From the Guidelines
Biktarvy has a very low incidence of lactic acidosis, and it is not a major concern for most patients taking this medication. The incidence of lactic acidosis with Biktarvy is extremely low, estimated to be less than 1% of patients taking the medication, as it contains tenofovir alafenamide (TAF) rather than the older tenofovir disoproxil fumarate (TDF), which had a higher association with mitochondrial toxicity 1. Lactic acidosis occurs when the body produces excessive lactic acid due to mitochondrial dysfunction caused by nucleoside reverse transcriptase inhibitors (NRTIs), particularly older ones.
Some key points to consider about lactic acidosis and Biktarvy include:
- The estimated incidence of lactic acidosis is 1.3 cases/1000 person-years of NRTI exposure 1
- Symptoms of lactic acidosis include fatigue, nausea, vomiting, abdominal pain, difficulty breathing, and in severe cases, it can be life-threatening
- Patients with pre-existing liver disease, obesity, or female sex may have slightly higher risk 1
- Regular monitoring of symptoms and laboratory tests during Biktarvy therapy is recommended, especially in patients with risk factors, though routine lactic acid level monitoring is not required for most patients due to the low incidence 1
Given the low incidence of lactic acidosis with Biktarvy and the potential severity of the condition, it is essential to monitor patients for symptoms and laboratory abnormalities, particularly those with risk factors. However, the benefits of Biktarvy in treating HIV infection outweigh the risks of lactic acidosis for most patients.
From the Research
Lactic Acidosis Incidence with Biktarvy
- Lactic acidosis is a rare but documented adverse effect of nucleoside reverse transcriptase inhibitors (NRTIs) present in Biktarvy 2.
- The incidence of lactic acidosis with Biktarvy is not well-established, but it is thought to be related to mitochondrial impairment caused by NRTIs 2.
- A case study reported a patient who developed persistent lactic acidosis despite clinical improvement while taking an inappropriately high dosage of Biktarvy 2.
- The patient's lactic acidosis resolved after Biktarvy was temporarily held, highlighting the importance of maintaining wide differentials for lactic acidosis and thorough medication reconciliation 2.
Biktarvy Efficacy and Safety
- Biktarvy has demonstrated efficacy as treatment for both anti-retroviral naïve and virologically suppressed HIV-1 infection in patients switching therapy 3.
- The efficacy of Biktarvy in clinical practice is comparable to phase III trials, but adverse effects and discontinuation rates were found to be higher in real-world studies 4.
- Biktarvy was non-inferior to dolutegravir-containing regimens for efficacy and safety in two randomized, double-blind, multicenter, phase 3, non-inferiority trials 5.
- The long-term data support the use of Biktarvy as a safe, well-tolerated, and durable treatment for people with HIV, with no emergent resistance 5.
Real-World Evidence and Future Prospects
- Real-world studies on the use of Biktarvy in clinical practice have shown more demographic diversity compared to drug approval trials, but further prospective studies are required on under-represented groups 4.
- Biktarvy is recommended as initial and long-term therapy for the treatment of HIV infection, according to recent HIV guidelines 6.
- The development of a long-acting once-monthly regimen using a novel nano-formulation of Biktarvy is a potential future prospect 6.