Elsevier

The Lancet

Volume 382, Issue 9899, 5–11 October 2013, Pages 1195-1203
The Lancet

Articles
Antiretroviral therapy to prevent HIV transmission in serodiscordant couples in China (2003–11): a national observational cohort study

https://doi.org/10.1016/S0140-6736(12)61898-4Get rights and content

Summary

Background

On the basis of the results of the randomised clinical trial HPTN 052 and observational studies, WHO has recommended that antiretroviral therapy be offered to all HIV-infected individuals with uninfected partners of the opposite sex (serodiscordant couples) to reduce the risk of transmission. Whether or not such a public health approach is feasible and the outcomes are sustainable at a large scale and in a developing country setting has not previously been assessed.

Methods

In this retrospective observational cohort study, we included treated and treatment-naive HIV-positive individuals with HIV-negative partners of the opposite sex who had been added to the national HIV epidemiology and treatment databases between Jan 1, 2003 and Dec 31, 2011. We analysed the annual rate of HIV infection in HIV-negative partners during follow-up, stratified by treatment status of the index partner. Cox proportional hazards analyses were done to examine factors related to HIV transmission.

Findings

Based on data from 38 862 serodiscordant couples, with 101 295·1 person-years of follow-up for the seronegative partners, rates of HIV infection were 2·6 per 100 person-years (95% CI 2·4–2·8) among the 14 805 couples in the treatment-naive cohort (median baseline CD4 count for HIV-positive partners 441 cells per μl [IQR 314–590]) and 1·3 per 100 person-years (1·2–1·3) among the 24 057 couples in the treated cohort (median baseline CD4 count for HIV-positive partners 168 cells per μl [62–269]). We calculated a 26% relative reduction in HIV transmission (adjusted hazard ratio 0·74, 95% CI 0·65–0·84) in the treated cohort. The reduction in transmission was seen across almost all demographic subgroups and was significant in the first year (0·64, 0·54–0·76), and among couples in which the HIV-positive partner had been infected by blood or plasma transfusion (0·76, 0·59–0·99) or heterosexual intercourse (0·69, 0·56–0·84), but not among couples in which the HIV-positive partner was infected by injecting drugs (0·98, 0·71–1·36).

Interpretation

Antiretroviral therapy for HIV-positive individuals in serodiscordant couples reduced HIV transmission across China, which suggests that the treatment-as-prevention approach is a feasible public health prevention strategy on a national scale in a developing country context. The durability and generalisability of such protection, however, needs to be further studied.

Funding

Chinese Government's 12th Five-Year Plan, the National Natural Science Foundation of China, and the Canadian International Development Research Centre.

Introduction

The beneficial role of antiretroviral therapy in reduction of mortality in people infected with HIV has been clearly shown.1, 2, 3, 4, 5 The additional role of antiretroviral therapy in reduction of HIV viral load and thereby prevention of transmission of HIV6, 7 in serodiscordant couples (in which one partner is HIV-positive and the other HIV-negative) was suggested by investigators of several observational studies8, 9, 10 and in 2011 was lent support by the results of the prospective, randomised clinical trial HPTN 052.11 Because of the strength of these studies, but despite the absence of evidence to show the feasibility and durability of such a public health approach on a national scale, WHO has issued guidelines recommending that antiretroviral therapy be offered to the HIV-positive partner from all serodiscordant couples, irrespective of CD4 cell count, to reduce the risk of HIV transmission.12

By the end of 2011, China had an estimated 780 000 people infected with HIV. Since the beginning of the national treatment programme in 2003, a cumulative total of 157 050 individuals have received antiretroviral therapy.13 One meta-analysis of studies in HIV serodiscordant couples from China reported an overall rate of 1·2 infections per 100 person-years (95% CI 0·9–1·7).14 However, these individual studies did not measure the effect of antiretroviral treatment on transmission, so the meta-analysis was also unable to analyse the effect of treatment. The investigators did, however, suggest that treatment was beneficial on the basis of a subanalysis that showed a decrease in rates of infection in the years after the scale-up of treatment (2005–11), compared with the years before treatment was available (1994–2004). In this study, our aim was to measure the effect of antiretroviral therapy on the transmission of HIV in serodiscordant couples across China, and thereby assess the feasibility and durability of such a treatment-as-prevention approach on a national scale in a developing country context.

Section snippets

Study design and procedures

All individuals in China who test HIV-positive are reported to the National Center for AIDS/STD Control and Prevention at the Chinese Center for Disease Control and Prevention (China CDC). Baseline data from these individuals, including demographic characteristics, route of infection, and CD4 cell count, are captured in the national HIV epidemiology database. The local CDC follows up individuals who report a spouse or regular sex partner with whom they cohabit, and tests them for HIV, with

Results

As of Dec 31, 2011, 444 712 HIV-positive individuals were recorded in China's national HIV epidemiology database. 56 726 of these individuals were identified as having an HIV serodiscordant spouse or cohabiting partner of the opposite sex at their baseline visit. 2607 couples were excluded because their epidemiology and treatment database records could not be matched, and a further 2883 couples were excluded because they had previously received treatment. Of the remaining couples, 26 180 had

Discussion

In this retrospective analysis of China's national HIV epidemiology and treatment databases from 2003 to 2011, which included 38 862 treatment-naive and treated HIV serodiscordant couples, we noted a 26% relative reduction in HIV infection in couples in which the index patient was treated for HIV (panel). The reduction in transmission was significant in the first year of follow-up and was seen across most baseline demographic characteristics, with a few exceptions.

Antiretroviral treatment as a

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