gravir, emtricitabine or tenofovir alafenamide on mating or fertility (see section 5.3).
4.7 Effects on ability to drive and use machines
Patients should be informed that dizziness has been reported during treatment with the components of Biktarvy (see section 4.8).
4.8 Undesirable effects
Summary of the safety profile
The assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies with Biktarvy. In clinical studies of treatment-naive patients receiving Biktarvy through 48 weeks, the most frequently reported adverse reactions were headache (5%), diarrhoea (5%) and nausea (4%).
Tabulated summary of adverse reactions
The adverse reactions in Table 2 are listed by system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Table 2: Tabulated list of adverse reactions1
Frequency
Adverse reaction
Blood and lymphatic system disorders
Uncommon:
anaemia2
Psychiatric disorders
Common:
depression, abnormal dreams
Uncommon:
suicidal behaviour, anxiety, sleep disorders
Nervous system disorders
Common:
headache, dizziness
Gastrointestinal disorders
Common:
diarrhoea, nausea
Uncommon:
vomiting, abdominal pain, dyspepsia, flatulence
Hepatobiliary disorders
Uncommon:
hyperbilirubinaemia
Skin and subcutaneous tissue disorders
Uncommon:
angioedema2,3, rash, pruritus
Musculoskeletal and connective tissue disorders
Uncommon:
arthralgia3
General disorders and administration site conditions
Common:
fatigue
1 With the exception of angioedema and anaemia (see footnote 2), all adverse reactions were identified from clinical studies of emtricitabine+tenofovir alafenamide containing products. The frequencies were derived from Phase 3 Biktarvy clinical studies in treatment-naïve patients through 48 weeks (GS-US-380-1489 and GS-US-380-1490)
2 This adverse reaction was not observed in the clinical studies of emtricitabine+tenofovir alafenamide containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
3 This adverse reaction was identified through post-marketing surveillance for emtricitabine but was not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies of emtricitabine. The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n=1563).
Description of selected adverse reactions
Metabolic parameters
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Immune Reactivation Syndrome
In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Osteonecrosis
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. The frequency of this i |
