Articles tagged as "HIV Treatment"

Antiretroviral therapy dramatically reduces transmission of HIV to sexual partners

Antiretroviral therapy for the prevention of HIV-1 transmission.

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR. N Engl J Med. 2016 Jul 18. [Epub ahead of print]

Background: An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.

Methods: We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis.

Results: Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant.

Conclusions: The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581.).

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Editor’s notes: The HPTN 052 trial has been a landmark study in establishing antiretroviral therapy as a strategy for preventing onward transmission of HIV. It was a study of more than 800 couples. More than half of the couples were in African countries. In each couple, one sexual partner was HIV positive and the other HIV negative.  The participants living with HIV were randomised either to receive immediate antiretroviral therapy or to delay until their CD4 count fell to 350, an approved approach at that time. The HIV negative partners were then monitored for acquisition of HIV.  When new HIV infections occurred, the virus was studied for genetic similarity to the virus of the known positive partner. The interim analysis was published in 2011.  It illustrated the programme to be so effective that the randomisation was ended and all the participants living with HIV were offered antiretroviral therapy. 

This article presents data after five years of follow-up, and if anything the results are even more remarkable. In more than 10 000 person-years of follow up, there were only eight transmissions of genetically linked virus from participants receiving antiretroviral therapy. Of these transmissions, four occurred early in treatment when the viral load would not be expected to be suppressed.  The other four occurred after treatment failure. In this enormous study, there were therefore no linked transmissions from participants who were stable on treatment without detectable viraemia. The study provides powerful support for the UNAIDS 90-90-90 treatment target.  The widest possible effective use of antiretroviral therapy will not only improve the health of people treated but could have a dramatic effect on new HIV infections.

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Weekend breaks on efavirenz-based ART non-inferior in adolescents

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial.

Butler K, Inshaw J, Ford D, Bernays S, Scott K, Kenny J, Klein N, Turkova A, Harper L, Nastouli E, Paparini S, Choudhury R, Rhodes T, Babiker A, Gibb D. Health Technol Assess. 2016 Jun;20(49):1-108. doi: 10.3310/hta20490.

Background: For human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings.

Objectives: To determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy; CT). Secondary objectives included the occurrence of new clinical HIV events or death, changes in immunological status, emergence of HIV drug resistance, drug toxicity and changes in therapy.

Design: Open, randomised, non-inferiority trial.

Setting: Europe, Thailand, Uganda, Argentina and the USA.

Participants: Young people (aged 8-24 years) on EFV plus two nucleoside reverse transcriptase inhibitors and with a HIV-1 ribonucleic acid level [viral load (VL)] of < 50 copies/ml for > 12 months.

Interventions: Young people were randomised to continue daily ART (CT) or change to SCT (5 days on, 2 days off ART).

Main outcome measures: Follow-up was for a minimum of 48 weeks (0, 4 and 12 weeks and then 12-weekly visits). The primary outcome was the difference between arms in the proportion with VL > 50 copies/ml (confirmed) by 48 weeks, estimated using the Kaplan-Meier method (12% non-inferiority margin) adjusted for region and age.

