The FDA has approved daclatasvir (Daklinza – BMS), an oral direct-acting antiviral drug, for use with sofosbuvir (Sovaldi) for treatment of chronic hepatitis C virus (HCV) genotype 3 infection. Daclatasvir is the first drug approved for this indication that does not require the addition of interferon or ribavirin. It is approved in Japan and Europe in combination with other drugs for treatment of HCV genotypes 1-4.

The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the...

The FDA has approved tenofovir alafenamide (Vemlidy – Gilead) for treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. It is the first single-drug product containing tenofovir alafenamide (TAF), a prodrug of the nucleotide reverse transcriptase inhibitor tenofovir, to become available; several combination products containing TAF are approved for treatment of HIV-1 infection. Tenofovir disoproxil fumarate (TDF; Viread – Gilead), another tenofovir prodrug, has been used for many years for treatment of chronic HBV infection; a generic...

Famciclovir (Famvir - SmithKline Beecham) is now available in the USA for oral treatment of acute uncomplicated herpes zoster (shingles). The manufacturer claims that use of the drug reduces the duration of postherpetic neuralgia. Famciclovir is similar to acyclovir (Zovirax - Burroughs Wellcome), which has been the drug of choice for treatment of varicella-zoster and herpes simplex virus infections (Medical Letter, 36:27, 1994).

The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US. Sofosbuvir (Sovaldi) was approved earlier for use in combination with other antiviral drugs for treatment of HCV infection. Ledipasvir is a new drug.

Maribavir (Livtencity – Takeda), an oral cytomegalovirus (CMV) pUL97 kinase inhibitor, has been approved by the FDA for treatment of post-transplant CMV infection refractory to standard antiviral therapy in patients ≥12 years old who weigh at least 35 kg.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupilumab is the first biologic drug to be approved in the US for this indication. It has been available for years for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.

On July 12, 2021, the FDA added a warning to the Fact Sheet for the Johnson & Johnson (Janssen) adenovirus-based COVID-19 vaccine about an increased risk of Guillain-Barré syndrome (GBS) following administration of the product.

Lopinavir/ritonavir is the first fixed-dose combination of protease inhibitors approved by the FDA for the treatment of HIV infection. It is being marketed for use with other drugs in adults and children more than six months old. Lopinavir is a new drug available only in this combination. Ritonavir is often used with other protease inhibitors to raise their plasma concentrations.

Etravirine (Intelence - Tibotec), a new non-nucleoside reverse transcriptase inhibitor (NNRTI), has received fast-track FDA approval for use in combination therapy in treatment-experienced adults who have HIV-1 infection resistant to an NNRTI and other antiretroviral agents.