Mavyret approved for pediatric HCV patients
A fixed combination of glecaprevir and pibrentasvir (Mavyret) is now approved for the treatment of all six genotypes of hepatitis C virus (HCV) infection in children ages 12 to 17 or weighing at least 99.2 lb (45 kg). Glecaprevir and pibrentasvir, an HCV NS3/4A protease inhibitor, was previously approved for adults with HCV and is a product of AbbVie.
Glecaprevir and pibrentasvir is a once-daily treatment that acts by targeting and inhibiting proteins required for HCV replication. No dosage adjustment is needed for pediatric patients 12 years of age or older or weighing 99.2 lb (45 kg) or more.
Glecaprevir and pibrentasvir is now indicated for adult and pediatric patients age 12 or older, weighing 99.2 lb (45 kg) or more, with chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); the treatment is also indicated for adult and pediatric patients age 12 or older or weighing 99.2 lb (45 kg) or more with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
The prescribing information for glecaprevir and pibrentasvir has a boxed warning for the risk of hepatitis B virus (HBV) reactivation in patients who are coinfected with HCV infection and HBV infection. Patients must be tested for evidence of a current or prior HBV infection before starting glecaprevir and pibrentasvir.
Boxed warning added to insomnia medications
The FDA added a boxed warning to the labeling and medication guides for several common prescription insomnia medications because of complex sleep behaviors associated with these medications, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These behaviors have resulted in deaths and appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription sleep medications.
Sixty-six cases of complex sleep behaviors have occurred with these medications over the past 26 years, including accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures (leading to the loss of a limb), carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries (for example, gunshot wounds and apparent suicide attempts). Patients usually did not remember the events.
A contraindication is being added to labeling to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem. Providers should not prescribe these drugs to patients who have previously experienced complex sleep behaviors after taking any of these medications. Patients should be advised that although rare, the behaviors caused by these medications have led to serious injuries or death. Patients who have experienced an episode of complex sleep behavior should stop taking these medications.
Gilead Sciences donating free Truvada for PrEP to support US initiative to end HIV epidemic
Gilead Sciences will donate over 2 million bottles of Truvada (a two-drug combination tablet of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for preexposure prophylaxis (PrEP) annually to the CDC to support its efforts to help prevent HIV and end the HIV epidemic. Truvada is indicated in combination with safer sex practices for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk adults and adolescents who are HIV-negative and weigh 77.1 lb (35 kg) or more.
The annual donation will provide the CDC with up to 2.4 million bottles of Truvada for uninsured individuals in the US at risk for HIV. The donation extends up to 2030 and will transition to Descovy (a two-drug fixed-dose combination of emtricitabine 200 mg and tenofovir alafenamide 25 mg) if Descovy receives FDA approval for use as PrEP.