Efficacy of generic sofosbuvir with daclatasvir compared to sofosbuvir/ledipasvir in genotype 4 hepatitis C virus: A prospective comparison with historical control.

Background and Aim: Management of genotype 4 hepatitis C virus (HCV) has shifted to interferon-free regimens with a high sustained virological response (SVR-12), especially with NS5B/NS5A inhibitor combinations such as sofosbuvir and ledipasvir (Sof-Led). The guidelines have recommended the combination of sofosbuvir and another NS5A inhibitor, daclatasvir, to manage HCV genotypes 1-3. However, its use was extended to genotype 4 HCV based on extrapolating evidence. Our aim is to assess the efficacy of generic sofosbuvir + branded daclatasvir (Sof-Dac) compared to the Sof-Led combination in treating genotype 4 HCV. Methods: This study is an open-label, 2-period, noninferiority study that compared patients receiving a combination of generic sofosbuvir 400 mg and daclatasvir 60 mg orally daily (Group 2) prospectively to a historical control (Group 1) that included patients who received a combination of sofosbuvir/ledipasvir 400/90 mg orally daily. The primary endpoint is the proportion of patients who achieved SVR-12. Results: The study included 111 patients in the (Sof-Led) Group 1 and 109 patients (Sof-Dac) Group 2. For the primary outcome, SVR-12 was achieved in 106 (95.5%) of the patients in Group 1 versus 108 (99.1%) in Group 2 (p = 0.2). In addition, all patients who achieved SVR-12 also achieved SVR-24. Conclusion: Generic sofosbuvir combined with branded daclatasvir was safe and effective for treating genotype 4 HCV compared to Sof-Led. This combination may significantly reduce the cost burden, enabling a larger pool of treated patients. Office of research affairs at KFSHRC RAC# 2171 036.

Comorbidities in Clinical and Polysomnographic Features of Obstructive Sleep Apnea: A Single Tertiary Care Center Experience.

BACKGROUND: Research on obstructive sleep apnea (OSA) is inadequate in Saudi Arabia, particularly among patients with comorbidities. This study investigates comorbidities in patients with different severity of apnea based on the Apnea-Hypopnea Index (AHI). METHODS: The retrospective charts review that included a cohort of 4391 patients who underwent polysomnography (PSG) between 2003 and 2019. The AHI is classified into four ordinal groups: normal, mild, moderate, and severe. Ordinal logistic regression was used to model proportional odds of a higher AHI category. RESULTS: Gender was distributed equally in the study sample. The average age was 49.6 ± 14.8 years and the average AHI was 16.1 ± 22 per hour. Hypertension (43.2%) and diabetes mellitus (37.3%) were the most common comorbidities: Mild OSA 28.9%, Moderate OSA 15.6%, and severe 16.4%. The severity of apnea increased with age and BMI classes. The prevalence of hypertension increased with the severity of apnea: 42.9% in mild, 47.4% in moderate, and 54.6% in severe AHI. The prevalence of coronary artery disease (CAD), congestive heart failure (CHF), and diabetes mellitus (DM) increased with the severity of apnea. Comorbidities was more among OSA patients with excessive sleepiness. After adjustment for age and gender, greater proportional odds of severe AHI were observed in males (aOR = 1.8), 30-59 years (aOR = 2.064), 60 years or above (aOR = 2.873), obese class II (aOR = 2.016), obese class III (aOR = 2.527), and in patients with hypertension (aOR = 1.272). CONCLUSION: Hypertension and obesity were highly prevalent in the study cohort and were associated with greater proportional odds of severe AHI.