Results: In total, 199 young people (11 countries) were randomised (n = 99 SCT group, n = 100 CT group) and followed for a median of 86 weeks. Overall, 53% were male; the median age was 14 years (21% ≥ 18 years); 13% were from the UK, 56% were black, 19% were Asian and 21% were Caucasian; and the median CD4% and CD4 count were 34% and 735 cells/mm3, respectively. By week 48, only one participant (CT) was lost to follow-up. The SCT arm had a 27% decreased drug exposure as measured by the adherence questionnaire and a MEMSCap Medication Event Monitoring System (MEMSCap Inc., Durham, NC, USA) substudy (median cap openings per week: SCT group, n = 5; CT group, n = 7). By 48 weeks, six participants in the SCT group and seven in the CT group had a confirmed VL > 50 copies/ml [difference -1.2%, 90% confidence interval (CI) -7.3% to 4.9%] and two in the SCT group and four in the CT group had a confirmed VL > 400 copies/ml (difference -2.1%, 90% CI -6.2% to 1.9%). All six participants in the SCT group with a VL > 50 copies/ml resumed daily ART, of whom five were resuppressed, three were on the same regimen and two with a switch; two others on SCT resumed daily ART for other reasons. Overall, three participants in the SCT group and nine in the CT group (p = 0.1) changed ART regimen, five because of toxicity, four for simplification reasons, two because of compliance issues and one because of VL failure. Seven young people (SCT group, n = 2; CT group, n = 5) had major non-nucleoside reverse transcriptase inhibitor mutations at VL failure, of whom two (n = 1 SCT group, n = 1 CT group) had the M184V mutation. Two young people had new Centers for Disease Control B events (SCT group, n = 1; CT group, n = 1). There were no significant differences between SCT and CT in grade 3/4 adverse events (13 vs. 14) or in serious adverse events (7 vs. 6); there were fewer ART-related adverse events in the SCT arm (2 vs. 14; p = 0.02). At week 48 there was no evidence that SCT led to increased inflammation using an extensive panel of markers. Young people expressed a strong preference for SCT in a qualitative substudy and in pre- and post-trial questionnaires. In total, 98% of the young people are taking part in a 2-year follow-up extension of the trial.

Conclusions: Non-inferiority of VL suppression in young people on EFV-based first-line ART with a VL of < 50 copies/ml was demonstrated for SCT compared with CT, with similar resistance, safety and inflammatory marker profiles. The SCT group had fewer ART-related adverse events. Further evaluation of the immunological and virological impact of SCT is ongoing. A limitation of the trial is that the results cannot be generalised to settings where VL monitoring is either not available or infrequent, nor to use of low-dose EFV. Two-year extended follow-up of the trial is ongoing to confirm the durability of the SCT strategy. Further trials of SCT in settings with infrequent VL monitoring and with other antiretroviral drugs such as tenofovir alafenamide, which has a long intracellular half-life, and/or dolutegravir, which has a higher barrier to resistance, are planned.

Trial registration: Current Controlled Trials ISRCTN97755073; EUDRACT 2009-012947-40; and CTA 27505/0005/001-0001.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (projects 08/53/25 and 11/136/108), the European Commission through EuroCoord (FP7/2007/2015), the Economic and Social Research Council, the PENTA Foundation, the Medical Research Council and INSERM SC10-US19, France, and will be published in full in Health Technology Assessment; Vol. 20, No. 49. See the NIHR Journals Library website for further project information.

Abstract  Full-text [free] access 

Editor’s notes: Adherence to ART has been shown to deteriorate in adolescence, with missed doses occurring particularly at weekends. Pharmacokinetic properties of some ART drugs, such as efavirenz, allow for a break in pill taking without a break in effective treatment. Non-inferiority trials evaluating five days on, two days off in adults have shown continuous ART to be non-inferior with low rates of virologic rebound.  This formed the rationale for this global, randomised Phase II/III trial in young people.

In the BREATHER trial, non-inferiority of viral suppression in adolescents on efavirenz-based first-line ART was shown for short-cycle treatment compared with continuous treatment. Overall 93% of adolescents remained virally suppressed. Findings from the two-year long-term follow-up phase will confirm if short-cycle treatment is effective and safe in this population.  Further studies are required to confirm the applicability of this strategy in real-life settings where viral load monitoring is likely to be less frequent than in a trial setting.

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Getting to 90-90-90 in China: where are the gaps?

Disparities in HIV care along the path from infection to viral suppression: a cross-sectional study of HIV/AIDS patient records in 2013, Shandong province, China.

Zhang N, Bussell S, Wang G, Zhu X, Yang X, Huang T, Qian Y, Tao X, Kang D, Wang N. Clin Infect Dis. 2016 Jul 1;63(1):115-21. doi: 10.1093/cid/ciw190. Epub 2016 Mar 29.

Background: The 90-90-90 targets recommended by the Joint United Nations Programme on HIV/AIDS require strengthening human immunodeficiency virus (HIV) care, which includes diagnosis, linkage to and retention in care, assessment for treatment suitability, and optimization of HIV treatment. We sought to quantify patient engagement along the continuum, 10 years after introduction of Chinese HIV care policies.

