“We are pleased to provide new therapeutic options for younger patients living with HIV and chronic hepatitis B and will work to make these pediatric formulations available as quickly as possible,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.
The new indications are supported by clinical data from three studies examining the use of Viread among children and adolescents with HIV and among adolescents with chronic HBV. The safety and efficacy of Viread has not been established in children less than 2 years of age for HIV treatment, or in children less than 12 years of age for the treatment of chronic HBV.
In an effort to accelerate the availability of pediatric formulations in low-income countries, where the majority of children with HIV live, Gilead has established incentives to encourage its Indian generic manufacturing partners to develop pediatric formulations of its HIV treatments. Through these partnerships, Gilead already makes Viread available at significantly reduced cost for adults living with HIV and chronic HBV in low-income countries.
EU Important Safety Product Information About Viread, Including Boxed Warnings
- Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues, including tenofovir disoproxil fumarate. Lactic acidosis has a high mortality and patients at increased risk should be followed closely.
- A multidisciplinary approach is recommended for the management of children and adolescents to weigh on a case-by-case basis the benefit-risk balance of treatment.
- Rare events of renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate.
- It is recommended that creatinine clearance is calculated in all adult patients prior to initiation therapy with Viread and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year and the very three months. In patients at risk for renal impairment, more frequent monitoring should be considered. In children and adolescents, renal function (creatinine clearance and serum phosphate) should be evaluated prior to treatment and monitored during treatment as in adults.
- If renal abnormalities are detected or suspected in children and adolescents, consultation with a nephrologist should be obtained to consider interruption of Viread treatment.
- Use of Viread should be avoided with concurrent or recent use of nephrotoxic medications. If concomitant use of Viread and nephrotoxic agents is unavoidable, renal function must be monitored weekly.
- Dose interval adjustment is recommended in adult patients with moderate renal impairment (creatinine clearance 30-49 mL/min).
- Viread is not recommended in adult patients with severe renal impairment (creatinine clearance < 30 mL/min). If no alternative treatment is available, prolonged dose intervals may be used.
- Viread is not recommended for use in children and adolescents with renal impairment.
- Bone abnormalities (infrequently leading to fractures) may be associated with proximal renal tubulopathy and appropriate consultation should be obtained if suspected.
- Viread may cause a reduction in bone mineral density (BMD) and the effects of Viread associated changes in BMD on long term bone health and future fracture risk are currently unknown in children and adolescents. If bone abnormalities are detected or suspected in children and adolescents, consultation with an endocrinologist and /or nephrologist should be obtained.
- Immune reconstitution syndrome has been reported in patients treated with combination therapy, including Viread.
- Redistribution and/or accumulation of body fat have been observed in patients taking anti-HIV medicines. The cause and long-term effect of these conditions are unknown.