jules levin, NATAP: WHO new ART guidlines (0096)

Rapid advice: antiretroviral therapy for HIV infection in adults and adolescents

On the eve of World AIDS Day, the World Health Organization (WHO) released 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.

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

a. 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)

b. 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

a. Start ART in all pregnant women with HIV and CD4 count <350 cells/mm3, irrespective of clinical symptoms.

(Strong recommendation, moderate quality of evidence)

b. 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)

c. 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)

d. 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

e. Do not start EFV during the first-trimester of pregnancy.

(Strong recommendation, low quality of evidence)

Recommendation 6

When to switch ART

a. Where available, use viral load (VL) to confirm treatment failure.

(Strong recommendation, low quality of evidence)

b. Where routinely available, use VL every 6 months to detect viral replication.

(Conditional recommendation, low quality of evidence)

c. A persistent VL above 5 000 copies/ml confirms treatment failure.

(Conditional recommendation, low quality of evidence)

d. When VL is not available, use immunological criteria to confirm clinical failure.

(Strong recommendation, moderate quality of evidence)

Recommendation 7

Second-line ART

a. A boosted protease inhibitor (PI/r) plus two nucleoside analogues (NRTIs) are recommended for second-line ART.

(Strong recommendation, moderate quality of evidence)

b. ATV/r and LPV/r are the preferred boosted PI’s for secondline ART.

(Strong recommendation, moderate quality of evidence)

c. 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.17–22 The panel concluded that an NRTI backbone should be maintained.

Recommendation 8

Third-line regimens

a. 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)

b. 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)

c. 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)

Rapid advice – English [pdf 305kb]

Key messages – English [pdf 259kb]


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