Two Indian generic drug manufacturing companies announced they would begin producing generic daclatasvir and ledipasvir. (Photo: Manjunath Kiran/AFP)
In December, Natco Pharma Limited and Hetero, two of India’s largest generic drug manufacturing companies, announced that they had received approval to begin manufacturing low-cost, generic versions of daclatasvir and ledipasvir, two new direct-acting antiretroviral (DAA) treatments for hepatitis C virus (HCV). The drugs, when taken in combination with the DAA sofosbuvir and/or other treatments, have cure rates as high as 98%—the highest of any approved HCV treatment to date. In addition, both are highly effective in treating multiple HCV genotypes, and the generic versions are expected to be less expensive than previously available treatments. Their release will begin the process of improving treatment access for the approximately 170 million people currently living with the virus globally, including five million people living with HIV.
“The majority of individuals living with HCV live in low- and middle-income countries where the patented, brand-name versions of DAAs are not affordable or accessible,” said Giten Khwairakpam, TREAT Asia’s project manager for community and policy. “This approval will allow medicines that are pan-genotypic in nature to be available at a much lower cost. This has the potential to save millions of lives if we can get the drugs into the hands of patients.”
In the fall of 2015, TREAT Asia and other regional health advocacy organizations sent a letter to India’s drug regulatory authorities requesting that they waive the requirement that local clinical trials of generic daclatasvir and ledipasvir occur before approval—a process that would have substantially delayed the release of the generic drugs. In November, the committee officially did so, facilitating the December announcement.
Sofosbuvir became the first DAA to receive approval by the U.S. Food and Drug Administration in December 2013, but had an initial price tag of $84,000 for a 12-week course. Since then, global HIV and health advocates have played a critical role in driving down the price of DAAs in lower-income countries. In December 2014, Indian pharmaceutical companies began manufacturing generic sofosbuvir, and today they are selling a 12-week course of the drug for approximately $900. Generic daclatasvir is expected to sell for approximately $276 for a 12-week course (or $1,188 in combination with sofosbuvir), and a pill containing both ledipasvir and sofosbuvir (brand name Harvoni®) is expected to sell for approximately $1,107.
However, while the availability of generic sofosbuvir has begun to slowly increase the low rate of HCV treatment access in the Asia-Pacific region, barriers remain in many countries. While the generic prices represent a drastic reduction relative to the cost in high-income Western countries, they are still far above what many low-income countries can afford on a large scale. And in other countries, patent and trade regulations have prevented import and/or slowed the process of registering the drug. But national and regional advocates are working to overcome these obstacles with increasing success. “Civil society is working with the pharmaceutical industry and national governments to allow for import and faster registration of these drugs, while also keeping the price negotiations going,” says Khwairakpam.
In Indonesia, for example, delays have held up the process of registering sofosbuvir, but one large state hospital and a state-owned pharmaceutical company have imported limited amounts of the drug using a special import license. Advocates have also succeeded in importing small quantities using buyers’ clubs. Aditya Wardhana, executive director of the Indonesia AIDS Coalition, reports that the country plans to use similar mechanisms to import the newer drugs from India. “We’ve also heard that these important medications will be covered by our national health scheme once the registration process goes through,” he says. “So it is very important that treatment activists continue to demand transparency, so we can ensure this process runs on track.”