Journal of the International Association of Providers of AIDS Care, Aug 25, 2015
In this article, we sought to understand the perceptions and practice of providers on anal cancer... more In this article, we sought to understand the perceptions and practice of providers on anal cancer screening in HIV-infected patients. Providers in an academic outpatient HIV practice were surveyed. Data were analyzed to determine the acceptability and perceptions of providers on anal Papanicolaou tests. Survey response rate was 55.3% (60.7% among male and 47.4% among female providers). One-third of the providers had received screening requests from patients. Female providers had higher self-rated comfort with anal Papanicolaou tests, with a mean score of 7.1 (95% confidence interval [CI] 4.7-9.5) compared to 3.6 (95% CI 1.5-5.7) for male providers, P ¼ .02. Sixty-seven percent of male providers and 37.5% of female providers would like to refer their patients for screening rather than perform the test themselves. Only 54.2% of our providers have ever performed anal cytology examination. Our survey revealed that not all providers were comfortable performing anal cancer screening for their patients.
Acute upper gastrointestinal bleeding (UGIB) affects large number of elderly with high rates of m... more Acute upper gastrointestinal bleeding (UGIB) affects large number of elderly with high rates of morbidity and mortality. Early identification and management of the factors predicting in-hospital mortality might decrease mortality. This study was conducted to identify the causes of acute UGIB and the predictors of in-hospital mortality in elderly Egyptian patients. 286 elderly patients with acute UGIB were divided into: bleeding variceal group (161 patients) and bleeding nonvariceal group (125 patients). Patients' monitoring was done during hospitalization to identify the risk factors that might predict in-hospital mortality in elderly. Variceal bleeding was the most common cause of acute UGIB in elderly Egyptian patients. In-hospital mortality rate was 8.74%. Increasing age, hemodynamic instability at presentation, co-morbidities (especially liver cirrhosis associated with other co-morbidity) and failure to control bleeding were the predictors of in-hospital mortality. Increasing age, hemodynamic instability at presentation, co-morbidities (especially liver cirrhosis associated with other comorbidity) and failure to control bleeding should be considered when triaging those patients for immediate resuscitation, close observation, and early treatment. Abbreviations: ALT = alanine transferase, AST = aspartate aminotransferase, AUC = area under the curve, GAVE = gastric antral vascular ectasia, GI = gastrointestinal, Hb = hemoglobin, n = number, PHT = portal hypertension, ROC = receiver operating characteristic, SD = standard deviation, UGIB = upper gastrointestinal bleeding, WBCs = white blood cells.
Background With the advent of efficacious oral Direct-acting antivirals (DAAs) for hepatitis C vi... more Background With the advent of efficacious oral Direct-acting antivirals (DAAs) for hepatitis C virus(HCV), identification of characteristics associated with adherence is critical to treatment success. We examined correlates of sub-optimal adherence to HCV therapy in a single-arm, multinational, clinical trial. Methods ACTG A5360 enrolled HCV treatment-naïve persons without decompensated cirrhosis from 5 countries. All participants received a 12-weeks course of sofosbuvir/velpatasvir at entry. In-person visits occurred at initiation and week 24, sustained virologic response (SVR) assessment. Adherence at week 4 was collected remotely and was dichotomized optimal (100%, no missed doses) versus sub-optimal (<100%). Correlates of sub-optimal adherence were explored using logistic regression. Results 400 participants enrolled; 399 initiated treatment; 395/397 (99%) reported completing at week 24.. Median age was 47 years with 35% female. Among the 368 reporting optimal adherence at we...
