title: Telbivudine plus tenofovir in combination therapy in patients with chronic hepatitis B infection--an Indian experience.
abstract: OBJECTIVE
  To investigate the efficacy and safety ofTelbivudine +Tenofovir combination therapy in chronic hepatitis B patients, over a period of 52 weeks, in real life clinical settings.
  
  
  METHODS
  HBeAg-positive and HBeAg-negative adult CHB patients, with hepatitis B virus (HBV) DNA > 4 log10 copies/ml and ALT 1.2 times above upper limit of normal (> 30 IU/L) were started on a combination of Telbivudine 600 mg + Tenofovir 300 mg in a real life clinical setting. The reduction in serum HBV DNA levels from baseline was evaluated at Week 24 and 52. The HBV DNA was measured using the PCR test with a lower limit of detection of 100 IU/ml
  
  
  RESULTS
  21 (2 female/19 male) patients, with mean (SD) age of 46.2 (13.2), were prescribed this regimen. 70% of them were HBeAg negative at baseline. Data of 11 out of 21 patients was available at week 52. The mean HBA-DNA reduction from baseline to week 24 (n = 15) was 2.6 log10 copies/mL (p = .000) and 4.0 log10 copies/mL (p = .001) at week 52 (n = 11). By the end of study visit at week 52, 10 out of 11 patients had achieved the HBV-DNA levels of < 100 lu/ml. The mean ALT levels came down by 101.4 IU/L (p = .005) at week 24 (n = 15) and by 104.6 IU/L at week 52 (n = 11). 7 patients achieved ALT normalisation (ALT < 40 IU/L) at week 24, with additional 4 achieving the goals at week 52. Combination therapy was well tolerated, with no safety related concerns. No cases of virological breakthrough or primary treatment failure were observed. Being a real life setting, there were certain limitations: Out of 10 patients whose data was not available at 52 weeks, 5 patients were lost to follow-up; another 2 coming from far off remote areas were unable to report for follow-up every 3 months. 1 patient who was on chemotherapy expired due to progression of the malignancy, another patient with decompensated liver disease expired due to disease progression. Yet another patient was a pregnant lady on therapy who stopped treatment post partum to breast feed the baby.
  
  
  CONCLUSIONS
  Chronic hepatitis B patients treated with Telbivudine + Tenofovir combination exhibited significant virologic and biochemical responses, over the period of 1 year. However, the mean decline in HBV DNA over 1 year with combination therapy was not higher than that seen with monotherapy.
authors: Chittaranjan
authors: C
authors: Panda
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D000077712:Telbivudine; D000068698:Tenofovir; D013936:Thymidine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D063065:Organophosphonates; D000077712:Telbivudine; D000068698:Tenofovir; D000410:Alanine Transaminase; D000225:Adenine; D013936:Thymidine