User login
A combination intervention that included standard of care antiretroviral therapy (ART), systems navigation, and psychosocial counseling showed success in HIV-infected people who inject drugs (PWID), according to the results of a randomized study in the Lancet.
The intervention patients showed an increase in both the use of ART and medication-assisted treatment (MAT) for drug use. In addition, they showed a reduced mortality, compared with standard-of-care controls. The study was carried out in one community site in the Ukraine and two health center sites in Vietnam.
A unique aspect of the study was that each HIV-positive PWID recruited one or more HIV-negative injection partners who were followed throughout the study to determine any change in their HIV status, according to a report by William C. Miller, MD, PhD, of the Ohio State University, Columbus, and his colleagues.
The study included 502 eligible and enrolled HIV-positive PWID along with 806 eligible and enrolled injection partners. The subjects comprised 85% men, with 65% of the participants between the ages of 30-39 years at time of enrollment. Patients were randomized to the intervention group (25%) or the standard of care–only group (75%).
At 1 year, self-reported ART use was higher among the index participants in the intervention group than in the standard of care group (probability ratio,1.7; 95% confidence interval, 1.4-1.9) and viral suppression also was higher with the intervention group than with standard of care (PR 1.7; 95% CI, 1.3-2.2). In addition, MAT use was higher with the intervention than with standard of care (PR, 1.7; 95% CI, 1.3-2.2). Seven HIV infections occurred during the study, all in the injection partners of the standard of care group, with none in the intervention group partners, but the study was not powered to determine if this was a significant difference.
Mortality was lower in the intervention group than in the standard of care group with 5.6 deaths/100 person-years (95% CI, 2.6-10.6) in the intervention group vs. 12.1 deaths/100 person-years (95% CI, 9.1-15.6) in the standard of care group (hazard ratio, 0.47; 95% CI 0.22-0.90). Similarly, mortality also was lower among injection partners in the intervention group than in the standard of care group (0.46 deaths/100 person-years; 95% CI, 0.01-2.6 vs. 2.6 deaths/100 person-years; 95% CI, 1.5-4.1, respectively (HR, 0.17; 95% CI, 0.01-0.84).
“This vanguard study provides evidence that a flexible, scalable intervention increases ART and MAT use and reduced mortality among PWID,” according to the authors. “The intervention might have reduced HIV incidence, but incidence was low in both groups of uninfected partners. This low incidence presents a challenge for any similar future trial assessing transmission and precludes a future randomized controlled trial,” they concluded.
The study was funded by the National Institutes of Health and the authors reported no conflicts of interest within the scope of the study.
SOURCE: Miller WC et al. Lancet 2018;392:747-59.
Although the study had unexpectedly low incidences of HIV infection in the standard of care population controls, which made it not powered to find a statistically significant difference in HIV incidence in the two groups, given the results, standard of care may be considered substandard in trials such as these, according to Don C. Des Jarlais, MD, and Huong Thi Duong, MD.
Because of this, “we propose that, when an incident case of HIV is identified, ART [antiretroviral therapy] and MAT [medication-assisted therapy] should be offered immediately, and all reasonable attempts should be made to identify potential sources of transmission and people who might have been infected within the person’s injecting and sexual networks,” in any future trials, “even if supplying ethically acceptable standard of care might make the study extremely expensive,” Dr. Des Jarlais and Dr. Duong wrote.
They pointed out that, because combined prevention and care have ended HIV epidemics among people who inject drugs (PWID) in high-income countries, the same should be the case for low- and middle-income settings, especially as MAT has been shown to be quite effective among these latter groups as well.
“Governments and community-based organizations should now unambiguously commit to the goal of using evidence-based interventions to end HIV epidemics among PWID globally,” Dr. Jarlais and Dr. Duong concluded.
Dr. Des Jarlais of the Icahn School of Medicine at Mount Sinai, N.Y., and Dr. Duong of Hai Phong (Vietnam) University of Medicine and Pharmacy made their comments in an accompanying editorial (Lancet 2018;392:714-6) .
Although the study had unexpectedly low incidences of HIV infection in the standard of care population controls, which made it not powered to find a statistically significant difference in HIV incidence in the two groups, given the results, standard of care may be considered substandard in trials such as these, according to Don C. Des Jarlais, MD, and Huong Thi Duong, MD.