BACKGROUND Despite widespread availability of direct-acting antivirals including generic formulat... more BACKGROUND Despite widespread availability of direct-acting antivirals including generic formulations, limited progress has been made in the global adoption of hepatitis C virus (HCV) treatment. Barriers to treatment scale-up include availability and access to diagnostic and monitoring tests, health-care infrastructure, and requirement for frequent visits during treatment. METHODS ACTG A5360 was a phase 4, open-label, single-arm trial across 38 sites in Brazil, South Africa, Thailand, Uganda, and the USA. Key inclusion criteria were age of 18 years or older, evidence of active HCV infection (HCV RNA >1000 IU/mL) and HCV treatment-naive; patients with compensated cirrhosis and HIV/HCV co-infection were included but their enrolment was capped. All participants received a fixed dose combination of oral sofosbuvir (400 mg) and velpatasvir (100 mg) once daily for 12 weeks. The minimal monitoring (MINMON) approach consisted of four components: (1) there was no pre-treatment genotyping; (2) the entire treatment course (84 tablets) was dispensed at entry; (3) there were no scheduled visits or laboratory monitoring; and (4) there were two points of remote contact, at week 4 for adherence and week 22, to schedule outcome assessment at week 24 (-2 weeks to +4 weeks). Participants who missed the week 24 window could return for a visit to assess treatment response any time before week 72. Unplanned visits for any reason were permissible before the week 24 visit. The primary efficacy outcome was sustained virological response (SVR), defined as HCV RNA less than the lower limit of quantification measured at least 22 weeks post-treatment initiation; the primary safety outcome was serious adverse events. The primary efficacy analysis included all participants who initiated treatment, using a missing=failure approach. The primary safety analysis included all participants who initiated treatment and had at least one post-treatment assessment. This trial is registered at ClinicalTrials.gov, NCT03512210. FINDINGS Between Oct 22, 2018, and July 19, 2019, 400 participants were enrolled across all 38 sites; 399 initiated treatment. At the SVR assessment visit, 355 (89%) of 397 participants reported taking 100% of the trial medication during the 12-week treatment period; two patients did not have any follow-up visits after the entry visit and were excluded from the safety analyses. Overall, 379 of the 399 who initiated treatment had an SVR (95·0%, 95% CI 92·4-96·7). 14 (4%) of 397 participants reported serious adverse events between treatment initiation and week 28; none were treatment related or led to treatment discontinuation or death. 15 (4%) of 399 participants had unplanned visits; none were related to treatment. INTERPRETATION In this diverse global population of people with HCV, the MINMON approach with sofosbuvir-velpatasvir treatment was safe and achieved SVR comparable to standard monitoring observed in real-world data. Coupled with innovative case finding strategies, this strategy could be crucial to the global HCV elimination agenda. FUNDING US National Institutes of Health and Gilead Sciences.
In 2016 the World Health Organization developed a plan for viral hepatitis elimination by 2030. G... more In 2016 the World Health Organization developed a plan for viral hepatitis elimination by 2030. Globally, control of Hepatitis B (HBV) and C (HCV) are the most challenging aspects of viral hepatitis elimination. In many developed countries elimination of HBV could be targeted to special populations mostly immigrants from low resource settings. Elimination of HCV however remains a challenge globally. Barriers to HCV elimination include high cost of medications and the ability to engage specific at-risk populations as well as individuals who are out of medical care. In the context of the COVID-19 pandemic, treatment access and screening has been further negatively impacted by social distancing rules and COVID-19 related anxieties. This threatens to throw most countries off course in their elimination efforts. Prior to the pandemic, some states in the US had had scaled up their elimination efforts with plans to ramp up testing and treatment using Netflix like payment models for HCV DAA...
Background Many pediatric and some adult people living with HIV (PLWH) are unable to swallow tabl... more Background Many pediatric and some adult people living with HIV (PLWH) are unable to swallow tablets and require alternative antiretroviral formulations (ARVF) such as liquids, chewable tablets, or powders for suspension. A growing number of issues with the timely procurement of alternative ARVF have been reported; the full scope of this problem is unknown. Without access to appropriate treatment, PLWH are at increased risk of poor disease outcomes. This study’s objective was to determine the scope of availability issues of ARVF and its potential impact on patient care. Methods An online survey invitation was sent to members of AAHIVM and the ACCP HIV PRN. Data collection included provider demographics, number of issues related to ARVF availability, time spent procuring ARVFs, and identification of unavailable formulations. To determine potential impact on clinical care and cost of care the time required to resolve shortages was summarized. Results The analyzable sample was 154, a m...
