Reducing HIV Risk Of Breastfeeding With Three-Drug Prophylaxis

[Guest guest]

Reducing HIV Risk Of Breastfeeding With Three-Drug Prophylaxis

Article Date: 14 Jan 2011 - 0:00 PST

The risk of transmitting HIV to infants during breastfeeding can be halved with

a triple-drug regimen taken by mothers. These findings indicate that

prophylaxis* with a three-drug regimen can safely replace older regimens in

Africa, concludes the Article published Online first in Lancet Infectious

Diseases.

Breastfeeding is vital for child health and development in low-resource

settings, but infants born to HIV-positive mothers can be infected through

breastfeeding. So a team of researchers from the World Health Organization (WHO)

and five study sites in Burkina Faso, Kenya, and South Africa conducted a

randomized, controlled trial to investigate whether three antiretroviral (ARV)

drugs taken together by women during pregnancy and breastfeeding are more

effective than the standard regimen used to prevent mother-to-child HIV

transmission in these countries.

The Kesho Bora Study (meaning " a better future " in Swahili) enrolled

HIV-positive pregnant women with CD4 cell counts 200-500 cells/mm3.** 824 women

were randomly assigned to take either triple antiretroviral prophylaxis in late

pregnancy and during breastfeeding, or the standard recommended regimen at the

time. All infants received recommended drugs at and after birth. The study was a

collaboration between and funded by several national and international

institutions.***

The prophylaxis given to mothers was one of a combination of zidovudine (AZT),

lamivudine (3TC), and lopinavir boosted with ritonavir (LOP-r) twice daily

started at 28-34 weeks of pregnancy to a maximum of 6.5 months of breastfeeding;

or zidovudine (AZT) alone twice daily for a similar time period during pregnancy

plus single-dose nevirapine (NVP) during labour.

The cumulative rate of HIV transmission at 12 months of age was 43% lower with

the triple-drug regimen compared with the standard regimen (5.4% vs 9.5%,

p=0.02). The cumulative rate of infant HIV infection at age 6 weeks was not

significantly different between the groups, but the risk of transmission during

breastfeeding was 53% lower in the triple-drug group (2.2% vs. 4.7%, p=0•049).

The greatest reduction was among the infants of women with CD4 cell counts

200-350 cells/mm3. At 12 months of age, 10•2% of infants from mothers in the

triple-drug group had been infected with HIV or died compared with 16•0% of

infants from mothers taking the standard regimen (p=0.017).

The Kesho Bora investigators also report that the three-drug regimen and the

standard regimen were equally safe - no differences were found in serious

adverse events between the groups. The authors conclude that " triple-ARV

prophylaxis during pregnancy and continued during breastfeeding is safe and

reduces the risk of HIV-1 transmission to infants " .

Starting ARV prophylaxis earlier in pregnancy is more effective to reduce infant

HIV infection, so " women should be encouraged to plan pregnancies and attend

antenatal care sufficiently early " , to diagnose and assess maternal HIV

infection and start ARVs, say the authors. " However, for programmes to ensure

timely screening and staging, rapid access to antiretrovirals, and comprehensive

but rapid counselling to ensure good adherence to treatment or prophylaxis will

be a challenge. "

WHO guidelines were strongly influenced by the preliminary results of the Kesho

Bora study - the revised WHO guidelines now recommend long-term treatment for

all women with CD4 cell counts below 350 cells/mm3 and ARV prophylaxis (either

to the mother or to the child) for the whole period of breastfeeding if the

mother is not already receiving ARV treatment for her own health.

Click here to view Article and Comment

Notes

*Drugs taken to prevent HIV infection are known as antiretroviral (ARV)

prophylaxis.

** Women with CD4-cell counts 200-500 cells/mm3 only were included, which is a

critical group with immune-system impairment. Women with CD4 cell counts below

200 cells/mm3 were not included in the randomized trial as they were all given

ARV treatment for their own health.

*** Funding sources: Agence nationale de recherches sur le sida et les hépatites

virales (France), Department for International Development (UK), European and

Developing Countries Clinical Trials Partnership, Thrasher Research Fund,

Belgian Directorate General for International ation (Belgium), Centers for

Disease Control and Prevention (USA), Eunice Kennedy Shriver National Institute

of Child Health and Human Development (USA), and UNDP/UNFPA/World Bank/WHO

Special Programme of Research, Development and Research Training in Human

Reproduction.

