NEW HIV TREATMENT GUIDELINES

KUALA LUMPUR, Malaysia — The World Health Organization has unveiled its much-anticipated new HIV treatment guidelines. Officials say the new approach will prevent 3 million deaths by 2025 and will stop 3.5 million new infections.

"The WHO estimates that these new guidelines will have an unprecedented impact," director-general Margaret Chan, MD, told a packed room here at the 7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention.

An estimated 17 million people are eligible to take antiretroviral drugs, but under the new recommendations this number will increase to 26 million.

The approach reflects the growing body of evidence that treating patients earlier at higher CD4 cell counts, when immune systems are still largely intact, can greatly reduce mortality and prevent HIV transmission.

"Prior WHO guidelines had been for treatment at much later stages of disease," IAS president-elect Chris Beyrer, MD, professor and associate director for public health, Johns Hopkins Center for Global Health, Baltimore, Maryland, toldMedscape Medical News. "These revisions are based on our new understanding that earlier treatment can have a huge impact on the clinical care of the patient," he said. "It also turns out that it has a big impact on reducing tuberculosis morbidity and mortality, which is very important in the Asia-Pacific region and Africa."

The other critical improvement with these new recommendations, said Dr. Beyrer, is the reduction in HIV transmission. "This is a very important announcement, really. WHO guidelines play a normative roll — they're paid attention to by global ministers of health, and that really matters."

The new guidelines recommend starting antiretroviral therapy in all patients with a CD4 cell count of 500 cells/mm² or less. Other people should be started on antiretrovirals right away — regardless of CD4 counts — such as HIV-positive serodiscordant couples, patients with hepatitis-B coinfection, women pregnant or breast-feeding, and children younger than 5 years of age.

The recommendations call for new first-line antiretroviral regimens. Stavudine is currently being phased out as a first-line option for adults and adolescents.

First-Line Antiretroviral Regimens

Patients	Preferred First-Line Option	Alternate First-Line Option
Adults including pregnant and breastfeeding women and people with tuberculosis, hepatitis B coinfection	TDF + 3TC (or FTC) + EFV	AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + NVP
Adolescents age 10 to 19 years and >35 kg	TDF + 3TC (or FTC) + EFV	AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + NVP ABC + 3TC + EFV (or NVP)
Children age 3 to 9 years and adolescents <35 kg="" td="">	ABC + 3TC + EFV	ABC + 3TC + NVP AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + EFV TDF + 3TC (or FTC) + NVP
Children <3 td="" years="">	ABC or AZT + 3TC + LPV/r	ABC + 3TC + NVP AZT + 3TC + NVP
3TC: lamivudine ABC: abacavir AZT: zidovudine (also known as ZDV) EFV: efavirenz FTC: emtricitabine (Emtriva, Gilead) LPV/r: lopinavir/ritonavir (Kaletra/Aluvia, Abbott Laboratories) NVP: nevirapine (Viramune, Boehringer Ingelheim) TDF: tenofovir disoproxil fumarate (Viread, Gilead)

Viral load testing is the recommended approach to monitor the success of therapy or identify treatment failure.

Simple, safer, once-daily, single-pill antiretroviral regimens have become more affordable and more widely available in low- and middle-income countries, report the guideline authors. Countries are moving toward earlier initiation of triple-drug regimens and simplified programming for the prevention of mother-to-child transmission of HIV.

The complete guidelines are available online.

Dr. Chan and Dr. Beyrer have reported no relevant financial relationships.

The 7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. Presented June 30, 2013.