV infection. On the basis of a US survey of treatment-naive patients from the Centers for Disease Control and Prevention, we used a baseline prevalence of drug resistance of 8.3%. RESULTS: A strategy of genotype-resistance testing at initial diagnosis of HIV infection increased per-person quality-adjusted life expectancy by 1.0 months, with an incremental cost-effectiveness ratio of 23,900 dollars per quality-adjusted life-year gained, compared with no genotype testing. The cost-effectiveness ratio for resistance testing remained less than 50,000 dollars per quality-adjusted life-year gained, unless the prevalence of resistance was < or =1%, a level lower than those reported in most regions of the United States and Europe. In sensitivity analyses, the cost-effectiveness remained favorable through wide variations in baseline assumptions, including variations in genotype cost, prevalence of resistance overall and to individual drug classes, and sensitivity of resistance testing. CONCLUSIONS: Genotype-resistance testing of chronically HIV-infected, antiretroviral-naive patients is likely to improve clinical outcomes and is cost-effective, compared with other HIV care in the United States. Resistance testing at the time of diagnosis should be the standard of care.

Adult↗

Clinical impact and cost-effectiveness of co-trimoxazole prophylaxis in patients with HIV/AIDS in Côte d'Ivoire: a trial-based analysis.

BACKGROUND: In 2000, WHO/UNAIDS recommended co-trimoxazole prophylaxis for persons at early stages of HIV infection (WHO stage > or = 2) in sub-Saharan Africa. OBJECTIVE: To assess the cost-effectiveness of alternative strategies for initiation of co-trimoxazole in Côte d'Ivoire. DESIGN: Cost-effectiveness analysis with an HIV simulation model using clinical and cost data from a randomized trial of co-trimoxazole in HIV-infected adults. METHODS: The study included HIV-infected patients in Côte d'Ivoire, with median age 33 years. Thirty-four percent were classified as WHO stage 2, 59% as stage 3, and 7% as stage 4. The mean CD4 cell count was 331 x 10(6) cells/l. The interventions were no prophylaxis, clinical criteria-based co-trimoxazole initiation (early: WHO stage > or = 2; late: WHO stage > or = 3), CD4-based co-trimoxazole initiation (< 500, < 200, < 50 x 10(6) CD4 cells/l). The outcome measures were life expectancy, lifetime costs, and incremental cost-effectiveness. RESULTS: The most effective strategy, initiation of co-trimoxazole prophylaxis at WHO stage > or = 2, increased undiscounted life expectancy by 5.2 months, discounted life expectancy by 4.4 months, and lifetime costs by US dollars 60, compared with no prophylaxis. Delaying prophylaxis initiation until WHO stage >or = 3 was less costly and less effective. All CD4-based strategies were dominated. The incremental cost-effectiveness of early versus late co-trimoxazole prophylaxis initiation was US dollars 200/year of life gained. Results were stable despite wide variations in plausible assumptions about bacterial resistance and the prophylaxis efficacy on co-trimoxazole-resistant strains. CONCLUSIONS: For HIV-infected adults in Côte d'Ivoire, co-trimoxazole prophylaxis is reasonably cost-effective and most effective if initiated when WHO stage > or = 2. Early co-trimoxazole prophylaxis will prevent complications prior to antiretroviral therapy initiation and should be considered an essential component of care for early HIV in sub-Saharan Africa.

AIDS-Related Opportunistic Infections↗

Cost-effectiveness of enfuvirtide in treatment-experienced patients with advanced HIV disease.

OBJECTIVE: Enfuvirtide (ENF) has been shown to improve short-term virologic responses when given to highly treatment-experienced patients with advanced HIV disease. Because of the high cost of ENF compared with other antiretroviral agents, our objectives were to determine the potential long-term clinical impact and cost-effectiveness of ENF in these patients. METHODS: We used a computer simulation model of HIV disease to project life expectancy, quality-adjusted life expectancy, cost, and cost-effectiveness of ENF in treatment-experienced patients. Input data were from the T-20 versus Optimized Regimen Only (TORO) 1 and 2 trials, 2 studies comparing ENF plus an optimized background regimen (OBR) with an OBR alone. RESULTS: ENF plus an OBR increased projected discounted quality-adjusted life expectancy from 45.4 months with an OBR alone to 54.9 months, a difference of 9.5 quality-adjusted life-months. At the current annual ENF cost of US 18,500 dollars per year (in 2001 US dollars), the incremental cost-effectiveness ratio for ENF plus an OBR was US 69,500 dollars per quality-adjusted life-year (QALY) compared with an OBR alone. When 48-week virologic suppression rates for ENF plus an OBR were varied from a 50% reduction to a 250% increase in the suppression rate attributable to ENF, gains in quality-adjusted life expectancy ranged from 4.5 to 25.9 quality-adjusted life-months compared with an OBR alone, with cost-effectiveness ratios ranging from US 97,900 dollars per QALY to US 52,300 dollars per QALY gained. If ENF is continued after the HIV RNA level returns to the pretreatment baseline, the cost-effectiveness ratio increases to US 168,200 dollars per QALY. CONCLUSIONS: In highly treatment-experienced patients, ENF plus an OBR provides substantial gains in quality-adjusted life expectancy compared with an OBR alone. Although ENF plus an OBR is less cost-effective than other commonly used interventions in HIV disease, its use may be justified, given the poor prognosis of these patients and their otherwise limited options for antiretroviral therapy.

Adult↗