Methods: We included patients from Shandong, China, who were diagnosed with HIV from 1992 to 2013. Records were obtained from the HIV/AIDS Comprehensive Response Information Management System to populate a 7-step HIV care continuum. Pearson chi2 test and multivariate logistic regression were used for analysis.

Results: Of 6500 estimated HIV-infected persons, 60.1% were diagnosed, of whom 41.9% received highly active antiretroviral therapy (HAART). Only 59.6% of patients on HAART and 15% of all infected persons achieved viral suppression. Children infected by mother-to-child transmission (MTCT) and persons infected by intravenous drug use were less likely to be linked to and retained in care (odds ratio [OR], 0.33 [95% confidence interval {CI}, .14-.80] and OR, 0.58 [95% CI, .40-.90], respectively). Persons tested in custodial institutions were substantially less likely to be on HAART (OR, 0.22 [95% CI, .09-.59]) compared with those tested in medical facilities. Patients on HAART infected by homosexual or heterosexual transmission and those infected by MTCT were less likely to achieve viral suppression (OR, 0.18 [95% CI, .09-.34]; OR, 0.12 [95% CI, .06-.22]; OR, 0.07 [95% CI, .02-.20], respectively).

Conclusions: Our report suggests, at the current rate, Shandong Province has to accelerate HIV care efforts to close disparities in HIV care and achieve the 90-90-90 goals equitably.

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Editor’s notes: The UNAIDS treatment target set for 2020 aim for at least 90 percent of all people living with HIV to be diagnosed, at least 90 percent of people diagnosed to receive antiretroviral therapy, and for treatment to be effective and consistent enough in at least 90 percent of those people on treatment to suppress the virus. This would result in about 73% of all people living with HIV being virally suppressed.

This study estimated coverage of HIV diagnosis, antiretroviral treatment and viral suppression in Shandong Province in 2013, 10 years after the introduction of a Chinese HIV care policy.

The authors found that overall, only about 60% of people on ART and 15% of all people living with HIV achieved viral suppression (defined in this analysis as having a viral load of less than HIV RNA 50 copies per mL). This is in sharp contrast with recently published figures from Botswana where 97% of people on ART, and about 70% of persons living with HIV were virally suppressed (there defined as having a viral load of less than 400 copies per mL).

With only 15% of persons with HIV being virally suppressed in Shandong Province, a big gap remains for reaching the UNAIDS target of 73%. The authors demonstrate that despite a free, inclusive, nationwide HIV care policy, significant inequalities in HIV testing and treatment exist in Shandong Province. For example people who inject drugs and people in custodial institutions were much less likely to be initiated on ART.

The authors conclude that to achieve the 90-90-90 UNAIDS treatment target, Shandong Province needs to close these disparities in HIV care. 

Asia
China
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Showing they care: lay-counsellors, home-based testing and the value of follow-up support

How home HIV testing and counselling with follow-up support achieves high testing coverage and linkage to treatment and prevention: a qualitative analysis from Uganda.

Ware NC, Wyatt MA, Asiimwe S, Turyamureeba B, Tumwesigye E, van Rooyen H, Barnabas RV, Celum CL. J Int AIDS Soc. 2016 Jun 28;19(1):20929. doi: 10.7448/IAS.19.1.20929. eCollection 2016.

Introduction: The successes of HIV treatment scale-up and the availability of new prevention tools have raised hopes that the epidemic can finally be controlled and ended. Reduction in HIV incidence and control of the epidemic requires high testing rates at population levels, followed by linkage to treatment or prevention. As effective linkage strategies are identified, it becomes important to understand how these strategies work. We use qualitative data from The Linkages Study, a recent community intervention trial of community-based testing with linkage interventions in sub-Saharan Africa, to show how lay counsellor home HIV testing and counselling (home HTC) with follow-up support leads to linkage to clinic-based HIV treatment and medical male circumcision services.

