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New WHO HIV recommendations on HIV ART treatment, prevention & infant feeding to improve health, reduce infections and save lives
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World AIDS Day 2009
30 November 2009 -- On the eve of World AIDS Day, WHO is releasing new recommendations on treatment, prevention and infant feeding in the context of HIV, based on the latest scientific evidence.
WHO now recommends earlier initiation of antiretroviral therapy (ART) for adults and adolescents, the delivery of more patient-friendly antiretroviral drugs (ARVs), and prolonged use of ARVs to reduce the risk of mother-to-child transmission of HIV. For the first time, WHO recommends that HIV-positive mothers or their infants take ARVs while breastfeeding to prevent HIV transmission.
"These new recommendations are based on the most up to date, available data," said Dr Hiroki Nakatani, Assistant Director General for HIV/AIDS, TB, Malaria and Neglected Tropical Diseases at the World Health Organization. "Their widespread adoption will enable many more people in high-burden areas to live longer and healthier lives."
An estimated 33.4 million people are living with HIV/AIDS, and there are some 2.7 million new infections each year. Globally, HIV/AIDS is the leading cause of mortality among women of reproductive age.
New treatment recommendations
In 2006, WHO recommended that all patients start ART when their CD4 count (a measure of immune system strength) falls to 200 cells/mm3 or lower, at which point they typically show symptoms of HIV disease. Since then, studies and trials have clearly demonstrated that starting ART earlier reduces rates of death and disease. WHO is now recommending that ART be initiated at a higher CD4 threshold of 350 cells/mm3 for all HIV-positive patients, including pregnant women, regardless of symptoms.
WHO also recommends that countries phase out the use of Stavudine, or d4T, because of its long-term, irreversible side-effects. Stavudine is still widely used in first-line therapy in developing countries due to its low cost and widespread availability. Zidovudine (AZT) or Tenofovir (TDF) are recommended as less toxic and equally effective alternatives.
The 2009 recommendations outline an expanded role for laboratory monitoring to improve the quality of HIV treatment and care. They recommend greater access to CD4 testing and the use of viral load monitoring when necessary. However, access to ART must not be denied if these monitoring tests are not available.
Preventing mother-to-child transmission and improving child survival
In 2006, WHO recommended that ARVs be provided to HIV-positive pregnant women in the third trimester (beginning at 28 weeks) to prevent mother-to-child transmission of HIV. At the time, there was insufficient evidence on the protective effect of ARVs during breastfeeding. Since then, several clinical trials have shown the efficacy of ARVs in preventing transmission to the infant while breastfeeding. The 2009 recommendations promote the use of ARVs earlier in pregnancy, starting at 14 weeks and continuing through the end of the breastfeeding period.
WHO now recommends that breastfeeding continue until the infant is 12 months of age, provided the HIV-positive mother or baby is taking ARVs during that period. This will reduce the risk of HIV transmission and improve the infant's chance of survival.
"In the new recommendations, we are sending a clear message that breastfeeding is a good option for every baby, even those with HIV-positive mothers, when they have access to ARVs," said Daisy Mafubelu, WHO's Assistant Director General for Family and Community Health.
National health authorities are encouraged by WHO to identify the most appropriate infant feeding practice (either breastfeeding with ARVs or the use of infant formula) for their communities. The selected practice should then be promoted as the single standard of care.
Related links
Rapid advice: antiretroviral therapy for HIV infection in adults and adolescents
Rapid advice: use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants
Rapid advice: WHO principles and recommendations on infant feeding in the context of HIV
Benefits and challenges
An earlier start to antiretroviral treatment boosts the immune system and reduces the risks of HIV-related death and disease. It also lowers the risk of HIV and TB transmission.
The new prevention of mother to child transmission (PMTCT) recommendations have the potential to reduce mother-to-child HIV transmission risk to 5% or lower. Combined with improved infant feeding practices, the recommendations can help to improve child survival.
The main challenge lies in increasing the availability of treatment in resource-limited countries. The expansion of ART and PMTCT services is currently hindered by weak infrastructure, limited human and financial resources, and poor integration of HIV-specific interventions within broader maternal and child health services.
The recommendations, if adopted, will result in a greater number of people needing treatment. The associated costs of earlier treatment may be offset by decreased hospital costs, increased productivity due to fewer sick days, fewer children orphaned by AIDS and a drop in HIV infections.
Another challenge lies in encouraging more people to receive voluntary HIV testing and counselling before they have symptoms. Currently, many HIV-positive people are waiting too long to seek treatment, usually when their CD4 count falls below 200 cells/mm3. However, the benefits of earlier treatment may also encourage more people to undergo HIV testing and counselling and learn their HIV status.
WHO, in collaboration with key partners, will provide technical support to countries to adapt, adopt and implement the revised guidelines. Implemented at a wide scale, WHO's new recommendations will improve the health of people living with HIV, reduce the number of new HIV infections and save lives.
They issued 8 recommendations:
Recommendation 1
When to start
1. Start antiretroviral treatment in all patients with HIV who have CD4 count <350 cells/mm3 irrespective of clinical
symptoms.