Source: The Lancet

[Guest guest]

Reducing HIV Risk Of Breastfeeding With Three-Drug Prophylaxis

Article Date: 14 Jan 2011 - 0:00 PST

The risk of transmitting HIV to infants during breastfeeding can be halved with

a triple-drug regimen taken by mothers. These findings indicate that

prophylaxis* with a three-drug regimen can safely replace older regimens in

Africa, concludes the Article published Online first in Lancet Infectious

Diseases.

Breastfeeding is vital for child health and development in low-resource

settings, but infants born to HIV-positive mothers can be infected through

breastfeeding. So a team of researchers from the World Health Organization (WHO)

and five study sites in Burkina Faso, Kenya, and South Africa conducted a

randomized, controlled trial to investigate whether three antiretroviral (ARV)

drugs taken together by women during pregnancy and breastfeeding are more

effective than the standard regimen used to prevent mother-to-child HIV

transmission in these countries.

The Kesho Bora Study (meaning " a better future " in Swahili) enrolled

HIV-positive pregnant women with CD4 cell counts 200-500 cells/mm3.** 824 women

were randomly assigned to take either triple antiretroviral prophylaxis in late

pregnancy and during breastfeeding, or the standard recommended regimen at the

time. All infants received recommended drugs at and after birth. The study was a

collaboration between and funded by several national and international

institutions.***

The prophylaxis given to mothers was one of a combination of zidovudine (AZT),

lamivudine (3TC), and lopinavir boosted with ritonavir (LOP-r) twice daily

started at 28-34 weeks of pregnancy to a maximum of 6.5 months of breastfeeding;

or zidovudine (AZT) alone twice daily for a similar time period during pregnancy

plus single-dose nevirapine (NVP) during labour.

The cumulative rate of HIV transmission at 12 months of age was 43% lower with

the triple-drug regimen compared with the standard regimen (5.4% vs 9.5%,

p=0.02). The cumulative rate of infant HIV infection at age 6 weeks was not

significantly different between the groups, but the risk of transmission during

breastfeeding was 53% lower in the triple-drug group (2.2% vs. 4.7%, p=0•049).

The greatest reduction was among the infants of women with CD4 cell counts

200-350 cells/mm3. At 12 months of age, 10•2% of infants from mothers in the

triple-drug group had been infected with HIV or died compared with 16•0% of

infants from mothers taking the standard regimen (p=0.017).

The Kesho Bora investigators also report that the three-drug regimen and the

standard regimen were equally safe - no differences were found in serious

adverse events between the groups. The authors conclude that " triple-ARV

prophylaxis during pregnancy and continued during breastfeeding is safe and

reduces the risk of HIV-1 transmission to infants " .

Starting ARV prophylaxis earlier in pregnancy is more effective to reduce infant

HIV infection, so " women should be encouraged to plan pregnancies and attend

antenatal care sufficiently early " , to diagnose and assess maternal HIV

infection and start ARVs, say the authors. " However, for programmes to ensure

timely screening and staging, rapid access to antiretrovirals, and comprehensive

but rapid counselling to ensure good adherence to treatment or prophylaxis will

be a challenge. "

WHO guidelines were strongly influenced by the preliminary results of the Kesho

Bora study - the revised WHO guidelines now recommend long-term treatment for

all women with CD4 cell counts below 350 cells/mm3 and ARV prophylaxis (either

to the mother or to the child) for the whole period of breastfeeding if the

mother is not already receiving ARV treatment for her own health.

Click here to view Article and Comment

Notes

*Drugs taken to prevent HIV infection are known as antiretroviral (ARV)

prophylaxis.

** Women with CD4-cell counts 200-500 cells/mm3 only were included, which is a

critical group with immune-system impairment. Women with CD4 cell counts below

200 cells/mm3 were not included in the randomized trial as they were all given

ARV treatment for their own health.

*** Funding sources: Agence nationale de recherches sur le sida et les hépatites

virales (France), Department for International Development (UK), European and

Developing Countries Clinical Trials Partnership, Thrasher Research Fund,

Belgian Directorate General for International ation (Belgium), Centers for

Disease Control and Prevention (USA), Eunice Kennedy Shriver National Institute

of Child Health and Human Development (USA), and UNDP/UNFPA/World Bank/WHO

Special Programme of Research, Development and Research Training in Human

Reproduction.

Source: The Lancet