Treatment of sero discordant couples implications for young people
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TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE. JJ KUMWENDA (FRCP-UK). SYNOPSIS OF HPTN 052.

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TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE

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Treatment of sero discordant couples implications for young people

TREATMENT OF SERO-DISCORDANT COUPLES: IMPLICATIONS FOR YOUNG PEOPLE

JJ KUMWENDA (FRCP-UK)


Synopsis of hptn 052

SYNOPSIS OF HPTN 052

  • A randomized clinical trial to evaluate the effectiveness of Antiretroviral Therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in sero-discordant couples.


Study objectives

STUDY OBJECTIVES

  • Primary objective: To compare the rate of HIV infection among partners of HIV infected participants in two study arms

    • ARM 1: Antiretroviral therapy plus HIV primary care at time of enrolment

    • ARM 2: HIV primary care alone until the participant has two consecutive measurements of CD4 cell count below 250 cells/mm3 or develops an AIDS defining illness.


Study objectives1

STUDY OBJECTIVES

  • Evaluate the optimal time to begin antiretroviral therapy in order to reduce illness and death among people infected with HIV/AIDS.


Secondary objectives

Secondary objectives

  • Determine long term safety of ART

  • Characterize the pattern and rates of ART drug resistance

  • Assess factors associated with adherence to therapy

  • Evaluate effectiveness of couples counselling and characterize patterns of sexual behaviour in couples in both arms


Study design

Study design

  • Phase 3, two arms, randomized controlled multicenter clinical trial

  • Study population: HIV-1 sero-discordant couples in which the HIV infected partner is ART naive and has CD4 cell between 350 and 550 cells/mm3

  • Sample size: 1750 sero-discordant couples

  • Study arms: two arms, assigned 1:1 ratio.

    • ARM 1: ART at enrolment plus HIV primary care

    • ARM 2: HIV primary care alone until participant’s CD4 cell count falls below 250 on two consecutive times or develops an AIDS defining illness


Participating sites

PARTICIPATING SITES

  • Botswana: Gaborone

  • Brazil: 2 sites Porto Alegre and Rio de Janeiro

  • India: Chennai and PUNE

  • Kenya: Kisumu

  • Malawi: Blantyre and Lilongwe

  • South Africa: Johannesburg and Soweto

  • Thailand: Chiang Mai

  • USA: Massachusetts Boston

  • Zimbabwe: Harare


Results

Results

  • 1763 couples were enrolled from April 2005 to May 2010

  • 97% were heterosexual

  • Mean age was 33 years

  • Mean CD4 cell count at entry 436 cells/mm3 (364-522)


Dsmb findings in relation to hiv transmission

DSMB FINDINGS IN RELATION TO HIV TRANSMISSION

  • 39 cases of HIV transmission among previously uninfected partners

  • 28 transmissions were linked (i.e. The virus found in the infected partner did come from the index case)

  • 11 transmissions were not linked (virus found in the infected partner came from someone other than the partner registered in the study) or were still being analysed

  • 27 transmissions in the delayed arm versus 1 in the immediate arm

  • Over 96% reduction in HIV transmission in the immediate arm

  • HIV incidence as a whole in the study was lower than what was expected


Dsmb transmission in relation to benefits of starting art early

DSMB TRANSMISSION IN RELATION TO BENEFITS OF STARTING ART EARLY

  • 105 cases of ill health in total

  • 65 cases in delayed arm versus 40 in immediate arm

  • 17 cases of extrapulmonary TB in delayed arm compared to 3 in immediate arm

  • Deaths were 10 in immediate arm versus 13 in delayed arm


Issues when conducting 052

ISSUES WHEN CONDUCTING 052

  • Difficult to enrol young people (most go for HIV testing as couples but break up immediately if results are sero-discordant

  • Difficult to keep sero-discordant couples together. Required constant counselling

  • Keeping to schedule of events was a huge task


Issues related to young people

ISSUES RELATED TO YOUNG PEOPLE

  • HIV incidence highest in the 20-30 age group especially in women

  • 4.9% HIV prevalence in 15-24 year age group in Malawi more in girls 6.8% compared to 3.1% in boys

  • Trans-generational sex seems an important risk factor in girls

  • Only 42% Overall Knowledge in the adolescent age group about HIV prevention


What to with 052 results

What to with 052 results

  • Malawi to follow WHO recommendation to increase CD4 cell count threshold to 350 for initiating ART

  • Preparation underway to do district-wide door to door testing for couples. Uptake for HIV testing improves significantly on home testing

  • Increasing treatment threshold to 550 as was in 052 has both policy and resource implications

  • Governments normally follow WHO lead.


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