Because of this, “we propose that, when an incident case of HIV is identified, ART [antiretroviral therapy] and MAT [medication-assisted therapy] should be offered immediately, and all reasonable attempts should be made to identify potential sources of transmission and people who might have been infected within the person’s injecting and sexual networks,” in any future trials, “even if supplying ethically acceptable standard of care might make the study extremely expensive,” Dr. Des Jarlais and Dr. Duong wrote.
They pointed out that, because combined prevention and care have ended HIV epidemics among people who inject drugs (PWID) in high-income countries, the same should be the case for low- and middle-income settings, especially as MAT has been shown to be quite effective among these latter groups as well.
“Governments and community-based organizations should now unambiguously commit to the goal of using evidence-based interventions to end HIV epidemics among PWID globally,” Dr. Jarlais and Dr. Duong concluded.
Dr. Des Jarlais of the Icahn School of Medicine at Mount Sinai, N.Y., and Dr. Duong of Hai Phong (Vietnam) University of Medicine and Pharmacy made their comments in an accompanying editorial (Lancet 2018;392:714-6) .
Although the study had unexpectedly low incidences of HIV infection in the standard of care population controls, which made it not powered to find a statistically significant difference in HIV incidence in the two groups, given the results, standard of care may be considered substandard in trials such as these, according to Don C. Des Jarlais, MD, and Huong Thi Duong, MD.
Because of this, “we propose that, when an incident case of HIV is identified, ART [antiretroviral therapy] and MAT [medication-assisted therapy] should be offered immediately, and all reasonable attempts should be made to identify potential sources of transmission and people who might have been infected within the person’s injecting and sexual networks,” in any future trials, “even if supplying ethically acceptable standard of care might make the study extremely expensive,” Dr. Des Jarlais and Dr. Duong wrote.
They pointed out that, because combined prevention and care have ended HIV epidemics among people who inject drugs (PWID) in high-income countries, the same should be the case for low- and middle-income settings, especially as MAT has been shown to be quite effective among these latter groups as well.
“Governments and community-based organizations should now unambiguously commit to the goal of using evidence-based interventions to end HIV epidemics among PWID globally,” Dr. Jarlais and Dr. Duong concluded.
Dr. Des Jarlais of the Icahn School of Medicine at Mount Sinai, N.Y., and Dr. Duong of Hai Phong (Vietnam) University of Medicine and Pharmacy made their comments in an accompanying editorial (Lancet 2018;392:714-6) .
A combination intervention that included standard of care antiretroviral therapy (ART), systems navigation, and psychosocial counseling showed success in HIV-infected people who inject drugs (PWID), according to the results of a randomized study in the Lancet.
The intervention patients showed an increase in both the use of ART and medication-assisted treatment (MAT) for drug use. In addition, they showed a reduced mortality, compared with standard-of-care controls. The study was carried out in one community site in the Ukraine and two health center sites in Vietnam.
A unique aspect of the study was that each HIV-positive PWID recruited one or more HIV-negative injection partners who were followed throughout the study to determine any change in their HIV status, according to a report by William C. Miller, MD, PhD, of the Ohio State University, Columbus, and his colleagues.
The study included 502 eligible and enrolled HIV-positive PWID along with 806 eligible and enrolled injection partners. The subjects comprised 85% men, with 65% of the participants between the ages of 30-39 years at time of enrollment. Patients were randomized to the intervention group (25%) or the standard of care–only group (75%).
At 1 year, self-reported ART use was higher among the index participants in the intervention group than in the standard of care group (probability ratio,1.7; 95% confidence interval, 1.4-1.9) and viral suppression also was higher with the intervention group than with standard of care (PR 1.7; 95% CI, 1.3-2.2). In addition, MAT use was higher with the intervention than with standard of care (PR, 1.7; 95% CI, 1.3-2.2). Seven HIV infections occurred during the study, all in the injection partners of the standard of care group, with none in the intervention group partners, but the study was not powered to determine if this was a significant difference.
