Antibiotic Approvals in the Last Decade: Are We Keeping Up With Resistance?

OBJECTIVE: To review the spectrum of activity, efficacy, safety, and role in therapy of all antibiotics and related biologics approved by the Food and Drug Administration (FDA) in the last decade. DATA SOURCES: A literature search was performed using PubMed and Google Scholar (2010 to end May 2021) with the search terms' name of the antibiotic or the biologic. Data were also obtained from the prescribing information, FDA, and ClinicalTrials.gov websites. STUDY SELECTION: All relevant English-language, late phase clinical trials assessing the safety and efficacy of the identified drugs were included. Review articles and references of retrieved articles were evaluated for relevant data. DATA SYNTHESIS: Antibiotic resistance is a public health crisis, and antibiotic development is imperative to outpace the ability of bacteria to develop resistance. Only 17 new systemic antibiotics and 1 related biologic have been approved by the FDA since 2010. Among these drugs, 14 were approved for common bacterial infections, 1 was approved for Clostridioides difficile infection (CDI), 1 was licensed to prevent CDI recurrence, and 2 were approved for drug-resistant tuberculosis. Very few antibiotics are in clinical development. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: The arrival of these new antibiotics was welcomed with great enthusiasm, particularly when they met previously unmet medical needs. Unfortunately, the majority of them represent modifications to existing chemical structures rather than new drug classes. Despite the availability of these antibiotics, managing patients with deep-seated infections and those with extensively resistant gram-negative organisms remains challenging. CONCLUSIONS: The number of new antibiotics and their indications are not keeping up with resistance and the needs of the patients.

Management of Hepatitis C in the Older Adult.

OBJECTIVE: To provide a review of the epidemiology, clinical presentation, screening, diagnosis, treatment, and prevention of hepatitis C with an emphasis on older adults. DATA SOURCES: PubMed and Google Scholar were searched for relevant literature using a combination of the following terms: hepatitis C, epidemiology, hepatitis C virus (HCV), diagnosis, treatment, direct-acting antivirals (DAAs), and older adults. In addition, websites of the hepatitis C guidelines, Centers for Disease Control and Prevention (CDC), and manufacturers of DAAs were also reviewed for relevant information. (The authors reviewed the literature through May 2019. STUDY SELECTION/DATA EXTRACTION: The key resources reviewed were the CDC website, American Association for the Study of Liver Diseases/Infectious Diseases Society of America hepatitis C guidelines, prescribing information of DAAs, and pivotal clinical trials of DAAs. DATA SYNTHESIS: Hepatitis C disproportionately affects baby boomers and people who inject drugs (PWID). CDC recommends screening adults born from 1945 to 1965 and high-risk patients for the presence of hepatitis C antibody. The goal of therapy is to achieve sustained virologic response, defined as undetectable HCV ribonucleic acid 12 weeks after treatment completion. Treatment for those who are treatment-naive with or without compensated cirrhosis consists of administration of DAAs orally for 8 to 12 weeks. Regimen selection depends on HCV genotype, presence or absence of cirrhosis, comorbid conditions, and concurrent medications. Currently recommended DAAs are highly effective, well tolerated, and can be associated with significant drug interactions particularly in older adults. Access to DAAs remains an obstacle for many patients. CONCLUSION: Hepatitis C is common among baby boomers and PWID. Screening is recommended in these patient populations. Treatment with DAAs is curative and well tolerated.