Methods: We conducted 99 semi-structured individual interviews with study participants and three focus groups with 16 lay counsellors in Kabwohe, Sheema District, Uganda. The participant sample included both HIV+ men and women (N=47) and HIV-uncircumcised men (N=52). Interview and focus group audio-recordings were translated and transcribed. Each transcript was summarized. The summaries were analyzed inductively to identify emergent themes. Thematic concepts were grouped to develop general constructs and framing propositional statements.

Results: Trial participants expressed interest in linking to clinic-based services at testing, but faced obstacles that eroded their initial enthusiasm. Follow-up support by lay counsellors intervened to restore interest and inspire action. Together, home HTC and follow-up support improved morale, created a desire to reciprocate, and provided reassurance that services were trustworthy. In different ways, these functions built links to the health service system. They worked to strengthen individuals' general sense of capability, while making the idea of accessing services more manageable and familiar, thus reducing linkage barriers.

Conclusions: Home HTC with follow-up support leads to linkage by building "social bridges," interpersonal connections established and developed through repeated face-to-face contact between counsellors and prospective users of HIV treatment and male circumcision services. Social bridges link communities to the service system, inspiring individuals to overcome obstacles and access care.

Abstract  Full-text [free] access 

Editor’s notes: How can people be encouraged once they have received a positive HIV-test result to link and stay in treatment? This is a crucial question as the momentum for everyone living with HIV to be on antiretroviral therapy grows.  The authors of this paper demonstrate clearly and succinctly the value of personal contact in supporting people to test and the link to care. Lay-counsellors paying visits to people’s homes provided the encouragement to help some people to link to care. The home visits were seen by people visited as a sign that ‘someone cared’.  The personal attention and information provided promoted trust. The visits also created a sense of obligation: the person visited felt they should do something in return to please the counsellor.

Increasing numbers of people living with HIV does not necessarily mean that it is easier for someone coping with a positive-test result to link to care. We should not underestimate the continued burden that an HIV-positive test result places on individuals.  Many barriers remain both to testing and sustaining a link to care. The authors of this paper provide examples of how to overcome some of those barriers. However, while this paper provides encouraging findings on the value of the home-based activity, the findings also pose a challenge. Can such follow-up support services, which demand more than a single visit, be provided widely enough to benefit all people who need such attention and support? 

Africa
Uganda
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Patient navigators and financial incentives have no effect on HIV viral suppression in people with substance use disorders

Effect of patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use: a randomized clinical trial.  

Metsch LR, Feaster DJ, Gooden L, Matheson T, Stitzer M, Das M, Jain MK, Rodriguez AE, Armstrong WS, Lucas GM, Nijhawan AE, Drainoni ML, Herrera P, Vergara-Rodriguez P, Jacobson JM, Mugavero MJ, Sullivan M, Daar ES, McMahon DK, Ferris DC, Lindblad R, VanVeldhuisen P, Oden N, Castellon PC, Tross S, Haynes LF, Douaihy A, Sorensen JL, Metzger DS, Mandler RN, Colfax GN, del Rio C. JAMA. 2016 Jul 12;316(2):156-70. doi: 10.1001/jama.2016.8914.

Importance: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.

Objective: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.

Design, setting, and participants: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months.

Interventions: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment.

Main outcomes and measures: The primary outcome was HIV viral suppression (200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.

Results: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68).

Conclusions and relevance: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01612169.

Abstract access

Editor’s notes: Substance use in people living with HIV has consistently been shown to be associated with poor clinical outcomes. Within this population, management often requires a combination of treatment for both HIV and substance use disorders. It is evident that it is the poor engagement in one or both of these treatment approaches that contributes significantly to poor clinical outcomes. The author’s group aimed to fill a gap in current evidence and explore whether two activities, patient navigation and financial incentives, could potentially motivate engagement with both treatment approaches and ultimately improve HIV viral suppression.

This study tested, among people living with HIV in hospital,  with substance use disorders, six months of patient navigation alone (care co-ordination and case management), or six months of patient navigation alongside a financial incentive plan. While overall uptake and retention to the programme schedules were high, no differences in HIV-1 viral suppression rates (which were generally poor) or death by 12 months were noted.

