Understanding Genvoya's Potential Adverse Reactions and Strategies for Management
Genvoya is a brand-name drug used to treat HIV. It's a combination of four different medications: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide.
While common side effects of Genvoya include nausea, diarrhea, headache, and fatigue, it's important to be aware of the more serious adverse effects.
Kidney toxicity or worsening kidney function, including rare cases of acute renal failure and Fanconi syndrome, have been reported due to the tenofovir component. Bone mineral density loss is a concern with tenofovir-containing regimens, although tenofovir alafenamide (TAF) used in Genvoya is associated with an improved bone safety profile compared to tenofovir disoproxil fumarate (TDF). Lipid elevations including increases in total cholesterol, LDL (bad cholesterol), HDL (good cholesterol), and triglycerides have been observed in some treated patients.
If you have hepatitis B, you'll be tested for it before you begin taking Genvoya. The drug may cause liver problems, including hepatomegaly, dark urine, loss of appetite, pale stools, upper right abdominal pain, and jaundice (yellowing of your skin or the whites of your eyes). Worsening of hepatitis B can occur in people with hepatitis B infection and HIV who stop taking drugs containing emtricitabine or a different form of tenofovir.
Genvoya also has a boxed warning, the most serious warning from the Food and Drug Administration (FDA), due to the potential for serious side effects. These include new or worsening kidney disease, Fanconi syndrome, immune reconstitution syndrome, liver problems, high cholesterol, worsening of hepatitis B, depression, and increased risk of suicide.
Immune reconstitution syndrome (IRS) is a condition where your immune system reacts to infections that may already be present in your body. IRS can occur with Genvoya treatment. While some people taking Genvoya in clinical trials had increases in low-density lipoprotein (LDL) cholesterol and total cholesterol, the exact prevalence of this side effect is not clear.
If you develop a serious side effect while taking Genvoya, call your doctor right away. If you have symptoms of worsening hepatitis B, talk with your doctor. If you experience symptoms of liver problems, call your doctor right away. They'll likely order a blood test to check your liver function and to check for lactic acidosis or other liver issues.
For some people, Genvoya can cause an allergic reaction. If you've had a serious allergic reaction to Genvoya, your doctor may recommend taking a different medication instead.
While being treated with Genvoya, tests may be conducted to monitor cholesterol levels. If you or someone you know is in crisis and considering suicide or self-harm, seek support from the 988 Lifeline, Crisis Text Line, Befrienders Worldwide, or local emergency services.
Monitoring kidney function, bone health, and lipid levels is recommended during treatment with Genvoya to detect these rare but important adverse effects early. Discontinuations due to adverse events are relatively low, indicating that serious side effects are uncommon but important to monitor.
- The combination drug, Genvoya, used to treat HIV, includes a tenofovir component that might lead to unfavorable effects on bone health and kidney function, such as bone mineral density loss and rare cases of acute renal failure and Fanconi syndrome.
- People with a history of mental health issues should be aware that Genvoya has a boxed warning for potential side effects, including an increased risk of suicide and depression.
- Additionally, monitoring mental health, cholesterol levels, bone health, and kidney function is recommended during the treatment with Genvoya to catch any rare but serious adverse effects early, as discontinuations due to adverse events are relatively low.