Mortality was lower in the intervention group than in the standard of care group with 5.6 deaths/100 person-years (95% CI, 2.6-10.6) in the intervention group vs. 12.1 deaths/100 person-years (95% CI, 9.1-15.6) in the standard of care group (hazard ratio, 0.47; 95% CI 0.22-0.90). Similarly, mortality also was lower among injection partners in the intervention group than in the standard of care group (0.46 deaths/100 person-years; 95% CI, 0.01-2.6 vs. 2.6 deaths/100 person-years; 95% CI, 1.5-4.1, respectively (HR, 0.17; 95% CI, 0.01-0.84).
“This vanguard study provides evidence that a flexible, scalable intervention increases ART and MAT use and reduced mortality among PWID,” according to the authors. “The intervention might have reduced HIV incidence, but incidence was low in both groups of uninfected partners. This low incidence presents a challenge for any similar future trial assessing transmission and precludes a future randomized controlled trial,” they concluded.
The study was funded by the National Institutes of Health and the authors reported no conflicts of interest within the scope of the study.
SOURCE: Miller WC et al. Lancet 2018;392:747-59.
A combination intervention that included standard of care antiretroviral therapy (ART), systems navigation, and psychosocial counseling showed success in HIV-infected people who inject drugs (PWID), according to the results of a randomized study in the Lancet.
The intervention patients showed an increase in both the use of ART and medication-assisted treatment (MAT) for drug use. In addition, they showed a reduced mortality, compared with standard-of-care controls. The study was carried out in one community site in the Ukraine and two health center sites in Vietnam.
A unique aspect of the study was that each HIV-positive PWID recruited one or more HIV-negative injection partners who were followed throughout the study to determine any change in their HIV status, according to a report by William C. Miller, MD, PhD, of the Ohio State University, Columbus, and his colleagues.
The study included 502 eligible and enrolled HIV-positive PWID along with 806 eligible and enrolled injection partners. The subjects comprised 85% men, with 65% of the participants between the ages of 30-39 years at time of enrollment. Patients were randomized to the intervention group (25%) or the standard of care–only group (75%).
At 1 year, self-reported ART use was higher among the index participants in the intervention group than in the standard of care group (probability ratio,1.7; 95% confidence interval, 1.4-1.9) and viral suppression also was higher with the intervention group than with standard of care (PR 1.7; 95% CI, 1.3-2.2). In addition, MAT use was higher with the intervention than with standard of care (PR, 1.7; 95% CI, 1.3-2.2). Seven HIV infections occurred during the study, all in the injection partners of the standard of care group, with none in the intervention group partners, but the study was not powered to determine if this was a significant difference.
Mortality was lower in the intervention group than in the standard of care group with 5.6 deaths/100 person-years (95% CI, 2.6-10.6) in the intervention group vs. 12.1 deaths/100 person-years (95% CI, 9.1-15.6) in the standard of care group (hazard ratio, 0.47; 95% CI 0.22-0.90). Similarly, mortality also was lower among injection partners in the intervention group than in the standard of care group (0.46 deaths/100 person-years; 95% CI, 0.01-2.6 vs. 2.6 deaths/100 person-years; 95% CI, 1.5-4.1, respectively (HR, 0.17; 95% CI, 0.01-0.84).
“This vanguard study provides evidence that a flexible, scalable intervention increases ART and MAT use and reduced mortality among PWID,” according to the authors. “The intervention might have reduced HIV incidence, but incidence was low in both groups of uninfected partners. This low incidence presents a challenge for any similar future trial assessing transmission and precludes a future randomized controlled trial,” they concluded.
The study was funded by the National Institutes of Health and the authors reported no conflicts of interest within the scope of the study.
SOURCE: Miller WC et al. Lancet 2018;392:747-59.
FROM THE LANCET
Key clinical point: Mortality was lower in the intervention group and among their injection partners, compared with the standard of care group.
Major finding: Seven HIV infections occurred in injection partners of the standard-of-care group, with none in those of the intervention group, although this result was underpowered to detect significance.
Study details: Randomized, controlled vanguard study in 502 index HIV-infected participants and 806 uninfected injection partners in one Ukraine community site and two Vietnam health center sites.
Disclosures: The study was funded by the National Institutes of Health, and the authors reported no conflicts of interest within the scope of the study.
Source: Miller WC et al. Lancet 2018;392:747-59.