Shortly after announcing promising phase II data on its hepatitis C virus (HCV) regimen, Abbott Labs ( ABT - Analyst Report ) outlined its plans for the late-stage development of the regimen.

Abbott Labs is investigating a regimen consisting of three direct acting antivirals (DAA), with and without ribavirin, for the treatment of HCV in genotype 1 (GT1) non-cirrhotic, treatment-naïve as well as treatment-experienced patients. The DAAs that will be evaluated in the study are ABT-450/r (protease inhibitor and ritonavir), ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor).

Phase III studies will be conducted to evaluate the safety and efficacy of the 12-week regimen in the above-mentioned patient population. Abbott Labs plans to conduct another phase III study which will study the DAAs plus ribavirin in patients with cirrhosis for 12 or 24 weeks.

The phase III program will involve more than 2,000 patients. While the duration of treatment will be 12 weeks for non-cirrhotic patients, cirrhotic patients receive treatment for 12 or 24 weeks. Post-treatment follow-up period will be 48 weeks for all the patients.

Top-line intent-to-treat results from the phase IIb AVIATOR study showed that 97.5% of treatment-naïve GT1 patients and 93.3% in GT1 null responder patients achieved SVR12. These results were presented at the recently held annual meeting of the American Association for the Study of Liver Disease (AASLD).

The HCV market represents huge commercial potential. It is estimated that about 170 million people suffer from HCV infection across the world. However, a huge number of HCV patients go untreated leaving the field open for new treatments.

Besides Abbott Labs, companies like Gilead ( GILD - Analyst Report ) are trying to develop the next crop of drugs, which are expected to change the treatment paradigm for HCV patients by providing them with all-oral treatment regimens. The development of a treatment which does not require the administration of interferon, thereby doing away with a whole range of side effects, would be a major boon for patients and would find several takers. The treatment duration will also be shorter.

Treatments being developed include HCV polymerase inhibitors and HCV NS5A inhibitors. The future HCV market will most likely consist of cocktail treatment regimens developed by combining different oral treatments.

We currently have a Neutral recommendation on Abbott Labs, which carries a Zacks #3 Rank (short-term ‘Hold’ rating). Abbott Labs remains on track to split into two separate publicly traded companies on January 1, 2013. While one company will deal in diversified medical products, the other (AbbVie) will focus on research-based pharmaceuticals.

We are positive on the split which should allow the two separate entities to perform in a more focused manner. Moreover, with Humira continuing to perform well, concerns regarding AbbVie’s growth prospects should abate. The company’s pipeline is also moving along. The successful development of the interferon-free HCV regimen would be a major boost for the stock.