Abstract
INTRODUCTION
More than half of the intravenous drug users (IDUs) are infected with hepatitis C infection (HCV) in Turkey and there has been a trend to increase in the numbers of IDUs. Direct-acting antivirals (DAAs) have been recently reimbursed for HCV treatment. We analyzed for the efficiency and safety of DAAs for Turkish IDUs.
METHODS
From 37 centers, 18 years old and above patients planned DAA treatment between April 2017 and September 2018 were enrolled into the study.
RESULTS
Among the 2230 patients, the way of transmission was unknown in 1754 and among the remaining 476, 169 (7.8% of all) were IDUs (159, 94.1% male, mean age 31±10 years). Genotypes were G3: 80 (47.6%), G1: 54 (32.1%), G2: 17 (10.1%), G4: 16 (9.5%), and G5: 1 (0.6%). Among G1, 54 were subgenotyped: 30 (55.6%) were G1a and 24 (44.6%) were G1b. Eight (4.8%) patients were cirrhotic; 7 Child-Pugh A, 1 Child-Pugh B–C. In 92 (48%), a liver biopsy was available: mean histologic activity index (HAI) was 7.5 and fibrosis score was 2.4. HAI was mild (1–6) in 35.9%, moderate (7–12) in 60.8%, and severe (13–14) in 3.3%. Fibrosis was mild in 54.4%, moderate in 43.3%, and advanced in 2.3%. 19(11.8%) patients were treatment–experienced (relapse 14, non-responder 5): pegylated-interferon+ribavirin (PR) in 16 (84.2%), PR+Boceprevir in 2 (10.5%), and PR+Telaprevir in 1 (%5.3). Viral response rates at treatment week 4, at the end of treatment and at SVR12 were 87% (47/54), 98.7% (76/77), and 98.6% (71/72) respectively. At SVR12 mean ALT 18 IU/mL, AST 21 IU/mL, albumin 4.2 g/dL, and prothrombin time 12.4 sec. DAAs were generally well tolerated. On treatment; 11 patients (6.5%) experienced adverse events: insomnia 5 (3.0%), asthenia 4 (2.4%), pruritus 3 (1.8%), headache 2 (1.2%), weight gain 2 (1.2%), and miscellaneous 5 (3.0%).
CONCLUSION
Compared to all of the other patients in the database, IDUs were younger (58±12 years vs. 31±10 years, p<0.001) and the rate of male/female was higher (950 male-42.6%/1111 female-57.4% vs.159 male-%94.1/10 female-5.9%, p<0.001). Cirrhosis frequency was lower (303/2061; 14.7% vs.8/169; 4.8%, p<0.05). The majority of genotypes among other patients G1 is 92% and G2 plus G3 are 8%. However among IDUS, rate of G3 is 47.6%, G1: 32.1%, and G2: 10.1%. IDUs with HCV were shown to younger, higher rate of male gender, and with less severe liver disease. DAAs were found efficacious and safe in this group.
Keywords: HCV, IDU, SVR12
Table 1.
| Drugs | n | % |
|---|---|---|
| Sofosbuvir + Ribavirin | 89 | 59.4 |
| Ledipasvir + Sofosbuvir | 23 | 14.2 |
| Paritaprevir + Ritonavir + Ombitasvir + Dasabuvir + Ribavirin | 21 | 13 |
| Paritaprevir + Ritonavir + Ombitasvir + Ribavirin | 12 | 7.4 |
| Paritaprevir + Ritonavir + Ombitasvir + Dasabuvir | 11 | 6.8 |
| Ledipasvir + Sofosbuvir + Ribavirin | 6 | 3.7 |
Direct acting antivirals used in HCV patients using intravenous drug
Footnotes
This study was supported by Gilead Sciences, was not involved to the content of the study/publication; no involvement to the decision to submit for publication.