B63 In the USA, African Americans have a higher burden of certain cancers and tend to have poorer... more B63 In the USA, African Americans have a higher burden of certain cancers and tend to have poorer outcomes. We hypothesized that the observed disparity by ethnicity in outcomes of patients diagnosed with non-small cell lung cancer could be explained by socio-economic differences between ethnic groups. To identify the possible causes of these disparities we studied a cohort of 367 non-small cell lung cancer (NSCLC) patients diagnosed in a tertiary institution in a Metropolitan area in the State of Maryland from January 1st, 1990 to December 31st, 1992 67.6 % of the patients were white Caucasians and 32.4% were African American. Based on the median incomes of their census tract of residence, 89 patients were classified as low income and 278 as higher income. Survival analysis, chi-squared tests and Cox-regression were used to study the effects of socio-economic status (SES), marital status, and racial composition of census tracts on survival. Among Stage I patients, 5 year survival ...
Jaids Journal of Acquired Immune Deficiency Syndromes, Oct 1, 2014
Background: With improved access to antiretroviral therapy in resource-constrained settings, long... more Background: With improved access to antiretroviral therapy in resource-constrained settings, long-term retention in HIV clinics has become an important means of reducing costs and improving outcomes. Published data on retention in HIV clinics beyond 24 months are, however, limited. In our clinic in rural Haiti, we hypothesized that individuals residing in locations with higher transportation costs to clinic would have poorer retention than those who had lower costs. Methods: We used a retrospective cohort design to evaluate potential predictors of HIV clinic retention. Patient information was abstracted from the electronic medical records. Cox proportional hazards regression was used to identify independent predictors of 4-year clinic retention. Results: There were 410 patients in our cohort, 266 (64.9%) females and 144 (35.1%) males. Forty-five (11%) patients lived in locations with transportation costs .$2. Males were 1.5 times more likely to live in municipalities with transportation costs to clinic of .$2. Multivariate analysis suggested that age ,30 years, male gender, and transportation cost were independent predictors of loss to follow-up (LTFU):
Journal of the International Association of Providers of AIDS Care (JIAPAC)
People living with HIV are at high risk for anal cancer (AC); however, the impact of screening fo... more People living with HIV are at high risk for anal cancer (AC); however, the impact of screening for and treatment of precancerous anal lesions on AC incidence remains uncertain. In 2013, we conducted a survey of HIV providers evaluating the perceived need for an institutional AC screening program. Based on an overwhelmingly positive response, we established a dedicated AC screening clinic (including provision of high-resolution anoscopies) embedded within the institutional HIV clinic. Here, we describe that referral of high-risk patients in the first 3 years was lower than expected. Referral patterns suggest that screening practices vary widely among HIV providers within the institution. Anal cancer clinic patients who completed a perception survey rated the value of AC screening as high, with perceived positive health impact, and identified their providers as the main source of information on AC and AC screening. Our findings imply remaining provider-related barriers to AC screening.
Journal of the International Association of Providers of AIDS Care (JIAPAC), 2015
In this article, we sought to understand the perceptions and practice of providers on anal cancer... more In this article, we sought to understand the perceptions and practice of providers on anal cancer screening in HIV-infected patients. Providers in an academic outpatient HIV practice were surveyed. Data were analyzed to determine the acceptability and perceptions of providers on anal Papanicolaou tests. Survey response rate was 55.3% (60.7% among male and 47.4% among female providers). One-third of the providers had received screening requests from patients. Female providers had higher self-rated comfort with anal Papanicolaou tests, with a mean score of 7.1 (95% confidence interval [CI] 4.7-9.5) compared to 3.6 (95% CI 1.5-5.7) for male providers, P = .02. Sixty-seven percent of male providers and 37.5% of female providers would like to refer their patients for screening rather than perform the test themselves. Only 54.2% of our providers have ever performed anal cytology examination. Our survey revealed that not all providers were comfortable performing anal cancer screening for t...
