SAN FRANCISCO, CA—Among patients with HIV and hepatitis C virus (HCV) co-infection, daclatasvir and sofosbuvir (DCV + SOF) is associated with a superior 12-week sustained virologic response (SVR12) rate compared to sofosbuvir and ribavirin (SOF + R), according to a systematic review of clinical trial data, reported at the The Liver Meeting® 2015.
“After adjustment for cross-trial differences in baseline characteristics, DCV + SOF was associated with a significantly higher week 12 post-treatment SVR12 rate and with similar or lower rates of AEs than SOF + R in HIV/HCV co-infected patients,” reported lead study author and Elyse Swallow, MA, of the Health Economics and Outcomes Research Analysis Group, Inc., in Boston, MA, and colleagues at Bristol-Myers Squibb in Princeton, NJ.
The team conducted a systematic literature review of Phase 3 clinical trials “suitable for comparison with the trial of DCV+ SOF in HIV/HCV co-infected patients (ALLY-2),” Swallow reported. They identified two such trials (PHOTON-1 and PHOTON-2), from which data was pooled with ALLY-2 data for analysis.
“When multiple durations of SOF + R were assessed for the same genotype, only the arm with the FDA/EMA [US Food and Drug Administration/European Medicines Agency]-approved duration was included in the present analysis,” they reported. “Patients enrolled in ALLY-2 were subject to the inclusion and exclusion criteria reported in the PHOTON trials.”
To adjust for baseline differences between the trials, ALLY-2 patients were statistically weighted “to match all available summary baseline characteristics reported in both the ALLY-2 and PHOTON trials,” Swallow reported. These factors included patient age, sex, body mass index (BMI), race and ethnicity, treatment-naïve status, viral genotypes, HCV RNA level, IL28B genotype, cirrhosis status, CD4 T-cell count and combination antiretroviral therapy (cART) regimens, she explained.
Sustained virologic response at SVR12, discontinuation due to adverse events (AEs), and rates of specific AEs reported for both SOF + R trials were compared between the treatments.
“Ninety-one of 153 patients from ALLY-2 who were treated with 12 weeks of DCV + SOF met the inclusion criteria of the PHOTON trials and were included in the analysis,” Swallow reported. “Forty-two of the 497 patients from the PHOTON trials who were treatment-naïve, genotype 3, and treated with 12 rather than 24 weeks of SOF + R were excluded.”
The SVR12 rate was “significantly higher among patients treated with DCV + SOF than those treated with SOF + R both before (96.7% vs. 84.6%; P=0.002) and after (99.99% vs. 84.6%; P<0.001),” Swallow reported.
Lower rates of discontinuation due to AEs and other specific AEs (eg, cough diarrhea, insomnia, nasopharyngitis, others) were seen in patients receiving DCV + SOF after adjustment. She noted that “there were longer significant differences in the rates of any AE or irritability.”