Background In 2015, the development of well tolerated and highly effective direct acting antivirals (DAAs) for hepatitis C virus (HCV) dramatically changed the therapeutic landscape. However, data are lacking on the effectiveness and safety of these combinations in patients coinfected with human immunodeficiency virus type 1(HIV-1).
Purpose To provide preliminary data on the effectiveness and safety of DAAs for the treatment of hepatitis C infection in a HIV/HCV coinfected population, under routine clinical practice.
Material and methods Design: observational, descriptive, prospective study.
Inclusion criteria: coinfected patients who had finished their treatment with DAAs before 9 October 2015.
Variables: demographic and baseline clinical data; HCV genotype; sex; prior response to HCV treatment; grade of fibrosis; presence or absence of decompensated cirrhosis; blood count; ALT; and AST.
Effectiveness analysis: viral Load (VL) at the end of treatment or sustained virologic response at week 12 if available.
Safety analysis: adverse drug events (ADEs), including laboratory abnormalities.
Results Of the 95 patients enrolled, 72.6% had genotype 1 infection, 14.7% genotype 4 and 12.6% genotype 3. Overall, 70.5% were men, 54.7% had been previously treated for HCV and 65.3% had cirrhosis. 15 (15.8%) patients had developed decompensated cirrhosis.
The most frequent treatments were: sofosbuvir/ledipasvir (41.0%), ombitasvir/paritaprevir/ritonavir and dasabuvir (20.0%) and sofosbuvir and daclatasir (20.0%). Ribavirin was part of the treatment in 51.6% of cases. Duration of treatment was 12 weeks in 56.8% of cases.
At the end of treatment, no patient had confirmed HIV-1 virologic rebound. Undetectable HCV VL was achieved in 80/83 patients (2 patients died during treatment because of other causes and 1 patient decided to stop treatment). Serum transaminases were normalised in 79.6% of patients, and 7/8 patients achieved SVR (no data for SVR still available for the remaining patients).
No patient discontinued treatment because of ADEs. Only 3 ADEs of grade III were identified (insomnia in 2 patients treated with sofosbuvir and daclatasvir and in 1 patient treated with sofosbuvir/ledipasvir). Common ADEs of grade I-II identified were: headache (30.5%), fatigue (28.4%), anaemia (17.9%) prurito (17.9%), insomnia (16.8%), dry skin (15.8%), irritability (14.7%), decreased appetite (14.7%) and nausea (11.6%).
Conclusion Preliminary data corroborate the high effectiveness and good safety profile of DAA regimens in HIV/HCV coinfected populations.
References and/or Acknowledgements
Rev Esp Quimioter 2015;28(Suppl 1):4851
References and/or AcknowledgementsNo conflict of interest.
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