One factor that must be highlighted is that the participation in actual substance use treatment programmes post hospital discharge was low across all groups (average 24.8%), primarily due to a lack of available services in the regions. It may be that the programme may have been more effective in a different population of people already established in substance use treatment programmes, or if treatment had been more easily accessible.

The study serves as a reminder that such key populations are extremely vulnerable with a number of comorbidities and competing priorities. While not supporting health care navigation or financial incentives in their defined setting, the study findings emphasise a need to develop and tailor, cost-effective activities to improve health outcomes in this group.

Northern America
United States of America
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Identifying important proximal epidemiological parameters for HIV prevention

Prospects for HIV control in South Africa: a model-based analysis.

Johnson LF, Chiu C, Myer L, Davies MA, Dorrington RE, Bekker LG, Boulle A, Meyer-Rath G. Glob Health Action. 2016 Jun 8;9:30314. doi: 10.3402/gha.v9.30314. eCollection 2016.

Background: The goal of virtual elimination of horizontal and mother-to-child HIV transmission in South Africa (SA) has been proposed, but there have been few systematic investigations of which interventions are likely to be most critical to reducing HIV incidence.

Objective: This study aims to evaluate SA's potential to achieve virtual elimination targets and to identify which interventions will be most critical to achieving HIV incidence reductions.

Design: A mathematical model was developed to simulate the population-level impact of different HIV interventions in SA. Probability distributions were specified to represent uncertainty around 32 epidemiological parameters that could be influenced by interventions, and correlation coefficients (r) were calculated to assess the sensitivity of the adult HIV incidence rates and mother-to-child transmission rates (2015-2035) to each epidemiological parameter.

Results: HIV incidence in SA adults (ages 15-49) is expected to decline from 1.4% in 2011-2012 to 0.29% by 2035 (95% CI: 0.10-0.62%). The parameters most strongly correlated with future adult HIV incidence are the rate of viral suppression after initiating antiretroviral treatment (ART) (r=-0.56), the level of condom use in non-marital relationships (r=-0.40), the phase-in of intensified risk-reduction counselling for HIV-positive adults (r=0.29), the uptake of medical male circumcision (r=-0.24) and the phase-in of universal ART eligibility (r=0.22). The paediatric HIV parameters most strongly associated with mother-to-child transmission rates are the relative risk of transmission through breastfeeding when the mother is receiving ART (r=0.70) and the rate of ART initiation during pregnancy (r=-0.16).

Conclusions: The virtual elimination target of a 0.1% incidence rate in adults will be difficult to achieve. Interventions that address the infectiousness of patients after ART initiation will be particularly critical to achieving long-term HIV incidence declines in South Africa.

Abstract  Full-text [free] access 

Editor’s notes: Despite substantial progress in controlling HIV in South Africa, incidence rates remain very high. There is a continued need to identify and prioritise HIV prevention programmes to improve the impact of existing programmes. A deterministic compartmental model was used to simulate the impact of HIV programmes in South Africa. The modeling study aimed at identifying proximal epidemiological parameters that are important in reducing HIV incidence. The authors of this paper also aimed to evaluate the possibility of achieving the ‘virtual elimination’ targets that have been suggested for both heterosexual and mother-to-child transmission and the UNAIDS 90-90-90 treatment target. The model was parameterised using behavioural and demographic data for South Africa.  The results from the study suggest that for the purpose of preventing heterosexual and mother-to-child transmission of HIV in South Africa, the most important proximal epidemiological parameter to focus on is the infectiousness of people receiving antiretroviral therapy. The model predicts that the virtual elimination target of a 0.1% incidence rate in adults will be difficult to achieve. The authors emphasized on the need to scale-up existing HIV prevention and treatment programmes in order to reduce HIV incidence in South Africa.

Africa
South Africa
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Immediate initiation of HIV treatment is cost-effective, but needs a large portion of health system spending

Changing HIV treatment eligibility under health system constraints in sub-Saharan Africa: Investment needs, population health gains, and cost-effectiveness.

