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  1. 1
    Peer Reviewed

    Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial.

    Iwuji CC; Orne-Gliemann J; Tanser F; Boyer S; Lessells RJ; Lert F; Imrie J; Barnighausen T; Rekacewicz C; Bazin B; Newell ML; Dabis F

    Trials. 2013; 14:230.

    BACKGROUND: Antiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial's secondary outcomes. METHODS/DESIGN: A cluster-randomised trial in 34 (2 x 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 x 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/muL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters. DISCUSSION: We aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability. TRIAL REGISTRATION: NCT01509508; South African Trial Register: DOH-27-0512-3974.
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  2. 2

    Global report: UNAIDS report on the global AIDS epidemic 2013.

    Joint United Nations Programme on HIV / AIDS [UNAIDS]

    Geneva, Switzerland, UNAIDS, 2013. [198] p.

    The 2013 report on the global AIDS epidemic contains the latest data on numbers of new HIV infections, numbers of people receiving antiretroviral treatment, AIDS-related deaths and HIV among children. This report, which follows the endorsement of the 2011 United Nations Political Declaration on HIV and AIDS outlining global targets to achieve by 2015, summarizes progress towards 10 key targets and reviews commitments and future steps. While recognizing significant achievements, UNAIDS warns of slowing progress in meeting some targets. In 2012, there were 35 million people living with HIV (PLHIV), and 2.3 million new infections-a 33 percent decrease from 2001, including significant reductions in new infections among children. More people than ever are on antiretroviral therapy (ART). Twenty-six countries have achieved the global target of halving sexual HIV transmission by 2015, but other countries are not on track to meet this target, hence the need to enhance prevention efforts. Globally, countries have made limited progress in reducing HIV transmission by 50 percent among people who inject drugs. While ART coverage is high, and approaching the target of 15 million PLHIV on treatment, coverage in low- and middle-income countries represented only 34 percent of 28 million eligible PLHIV in 2013. Stigma, discrimination and criminalization towards PLHIV continue; specifically, 60 percent of countries report laws that inhibit access to HIV services by key populations. The results of this report should be used by countries to refocus and maintain their commitments. The authors urged strengthened global commitment to achieve the goal of zero new HIV infections, discrimination, and AIDS-related deaths.
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  3. 3
    Peer Reviewed

    Access to HIV drugs should be widened, says WHO.

    Gulland A

    BMJ. 2013; 347:f4172.

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  4. 4

    Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for a public health approach.

    World Health Organization [WHO]. Department of HIV / AIDS; Joint United Nations Programme on HIV / AIDS [UNAIDS]

    Geneva, Switzerland, WHO, 2013. [272] p.

    The 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection provide new guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the care of people living with HIV and the use of antiretroviral (ARV) drugs for treating and preventing HIV infection.
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  5. 5

    Scaling up antiretroviral therapy in resource-limited settings: adapting guidance to meet the challenges.

    Vitoria M; Vella S; Ford N

    Current Opinion In HIV and AIDS. 2013 Jan; 8(1):12-8.

    PURPOSE OF REVIEW: This review describes the evolution of WHO guidelines for antiretroviral therapy (ART) in HIV-infected individuals, considering the key epidemiological, scientific, programmatic, and political changes over the last decade, and highlights the major trends for the management of the HIV disease in future guidelines revisions. RECENT FINDINGS: In the last few years, new evidence has emerged supporting the potential preventive benefit of ART in reducing HIV transmission. This, together with the potential clinical benefits of earlier initiation of therapy, has led to the consideration of the broader strategic use of ART, taking into account the clinical and public health benefit, and programmatic feasibility. SUMMARY: In 2002, WHO established its first guidelines for ART use, primarily focused on a public health approach for resource-limited settings. These recommendations were updated in 2003, 2006, and 2010, incorporating progressive changes reflecting progressive increase in the knowledge of HIV pathogenesis, development of new drugs and diagnostics, and increased experience of HIV treatment and prevention programs. The impact of several international political commitments and scale-up initiatives such as the 3 by 5 Initiative, Universal Access targets, and the Treatment 2.0 Strategy were also important drivers of the global response, increasing the treatment coverage and catalyzing the necessary environment for the establishment of operational and programmatic components for an expanded and sustainable global response to HIV/AIDS.
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