Journal of the International Association of Providers of AIDS Care, Aug 25, 2015
In this article, we sought to understand the perceptions and practice of providers on anal cancer... more In this article, we sought to understand the perceptions and practice of providers on anal cancer screening in HIV-infected patients. Providers in an academic outpatient HIV practice were surveyed. Data were analyzed to determine the acceptability and perceptions of providers on anal Papanicolaou tests. Survey response rate was 55.3% (60.7% among male and 47.4% among female providers). One-third of the providers had received screening requests from patients. Female providers had higher self-rated comfort with anal Papanicolaou tests, with a mean score of 7.1 (95% confidence interval [CI] 4.7-9.5) compared to 3.6 (95% CI 1.5-5.7) for male providers, P ¼ .02. Sixty-seven percent of male providers and 37.5% of female providers would like to refer their patients for screening rather than perform the test themselves. Only 54.2% of our providers have ever performed anal cytology examination. Our survey revealed that not all providers were comfortable performing anal cancer screening for their patients.
Acute upper gastrointestinal bleeding (UGIB) affects large number of elderly with high rates of m... more Acute upper gastrointestinal bleeding (UGIB) affects large number of elderly with high rates of morbidity and mortality. Early identification and management of the factors predicting in-hospital mortality might decrease mortality. This study was conducted to identify the causes of acute UGIB and the predictors of in-hospital mortality in elderly Egyptian patients. 286 elderly patients with acute UGIB were divided into: bleeding variceal group (161 patients) and bleeding nonvariceal group (125 patients). Patients' monitoring was done during hospitalization to identify the risk factors that might predict in-hospital mortality in elderly. Variceal bleeding was the most common cause of acute UGIB in elderly Egyptian patients. In-hospital mortality rate was 8.74%. Increasing age, hemodynamic instability at presentation, co-morbidities (especially liver cirrhosis associated with other co-morbidity) and failure to control bleeding were the predictors of in-hospital mortality. Increasing age, hemodynamic instability at presentation, co-morbidities (especially liver cirrhosis associated with other comorbidity) and failure to control bleeding should be considered when triaging those patients for immediate resuscitation, close observation, and early treatment. Abbreviations: ALT = alanine transferase, AST = aspartate aminotransferase, AUC = area under the curve, GAVE = gastric antral vascular ectasia, GI = gastrointestinal, Hb = hemoglobin, n = number, PHT = portal hypertension, ROC = receiver operating characteristic, SD = standard deviation, UGIB = upper gastrointestinal bleeding, WBCs = white blood cells.
Background With the advent of efficacious oral Direct-acting antivirals (DAAs) for hepatitis C vi... more Background With the advent of efficacious oral Direct-acting antivirals (DAAs) for hepatitis C virus(HCV), identification of characteristics associated with adherence is critical to treatment success. We examined correlates of sub-optimal adherence to HCV therapy in a single-arm, multinational, clinical trial. Methods ACTG A5360 enrolled HCV treatment-naïve persons without decompensated cirrhosis from 5 countries. All participants received a 12-weeks course of sofosbuvir/velpatasvir at entry. In-person visits occurred at initiation and week 24, sustained virologic response (SVR) assessment. Adherence at week 4 was collected remotely and was dichotomized optimal (100%, no missed doses) versus sub-optimal (<100%). Correlates of sub-optimal adherence were explored using logistic regression. Results 400 participants enrolled; 399 initiated treatment; 395/397 (99%) reported completing at week 24.. Median age was 47 years with 35% female. Among the 368 reporting optimal adherence at we...