(Strong recommendation, moderate quality of evidence)
2. CD4 testing is required to identify if patients with HIV and WHO clinical stage 1 or 2 disease need to start antiretroviral
treatment.
(Strong recommendation, low quality of evidence)
3. Start antiretroviral treatment in all patients with HIV and WHO clinical stage 3 or 4 irrespective of CD4 count.
(Strong recommendation, low quality of evidence)
Recommendation 2
What to start
Start one of the following regimens in ART-naïve individuals eligible for treatment.
AZT + 3TC + EFV
AZT + 3TC + NVP
TDF + 3TC or FTC + EFV
TDF + 3TC or FTC + NVP
(Strong recommendation, moderate quality of evidence)
On the issue of progressive reduction in the use of d4T, in settings where d4T regimens are used as the principal option for starting ART,
countries should develop a plan to move towards AZT- or TDF-based first-line regimens, based on an assessment of the cost and feasibility. Systems to prevent, monitor and manage d4T-related toxicities should be implemented.
Recommendation 3
ART for HIV/tuberculosis co-infection
1. Start ART in all HIV-infected individuals with active tuberculosis (TB) irrespective of CD4 cell count.
(Strong recommendation, low quality of evidence)
2. Start TB treatment first, followed by ART as soon as possible after starting TB treatment.
(Strong recommendation, moderate quality of evidence)
3. Use efavirenz (EFV) as the preferred non-nucleoside reverse transcriptase inhibitor (NNRTI) in patients starting ART
while on TB treatment.
(Strong recommendation, high quality of evidence)
Recommendation 4
ART for HIV/HBV co-infection
1. Start ART in all HIV/HBV co-infected individuals who require treatment for their HBV infection, irrespective of CD4 cell
count or WHO clinical stage.
(Strong recommendation, low quality of evidence)
1. Start TDF and 3TC or FTC containing antiretroviral regimens in all HIV/HBV co-infected individuals needing treatment.
(Strong recommendation, moderate quality of evidence)
Remarks: In developing these recommendations, the panel placed high value on promoting HBV diagnosis and more effective treatment
of HIV/HBV co-infection.
Recommendation 5
ART for pregnant women
1. Start ART in all pregnant women with HIV and CD4 count <350 cells/mm3, irrespective of clinical symptoms.
(Strong recommendation, moderate quality of evidence)
2. CD4 testing is required to identify if pregnant women with HIV and WHO clinical stage 1 or 2 disease need to start
antiretroviral treatment or prophylaxis.
(Strong recommendation, low quality of evidence)
3. Start ART in all pregnant women with HIV and WHO clinical stage 3 or 4, irrespective of CD4 count.
(Strong recommendation, low quality of evidence)
4. Start one the following regimens in ART-naïve pregnant women eligible for treatment.
(Strong recommendation, moderate quality of evidence)
AZT + 3TC + EFV
AZT + 3TC + NVP
TDF + 3TC or FTC+ EFV
TDF + 3TC or FTC + NVP
5. Do not start EFV during the first-trimester of pregnancy.
(Strong recommendation, low quality of evidence)
Recommendation 6
When to switch ART
1. Where available, use viral load (VL) to confirm treatment failure.
(Strong recommendation, low quality of evidence)
2. Where routinely available, use VL every 6 months to detect viral replication.
(Conditional recommendation, low quality of evidence)
3. A persistent VL above 5 000 copies/ml confirms treatment failure.
(Conditional recommendation, low quality of evidence)
4. When VL is not available, use immunological criteria to confirm clinical failure.
(Strong recommendation, moderate quality of evidence)
Recommendation 7
Second-line ART
1. A boosted protease inhibitor (PI/r) plus two nucleoside analogues (NRTIs) are recommended for second-line ART.
(Strong recommendation, moderate quality of evidence)
2. ATV/r and LPV/r are the preferred boosted PI's for secondline ART.
(Strong recommendation, moderate quality of evidence)
3. Simplification of second NRTI options is recommended.
· If d4T or AZT has been used in first-line, use TDF + 3TC or FTC as the NRTI backbone in second-line.
· If TDF has been used in first-line, use AZT + 3TC as the NRTI backbone in second-line.
(Strong recommendation, moderate quality of evidence)
On the question of whether PI monotherapy could be used as secondline
ART, there is moderate quality of evidence from nine RCTs
and individual study reports showing less virological suppression
and higher rates of viral rebound for PI monotherapy compared to
standard triple ART regimens.17Ð22 The panel concluded that an NRTI
backbone should be maintained.
Recommendation 8
Third-line regimens
1. National programmes should develop policies for third-line therapy that consider funding, sustainability and the provision
of equitable access to ART.
(Conditional recommendation, low quality of evidence)
2. Third-line regimens should include new drugs likely to have anti HIV activity such as integrase inhibitors and second generation NNRTIs and PIs.
(Conditional recommendation, low quality of evidence)
3. Patients on a failing second-line regimen with no new ARV options, should continue with a tolerated regimen.
(Conditional recommendation, very low quality of evidence)
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