Annual vaccination in the US against influenza A and B viruses is recommended for everyone ≥6 months old without a contraindication. Influenza vaccines available in the US for the 2024-2025 season are listed in Table 2.

The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.

Entecavir (Baraclude - Bristol-Myers Squibb), a nucleoside analog, has been approved by the FDA for treatment of adults with active chronic hepatitis B virus (HBV) infection.

The FDA has approved Mavyret (Abbvie) and Vosevi (Gilead), two new fixed-dose combinations of direct-acting antiviral (DAA) drugs, for treatment of chronic hepatitis C virus (HCV) infection caused by any of the six major HCV genotypes in patients without cirrhosis or with compensated cirrhosis. Both are approved for use in treatment-experienced patients. Mavyret is also approved for treatment-naive patients.

The FDA has approved the nucleotide polymerase inhibitor sofosbuvir (Sovaldi – Gilead) for use in combination with other antiviral drugs for treatment of chronic hepatitis C virus (HCV) infection.

The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.

Truvada (Gilead), an oral fixed-dose combination of the antiretrovirals emtricitabine and tenofovir disoproxil fumarate frequently used for treatment of HIV infection,1 has now also been approved by the FDA for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk. It is the first drug to be approved for this indication. The CDC has been recommending Truvada off-label for pre-exposure prophylaxis in men who have sex with men since 2011.2 A 30-day supply of Truvada costs about $1160.3CLINICAL STUDIES — Approval for the new indication was based on 2...

Harvoni, a once-daily fixed-dose combination of the direct-acting antiviral agents ledipasvir and sofosbuvir approved by the FDA in 2014 for treatment of hepatitis C virus (HCV) genotype 1 infection,1 has now been approved for use in patients infected with HCV genotype 4, 5, or 6, and in patients co-infected with HCV and HIV-1. A 12-week course of treatment with Harvoni plus ribavirin has also been approved as an alternative to 24 weeks of Harvoni alone for treatment-experienced, cirrhotic patients with HCV genotype 1 infection.HCV genotypes 4, 5, and 6 are responsible for <2% of HCV cases...

The FDA has approved letermovir (Prevymis – Merck), a cytomegalovirus (CMV) DNA terminase complex inhibitor, for prophylaxis of CMV infection and disease in CMV-seropositive adult recipients of an allogeneic hematopoietic cell transplant (HCT). Letermovir is the first CMV DNA terminase complex inhibitor to be approved in the US and the only drug specifically indicated for CMV prophylaxis in HCT patients. It is not approved for treatment of CMV infection.

Interferon β-1b (Betaseron - Berlex), an analog of human interferon β pro-duced in E. coli, may soon be approved by the US Food and Drug Administration for treatment of relapsing-remitting multiple sclerosis (MS), the most common form of the disease (G Mitchell, Med Clin North Am, 77:231, 1993).