BACKGROUND Despite widespread availability of direct-acting antivirals including generic formulat... more BACKGROUND Despite widespread availability of direct-acting antivirals including generic formulations, limited progress has been made in the global adoption of hepatitis C virus (HCV) treatment. Barriers to treatment scale-up include availability and access to diagnostic and monitoring tests, health-care infrastructure, and requirement for frequent visits during treatment. METHODS ACTG A5360 was a phase 4, open-label, single-arm trial across 38 sites in Brazil, South Africa, Thailand, Uganda, and the USA. Key inclusion criteria were age of 18 years or older, evidence of active HCV infection (HCV RNA >1000 IU/mL) and HCV treatment-naive; patients with compensated cirrhosis and HIV/HCV co-infection were included but their enrolment was capped. All participants received a fixed dose combination of oral sofosbuvir (400 mg) and velpatasvir (100 mg) once daily for 12 weeks. The minimal monitoring (MINMON) approach consisted of four components: (1) there was no pre-treatment genotyping; (2) the entire treatment course (84 tablets) was dispensed at entry; (3) there were no scheduled visits or laboratory monitoring; and (4) there were two points of remote contact, at week 4 for adherence and week 22, to schedule outcome assessment at week 24 (-2 weeks to +4 weeks). Participants who missed the week 24 window could return for a visit to assess treatment response any time before week 72. Unplanned visits for any reason were permissible before the week 24 visit. The primary efficacy outcome was sustained virological response (SVR), defined as HCV RNA less than the lower limit of quantification measured at least 22 weeks post-treatment initiation; the primary safety outcome was serious adverse events. The primary efficacy analysis included all participants who initiated treatment, using a missing=failure approach. The primary safety analysis included all participants who initiated treatment and had at least one post-treatment assessment. This trial is registered at ClinicalTrials.gov, NCT03512210. FINDINGS Between Oct 22, 2018, and July 19, 2019, 400 participants were enrolled across all 38 sites; 399 initiated treatment. At the SVR assessment visit, 355 (89%) of 397 participants reported taking 100% of the trial medication during the 12-week treatment period; two patients did not have any follow-up visits after the entry visit and were excluded from the safety analyses. Overall, 379 of the 399 who initiated treatment had an SVR (95·0%, 95% CI 92·4-96·7). 14 (4%) of 397 participants reported serious adverse events between treatment initiation and week 28; none were treatment related or led to treatment discontinuation or death. 15 (4%) of 399 participants had unplanned visits; none were related to treatment. INTERPRETATION In this diverse global population of people with HCV, the MINMON approach with sofosbuvir-velpatasvir treatment was safe and achieved SVR comparable to standard monitoring observed in real-world data. Coupled with innovative case finding strategies, this strategy could be crucial to the global HCV elimination agenda. FUNDING US National Institutes of Health and Gilead Sciences.
In 2016 the World Health Organization developed a plan for viral hepatitis elimination by 2030. G... more In 2016 the World Health Organization developed a plan for viral hepatitis elimination by 2030. Globally, control of Hepatitis B (HBV) and C (HCV) are the most challenging aspects of viral hepatitis elimination. In many developed countries elimination of HBV could be targeted to special populations mostly immigrants from low resource settings. Elimination of HCV however remains a challenge globally. Barriers to HCV elimination include high cost of medications and the ability to engage specific at-risk populations as well as individuals who are out of medical care. In the context of the COVID-19 pandemic, treatment access and screening has been further negatively impacted by social distancing rules and COVID-19 related anxieties. This threatens to throw most countries off course in their elimination efforts. Prior to the pandemic, some states in the US had had scaled up their elimination efforts with plans to ramp up testing and treatment using Netflix like payment models for HCV DAA...
Background Many pediatric and some adult people living with HIV (PLWH) are unable to swallow tabl... more Background Many pediatric and some adult people living with HIV (PLWH) are unable to swallow tablets and require alternative antiretroviral formulations (ARVF) such as liquids, chewable tablets, or powders for suspension. A growing number of issues with the timely procurement of alternative ARVF have been reported; the full scope of this problem is unknown. Without access to appropriate treatment, PLWH are at increased risk of poor disease outcomes. This study’s objective was to determine the scope of availability issues of ARVF and its potential impact on patient care. Methods An online survey invitation was sent to members of AAHIVM and the ACCP HIV PRN. Data collection included provider demographics, number of issues related to ARVF availability, time spent procuring ARVFs, and identification of unavailable formulations. To determine potential impact on clinical care and cost of care the time required to resolve shortages was summarized. Results The analyzable sample was 154, a m...