Hontelez JA, Chang AY, Ogbuoji O, Vlas SJ, Barnighausen T, Atun R. AIDS. 2016 Jun 29. [Epub ahead of print]

Objective: We estimated the investment need, population health gains, and cost-effectiveness of different policy options for scaling-up prevention and treatment of HIV in the 10 countries that currently comprise 80% of all people living with HIV in sub-Saharan Africa (Ethiopia, Kenya, Malawi, Mozambique, Nigeria, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe).

Design: We adapted the established STDSIM model, to capture the health system dynamics: demand-side and supply-side constraints in the delivery of antiretroviral treatment (ART).

Methods: We compared different scenarios of supply-side (i.e. health system capacity) and demand-side (i.e. health seeking behavior) constraints, and determined the impact of changing guidelines to ART eligibility at any CD4 cell count within these constraints.

Results: Continuing current scale-up would require US$178 billion by 2050. Changing guidelines to ART at any CD4 cell count is cost-effective under all constraints tested in the model, especially in demand-side constrained health systems because earlier initiation prevents loss to follow-up of patients not yet eligible. Changing guidelines under current demand-side constraints would avert 1.8 million infections at US$208 per life-year saved.

Conclusions: Treatment eligibility at any CD4 cell count would be cost-effective, even under health system constraints. Excessive loss to follow up and mortality in patients not eligible for treatment can be avoided by changing guidelines in demand-side constrained systems. The financial obligation for sustaining the AIDS response in sub-Saharan Africa over the next 35 years is substantial, and requires strong, long-term commitment of policy makers and donors to continue to allocate substantial parts of their budgets.

Abstract access

Editor’s notes: Recent WHO guidelines recommend that everyone who is diagnosed as HIV positive should be allowed to start treatment immediately, a change to the former guideline where their CD4 count (a measure of disease progression) was the main criteria for starting treatment. This paper uses a model to look at the costs and benefits of changing to this immediate treatment regimen in the sub-Saharan African countries most affected by the epidemic. The authors find that allowing all HIV people living with HIV to access treatment is cost-effective, and this finding does not change when the model assumptions are varied. However, the impact of this change on the health system budgets in these countries is very substantial, and the authors suggest that a large commitment is necessary from policymakers and donors to sustain this response as short-term spending will not be enough to make an impact.

Africa
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Less than half of HIV-positive people identified through HBTC link to care in large community study in KwaZulu-Natal

 Access to HIV care in the context of universal test and treat: challenges within the ANRS 12249 TasP cluster-randomized trial in rural South Africa.

Plazy M, Farouki KE, Iwuji C, Okesola N, Orne-Gliemann J, Larmarange J, Lert F, Newell ML, Dabis F, Dray-Spira R. J Int AIDS Soc. 2016 Jun 1;19(1):20913. doi: 10.7448/IAS.19.1.20913. eCollection 2016.

Introduction: We aimed to quantify and identify associated factors of linkage to HIV care following home-based HIV counselling and testing (HBHCT) in the ongoing ANRS 12249 treatment-as-prevention (TasP) cluster-randomized trial in rural KwaZulu-Natal, South Africa.

Methods: Individuals ≥16 years were offered HBHCT; those who were identified HIV positive were referred to cluster-based TasP clinics and offered antiretroviral treatment (ART) immediately (five clusters) or according to national guidelines (five clusters). HIV care was also available in the local Department of Health (DoH) clinics. Linkage to HIV care was defined as TasP or DoH clinic attendance within three months of referral among adults not in HIV care at referral. Associated factors were identified using multivariable logistic regression adjusted for trial arm.

Results: Overall, 1323 HIV-positive adults (72.9% women) not in HIV care at referral were included, of whom 36.9% (n=488) linked to care <3 months of referral (similar by sex). In adjusted analyses (n=1222), individuals who had never been in HIV care before referral were significantly less likely to link to care than those who had previously been in care (<33% vs. >42%, p<0.001). Linkage to care was lower in students (adjusted odds-ratio [aOR]=0.47; 95% confidence interval [CI] 0.24-0.92) than in employed adults, in adults who completed secondary school (aOR=0.68; CI 0.49-0.96) or at least some secondary school (aOR=0.59; CI 0.41-0.84) versus ≤ primary school, in those who lived at 1 to 2 km (aOR=0.58; CI 0.44-0.78) or 2-5 km from the nearest TasP clinic (aOR=0.57; CI 0.41-0.77) versus <1 km, and in those who were referred to clinic after ≥2 contacts (aOR=0.75; CI 0.58-0.97) versus those referred at the first contact. Linkage to care was higher in adults who reported knowing an HIV-positive family member (aOR=1.45; CI 1.12-1.86) versus not, and in those who said that they would take ART as soon as possible if they were diagnosed HIV positive (aOR=2.16; CI 1.13-4.10) versus not.

