The current choice for treating hepatitis C in HIV patients is the combination of sofosbuvir and daclatasvir. Other combinations have multiple interactions with frequently used anti-retroviral therapy (ART) drugs and are frequently contraindicated. Even daclatasvir should be used at an increased dose of 90 mg instead of 60 mg to compensate for accelerated metabolism in interaction with efavirenz which is commonly used in ART. In this study we have used a single tablet approach to treating such patients and have evaluated the response.

90mg daclatasvir and 400mg sofosbuvir were co-formulated into a fixed-dose combination (FDC) tablet (Sovodak 90/400, Rojan Pharma, Tehran, Iran). HIV patients from 9 centers were treated for 12 wks with a single daily pill according to existing guidelines. Patients with cirrhosis were treated for 24 weeks. Response to treatment was evaluated 12 weeks after end of treatment (SVR12). ClinicalTrials.gov ID: NCT03369327.

By the time of this report 136 patients had finished the follow-up period. 46% were genotype 1 and 45% genotype 3. 16% had cirrhosis and 12% were treatment experienced. 131 patients achieved SVR12 (96.3%). One patient died during treatment due to sepsis and decompensated cirrhosis. Four patients did not achieve SVR12. No significant adverse events were reported.

The FDC of 90mg daclatasvir and 400mg sofosbuvir which is only available in Iran is an effective and safe treatment for patients coinfected with HIV and hepatitis C. The combination works well in patients on efavirenz in which dose adjustment is required. Patients with cirrhosis, previous treatment failure, and various genotypes respond identically.