B63 In the USA, African Americans have a higher burden of certain cancers and tend to have poorer... more B63 In the USA, African Americans have a higher burden of certain cancers and tend to have poorer outcomes. We hypothesized that the observed disparity by ethnicity in outcomes of patients diagnosed with non-small cell lung cancer could be explained by socio-economic differences between ethnic groups. To identify the possible causes of these disparities we studied a cohort of 367 non-small cell lung cancer (NSCLC) patients diagnosed in a tertiary institution in a Metropolitan area in the State of Maryland from January 1st, 1990 to December 31st, 1992 67.6 % of the patients were white Caucasians and 32.4% were African American. Based on the median incomes of their census tract of residence, 89 patients were classified as low income and 278 as higher income. Survival analysis, chi-squared tests and Cox-regression were used to study the effects of socio-economic status (SES), marital status, and racial composition of census tracts on survival. Among Stage I patients, 5 year survival ...
Jaids Journal of Acquired Immune Deficiency Syndromes, Oct 1, 2014
Background: With improved access to antiretroviral therapy in resource-constrained settings, long... more Background: With improved access to antiretroviral therapy in resource-constrained settings, long-term retention in HIV clinics has become an important means of reducing costs and improving outcomes. Published data on retention in HIV clinics beyond 24 months are, however, limited. In our clinic in rural Haiti, we hypothesized that individuals residing in locations with higher transportation costs to clinic would have poorer retention than those who had lower costs. Methods: We used a retrospective cohort design to evaluate potential predictors of HIV clinic retention. Patient information was abstracted from the electronic medical records. Cox proportional hazards regression was used to identify independent predictors of 4-year clinic retention. Results: There were 410 patients in our cohort, 266 (64.9%) females and 144 (35.1%) males. Forty-five (11%) patients lived in locations with transportation costs .$2. Males were 1.5 times more likely to live in municipalities with transportation costs to clinic of .$2. Multivariate analysis suggested that age ,30 years, male gender, and transportation cost were independent predictors of loss to follow-up (LTFU):
Journal of the International Association of Providers of AIDS Care (JIAPAC)
People living with HIV are at high risk for anal cancer (AC); however, the impact of screening fo... more People living with HIV are at high risk for anal cancer (AC); however, the impact of screening for and treatment of precancerous anal lesions on AC incidence remains uncertain. In 2013, we conducted a survey of HIV providers evaluating the perceived need for an institutional AC screening program. Based on an overwhelmingly positive response, we established a dedicated AC screening clinic (including provision of high-resolution anoscopies) embedded within the institutional HIV clinic. Here, we describe that referral of high-risk patients in the first 3 years was lower than expected. Referral patterns suggest that screening practices vary widely among HIV providers within the institution. Anal cancer clinic patients who completed a perception survey rated the value of AC screening as high, with perceived positive health impact, and identified their providers as the main source of information on AC and AC screening. Our findings imply remaining provider-related barriers to AC screening.
Journal of the International Association of Providers of AIDS Care (JIAPAC), 2015
In this article, we sought to understand the perceptions and practice of providers on anal cancer... more In this article, we sought to understand the perceptions and practice of providers on anal cancer screening in HIV-infected patients. Providers in an academic outpatient HIV practice were surveyed. Data were analyzed to determine the acceptability and perceptions of providers on anal Papanicolaou tests. Survey response rate was 55.3% (60.7% among male and 47.4% among female providers). One-third of the providers had received screening requests from patients. Female providers had higher self-rated comfort with anal Papanicolaou tests, with a mean score of 7.1 (95% confidence interval [CI] 4.7-9.5) compared to 3.6 (95% CI 1.5-5.7) for male providers, P = .02. Sixty-seven percent of male providers and 37.5% of female providers would like to refer their patients for screening rather than perform the test themselves. Only 54.2% of our providers have ever performed anal cytology examination. Our survey revealed that not all providers were comfortable performing anal cancer screening for t...
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Papers by Leonard Sowah