Conclusions: Fewer than 40% of HIV-positive adults not in care at referral were linked to HIV care within three months of HBHCT in the TasP trial. Achieving universal test and treat coverage will require innovative interventions to support linkage to HIV care.

Abstract  Full-text [free] access 

Editor’s notes: The UNAIDS treatment target set for 2020 aims for at least 90 percent of all people living with HIV to be diagnosed, at least 90 percent of people diagnosed to receive antiretroviral therapy, and for treatment to be effective and consistent enough in at least 90 percent of people on treatment to suppress the virus. This would result in about 73% of all HIV-positive people being virally suppressed. 

This manuscript describes the linkage to care after being diagnosed HIV- positive during home based testing and counselling (HBTC) in a Treatment as Prevention trial in Kwazulu-Natal, South Africa. About 30% of consenting participants were HIV-positive. Some 43% of these participants were new diagnoses, 26% had previously been diagnosed but never accessed care, and about 31% had already accessed HIV care but dropped out of care. The authors found disappointingly low linkage proportions: fewer than 40% of participants diagnosed through HBTC accessed an HIV clinic within three months of referral. 

Although stigma is a commonly cited barrier to adherence, the authors did not find an association between perceived stigma and linkage to care. They did find that people with HIV-positive family members were more likely to access HIV care than people who did not, and suggest that this might be because they are more confident in disclosing their status and more likely to receive family support.

These findings are particularly relevant in the context of the results of the parent Treatment as Prevention trial, which were reported at the AIDS2016 conference in Durban. The trial found no effect on HIV incidence of offering immediate ART, mainly due to the low rates of linkage to care following HIV diagnosis. This underscores that while HBTC is useful to ensure that HIV-positive people know their status, further programmes are necessary to maximise the number of people linked to care and initiating ART.

Africa
South Africa
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Antiretroviral therapy: being reborn into uncertainty

What will become of me if they take this away? Zimbabwean women's perceptions of "free" ART.

Gona CM, McGee E, DeMarco R. J Assoc Nurses AIDS Care. 2016 May 13. pii: S1055-3290(16)30040-1. doi: 10.1016/j.jana.2016.05.001. [Epub ahead of print]

The evolution of antiretroviral therapies (ART) has redefined HIV infection from a life-threatening disease to a chronic manageable condition. Despite ART, HIV infection remains a serious health burden in Zimbabwe, particularly among women of reproductive age. In this interpretive phenomenology study, we interviewed 17 women with advanced HIV infection to uncover and understand their experiences of living with HIV infection in the ART era. Two themes (knowing the restorative power of ART and the heavy burden of being infected with HIV) reflected the women's experiences. ART brought physical and mental relief, but did not change the sobering reality of poverty or the challenges posed by the infective nature of HIV. The heavily donor-funded Zimbabwean ART program has been a success story, but there is uncertainty over its long-term sustainability. In resource-limited countries, clinicians and other stakeholders should continue to focus on HIV prevention as the cornerstone of HIV programming.

Abstract access

Editor’s notes: In Zimbabwe, as in much of sub-Saharan Africa, women are disproportionately affected by HIV infection. In 2013, women comprised 59% of adults living with HIV. Between 2007 and 2010, women accounted for 64% of people enrolled on ART in the country. Currently only 77% of women in clinical need of ART have access to it with most accessing it through a government and donor-funded ‘cost-free’ programme.  For women in Zimbabwe, living with HIV infection, normal life not only depends on the assurance of uninterrupted access to ART, but also the ability to get married and bear children.

