A caution has been issued by the European Medicines Agency and the US FDA regarding hepatic issues concerning darunavir. About 0.5% of patients taking darunavir/ritonavir during its clinical development were diagnosed with drug-induced hepatitis. Patients with pre-existing liver problems, including hepatitis B or hepatitis C infection, had a greater risk of developing such a complication. No adjustment in the dose of DRV/r is recommended for patients with mild or moderate liver problems, but the US product label now notes that the drug is not recommended for patients with severe liver problems.

Liver function should be monitored in all patients before treatment with darunavir/ritonavir is started, and monitoring of ALT/AST levels should be increased in patients with pre-existing liver problems during the first few months of therapy with the drug. If a patient experiences a worsening of their liver function, or if they develop symptoms suggestive of drug-induced hepatitis (tiredness, weight loss, nausea, yellowing of the skin, dark urine, pain in the liver, or an enlarged liver) doctors are recommended to consider either interrupting or stopping treatment with the DRV/r.

In the POWER studies, side-effects were mild to moderate, and were similar across all doses of darunavir. The commonest side-effects were diarrhoea, nausea, and headache, but these were less common in the darunavir arms than in patients taking the comparator protease inhibitor.1 2 Around 7% of patients also experienced skin rash, which was serious in a few cases .


  1. Grinsztejn B et al. TMC114/ritonavir is well tolerated in 3-class-experienced patients: week 24 primary analysis of POWER 1 (TMC114-C213). Third International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, abstract WeOaLB6, 2005
  2. Lazzarin A et al. TMC114 provides durable viral load suppression in treatment-experienced patients: POWER 1 and 2 combined 48 week analysis. 16th International AIDS Conference, Toronto, abstract TuAb0104, 2006
Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap

This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.