Global HIV Programme
The WHO Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes leads the development and implementation of the global health sector strategy on the elimination of HIV as a public health threat.

Monitoring toxicity of antiretrovirals

With the rapid scale-up of antiretroviral therapy, and the increasing use of antiretrovirals to prevent HIV, the need to monitor toxicity of these drugs has increased substantially. Toxicity issues and adverse events associated with antiretrovirals are currently identified only intermittently and are not widely reported. Nevertheless, they are of critical importance when seeking to increase the impact of antiretroviral therapy.

Antiretroviral drug toxicity monitoring not only addresses toxicity associated with the long-term use of antiretrovirals for treatment, but also the adverse outcome associated with the use of antiretrovirals during pregnancy and breastfeeding, in infants and children, and by people who use them to prevent HIV infection, such as HIV negative individuals using pre-exposure prophylaxis (PreP) and among HIV serodiscordant couples.

WHO recommends that countries consider a combination of approaches to monitor antiretroviral drug toxicity and promote patient safety. This includes surveillance of safety in pregnancy, as well as active and routine toxicity monitoring in all populations, including adults, adolescents and children.

Webinar

25 November 2022 - WHO webinar on toxicity monitoring approaches for new antiretrovirals: strengthening country planning and implementation 2022 and 2023

Guidelines and technical documents

Consolidated guidelines on person-centred HIV strategic information: strengthening routine data for impact

As the HIV response moves to focusing on closing the remaining gaps in prevention, testing and treatment services, an evolution in the underlying routine...

Guidelines on long-acting injectable cabotegravir for HIV prevention

In this guideline, WHO recommends that long-acting injectable cabotegravir (CAB-LA) may be offered as an additional HIV prevention option for people...

Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach

These consolidated guidelines on HIV prevention, testing, treatment, service delivery  and monitoring bring together existing and new clinical and...

Surveillance of antiretroviral toxicity: global HIV, hepatitis and STIs programme: what's new in person-centred HIV patient and antiretroviral drug toxicity monitoring

In April 2020, new directions in global guidance for HIV strategic information and treatment monitoring were updated. This technical update outlines the...

WHO implementation tool for monitoring the toxicity of new antiretroviral and antiviral medicines in HIV and viral hepatitis programmes

In the current context of treatment being rapidly scaled up, prolonged exposure to ARV drugs and transition to new antiretroviral (ARV) drugs, ARV toxicity...

Implementation tool for pre-exposure prophylaxis of HIV infection - Monitoring and evaluation

WHO's oral pre-exposure prophylaxis (PrEP) implementation tool serves as practical toolkit on how to consider the introduction of PrEP and start implementation....

Meeting reports

Update on the transition to dolutegravir-based antiretroviral therapy

This technical report summarizes the discussions on the status of programmatic transition to tenofovir, lamivudine and dolutegravir (TLD) in low–...

Priorities for antiretroviral drug optimization in adults and children report of a CADO, PADO and HIVResNet joint meeting

The CADO-4 and the PADO-5 meetings were held virtually between September and October 2021 to promote alignment and synergy across these two expert groups...

Approaches to enhance and accelerate study of new drugs for HIV and associated infections in pregnant women

Multiple agencies and actors have voiced their concerns around the exclusion of pregnant women from clinical trials and the associated harm and risks of...

WHO think-tank meeting on optimizing antiretroviral therapy

On 12 March 2020,  WHO organized a think-tank meeting with people living with HIV, academics, researchers and key stakeholders to identify...

WHO Technical review meeting on country experiences in ARV toxicity surveillance

 WHO convened a technical review meeting in Geneva on 7 and 8 November 2013, on surveillance of antiretroviral (ARV) drug toxicity within antiretroviral...