The authors of this paper report on Zimbabwean women’s experiences of living with HIV infection while on ART. The study was nested within an ongoing clinical trial. Women were interviewed through in-depth, individual, face-to-face, open-ended interviews. 

The authors identify a number of important implications of the findings of this study. First, many women, in addition to concerns about their health, also had to contend with the effects of extreme poverty and gender inequality. For HIV treatment programmes to be successful, health care providers and policy makers should incorporate poverty reduction and gender equity components. Second, funding provisions should be put in place to ensure continued supplies of medications in order to reduce the reliance on external donor funding. Third, there is a need to clarify and strengthen policies regarding the continuation of treatment after the completion of a clinical trial to ensure participants’ continued access. Fourth, given the ability of ART to transform HIV into a chronic disease, reproductive health service provision should be prioritized to enable people living with HIV to have children if they wish. Further, and particularly in the light of these challenges, HIV prevention should be centralised as a focal point of HIV programming in order to reduce HIV incidence.

Africa
Zimbabwe
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Viral load testing is more cost-effective than CD4 testing

Laboratory monitoring of antiretroviral therapy for HIV infection: cost-effectiveness and budget impact of current and novel strategies.

Ouattara EN, Robine M, Eholie SP, MacLean RL, Moh R, Losina E, Gabillard D, Paltiel AD, Danel C, Walensky RP, Anglaret X, Freedberg KA. Clin Infect Dis. 2016 Jun 1;62(11):1454-62. doi: 10.1093/cid/ciw117. Epub 2016 Mar 1.

Background: Optimal laboratory monitoring of antiretroviral therapy (ART) for human immunodeficiency virus (HIV) remains controversial. We evaluated current and novel monitoring strategies in Cote d'Ivoire, West Africa.

Methods: We used the Cost-Effectiveness of Preventing AIDS Complications -International model to compare clinical outcomes, cost-effectiveness, and budget impact of 11 ART monitoring strategies varying by type (CD4 and/or viral load [VL]) and frequency. We included "adaptive" strategies (biannual then annual monitoring for patients on ART/suppressed). Mean CD4 count at ART initiation was 154/µL. Laboratory test costs were CD4=$11 and VL=$33. The standard of care (SOC; biannual CD4) was the comparator. We assessed cost-effectiveness relative to Cote d'Ivoire's 2013 per capita GDP ($1500).

Results: Discounted life expectancy was 16.69 years for SOC, 16.97 years with VL confirmation of immunologic failure, and 17.25 years for adaptive VL. Mean time on failed first-line ART was 3.7 years for SOC and <0.9 years for all routine/adaptive VL strategies. VL failure confirmation was cost-saving compared with SOC. Adaptive VL had an incremental cost-effectiveness ratio (ICER) of $4100/year of life saved compared with VL confirmation and increased the 5-year budget by $310/patient compared with SOC. Adaptive VL achieved an ICER <1x GDP if second-line ART and VL costs simultaneously decreased to $156 and $13, respectively.

Conclusions: VL confirmation of immunologic failure is more effective and less costly than CD4 monitoring in Cote d'Ivoire. Adaptive VL monitoring reduces time on failing ART, is cost-effective, and should become standard in Cote d'Ivoire and similar settings.

Abstract access 

Editor’s notes: Monitoring whether or not people are able to effectively use HIV antiretroviral therapy (ART) to supress viral load is important to maintaining individual and population health. There are two ways to monitor whether or not people are able to adhere to ART, assessing CD4 cell count or viral load. These tests require different amounts of expensive laboratory resources. This paper explores 11 ways in which ART regimens can be monitored in Cote d’Ivoire to assess the potential impact and cost-effectiveness of different strategies compared to current care (twice-yearly CD4 tests). The authors estimate that adding viral load failure confirmation to current practice would be cost saving. Adaptive viral load monitoring is found to be cost-effective. This approach involves decreasing monitoring from twice-annually to annually among people who present with suppressed viral loads for one year. In many countries, viral load monitoring is not generally available. This research is important because it illustrates that viral load monitoring strategies can be cost saving compared to CD4 counts, in line with WHO recommendations. 

Africa
Côte d'Ivoire
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